Vitamin D3 supplementation increases spine bone mineral density in adolescents and young adults with HIV infection being treated with tenofovir disoproxil fumarate: a randomized, placebo controlled trial

USDA-ARS?s Scientific Manuscript database

Background: Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized vitamin D3 (VITD3) would increase BMD in adolescents/young adults receiving TDF. Methods: Randomized double-blind placebo-controlled trial of directly observed VITD3 50,000 IU vs. placebo every 4 ...

An Evaluation of the Implementation of Hand Held Health Records with Adults with Learning Disabilities: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Turk, Vicky; Burchell, Sarah; Burrha, Sukhjinder; Corney, Roslyn; Elliott, Sandra; Kerry, Sally; Molloy, Catherine; Painter, Kerry

2010-01-01

Background: Personal health records were implemented with adults with learning disabilities (AWLD) to try to improve their health-care. Materials and Method: Forty GP practices were randomized to the Personal Health Profile (PHP) implementation or control group. Two hundred and one AWLD were interviewed at baseline and 163 followed up after 12…

The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial.

PubMed

Alyousif, Zainab; Miller, Jennifer L; Sandoval, Mariana Y; MacPherson, Chad W; Nagulesapillai, Varuni; Dahl, Wendy J

2018-04-27

Constipation is a frequent problem in adults with Prader-Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Adults with Prader-Willi syndrome (18-75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses. To our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader-Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation. ClinicalTrials.gov ( NCT03277157 ). Registered on 08 September 2017.

A Mixed-Methods Randomized Controlled Trial of Financial Incentives and Peer Networks to Promote Walking among Older Adults

ERIC Educational Resources Information Center

Kullgren, Jeffrey T.; Harkins, Kristin A.; Bellamy, Scarlett L.; Gonzales, Amy; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G.; Asch, David A.; Heisler, Michele; Karlawish, Jason

2014-01-01

Background: Financial incentives and peer networks could be delivered through eHealth technologies to encourage older adults to walk more. Methods: We conducted a 24-week randomized trial in which 92 older adults with a computer and Internet access received a pedometer, daily walking goals, and weekly feedback on goal achievement. Participants…

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally.

PubMed

Solomon, Todd M; Leech, Jarrett; deBros, Guy B; Murphy, Cynthia A; Budson, Andrew E; Vassey, Elizabeth A; Solomon, Paul R

2016-03-01

Alpha BRAIN® is a nootropic supplement that purports to enhance cognitive functioning in healthy adults. The goal of this study was to investigate the efficacy of this self-described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double blind, placebo-controlled design. A total of 63-treatment naïve individuals between 18 and 35 years of age completed the randomized, double-blind, placebo controlled trial. All participants completed a 2-week placebo run in before receiving active product, Alpha BRAIN® or new placebo, for 6 weeks. Participants undertook a battery of neuropsychological tests at randomization and at study completion. Primary outcome measures included a battery of neuropsychological tests and measures of sleep. Compared with placebo, Alpha BRAIN® significantly improved on tasks of delayed verbal recall and executive functioning. Results also indicated significant time-by-group interaction in delayed verbal recall for the Alpha BRAIN® group. The use of Alpha BRAIN® for 6 weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN®, and the results merit further study. Copyright © 2016 John Wiley & Sons, Ltd.

A pilot randomized controlled trial evaluating motivationally matched pedometer feedback to increase physical activity behavior in older adults.

PubMed

Strath, Scott J; Swartz, Ann M; Parker, Sarah J; Miller, Nora E; Grimm, Elizabeth K; Cashin, Susan E

2011-09-01

Increasing physical activity (PA) levels in older adults represents an important public health challenge. The purpose of this study was to evaluate the feasibility of combining individualized motivational messaging with pedometer walking step targets to increase PA in previously inactive and insufficiently active older adults. In this 12-week intervention study older adults were randomized to 1 of 4 study arms: Group 1--control; Group 2--pedometer 10,000 step goal; Group 3--pedometer step goal plus individualized motivational feedback; or Group 4--everything in Group 3 augmented with biweekly telephone feedback. 81 participants were randomized into the study, 61 participants completed the study with an average age of 63.8 ± 6.0 years. Group 1 did not differ in accumulated steps/day following the 12-week intervention compared with participants in Group 2. Participants in Groups 3 and 4 took on average 2159 (P < .001) and 2488 (P < .001) more steps/day, respectively, than those in Group 1 after the 12-week intervention. In this 12-week pilot randomized control trial, a pedometer feedback intervention partnered with individually matched motivational messaging was an effective intervention strategy to significantly increase PA behavior in previously inactive and insufficiently active older adults.

A randomized controlled trial to promote volunteering in older adults.

PubMed

Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

2014-12-01

Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.

PubMed

Chambers, Rachel; Tingey, Lauren; Beach, Anna; Barlow, Allison; Rompalo, Anne

2016-04-29

American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States. The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18-49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex. This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other rural and under-resourced health systems. Clinical Trials NCT02513225.

Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

PubMed Central

Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

2012-01-01

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Citation: Epstein DR; Sidani S; Bootzin RR; Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. SLEEP 2012;35(6):797-805. PMID:22654199

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial.

PubMed

McMurran, Mary; Day, Florence; Reilly, Joseph; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Moran, Paul; Crawford, Mike J

2017-12-01

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.

Perception of young adults with sickle cell disease or sickle cell trait about participation in the CHOICES randomized controlled trial.

PubMed

Hershberger, Patricia E; Gallo, Agatha M; Molokie, Robert; Thompson, Alexis A; Suarez, Marie L; Yao, Yingwei; Wilkie, Diana J

2016-06-01

To gain an in-depth understanding of the perceptions of young adults with sickle cell disease and sickle cell trait about parenthood and participating in the CHOICES randomized controlled trial that used computer-based, educational programmes. In the USA, there is insufficient education to assure that all young adults with sickle cell disease or sickle cell trait understand genetic inheritance risks and reproductive options to make informed reproductive decisions. To address this educational need, we developed a computer-based, multimedia program (CHOICES) and reformatted usual care into a computer-based (e-Book) program. We then conducted a two-year randomized controlled trial that included a qualitative component that would deepen understanding of young adults' perceptions of parenthood and use of computer-based, educational programmes. A qualitative descriptive approach completed after a randomized controlled trial. Sixty-eight men and women of childbearing age participated in semi-structured interviews at the completion of the randomized controlled trial from 2012-2013. Thematic content analysis guided the qualitative description. Three main themes were identified: (1) increasing knowledge and new ways of thinking and behaving; (2) rethinking parenting plans; and (3) appraising the program design and delivery. Most participants reported increased knowledge and rethinking of their parenting plans and were supportive of computer-based learning. Some participants expressed difficulty in determining individual transmission risks. Participants perceived the computer programs as beneficial to their learning. Future development of an Internet-based educational programme is warranted, with emphasis on providing tailored education or memory boosters about individual transmission risks. © 2015 John Wiley & Sons Ltd.

Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors among Remote Reservation-Dwelling American Indian Adults with Type 2 Diabetes

ERIC Educational Resources Information Center

Henderson, Jeffrey A.; Chubak, Jessica; O'Connell, Joan; Ramos, Maria C.; Jensen, Julie; Jobe, Jared B.

2012-01-01

We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes…

Effectiveness of the Self-Regulation eHealth Intervention "MyPlan1.0." on Physical Activity Levels of Recently Retired Belgian Adults: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Van Dyck, Delfien; Plaete, Jolien; Cardon, Greet; Crombez, Geert; De Bourdeaudhuij, Ilse

2016-01-01

The study purpose was to test the effectiveness of the self-regulation eHealth intervention "MyPlan1.0." to increase physical activity (PA) in recently retired Belgian adults. This study was a randomized controlled trial with three points of follow-up/modules (baseline to 1-week to 1-month follow-up). In total, 240 recently retired…

'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial.

PubMed

Gardner, Benjamin; Thuné-Boyle, Ingela; Iliffe, Steve; Fox, Kenneth R; Jefferis, Barbara J; Hamer, Mark; Tyler, Nick; Wardle, Jane

2014-09-20

Many older adults are both highly sedentary (that is, spend considerable amounts of time sitting) and physically inactive (that is, do little physical activity). This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ('tips') designed both to reduce sedentary behaviour and to increase physical activity in older adults. The intervention is based on the 'habit formation' model, which proposes that consistent repetition leads to behaviour becoming automatic, sustaining activity gains over time. The intervention is being developed iteratively, in line with Medical Research Council complex intervention guidelines. Selection of activity tips was informed by semi-structured interviews and focus groups with older adults, and input from a multidisciplinary expert panel. An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement. An exploratory randomized controlled trial will be conducted within a primary care setting, comparing the tips booklet with a control fact sheet. Retired, inactive and sedentary adults (n = 120) aged 60 to 74 years, with no physical impairments precluding light physical activity, will be recruited from general practices in north London, UK. The primary outcomes are recruitment and attrition rates. Secondary outcomes are changes in behaviour, habit, health and wellbeing over 12 weeks. Data will be used to inform study procedures for a future, larger-scale definitive randomized controlled trial. Current Controlled Trials ISRCTN47901994.

A Randomized Clinical Trial of Cognitive Enhancement Therapy for Adults with Autism Spectrum Disorders

DTIC Science & Technology

2015-10-01

This project is focused on conducting the first randomized-controlled trial of Cognitive Enhancement Therapy (CET) in 54 verbal adults with autism ...of the neuroplastic effects of CET on brain function in support of cognitive enhancement in adult autism . Analyses of treatment effects to date...the need and potential for CET to be a significant treatment advance for verbal adults with autism . Importantly, improvements were found in daily life function and in brain circuitry supporting core abilities.

Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

PubMed

Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

2017-09-15

Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study

PubMed Central

Morone, Natalia E.; Greco, Carol M.; Weiner, Debra K.

2008-01-01

The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, attention, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P = .008, P = .004) and SF-36 Physical Function (P = .03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function. PMID:17544212

Designing a Weight Gain Prevention Trial for Young Adults: The CHOICES Study

ERIC Educational Resources Information Center

Lytle, Leslie A.; Moe, Stacey G.; Nanney, M. Susie; Laska, Melissa N.; Linde, Jennifer A.; Petrich, Christine A.; Sevcik, Sarah M.

2014-01-01

Background: Young adults are at risk for weight gain. Little is known about how to design weight control programs to meet the needs of young adults and few theory-based interventions have been evaluated in a randomized control trial. The Choosing Healthy Options in College Environments and Settings (CHOICES) study was funded to create a…

A Case Control Study of Suicide and Attempted Suicide in Older Adults.

ERIC Educational Resources Information Center

Beautrais, Annette L.

2002-01-01

Risk factors for serious suicidal behavior among older adults were examined in a case control study of adults aged 55 and older who died by suicide or made suicide attempts and who were compared with randomly selected comparison subjects. Multivariate analyses suggested that mood disorders were the most significant risk factor for suicidal…

Virtual Reality Job Interview Training in Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Smith, Matthew J.; Ginger, Emily J.; Wright, Katherine; Wright, Michael A.; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale E.; Bell, Morris D.; Fleming, Michael F.

2014-01-01

The feasibility and efficacy of virtual reality job interview training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n = 16) or treatment-as-usual (TAU) (n = 10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic…

Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

ERIC Educational Resources Information Center

Dowling, S.; Hubert, J.; White, S.; Hollins, S.

2006-01-01

Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

Weight Management in Adults with Intellectual and Developmental Disabilities: A Randomized Controlled Trial of Two Dietary Approaches

ERIC Educational Resources Information Center

Ptomey, Lauren T.; Saunders, Richard R.; Saunders, Muriel; Washburn, Richard A.; Mayo, Matthew S.; Sullivan, Debra K.; Gibson, Cheryl A.; Goetz, Jeannine R.; Honas, Jeff J.; Willis, Erik A.; Danon, Jessica C.; Krebill, Ron; Donnelly, Joseph E.

2018-01-01

Background: The prevalence of obesity among individuals with intellectual and developmental disabilities (IDD) is equal to or greater than the general population. Methods: Overweight/obese adults (BMI =25 kg/m2) with mild-to-moderate intellectual and developmental disabilities were randomized to an enhanced stop light diet…

Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Bell, Chloe E.; Robbins, Steven J.

2007-01-01

Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

Revisited: A Systematic Review of Therapeutic Hypothermia for Adult Patients Following Traumatic Brain Injury.

PubMed

Watson, Hannah I; Shepherd, Andrew A; Rhodes, Jonathan K J; Andrews, Peter J D

2018-06-01

Therapeutic hypothermia has been of topical interest for many years and with the publication of two international, multicenter randomized controlled trials, the evidence base now needs updating. The aim of this systematic review of randomized controlled trials is to assess the efficacy of therapeutic hypothermia in adult traumatic brain injury focusing on mortality, poor outcomes, and new pneumonia. The following databases were searched from January 1, 2011, to January 26, 2018: Cochrane Central Register of Controlled Trial, MEDLINE, PubMed, and EMBASE. Only foreign articles published in the English language were included. Only articles that were randomized controlled trials investigating adult traumatic brain injury sustained following an acute, closed head injury were included. Two authors independently assessed at each stage. Quality was assessed using the Cochrane Collaboration's tool for assessing the risk of bias. All extracted data were combined using the Mantel-Haenszel estimator for pooled risk ratio with 95% CIs. p value of less than 0.05 was considered statistically significant. All statistical analyses were conducted using RevMan 5 (Cochrane Collaboration, Version 5.3, Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Twenty-two studies with 2,346 patients are included. Randomized controlled trials with a low risk of bias show significantly more mortality in the therapeutic hypothermia group (risk ratio, 1.37; 95% CI, 1.04-1.79; p = 0.02), whereas randomized controlled trials with a high risk of bias show the opposite with a higher mortality in the control group (risk ratio, 0.70; 95% CI, 0.60-0.82; p < 0.00001). Overall, this review is in-keeping with the conclusions published by the most recent randomized controlled trials. High-quality studies show no significant difference in mortality, poor outcomes, or new pneumonia. In addition, this review shows a place for fever control in the management of traumatic brain injury.

Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

PubMed

McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

2014-11-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

PubMed Central

McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

2014-01-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

A 12-Week Physical and Cognitive Exercise Program Can Improve Cognitive Function and Neural Efficiency in Community-Dwelling Older Adults: A Randomized Controlled Trial.

PubMed

Nishiguchi, Shu; Yamada, Minoru; Tanigawa, Takanori; Sekiyama, Kaoru; Kawagoe, Toshikazu; Suzuki, Maki; Yoshikawa, Sakiko; Abe, Nobuhito; Otsuka, Yuki; Nakai, Ryusuke; Aoyama, Tomoki; Tsuboyama, Tadao

2015-07-01

To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults. Randomized controlled trial. Kyoto, Japan. Community-dwelling older adults (N = 48) were randomized into an exercise group (n = 24) and a control group (n = 24). Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase. Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase. The outcome measures were global cognitive function, memory function, executive function, and brain activation (measured using functional magnetic resonance imaging) associated with visual short-term memory. Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group (P < .05). In addition, after the intervention, less activation was found in several brain regions associated with visual short-term memory, including the prefrontal cortex, in the exercise group (P < .001, uncorrected). A 12-week physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults, which is associated with improvements in memory and executive function. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: A small randomized controlled trial

PubMed Central

Creswell, J. David; Myers, Hector F.; Cole, Steven W.; Irwin, Michael R.

2009-01-01

Mindfulness meditation training has stress reduction benefits in various patient populations, but its effects on biological markers of HIV-1 progression are unknown. The present study tested the efficacy of an 8-week Mindfulness-based stress reduction (MBSR) meditation program compared to a 1-day control seminar on CD4+ T lymphocyte counts in stressed HIV infected adults. A single-blind randomized controlled trial was conducted with enrollment and follow-up occurring between November 2005 and December 2007. A diverse community sample of 48 HIV-1 infected adults was randomized and entered treatment in either an 8-week MBSR or a 1-day control stress reduction education seminar. The primary outcome was circulating counts of CD4+ T lymphocytes. Participants in the 1-day control seminar showed declines in CD4+ T lymphocyte counts whereas counts among participants in the 8-week MBSR program were unchanged from baseline to post-intervention (time × treatment condition interaction, p = .02). This effect was independent of antiretroviral (ARV) medication use. Additional analyses indicated that treatment adherence to the mindfulness meditation program, as measured by class attendance, mediated the effects of mindfulness meditation training on buffering CD4+ T lymphocyte declines. These findings provide an initial indication that mindfulness meditation training can buffer CD4+ T lymphocyte declines in HIV-1 infected adults. PMID:18678242

Free radicals and antioxidant enzymes in older adults after regular senior elastic band exercising: an experimental randomized controlled pilot study.

PubMed

Liao, Lin Yu; Chung, Wei Sheng; Chen, Kuei Min

2017-01-01

The aim of this study was to pilot test the effects of regular senior elastic band exercises on the generation of free radicals and antioxidant enzyme activities in older adults. Long-term regular exercises have positive health promotion outcomes. On the contrary, high-intensity, high-speed and short-term exercises in older adults may increase free radicals and cause chronic disease and ageing effect. A prospective randomized controlled pilot study. Data were collected during 2012. Twenty-five older adults were recruited from a community care centre, southern Taiwan and were randomly assigned to either an experimental or control group. Twenty-two participants completed the study: experimental group (n = 10) and control group (n = 12). The experimental group performed 6-month senior elastic band exercises while the control group kept regular daily routines. Both groups received blood tests (thiobarbituric acid-reacting substances and glutathione peroxidase) 30 minutes before the study began and 1 hour after the final intervention treatment. At the end of the 6-month senior elastic band exercises, no statistically significant differences in thiobarbituric acid-reacting substances and glutathione peroxidase values between the experimental and control groups. No significant differences existed in both thiobarbituric acid-reacting substances and glutathione peroxidase values before and after the 6-month senior elastic band exercises either. Regular senior elastic band exercises did not increase the generation of free radicals and antioxidant enzyme activities. Senior elastic band exercises have the potential to be promoted among older adults in the community as an exercise option without adverse effects on free radicals and have potential for mitigating ageing and increasing disease control. © 2016 John Wiley & Sons Ltd.

Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

PubMed

Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

2012-06-01

Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

Effects of physical exercise programme on happiness among older people.

PubMed

Khazaee-Pool, M; Sadeghi, R; Majlessi, F; Rahimi Foroushani, A

2015-02-01

This randomized-controlled trial investigated the effect of physical exercise programme (PEP) on happiness among older adults in Nowshahr, Iran. Results of this study on 120 male and female volunteers showed that an 8-week group physical exercise programme was significantly effective in older adults' happiness. Findings showed that physical exercise programme is so beneficial for increasing older adults' happiness. Physical activity is associated with well-being and happiness. The purpose of this study was to determine the effects of an 8-week long physical exercise programme (PEP) on happiness among older adults in Nowshahr, Iran. This was a randomized control trial study. The participants consisted of a group of 120 male and female volunteers (mean ± SD age: 71 ± 5.86 years) in a convenience sampling among older adults in public parks in Nowshahr, Iran. We randomly allocated them into experimental (n = 60) and control (n = 60) groups. A validated instrument was used to measure well-being and happiness [Oxford Happiness Inventory (OHI)]. Respondents were asked to complete the OHI before and 2 months after implementing PEP. The 8-week PEP was implemented with the intervention group. The statistical analysis of the data was conducted using paired t-test, Fisher's exact test and χ(2). Before the intervention, there was no significant difference in the happiness mean score between the case and control groups; however, after implementing PEP, happiness significantly improved among the experimental group (P = 0.001) and did not improve within the control group (P = 0.79). It can be concluded that PEP had positive effects on happiness among older adults. Planning and implementing of physical activity is so important for older happiness. © 2014 John Wiley & Sons Ltd.

Examining the Minimal Required Elements of a Computer-Tailored Intervention Aimed at Dietary Fat Reduction: Results of a Randomized Controlled Dismantling Study

ERIC Educational Resources Information Center

Kroeze, Willemieke; Oenema, Anke; Dagnelie, Pieter C.; Brug, Johannes

2008-01-01

This study investigated the minimally required feedback elements of a computer-tailored dietary fat reduction intervention to be effective in improving fat intake. In all 588 Healthy Dutch adults were randomly allocated to one of four conditions in an randomized controlled trial: (i) feedback on dietary fat intake [personal feedback (P feedback)],…

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of online cognitive treatment for problematic anger: a randomized controlled trial.

PubMed

Howie, Amanda J; Malouff, John M

2014-01-01

Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger.

Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial.

PubMed

Huang, Fang; Qian, Qiujin; Wang, Yufeng

2015-04-14

Attention-deficit hyperactivity disorder (ADHD) is a mental disorder beginning in childhood, and about half of patients have symptoms lasting into adulthood. Adult ADHD causes various impairments of emotional, self-esteem, and executive function and life quality aspects. Furthermore, adverse outcomes include academic and occupational failures, traffic accidents and substance abuse, which would be a family and social burden. A combination of medication and psychotherapy is recommended as the treatment for adult ADHD, and cognitive behavioral therapy (CBT) has been validated mostly with evidence-based researches. However, there has been a lack of randomized controlled trials of CBT for patients in China. Moreover, booster sessions of CBT for other disorders have proven effective in reducing recurrence and improving long-term outcomes, which has not been investigated for adult ADHD. This study will testify to the effect of CBT and explore the efficacy of subsequent booster sessions on adult ADHD. It is a three-armed randomized controlled trial to evaluate the efficacy of 12 weeks of CBT based on the published and validated manual and its booster sessions. The 12 weeks of CBT will be conducted weekly and will end at the 12th week, and then the booster sessions will be conducted monthly and end at the 24th week. There are three randomized groups, including a CBT with booster sessions group, a CBT group and a waiting group. Participants are outpatients of the Peking University Sixth Hospital who are diagnosed as having adult ADHD. The Primary efficacy endpoints are the scores of ADHD core symptoms at 12 and 24 weeks. Secondary endpoints include emotion, executive function, self-esteem, life quality and functional magnetic resonance imaging (fMRI) data at different time points, and the change within every group will also be analyzed. This is the first study to explore the efficacy of booster sessions of CBT in adult ADHD as far as we know. The results might increase proof of efficacy of CBT for adult ADHD in China, and the results showing efficacy of the booster sessions would also benefit our clinical practice. Current Controlled Trials: NCT02062411, date of registration: 12 February 2014.

Effects of music and music video interventions on sleep quality: A randomized controlled trial in adults with sleep disturbances.

PubMed

Huang, Chiung-Yu; Chang, En-Ting; Hsieh, Yuan-Mei; Lai, Hui-Ling

2017-10-01

The present study aimed to compare the effects of music and music video interventions on objective and subjective sleep quality in adults with sleep disturbances. A randomized controlled trial was performed on 71 adults who were recruited from the outpatient department of a hospital with 1100 beds and randomly assigned to the control, music, and music video groups. During the 4 test days (Days 2-5), for 30min before nocturnal sleep, the music group listened to Buddhist music and the music video group watched Buddhist music videos. They were instructed to not listen/watch to the music/MV on the first night (pretest, Day 1) and the final night (Day 6). The control group received no intervention. Sleep was assessed using a one-channel electroencephalography machine in their homes and self-reported questionnaires. The music and music video interventions had no effect on any objective sleep parameters, as measured using electroencephalography. However, the music group had significantly longer subjective total sleep time than the music video group did (Wald χ 2 =6.23, p=0.04). Our study results increase knowledge regarding music interventions for sleep quality in adults with sleep disturbances. This study suggested that more research is required to strengthen the scientific knowledge of the effects of music intervention on sleep quality in adults with sleep disturbances. (ISRCTN94971645). Copyright © 2017 Elsevier Ltd. All rights reserved.

Benefits from antidepressants: synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine.

PubMed

Gibbons, Robert D; Hur, Kwan; Brown, C Hendricks; Davis, John M; Mann, J John

2012-06-01

Some meta-analyses suggest that efficacy of antidepressants for major depression is overstated and limited to severe depression. To determine the short-term efficacy of antidepressants for treating major depressive disorder in youth, adult, and geriatric populations. Reanalysis of all intent-to-treat person-level longitudinal data during the first 6 weeks of treatment of major depressive disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine hydrochloride. All sponsor-conducted randomized controlled trials of fluoxetine and venlafaxine. Children's Depression Rating Scale-Revised scores (youth population), Hamilton Depression Rating Scale scores (adult and geriatric populations), and estimated response and remission rates at 6 weeks were analyzed for 2635 adults, 960 geriatric patients, and 708 youths receiving fluoxetine and for 2421 adults receiving immediate-release venlafaxine and 2461 adults receiving extended-release venlafaxine. Patients in all age and drug groups had significantly greater improvement relative to control patients receiving placebo. The differential rate of improvement was largest for adults receiving fluoxetine (34.6% greater than those receiving placebo). Youths had the largest treated vs control difference in response rates (24.1%) and remission rates (30.1%), with adult differences generally in the 15.6% (remission) to 21.4% (response) range. Geriatric patients had the smallest drug-placebo differences, an 18.5% greater rate of improvement, 9.9% for response and 6.5% for remission. Immediate-release venlafaxine produced larger effects than extended-release venlafaxine. Baseline severity could not be shown to affect symptom reduction. To our knowledge, this is the first research synthesis in this area to use complete longitudinal person-level data from a large set of published and unpublished studies. The results do not support previous findings that antidepressants show little benefit except for severe depression. The antidepressants fluoxetine and venlafaxine are efficacious for major depressive disorder in all age groups, although more so in youths and adults compared with geriatric patients. Baseline severity was not significantly related to degree of treatment advantage over placebo.

Mindfulness Training Increases Momentary Positive Emotions and Reward Experience in Adults Vulnerable to Depression: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Geschwind, Nicole; Peeters, Frenk; Drukker, Marjan; van Os, Jim; Wichers, Marieke

2011-01-01

Objective: To examine whether mindfulness-based cognitive therapy (MBCT) increases momentary positive emotions and the ability to make use of natural rewards in daily life. Method: Adults with a life-time history of depression and current residual depressive symptoms (mean age = 43.9 years, SD = 9.6; 75% female; all Caucasian) were randomized to…

A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

ERIC Educational Resources Information Center

Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

2012-01-01

Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

Evaluating Personalized Feedback Intervention Framing with a Randomized Controlled Trial to Reduce Young Adult Alcohol-Related Sexual Risk Taking.

PubMed

Lewis, Melissa A; Rhew, Isaac C; Fairlie, Anne M; Swanson, Alex; Anderson, Judyth; Kaysen, Debra

2018-03-06

The purpose of this study was to evaluate personalized feedback intervention (PFI) framing with two web-delivered PFIs aimed to reduce young adult alcohol-related risky sexual behavior (RSB). Combined PFIs typically use an additive approach whereby independent components on drinking and components on RSB are presented without the discussion of the influence of alcohol on RSB. In contrast, an integrated PFI highlights the RSB-alcohol connection by presenting integrated alcohol and RSB components that focus on the role of intoxication as a barrier to risk reduction in sexual situations. In a randomized controlled trial, 402 (53.98% female) sexually active young adults aged 18-25 were randomly assigned to a combined PFI, an integrated PFI, or attention control. All assessment and intervention procedures were web-based. At the 1-month follow-up, those randomly assigned to the integrated condition had a lower likelihood of having any casual sex partners compared to those in the control group. At the 6-month follow-up, the combined condition had a lower likelihood of having any casual sex partners compared to those in the control group. When examining alcohol-related RSB, at the 1-month follow-up, both interventions showed a lower likelihood of any drinking prior to sex compared to the control group. When examining alcohol-related sexual consequences, results showed a reduction in the non-zero count of consequences in the integrated condition compared to the control at the 1-month follow-up. For typical drinks per week, those in the combined condition showed a greater reduction in the non-zero count of drinks than those in the control condition at the 1-month follow-up. While there were no significant differences between the two interventions, the current findings highlight the utility of two efficacious web-based alcohol and RSB interventions among a national sample of at-risk young adults.

Mindfulness vs psychoeducation in adult ADHD: a randomized controlled trial.

PubMed

Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra

2018-06-01

Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p < .001, partial η 2  = 0.18) and in associated symptomatology, which persisted through 6 months of follow-up. There were no significant differences regarding symptom reduction between the treatment groups. Women benefited more compared to men irrespective of treatment group. Men showed the most pronounced changes under MAP. In the current study, MAP was not superior to PE regarding symptom reduction in adult ADHD. Both interventions, mindfulness meditation and PE, were efficacious in reducing symptom load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.

A Randomized Controlled Trial of Cognitive-Behavioral Therapy, Light Therapy, and Their Combination for Seasonal Affective Disorder

ERIC Educational Resources Information Center

Rohan, Kelly J.; Roecklein, Kathryn A.; Tierney Lindsey, Kathryn; Johnson, Leigh G.; Lippy, Robert D.; Lacy, Timothy J.; Barton, Franca B.

2007-01-01

This first controlled psychotherapy trial for seasonal affective disorder (SAD) compared SAD-tailored cognitive-behavioral therapy (CBT), light therapy (LT), and their combination to a concurrent wait-list control. Adults (N = 61) with major depression, recurrent with seasonal pattern, were randomized to one of four 6-week conditions: CBT (1.5-hr…

Screening for asymptomatic bacteriuria in adults: evidence for the U.S. Preventive Services Task Force reaffirmation recommendation statement.

PubMed

Lin, Kenneth; Fajardo, Kevin

2008-07-01

Asymptomatic bacteriuria is common, and screening for this condition in pregnant women is a well-established, evidence-based standard of current medical practice. Screening other groups of adults has not been shown to improve outcomes. To review new and substantial evidence on screening for asymptomatic bacteriuria, to support the work of the U.S. Preventive Services Task Force. English-language studies of adults (age >18 years) indexed in PubMed and the Cochrane Library and published from 1 January 2002 through 30 April 2007. For benefits of screening or treatment for screened populations, systematic reviews; meta-analyses; and randomized, controlled trials were included. For harms of screening, systematic reviews; meta-analyses; randomized, controlled trials; cohort studies; case-control studies; and case series of large multisite databases were included. Two reviewers independently reviewed titles, abstracts, and full articles for inclusion. Two reviewers extracted data from studies on benefits of screening and treatment (including decreases in the incidence of adverse maternal and fetal outcomes, symptomatic urinary tract infections, hypertension, and renal function decline). An updated Cochrane systematic review of 14 randomized, controlled trials of treatment supports screening for asymptomatic bacteriuria in pregnant women. A randomized, controlled trial and a prospective cohort study show that screening nonpregnant women with diabetes for asymptomatic bacteriuria is unlikely to produce benefits. No new evidence on screening men for asymptomatic bacteriuria or on harms of screening was found. The focused search strategy may have missed some smaller studies on the benefits and harms of screening for asymptomatic bacteriuria. The available evidence continues to support screening for asymptomatic bacteriuria in pregnant women, but not in other groups of adults.

Executive function in adults with attention-deficit/hyperactivity disorder during treatment with atomoxetine in a randomized, placebo-controlled, withdrawal study.

PubMed

Adler, Lenard; Tanaka, Yoko; Williams, David; Trzepacz, Paula T; Goto, Taro; Allen, Albert J; Escobar, Rodrigo; Upadhyaya, Himanshu P

2014-08-01

We assessed the executive function in adults with attention-deficit/hyperactivity disorder (ADHD) during atomoxetine treatment in a randomized withdrawal trial. Responders (Conners' ADHD Rating Scale-Investigator Rated: Screening Version [adult prompts] ≥30% reduction from baseline and Clinical Global Impression Scale-ADHD Severity score ≤3) to open-label atomoxetine (40-100 mg/d, 12 weeks) entered a 37-week double-blind maintenance period. Patients who maintained response (double-blind atomoxetine for 12 weeks) were randomized 1:1 to atomoxetine (80-100 mg/d, n = 266) or placebo (n = 258) for 25 weeks (total duration, 1 year). Patients and investigators were blinded to response criteria and randomization timing. Change in executive function was assessed with the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report and Informant T scores from the randomization to the last-observation-carried-forward postrandomization week 25 (after week 17). Of the enrolled patients (n = 2017; mean age, 33.2 years; male, 58.7%), 524 responders were randomized. During open-label atomoxetine, subscales and individual items on both BRIEF-A questionnaires showed significant improvement (P < 0.001). After randomization, the following T scores improved significantly (P ≤ 0.05) with patients in the atomoxetine group versus those in the placebo group: global executive composite, behavioral regulation, and metacognition indices; plan/organize, working memory, inhibit, task monitor and shift (both BRIEF-A questionnaires), emotional control and organization of materials (BRIEF-A Informant), and initiate (BRIEF-A Self-Report). Atomoxetine significantly improved the executive function compared with placebo, which was maintained for 25 weeks or more; the executive function of patients in the placebo group worsened but did not return to baseline levels after randomization.

Outcomes of a Peer Mentor Implemented Fitness Program in Older Adults: A Quasi-Randomized Controlled Trial

PubMed Central

Dorgo, Sandor; King, George A.; Bader, Julia O.; Limon, John S.

2013-01-01

Objectives To investigate the effectiveness of different applications of mentoring in an older adult exercise program, this study compared the physical fitness scores, the retention and participation rates of older adults trained by student mentors, peer mentors, peer mentors working independently of the researchers, and a non-exercising control group. Methods 106 older adults were recruited and assigned to one of the groups using quasi-randomization. All three experimental groups completed a 14-week intervention. Pre- and post-training assessments of fitness were completed, and retention and participation rates were compared. Results High retention and participation rates, as well as significant improvements in fitness scores from baseline to post-test were observed in all three mentored groups. While the control group showed improvement only in one fitness test, subjects in the mentored groups improved similarly in all measures, regardless of the type of mentoring received. Discussion These findings indicated effectiveness of the peer mentor model and suggested that with adequate preparation peer mentors may be capable of guiding older adult participants effectively without assistance from professional staff. PMID:23279966

Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

ERIC Educational Resources Information Center

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-01-01

Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

2011-01-01

Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients.

PubMed

Russell, Cynthia; Conn, Vicki; Ashbaugh, Catherine; Madsen, Richard; Wakefield, Mark; Webb, Andrew; Coffey, Deanna; Peace, Leanne

2011-01-01

Immunosuppressive medication non-adherence is one of the most prevalent but preventable causes of poor outcomes in adult renal transplant recipients, yet there is a paucity of studies testing interventions in this area. Using a randomized controlled trial design, 30 adult renal transplant recipients were screened for medication non-adherence using electronic monitoring. Fifteen non-adherent participants were randomized to receive either a continuous self-improvement intervention or attention control management. The six-month continuous self-improvement intervention involved the participant and clinical nurse specialist collaboratively identifying the person's life routines, important people, and possible solutions to enhance medication taking. The participant then received individual monthly medication taking feedback delivered via a graphic printout of daily medication taking generated from electronic monitoring. The mean medication adherence score for the continuous self-improvement intervention group (n = 8) was statistically significantly higher than the attention control group's (n = 5) mean medication adherence score (p = 0.03). The continuous self-improvement intervention effect size (Cohen's d) was large at 1.4. Participants' perceptions of the intervention were highly favorable. The continuous self-improvement intervention shows promise as an effective and feasible approach to improve medication adherence in adult renal transplant recipients. A fully-powered study with a diverse sample is needed to confirm these preliminary findings. © 2010 John Wiley & Sons A/S.

The effect of cognitive-motor dual task training with the biorescue force platform on cognition, balance and dual task performance in institutionalized older adults: a randomized controlled trial

PubMed Central

Delbroek, Tom; Vermeylen, Wietse; Spildooren, Joke

2017-01-01

[Purpose] This study investigates whether cognition, balance and dual task performance in institutionalized older adults improves by a virtual reality dual task training. [Subjects and Methods] Randomized controlled trial; Twenty institutionalized older adults with mild cognitive impairment (13 female, 7 male; average age, 87.2 ± 5.96 years) were randomized to the intervention (i.e. Virtual reality dual-task training using the BioRescue) or control group (no additional training). The intervention group took part in a 6-week training program while the elderly in the control group maintained their daily activities. Balance was measured with the Instrumented Timed Up-and-Go Test with and without a cognitive task. The Observed Emotion Rating Scale and Intrinsic Motivation Inventory were administered to evaluate the emotions and motivation regarding the exergaming program. [Results] The intervention group improved significantly on the total Timed Up-and-Go duration and the turn-to-sit duration during single-task walking in comparison to the control group who received no additional training. Participants found the virtual reality dual task training pleasant and useful for their concentration, memory and balance. Pleasure and alertness were the two emotions which were mostly seen during the intervention. [Conclusion] The BioRescue is a pleasant and interesting treatment method, well suited for institutionalized older adults in need of lifelong physical therapy. PMID:28744033

Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

PubMed

Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

2014-06-01

The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. clinicaltrials.gov Identifier: NCT01148186.

Dairy consumption and body mass index among adults: Mendelian randomization analysis of 184802 individuals from 25 studies

USDA-ARS?s Scientific Manuscript database

Background: Associations between dairy intake and body mass index (BMI) have been inconsistently observed in epidemiological studies; and the causal relationship remains ill defined. Using the Mendelian randomization (MR) approach and meta-analysis of selected randomized controlled trials (RCTs), we...

Efficacy of Learning Strategies Instruction in Adult Education

ERIC Educational Resources Information Center

Hock, Michael F.; Mellard, Daryl F.

2011-01-01

Results from randomized controlled trials of learning strategies instruction with 375 adult basic education participants are reported. Reading outcomes from whole group strategic instruction in 1 of 4 learning strategies were compared to outcomes of reading instruction delivered in the context of typical adult education units on social studies,…

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials.

PubMed

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required.

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials

PubMed Central

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required. PMID:29695993

Investigating Self-Control Resource Depletion as a Situational Risk Factor for Aversive Interpartner Communication by Young Adults With ADHD.

PubMed

Wymbs, Brian T

2018-06-01

Adults with attention-deficit hyperactivity disorder (ADHD) have more conflictual relations with their romantic partners than adults without ADHD. This study investigated whether adults with ADHD are differentially susceptible to conflict when self-control resources are depleted. Heterosexual adult couples (20 including at least one adult with ADHD; 12 including no adults with ADHD) were randomly assigned to have resources temporarily depleted or not. Positive and negative communication was assessed during a subsequent problem-solving task with their partners. Adults with ADHD whose self-control resources were depleted communicated less positively and more negatively with their romantic partners than adults without ADHD whose resources were depleted. Adults with ADHD appear to have a differential susceptibility to interpartner discord when their self-control resources have been depleted. Clinicians seeking to remediate discordant romantic relationships of adults with ADHD should consider evaluating how often their resources needed to manage their impulses are depleted.

The reinforcing value of vegetables does not increase with repeated exposure during a randomized controlled provided vegetable intervention among overweight and obese adults

USDA-ARS?s Scientific Manuscript database

Objective: The primary aim of this randomized controlled trial is to determine whether the relative reinforcing value (RRV) of vegetables compared to a snack food can be increased through repeated exposure (incentive sensitization) to amounts of vegetables recommended by the Dietary Guidelines for A...

Effectiveness of a Web-Based Intervention to Reduce Alcohol Consumption among French Hazardous Drinkers: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Guillemont, Juliette; Cogordan, Chloé; Nalpas, Bertrand; Nguyen-Thanh, Vi?t; Richard, Jean-Baptiste; Arwidson, Pierre

2017-01-01

This study aims to evaluate the effectiveness of a web-based intervention to reduce alcohol consumption among hazardous drinkers. A two-group parallel randomized controlled trial was conducted among adults identified as hazardous drinkers according to the Alcohol Use Disorders Identification Test. The intervention delivers personalized normative…

Integrating CHWs as part of the team leading diabetes group visits: A randomized controlled feasibility study

USDA-ARS?s Scientific Manuscript database

The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n=5...

Empowered Diabetes Management: Life Coaching and Pharmacist Counseling for Employed Adults with Diabetes

ERIC Educational Resources Information Center

Nishita, Christy; Cardazone, Gina; Uehara, Denise Lea; Tom, Tammy

2013-01-01

The Hawai'i Demonstration to Maintain Independence and Employment was a randomized controlled trial examining the effect of a participant-driven, multicomponent intervention on 190 employed adults with diabetes, 36% of whom were Asian and 35% of whom were Native Hawaiian or Pacific Islander. A no treatment concurrent control group was used, and…

Long-Term Impact of Fit and Strong! On Older Adults with Osteoarthritis

ERIC Educational Resources Information Center

Hughes, Susan L.; Seymour, Rachel B.; Campbell, Richard T.; Huber, Gail; Pollak, Naomi; Sharma, Leena; Desai, Pankaja

2006-01-01

Purpose: We present final outcomes from the multiple-component Fit and Strong! intervention for older adults with lower extremity osteoarthritis. Design and Methods: A randomized controlled trial compared the effects of this exercise and behavior-change program followed by home-based reinforcement (n = 115) with a wait list control (n = 100) at 2,…

Study protocol for a cluster randomized trial of the Community of Voices choir intervention to promote the health and well-being of diverse older adults.

PubMed

Johnson, Julene K; Nápoles, Anna M; Stewart, Anita L; Max, Wendy B; Santoyo-Olsson, Jasmine; Freyre, Rachel; Allison, Theresa A; Gregorich, Steven E

2015-10-13

Older adults are the fastest growing segment of the United States population. There is an immediate need to identify novel, cost-effective community-based approaches that promote health and well-being for older adults, particularly those from diverse racial/ethnic and socioeconomic backgrounds. Because choral singing is multi-modal (requires cognitive, physical, and psychosocial engagement), it has the potential to improve health outcomes across several dimensions to help older adults remain active and independent. The purpose of this study is to examine the effect of a community choir program (Community of Voices) on health and well-being and to examine its costs and cost-effectiveness in a large sample of diverse, community-dwelling older adults. In this cluster randomized controlled trial, diverse adults age 60 and older were enrolled at Administration on Aging-supported senior centers and completed baseline assessments. The senior centers were randomly assigned to either start the choir immediately (intervention group) or wait 6 months to start (control). Community of Voices is a culturally tailored choir program delivered at the senior centers by professional music conductors that reflects three components of engagement (cognitive, physical, and psychosocial). We describe the nature of the study including the cluster randomized trial study design, sampling frame, sample size calculation, methods of recruitment and assessment, and primary and secondary outcomes. The study involves conducting a randomized trial of an intervention as delivered in "real-world" settings. The choir program was designed using a novel translational approach that integrated evidence-based research on the benefits of singing for older adults, community best practices related to community choirs for older adults, and the perspective of the participating communities. The practicality and relatively low cost of the choir intervention means it can be incorporated into a variety of community settings and adapted to diverse cultures and languages. If successful, this program will be a practical and acceptable community-based approach for promoting health and well-being of older adults. ClinicalTrials.gov NCT01869179 registered 9 January 2013.

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

PubMed Central

Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

2014-01-01

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

POWERS forID: Personalized Online Weight and Exercise Response System for Individuals with Intellectual Disability: study protocol for a randomized controlled trial.

PubMed

Neumeier, William H; Guerra, Nichole; Thirumalai, Mohanraj; Geer, Betty; Ervin, David; Rimmer, James H

2017-10-23

Intellectual disability (ID) is characterized by limitations in intellectual functioning and adaptive behavior. Adults with ID exhibit higher rates of obesity and poorer health status compared to the general population. Continuity of care and barriers to health-related activities may contribute to the poorer health status observed in this population. To address this problem, a tailored weight management online health information and communication technology platform, known as POWERS forID , was developed and is being tested to determine if this delivery mechanism can improve weight maintenance/weight loss in adults with ID. Obese adults with mild-to-moderate ID (n = 70) are randomized to the POWERS forID intervention or control group for a 24-week trial. Each group undergoes an assessment that includes body weight, waist circumference, and percent body fat at baseline and at weeks 6, 12, and 24. Physical activity barriers, healthy eating barriers, food frequency, and psychosocial wellbeing are measured at baseline and at weeks 12 and 24. Blood lipids are assessed at baseline and 24 weeks. Participants randomized to POWERS forID receive access to the POWERS forID website and calls from a health coach (weekly during weeks 1-12, biweekly during weeks 13-24). The health coach employs motivational interviewing techniques adapted for individuals with ID to promote behavior change. Participants randomized to the control group receive standard clinical weight-loss care. Differences in weight, waist circumference, blood lipids, percent body fat, and psychosocial self-report will be assessed. Barriers and facilitators of implementation as well as perception of study outcomes will be conducted via qualitative analysis. POWERS forID is a novel information and communication technology platform designed to address health needs for adults with ID. This article describes the development and components of POWERS forID . The overall aim is to assess usability and feasibility of POWERS forID for promoting weight loss for obese adults with ID over the course of a 24-week randomized control trial. Clinicaltrials.gov, NCT03139760 . Registered on XXX.

Efficacy of Nasal Mometasone for the Treatment of Chronic Sinonasal Disease in Inadequately Controlled Asthma

PubMed Central

Dixon, Anne E.; Castro, Mario; Cohen, Rubin I.; Gerald, Lynn B.; Holbrook, Janet T.; Irvin, Charles G.; Mohapatra, Shyam; Peters, Stephen P.; Rayapudi, Sobharani; Sugar, Elizabeth A.; Wise, Robert A.

2014-01-01

Background Chronic sinonasal disease is common in asthma and associated with poor asthma control; however there are no long term trials addressing whether chronic treatment of sinonasal disease improves asthma control. Objective To determine if treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control as measured by the Childhood Asthma Control Test (cACT) and Asthma Control Test (ACT) in children and adults respectively. Methods A 24 week multi-center randomized placebo controlled double-blinded trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma. Treatments were randomly assigned with concealment of allocation. Results 237 adults and 151 children were randomized to nasal mometasone versus placebo, 319 participants completed the study. There was no difference in the cACT (difference in change with mometasone – change with placebo [ΔM - ΔP]: -0.38, CI: -2.19 to 1.44, p = 0.68 ages 6 to 11) or the ACT (ΔM - ΔP: 0.51, CI: -0.46 to 1.48, p = 0.30, ages 12 and older) in those assigned to mometasone versus placebo. In children and adolescents, ages 6 to 17, there was no difference in asthma or sinus symptoms, but a decrease in episodes of poorly controlled asthma defined by a drop in peak flow. In adults there was a small difference in asthma symptoms measured by the Asthma Symptom Utility Index (ΔM - ΔP: 0.06, CI: 0.01 to 0.11, p <0.01) and in nasal symptoms (sinus symptom score ΔM - ΔP: -3.82, CI: -7.19 to- 0.45, p =0.03), but no difference in asthma quality of life, lung function or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo. Conclusions Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control. Treatment of sinonasal disease in asthma should be determined by the need to treat sinonasal disease rather than to improve asthma control. PMID:25174863

Intensive client-centred occupational therapy in the home improves older adults' occupational performance. Results from a Danish randomized controlled trial.

PubMed

Nielsen, Tove Lise; Andersen, Niels Trolle; Petersen, Kirsten Schultz; Polatajko, Helene; Nielsen, Claus Vinther

2018-01-12

There is growing interest in enabling older adults' occupational performance. We tested whether 11 weeks of intensive client-centred occupational therapy (ICC-OT) was superior to usual practice in improving the occupational performance of home-dwelling older adults. An assessor-masked randomized controlled trial among adults 60 + with chronic health issues, who received or applied for homecare services. Recruitment took place September 2012 to April 2014. All participants received practical and personal assistance and meal delivery as needed. In addition, they were randomized to receive either a maximum 22 sessions of occupation-based ICC-OT (N = 59) or to receive usual practice with a maximum three sessions of occupational therapy (N = 60). The primary outcome was self-rated occupational performance assessed with the Canadian Occupational Performance Measure (COPM). No important adverse events occurred. ICC-OT was accepted by 46 participants (88%), usual practice by 60 (100%). After 3 months, the ICC-OT-group had improved 1.86 points on COPM performance; the Usual-Practice group had improved 0.61 points. The between-group difference was statistically significant (95% confidence interval 0.50 to 2.02), t-test: p = 0.001. ICC-OT improved older adults' occupational performance more effectively than usual practice. This result may benefit older adults and support programmatic changes.

Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial.

PubMed

Winter, Michiel M; van der Bom, Teun; de Vries, Leonie C S; Balducci, Anna; Bouma, Berto J; Pieper, Petronella G; van Dijk, Arie P J; van der Plas, Mart N; Picchio, Fernando M; Mulder, Barbara J M

2012-06-01

To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Multi-centre parallel randomized controlled trial. Patients with a systemic RV due to congenitally or surgically corrected transposition of the great arteries. Fifty-four adult patients with a systemic RV, were randomized using unmarked opaque envelopes to an intervention group (n = 28) with three training sessions per week for 10 consecutive weeks, and a control group (n = 26). Randomization was stratified by participating centre. At baseline, and follow-up, we determined maximal exercise capacity (V'O(2peak)), serum NT-proBNP levels, and quality of life by means of the SF-36, and the TAAQOL Congenital Heart Disease questionnaires. The final analysis was performed by linear regression, taking into account the stratified randomization. Forty-six patients were analysed (male 50%, age 32 ± 11 years, intervention group n = 24, control group n = 22). Analysis at 10 weeks showed a significant difference in V'O(2peak) (3.4 mL/kg/min, 95% CI: 0.2 to 6.7; P = 0.04) and resting systolic blood pressure (-7.6 mmHg, 95% CI: -14.0 to -1.3; P = 0.03) in favour of the exercise group. No significant changes were found in serum NT-proBNP levels or quality of life in the intervention group or in the control group nor between groups. None of the patients in the intervention group had to discontinue the training programme due to adverse events. In adult patients with a systemic RV exercise training improve exercise capacity. We recommend to revise restrictive guidelines, and to encourage patients to become physically active. ( The study was registered at http://trialregister.nl. Identifier: NTR1909.).

Effects of structured patient education in adults with atopic dermatitis: Multicenter randomized controlled trial.

PubMed

Heratizadeh, Annice; Werfel, Thomas; Wollenberg, Andreas; Abraham, Susanne; Plank-Habibi, Sibylle; Schnopp, Christina; Sticherling, Michael; Apfelbacher, Christian; Biedermann, Tilo; Breuer, Kristine; Fell, Isabel; Fölster-Holst, Regina; Heine, Guido; Grimm, Jennifer; Hennighausen, Lars; Kugler, Claudia; Reese, Imke; Ring, Johannes; Schäkel, Knut; Schmitt, Jochen; Seikowski, Kurt; von Stebut, Esther; Wagner, Nicola; Waßmann-Otto, Anja; Wienke-Graul, Ute; Weisshaar, Elke; Worm, Margitta; Gieler, Uwe; Kupfer, Joerg

2017-09-01

Atopic dermatitis (AD) is a chronic relapsing skin disease prevalent in 1% to 3% of adults in Western industrialized countries. We sought to investigate the effectiveness of educational training in an outpatient setting on coping with the disease, quality of life, symptoms, and severity in adults with AD. In this German prospective, randomized controlled multicenter study, adult patients with moderate-to-severe AD were educated by referring to a comprehensive 12-hour training manual consented by a multiprofessional study group from different centers (Arbeitsgemeinschaft Neurodermitisschulung für Erwachsene [ARNE]). Patients were randomly allocated to the intervention or waiting control groups. Study visits were performed at baseline and after 1 year (1 year of follow-up). Primary outcomes were defined as a decrease in (1) "catastrophizing cognitions" with respect to itching (Juckreiz-Kognitions-Fragebogen questionnaire), (2) "social anxiety" (Marburger Hautfragebogen questionnaire), (3) subjective burden by symptoms of the disease (Skindex-29 questionnaire), and (4) improvement of disease signs and symptoms assessed by using the SCORAD index at 1 year of follow-up. Data were analyzed on an intention-to-treat basis. At 1 year of follow-up, patients from the intervention group (n = 168) showed a significantly better improvement compared with the waiting group (n = 147) in the following defined primary study outcomes: coping behavior with respect to itching (P < .001), quality of life assessed by using the Skindex-29 questionnaire (P < .001), and the SCORAD index (P < .001). This is the first randomized, controlled multicenter study on patient education in adult AD. The ARNE training program shows significant beneficial effects on a variety of psychosocial parameters, as well as AD severity. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Implementation of Health Promotion in the Older Adults in Bangkok, Thailand

ERIC Educational Resources Information Center

Assantachai, Prasert; Bunnag, Chaweewan; Piya-Anant, Manee; Thamlikitkul, Visanu

2006-01-01

Effective strategies that bring health promotion messages to older adults in a developing country are needed. To evaluate the impact of various education media upon changes in knowledge and health behavior, a double-blind, randomized controlled trial was conducted involving 1,268 older adults in a southwest Bangkok suburb. Group teaching…

Protocol for Fit Bodies, Fine Minds: a randomized controlled trial on the affect of exercise and cognitive training on cognitive functioning in older adults

PubMed Central

O'Dwyer, Siobhan T; Burton, Nicola W; Pachana, Nancy A; Brown, Wendy J

2007-01-01

Background Declines in cognitive functioning are a normal part of aging that can affect daily functioning and quality of life. This study will examine the impact of an exercise training program, and a combined exercise and cognitive training program, on the cognitive and physical functioning of older adults. Methods/Design Fit Bodies, Fine Minds is a randomized, controlled trial. Community-dwelling adults, aged between 65 and 75 years, are randomly allocated to one of three groups for 16 weeks. The exercise-only group do three 60-minute exercise sessions per week. The exercise and cognitive training group do two 60-minute exercise sessions and one 60-minute cognitive training session per week. A no-training control group is contacted every 4 weeks. Measures of cognitive functioning, physical fitness and psychological well-being are taken at baseline (0 weeks), post-test (16 weeks) and 6-month follop (40 weeks). Qualitative responses to the program are taken at post-test. Discussion With an increasingly aged population, interventions to improve the functioning and quality of life of older adults are particularly important. Exercise training, either alone or in combination with cognitive training, may be an effective means of optimizing cognitive functioning in older adults. This study will add to the growing evidence base on the effectiveness of these interventions. Trial Registration Australian Clinical Trials Register: ACTRN012607000151437 PMID:17915035

The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults.

PubMed

Ramo, Danielle E; Thrul, Johannes; Delucchi, Kevin L; Ling, Pamela M; Hall, Sharon M; Prochaska, Judith J

2015-09-15

Tobacco use remains the leading cause of premature morbidity and mortality in the United States. Young adults are less successful at quitting, use cessation treatment less often than smokers of other ages, and can be a challenge to retain in treatment. Social media, integrated into the lives of many young adults, represents a promising strategy to deliver evidence-based smoking cessation treatment to a large, diverse audience. The goal of this trial is to test the efficacy of a stage-based smoking cessation intervention on Facebook for young adults age 18 to 25 on smoking abstinence, reduction in cigarettes smoked, and thoughts about smoking abstinence. This is a randomized controlled trial. Young adult smokers throughout the United States are recruited online and randomized to either the 3 month Tobacco Status Project intervention on Facebook or a referral to a smoking cessation website. The intervention consists of assignment to a secret Facebook group tailored to readiness to quit smoking (precontemplation, contemplation, preparation), daily Facebook contacts tailored to readiness to quit smoking, weekly live counseling sessions, and for those in preparation, weekly Cognitive Behavioral Therapy counseling sessions on Facebook. Primary outcome measure is biochemically-verified 7-day point prevalence abstinence from smoking at posttreatment (3 months), 6, and 12 months. Secondary outcome measures are reduction of 50 % or more in cigarettes smoked, 24 h quit attempts, and commitment to abstinence at each time point. A secondary aim is to test, within the TSP condition, the effect of a monetary incentive at increasing engagement in the intervention. This randomized controlled trial is testing a novel Facebook intervention for treating young adults' tobacco use. If efficacious, the social media intervention could be disseminated widely and expanded to address additional health risks. ClinicalTrials.gov: NCT02207036 , May 13, 2014.

Qigong or Yoga Versus No Intervention in Older Adults With Chronic Low Back Pain-A Randomized Controlled Trial.

PubMed

Teut, Michael; Knilli, Judith; Daus, Dorothea; Roll, Stephanie; Witt, Claudia M

2016-07-01

The aim of this study was to assess the effectiveness of the reduction of chronic lower back pain in older adults using either yoga classes or qigong classes compared with no intervention. Older adults (65 years of age and older) with chronic low back pain were enrolled in and randomly allocated to: 1) yoga (24 classes, 45 minutes each, during 3 months), 2) qigong (12 classes, 90 minutes each, during 3 months), or 3) a control group who received no additional intervention. The pain intensity item of the Functional Rating Index after 3 months was used as primary outcome parameter. A total of 176 patients were randomized (n = 61 yoga, n = 58 qigong, n = 57 control; mean age 73 ± 5.6 years, 89% female). The mean adjusted pain intensity after 3 months was 1.71 for the yoga group (95% confidence interval [CI], 1.54-1.89), 1.67 for the qigong group (95% CI, 1.45-1.89), and 1.89 for no intervention (95% CI, 1.67-2.11). No statistically significant group differences were observed. Possible explanations for this lack of pain relief might include the ineffectiveness of interventions, inappropriate outcomes, or differences in pain perception and processing in older adults. The aim of this study was to assess the effectiveness of the reduction of chronic lower back pain in older adults using either yoga classes or qigong classes compared with no intervention. This 3-armed randomized trial with 176 older adults showed that yoga and qigong were not superior to no treatment in reducing pain and increasing quality of life. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

Examining clinical supervision as a mechanism for changes in practice: a research protocol.

PubMed

Dilworth, Sophie; Higgins, Isabel; Parker, Vicki; Kelly, Brian; Turner, Jane

2014-02-01

This paper describes the research protocol for a study exploring if and how clinical supervision facilitates change in practice relating to psychosocial aspects of care for Health Professionals, who have been trained to deliver a psychosocial intervention to adults with cancer. There is a recognized need to implement care that is in line with clinical practice guidelines for the psychosocial care of adults with cancer. Clinical supervision is recommended as a means to support Health Professionals in providing the recommended psychosocial care. A qualitative design embedded within an experimental, stepped wedge randomized control trial. The study will use discourse analysis to analyse audio-recorded data collected in clinical supervision sessions that are being delivered as one element of a large randomized control trial. The sessions will be attended primarily by nurses, but including physiotherapists, radiation therapists, occupational therapists. The Health Professionals are participants in a randomized control trial designed to reduce anxiety and depression of distressed adults with cancer. The sessions will be facilitated by psychiatrists experienced in psycho-oncology and the provision of clinical supervision. The proposed research is designed specifically to facilitate exploration of the mechanisms by which clinical supervision enables Health Professionals to deliver a brief, tailored psychosocial intervention in the context of their everyday practice. This is the first study to use discourse analysis embedded within an experimental randomized control trial to explore the mechanisms of change generated within clinical supervision by analysing the discourse within the clinical supervision sessions. © 2013 John Wiley & Sons Ltd.

Meditation and Yoga for Posttraumatic Stress Disorder: A Meta-Analytic Review of Randomized Controlled Trials

PubMed Central

Gallegos, Autumn M.; Crean, Hugh F.; Pigeon, Wilfred R.; Heffner, Kathi L.

2018-01-01

Posttraumatic stress disorder (PTSD) is a chronic and debilitating disorder that affects the lives of 7-8% of adults in the U.S. Although several interventions demonstrate clinical effectiveness for treating PTSD, many patients continue to have residual symptoms and ask for a variety of treatment options. Complementary health approaches, such as meditation and yoga, hold promise for treating symptoms of PTSD. This meta-analysis evaluates the effect size (ES) of yoga and meditation on PTSD outcomes in adult patients. We also examined whether the intervention type, PTSD outcome measure, study population, sample size, or control condition moderated the effects of complementary approaches on PTSD outcomes. The studies included were 19 randomized control trials with data on 1,173 participants. A random effects model yielded a statistically significant ES in the small to medium range (ES = −.39, p < .001, 95% CI [−.57, −.22]). There were no appreciable differences between intervention types, study population, outcome measures, or control condition. There was, however, a marginally significant higher ES for sample size ≤ 30 (ES = −.78, k = 5). These findings suggest that meditation and yoga are promising complementary approaches in the treatment of PTSD among adults and warrant further study. PMID:29100863

A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

PubMed Central

Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

2009-01-01

Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

A randomized controlled trial on effects of the Transcendental Meditation program on blood pressure, psychological distress, and coping in young adults.

PubMed

Nidich, Sanford I; Rainforth, Maxwell V; Haaga, David A F; Hagelin, John; Salerno, John W; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H

2009-12-01

Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind-body intervention on blood pressure (BP), psychological distress, and coping in college students. This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were -2.0/-1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were -5.0/-2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). This is the first RCT to demonstrate that a selected mind-body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind-body program may reduce the risk for future development of hypertension in young adults.

Effects of leisure education on self-rated health among older adults.

PubMed

Chang, Liang-Chih; Yu, Ping; Jeng, Mei-Yuan

2015-01-01

This study examined whether a leisure education program could promote leisure autonomy and self-rated health (SRH) among older adults. A pretest-posttest randomized experimental design was conducted. Subjects were randomly assigned to either an experimental group (n = 30) or a control group (n = 30). Data related to leisure autonomy and SRH were collected shortly before and after the experiment. Pretest and posttest data were analyzed using an analysis of covariance. The results indicated that the average posttest scores of leisure autonomy and SRH in the experimental group were significantly higher than those in the control group. Implications of the results are discussed.

Relaxation therapy and anxiety, self-esteem, and emotional regulation among adults with intellectual disabilities: A randomized controlled trial.

PubMed

Bouvet, Cyrille; Coulet, Aurélie

2016-09-01

This pilot study is a randomized controlled trial on the effects of relaxation on anxiety, self-esteem, and emotional regulation in adults with intellectual disabilities (ID) working in a center of supported employment in France. We studied 30 adults with mild or moderate ID who were split at random into a relaxation group (RG, 15 subjects), who completed 10 sessions of relaxation therapy, and a control group (CG, 15 subjects), who were on a waiting list. The method used is the pretest and posttest. Variables were assessed by the State-Trait Anxiety Inventory form Y scale, the Rosenberg Self-Esteem scale, and the Emotion Regulation Questionnaire. We found that in the RG, relaxation significantly reduced state anxiety, t(14, 15) = 17.8***, d = -0.72, and improved self-esteem, t(14, 15) = -7.7***, d = 1.03, and cognitive reappraisal, t(14, 15) = -6.3***, d = 1.3, while the CG showed no change for these variables. We conclude that relaxation seems to be an interesting therapeutic option for reducing anxiety in people with ID in a supported employment setting. © The Author(s) 2015.

Effects of exercise and horticultural intervention on the brain and mental health in older adults with depressive symptoms and memory problems: study protocol for a randomized controlled trial [UMIN000018547].

PubMed

Makizako, Hyuma; Tsutsumimoto, Kota; Doi, Takehiko; Hotta, Ryo; Nakakubo, Sho; Liu-Ambrose, Teresa; Shimada, Hiroyuki

2015-11-04

Depressive symptoms and memory problems are significant risk factors for dementia. Exercise can reduce depressive symptoms and improve cognitive function in older people. In addition, the benefits of horticultural activity on physical and mental well-being have been demonstrated in people with dementia. Although evidence of such non-pharmacological interventions is mounting, no studies have examined whether physical exercise and horticultural activity exert a positive impact on brain and mental health (e.g., depressive symptoms) in non-demented older adults at high risk of cognitive impairment and depression. Therefore, we propose a randomized controlled trial to assess the efficacy and efficiency of physical exercise and horticultural activity in improving brain and mental health in community-dwelling older adults with memory problems and depressive symptoms. The 20-week randomized controlled trial will include 90 community-dwelling adults aged 65 years or older with memory problems and depressive symptoms. Participants will be randomized to one of three experiments: exercise, horticultural activity, or educational control group, using a 1:1:1 allocation ratio. The combined exercise program and horticultural activity program will consist of 20 weekly 90-minute sessions. Participants in the exercise group will practice aerobic exercise, muscle strength training, postural balance retraining, and dual-task training. The horticultural activity program will include crop-related activities, such as field cultivation, growing, and harvesting. Participants in the educational control group will attend two 90-minute educational classes during the 6-month trial period. Depressive symptoms and memory performance will be measured by the Geriatric Depression Scale-15, and the Logical Memory subtests of the Wechsler Memory Scale-Revised will be used to measure depressive symptoms and memory performance as primary outcomes, at baseline (prior to randomization), immediately following intervention (6 months from baseline), and 6 months after intervention. Hippocampal volume will be measured at baseline and immediately after intervention, using magnetic resonance imaging. Secondary outcomes will comprise cognitive function, including language, attention/executive performance, and processing speed; brain-derived neurotrophic-factor serum levels; and health-related quality of life. This intervention study will determine the clinical importance and efficacy of physical exercise and horticultural activity as non-pharmacological interventions in community-dwelling older adults at high risk of poor brain and mental health. UMIN000018547 ; registered 7 August 2015.

Assessing the Validity of the Quality of Life Enjoyment and Satisfaction Questionnaire--Short Form in Adults with ADHD

ERIC Educational Resources Information Center

Mick, Eric; Faraone, Stephen V.; Spencer, Thomas; Zhang, Huabin F.; Biederman, Joseph

2008-01-01

Objective: The authors assessed the psychometric properties of the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-QSF) in adults with ADHD. Method: One hundred fifty ADHD and 134 non-ADHD adults from a case-control study and 173 adults randomized to placebo or methylphenidate were assessed with the Q-LES-QSF and the…

Mindfulness-based stress reduction for chronic insomnia in adults older than 75 years: a randomized, controlled, single-blind clinical trial.

PubMed

Zhang, Jia-Xu; Liu, Xiao-Hui; Xie, Xin-Hui; Zhao, Dan; Shan, Mo-Shui; Zhang, Xi-Liang; Kong, Xiao-Ming; Cui, Hong

2015-01-01

To assess the effectiveness of mindfulness-based stress reduction (MBSR) for chronic insomnia and combined depressive or anxiety symptoms of older adults aged 75 years and over. A randomized, controlled, single-blind clinical trial. Participants included 60 adults aged 75 years and over with chronic insomnia. Participants were randomly assigned to the eight-week MBSR group or the wait-list control group. Assessments using the Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Sale (SAS), and Geriatric Depression Scale (GDS) were taken at baseline and post-treatment. For each outcome measure, a repeated measures analysis of variance was used to detect changes across assessments. There was a significant time × group interaction for the PSQI global score (P = .006); the MBSR group had a decrease in the PSQI global score (Cohen׳s d = 1.12), while the control group did not (Cohen׳s d = -0.06). Among the PSQI components, there was a significant time × group interaction for daytime dysfunction (P = .048); Cohen׳s d of the MBSR group was 0.76, while Cohen׳s d of control group was -0.04. There was no significant time × group interaction for the SAS score (P = .116), while for the GDS there was a significant time × group interaction (P = .039); the Cohen׳s d value for the MBSR group was 1.20, and it was 0.12 for the control group. This study demonstrated that the MBSR program could be a beneficial treatment for chronic insomnia in adults aged 75 years and older. Copyright © 2015 Elsevier Inc. All rights reserved.

Improving Motor Control in Walking: A Randomized Clinical Trial in Older Adults with Subclinical Walking Difficulty

PubMed Central

Brach, Jennifer S.; Lowry, Kristin; Perera, Subashan; Hornyak, Victoria; Wert, David; Studenski, Stephanie A.; VanSwearingen, Jessie M.

2016-01-01

Objective The objective was to test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait. Design Single blinded randomized clinical trial. Setting University research laboratory. Participants Forty older adults 65 years of age and older, with gait speed >1.0 m/s and impaired motor skill (Figure of 8 walk time > 8 secs). Interventions The two interventions included a task-oriented motor learning and a standard exercise program. Both interventions lasted 12 weeks, with twice weekly one hour physical therapist supervised sessions. Main Outcome Measures Two measure of the motor control of gait, gait variability and smoothness of walking, were assessed pre and post intervention by assessors masked to treatment arm. Results Of 40 randomized subjects; 38 completed the trial (mean age 77.1±6.0 years). Motor control group improved more than standard group in double support time variability (0.13 vs. 0.05 m/s; adjusted difference, AD=0.006, p=0.03). Smoothness of walking in the anterior/posterior direction improved more in motor control than standard for all conditions (usual: AD=0.53, p=0.05; narrow: AD=0.56, p=0.01; dual task: AD=0.57, p=0.04). Conclusions Among older adults with subclinical walking difficulty, there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking, while standard exercise does not. Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults, and needs to be evaluated in a definitive larger trial. PMID:25448244

The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults.

PubMed

Barnes, Deborah E; Santos-Modesitt, Wendy; Poelke, Gina; Kramer, Arthur F; Castro, Cynthia; Middleton, Laura E; Yaffe, Kristine

2013-05-13

The prevalence of cognitive impairment and dementia are projected to rise dramatically during the next 40 years, and strategies for maintaining cognitive function with age are critically needed. Physical or mental activity alone result in relatively small, domain-specific improvements in cognitive function in older adults; combined interventions may have more global effects. To examine the combined effects of physical plus mental activity on cognitive function in older adults. Randomized controlled trial with a factorial design. San Francisco, California. A total of 126 inactive, community-residing older adults with cognitive complaints. All participants engaged in home-based mental activity (1 h/d, 3 d/wk) plus class-based physical activity (1 h/d, 3 d/wk) for 12 weeks and were randomized to either mental activity intervention (MA-I; intensive computer) or mental activity control (MA-C; educational DVDs) plus exercise intervention (EX-I; aerobic) or exercise control (EX-C; stretching and toning); a 2 × 2 factorial design was used so that there were 4 groups: MA-I/EX-I, MA-I/EX-C, MA-C/EX-1, and MA-C/EX-C. Global cognitive change based on a comprehensive neuropsychological test battery. Participants had a mean age of 73.4 years; 62.7% were women, and 34.9% were Hispanic or nonwhite. There were no significant differences between the groups at baseline. Global cognitive scores improved significantly over time (mean, 0.16 SD; P < .001) but did not differ between groups in the comparison between MA-I and MA-C (ignoring exercise, P = .17), the comparison between EX-I and EX-C (ignoring mental activity, P = .74), or across all 4 randomization groups (P = .26). In inactive older adults with cognitive complaints, 12 weeks of physical plus mental activity was associated with significant improvements in global cognitive function with no evidence of difference between intervention and active control groups. These findings may reflect practice effects or may suggest that the amount of activity is more important than the type in this subject population. clinicaltrials.gov Identifier: NCT00522899.

Systematic Literature Review of Randomized Control Trials Assessing the Effectiveness of Nutrition Interventions in Community-Dwelling Older Adults

ERIC Educational Resources Information Center

Bandayrel, Kristofer; Wong, Sharon

2011-01-01

Objective: Nutrition interventions may play an important role in maintaining the health and quality of life in community-dwelling older adults. To the authors' knowledge, no systematic literature review has been conducted on the effectiveness of nutrition interventions in the community-dwelling older adult population. Design: Systematic literature…

Design and Recruitment for a Randomized Controlled Trial of Problem-Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services.

PubMed

Albert, Steven M; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F

2016-01-01

Addressing subthreshold depression (indicated prevention) and vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative (Dep-ABC) is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing, senior centers) who meet criteria for subthreshold depression and disability. Therefore, the authors examine the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and the baseline status of participants. Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves six to eight sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect well-being and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem-solving therapy is acceptable to this population and can be added to current services. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Design and Recruitment for a Randomized Controlled Trial of Problem Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services

PubMed Central

Albert, Steven M.; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F.

2015-01-01

Background Addressing subthreshold depression (indicated prevention) as well as vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing senior centers) who meet criteria for subthreshold depression and disability. Objective To examine (i) the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, (ii) the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and (iii) the baseline status of participants. Methods Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves 6–8 sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect wellbeing and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Results Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Conclusions Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem solving therapy is acceptable to this population and can be added to current services. PMID:26706911

The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial.

PubMed

Gustafson, David H; McTavish, Fiona; Gustafson, David H; Mahoney, Jane E; Johnson, Roberta A; Lee, John D; Quanbeck, Andrew; Atwood, Amy K; Isham, Andrew; Veeramani, Raj; Clemson, Lindy; Shah, Dhavan

2015-04-25

This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation). This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome. Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in which subsets of older adults. If Elder Tree can improve quality of life and reduce healthcare costs among older adults, it could suggest a promising way to ease the burden that advancing age can place on older adults, their families, and the healthcare system. ClinicalTrials.gov NCT02128789 . Registered on 26 March 2014.

Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial).

PubMed

Spaic, Tamara; Mahon, Jeff L; Hramiak, Irene; Byers, Nicole; Evans, Keira; Robinson, Tracy; Lawson, Margaret L; Malcolm, Janine; Goldbloom, Ellen B; Clarson, Cheril L

2013-10-09

Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care. Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications. The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes (T1D) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated. Despite the importance of minimizing loss to follow-up there are no randomized control trials evaluating models of transition from pediatric to adult diabetes care. This is a multicentre randomized controlled trial. A minimum of 188 subjects with T1D aged between 17 and 20 years will be evaluated. Eligible subjects will be recruited from three pediatric care centres and randomly assigned in a 1:1 ratio to a structured transition program that will span 18 months or to receive standard diabetes care. The structured transition program is a multidisciplinary, complex intervention aiming to provide additional support in the transition period. A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate. Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment. The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care. Secondary outcome measures include A1C frequency measurement and levels, diabetes related emergency room visits and hospital admissions, frequency of complication screening, and subject perception and satisfaction with care. This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults. NCT01351857.

Review of Yoga Therapy During Cancer Treatment

PubMed Central

Danhauer, Suzanne C.; Addington, Elizabeth L.; Sohl, Stephanie J.; Chaoul, Alejandro; Cohen, Lorenzo

2017-01-01

Purpose Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Methods Studies were identified via research databases and reference lists. Inclusion criteria: (1) children or adults undergoing cancer treatment; (2) intervention stated as yoga or component of yoga; and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria: (1) samples receiving hormone therapy only; (2) interventions involving only meditation; and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results Results of non-randomized (adult: n=8, pediatric: n=4) and randomized controlled trials (adult: n=13, pediatric: n=0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Conclusions Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines. PMID:28064385

Reducing the Need for Personal Supports among Workers with Autism Using an iPod Touch as an Assistive Technology: Delayed Randomized Control Trial

ERIC Educational Resources Information Center

Gentry, Tony; Kriner, Richard; Sima, Adam; McDonough, Jennifer; Wehman, Paul

2015-01-01

Personal digital assistants (PDAs) are versatile task organizers that hold promise as assistive technologies for people with cognitive-behavioral challenges. This delayed randomized controlled trial compared two groups of adult workers with autism spectrum disorder (ASD) to determine whether the use of an Apple iPod Touch PDA as a vocational…

Habit Reversal as a Treatment for Chronic Skin Picking: A Pilot Investigation

ERIC Educational Resources Information Center

Teng, Ellen J.; Woods, Douglas W.; Twohig, Michael P.

2006-01-01

The purpose of this study was to compare the effectiveness of habit reversal (HR) to a wait-list control as a treatment for chronic skin picking in adults. Twenty-five adults with a chronic skin-picking problem were randomly assigned to a wait-list control or HR group. At pretreatment, posttreatment, and a 3-month follow-up, self-reported skin…

Effect of peer support interventions on cardiovascular disease risk factors in adults with diabetes: a systematic review and meta-analysis.

PubMed

Patil, Sonal J; Ruppar, Todd; Koopman, Richelle J; Lindbloom, Erik J; Elliott, Susan G; Mehr, David R; Conn, Vicki S

2018-03-23

Peer support by persons affected with diabetes improves peer supporter's diabetes self-management skills. Peer support interventions by individuals who have diabetes or are affected by diabetes have been shown to improve glycemic control; however, its effects on other cardiovascular disease risk factors in adults with diabetes are unknown. We aimed to estimate the effect of peer support interventions on cardiovascular disease risk factors other than glycemic control in adults with diabetes. We conducted a systematic review and meta-analysis of randomized controlled trials comparing peer support interventions to a control condition in adults affected by diabetes that measured any cardiovascular disease risk factors [Body Mass Index, smoking, diet, physical activity, cholesterol level, glucose control and blood pressure]. Quality was assessed by Cochrane's risk of bias tool. We calculated standardized mean difference effect sizes using random effects models. We retrieved 438 citations from multiple databases including OVID MEDLINE, Cochrane database and Scopus, and author searches. Of 233 abstracts reviewed, 16 articles met inclusion criteria. A random effects model in a total of 3243 participants showed a positive effect of peer support interventions on systolic BP with a pooled effect size of 2.07 mmHg (CI 0.35 mmHg to 3.79 mmHg, p = 0.02); baseline pooled systolic blood pressure was 137 mmHg. There was a non-significant effect of peer support interventions on diastolic blood pressure, cholesterol, body mass index, diet and physical activity. Cardiovascular disease risk factors other than glycemic control outcomes were secondary outcomes in most studies and baseline values were normal or mildly elevated. Only one study reported smoking outcomes. We found a small (2 mmHg) positive effect of peer support interventions on systolic blood pressure in adults with diabetes whose baseline blood pressure was on average minimally elevated. Additional studies need to be conducted to further understand the effect of peer support interventions on high-risk cardiovascular disease risk factors in adults with diabetes.

Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial.

PubMed

Anton, Stephen D; Manini, Todd M; Milsom, Vanessa A; Dubyak, Pamela; Cesari, Matteo; Cheng, Jing; Daniels, Michael J; Marsiske, Michael; Pahor, Marco; Leeuwenburgh, Christiaan; Perri, Michael G

2011-01-01

Obesity and a sedentary lifestyle are associated with physical impairments and biologic changes in older adults. Weight loss combined with exercise may reduce inflammation and improve physical functioning in overweight, sedentary, older adults. This study tested whether a weight loss program combined with moderate exercise could improve physical function in obese, older adult women. Participants (N = 34) were generally healthy, obese, older adult women (age range 55-79 years) with mild to moderate physical impairments (ie, functional limitations). Participants were randomly assigned to one of two groups for 24 weeks: (i) weight loss plus exercise (WL+E; n = 17; mean age = 63.7 years [4.5]) or (ii) educational control (n = 17; mean age = 63.7 [6.7]). In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions within their community each week. During exercise sessions, participants engaged in brisk walking and lower-body resistance training of moderate intensity. Participants in the educational control group attended monthly health education lectures on topics relevant to older adults. Outcomes were: (i) body weight, (ii) walking speed (assessed by 400-meter walk test), (iii) the Short Physical Performance Battery (SPPB), and (iv) knee extension isokinetic strength. Participants randomized to the WL+E group lost significantly more weight than participants in the educational control group (5.95 [0.992] vs 0.23 [0.99] kg; P < 0.01). Additionally, the walking speed of participants in the WL+E group significantly increased compared with that of the control group (reduction in time on the 400-meter walk test = 44 seconds; P < 0.05). Scores on the SPPB improved in both the intervention and educational control groups from pre- to post-test (P < 0.05), with significant differences between groups (P = 0.02). Knee extension strength was maintained in both groups. Our findings suggest that a lifestyle-based weight loss program consisting of moderate caloric restriction plus moderate exercise can produce significant weight loss and improve physical function while maintaining muscle strength in obese, older adult women with mild to moderate physical impairments.

Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial

PubMed Central

Anton, Stephen D; Manini, Todd M; Milsom, Vanessa A; Dubyak, Pamela; Cesari, Matteo; Cheng, Jing; Daniels, Michael J; Marsiske, Michael; Pahor, Marco; Leeuwenburgh, Christiaan; Perri, Michael G

2011-01-01

Background: Obesity and a sedentary lifestyle are associated with physical impairments and biologic changes in older adults. Weight loss combined with exercise may reduce inflammation and improve physical functioning in overweight, sedentary, older adults. This study tested whether a weight loss program combined with moderate exercise could improve physical function in obese, older adult women. Methods: Participants (N = 34) were generally healthy, obese, older adult women (age range 55–79 years) with mild to moderate physical impairments (ie, functional limitations). Participants were randomly assigned to one of two groups for 24 weeks: (i) weight loss plus exercise (WL+E; n = 17; mean age = 63.7 years [4.5]) or (ii) educational control (n = 17; mean age = 63.7 [6.7]). In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions within their community each week. During exercise sessions, participants engaged in brisk walking and lower-body resistance training of moderate intensity. Participants in the educational control group attended monthly health education lectures on topics relevant to older adults. Outcomes were: (i) body weight, (ii) walking speed (assessed by 400-meter walk test), (iii) the Short Physical Performance Battery (SPPB), and (iv) knee extension isokinetic strength. Results: Participants randomized to the WL+E group lost significantly more weight than participants in the educational control group (5.95 [0.992] vs 0.23 [0.99] kg; P < 0.01). Additionally, the walking speed of participants in the WL+E group significantly increased compared with that of the control group (reduction in time on the 400-meter walk test = 44 seconds; P < 0.05). Scores on the SPPB improved in both the intervention and educational control groups from pre- to post-test (P < 0.05), with significant differences between groups (P = 0.02). Knee extension strength was maintained in both groups. Conclusion: Our findings suggest that a lifestyle-based weight loss program consisting of moderate caloric restriction plus moderate exercise can produce significant weight loss and improve physical function while maintaining muscle strength in obese, older adult women with mild to moderate physical impairments. PMID:21753869

A Randomized, Controlled Pilot Study of a Single-Session Psychoeducation Treatment for Urban, Culturally Diverse, Trauma-Exposed Adults.

PubMed

Ghafoori, Bita; Fisher, Dennis; Korosteleva, Olga; Hong, Madelyn

2016-06-01

This randomized pilot study aimed to determine whether a single session of psychoeducation improved mental health outcomes, attitudes toward treatment, and service engagement among urban, impoverished, culturally diverse, trauma-exposed adults. Sixty-seven individuals were randomly assigned to a single-session psychoeducation treatment or a delayed treatment comparison control group. The control group was found to be superior to the treatment group at posttest with respect to symptoms of posttraumatic stress disorder, anxiety, and occupational and family disability. At follow-up, all participants had completed the psychoeducation treatment, and a mixed-effects model indicated significant improvements over time in symptoms of posttraumatic stress disorder, anxiety, depression, somatization, and attitudes toward treatment. Ninety-eight percent of the participants reported the psychoeducation was helpful at follow-up. Participants also reported a 19.1% increase in mental health service utilization at follow-up compared with baseline. Implications for treatment and future research are discussed.

Randomized controlled trial comparing tailoring methods of multimedia-based fall prevention education for community-dwelling older adults.

PubMed

Schepens, Stacey L; Panzer, Victoria; Goldberg, Allon

2011-01-01

We attempted to determine whether multimedia fall prevention education using different instructional strategies increases older adults' knowledge of fall threats and their fall prevention behaviors. Fifty-three community-dwelling older adults were randomized to iwo educational groups or a control group. Multimedia-based educational interventions to increase fall threats knowledge and encourage fall prevention behaviors had two tailoring strategies: (1) improve content realism for individual learners (authenticity group) and (2) highlight program goals and benefits while using participants' content selections (motivation group). Knowledge was measured at baseline and 1-mo follow-up. Participants recorded prevention behaviors for 1 mo. Intervention group participants showed greater knowledge gains and posttest knowledge than did control group participants. The motivation group engaged in more prevention behaviors over 1 mo than did the other groups. Tailoring fall prevention education by addressing authenticity and motivation successfully improved fall threats knowledge. Combining motivational strategies with multimedia education increased the effectiveness of the intervention in encouraging fall prevention behaviors.

Analysis of acute naproxen administration on memory in young adults: A randomized, double-blind, placebo-controlled study.

PubMed

Wilson, Jack H; Criss, Amy H; Spangler, Sean A; Walukevich, Katherine; Hewett, Sandra

2017-10-01

Nonsteroidal anti-inflammatory drugs work by non-selectively inhibiting cyclooxygenase enzymes. Evidence indicates that metabolites of the cyclooxygenase pathway play a critical role in the process of learning and memory. We evaluated whether acute naproxen treatment impairs short-term working memory, episodic memory, or semantic memory in a young, healthy adult population. Participants received a single dose of placebo or naproxen (750 mg) in random order separated by 7-10 days. Two hours following administration, participants completed five memory tasks. The administration of acute high-dose naproxen had no effect on memory in healthy young adults.

Smartphone Technology and Text Messaging for Weight Loss in Young Adults: A Randomized Controlled Trial.

PubMed

Stephens, Janna D; Yager, Allison M; Allen, Jerilyn

Using smartphone technology and text messaging for health is a growing field. This type of technology is well integrated into the lives of young adults. However, few studies have tested the effect of this type of technology to promote weight loss in young adults OBJECTIVE:: The purpose of this study is to test the effectiveness of a behaviorally based smartphone application for weight loss combined with text messaging from a health coach on weight, body mass index (BMI), and waist circumference in young adults as compared with a control condition. Sixty-two young adults, aged 18 to 25 years, were randomized to receive (1) a smartphone application + health coach intervention and counseling sessions or (2) control condition with a counseling session. All outcome measures were tested at baseline and 3 months. These included weight, BMI, waist circumference, dietary habits, physical activity habits, and self-efficacy for healthy eating and physical activity. The sample was 71% female and 39% white, with an average age of 20 years and average BMI of 28.5 kg/m. Participants in the smartphone + health coach group lost significantly more weight (P = .026) and had a significant reduction in both BMI (P = .024) and waist circumference (P < .01) compared with controls. The results of this weight loss trial support the use of smartphone technology and feedback from a health coach on improving weight in a group of diverse young adults.

Results from the Xylitol for Adult Caries Trial (X-ACT)

PubMed Central

Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

2013-01-01

Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

Effect of dietary fiber on circulating C-reactive protein in overweight and obese adults: a meta-analysis of randomized controlled trials.

PubMed

Jiao, Jun; Xu, Jia-Ying; Zhang, Weiguo; Han, Shufen; Qin, Li-Qiang

2015-02-01

Previous studies suggested that dietary fiber intake may have a lowing effect on circulating C-reactive protein (CRP) level, a sensitive marker of inflammation, in overweight/obese adults with inconsistent results. A literature search was performed in April 2014 for related randomized controlled trials (RCTs) and meta-analysis was conducted. Meta-analysis including 14 RCTs showed that intervention with dietary fiber or fiber-rich food, compared with control, produced a slight, but significant reduction of 0.37 mg/L (95% CI -0.74, 0) in circulating CRP level among this population. Subgroup analyses showed that such a significant reduction was only observed after combining studies where the total fiber intake was 8 g/d higher in the intervention group than in the control group. No obvious heterogeneity and publication bias were found in the meta-analysis. In conclusion, this meta-analysis provides evidence that dietary fiber or food naturally rich in fiber has beneficial effects on circulating CRP level in overweight/obese adults.

Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety: a randomized controlled trial.

PubMed

Dear, Blake F; Zou, Judy B; Ali, Shehzad; Lorian, Carolyn N; Johnston, Luke; Sheehan, Joanne; Staples, Lauren G; Gandy, Milena; Fogliati, Vincent J; Klein, Britt; Titov, Nickolai

2015-03-01

There is preliminary support for internet-delivered cognitive behaviour therapy (iCBT) as a way of improving access to treatment among older adults with anxiety. The aim of this randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety. Successful applicants were randomly allocated to either the treatment group (n=35) or the waitlist control group (n=37). The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email. Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90% provided data at posttreatment. Significantly lower scores on measures of anxiety (Cohen's d=1.43; 95% CI: 0.89 - 1.93) and depression (Cohen's d=1.79; 95% CI: 1.21 - 2.32) were found among the treatment group compared to the control group at posttreatment. These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable. The treatment group had slightly higher costs ($92.2; 95% CI: $38.7 to $149.2) and Quality-Adjusted Life-Years (QALYs=0.010; 95% CI: 0.003 to 0.018) than the control group at posttreatment and the intervention was found to have a greater than 95% probability of being cost-effective. The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety. Australian and New Zealand Clinical Trials Registry: ACTRN12611000929909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000929909. Copyright © 2014. Published by Elsevier Ltd.

Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors.

PubMed

Rabin, Carolyn; Pinto, Bernardine; Fava, Joseph

2016-03-01

Young adult cancer survivors have a number of increased health and psychosocial risks. To minimize these risks, they must address any modifiable risk factors, for example increase their physical activity (PA) and reduce stress. Unfortunately, more than half of young survivors remain sedentary, and few participate in a structured form of relaxation. This study evaluated the feasibility, acceptability, and effects of a theory-based PA and meditation intervention for young survivors. Young adult cancer survivors (age 18-39 years) were randomized to receive the 12-week "RElaxation aNd Exercise for Wellness" (RENEW) intervention right away (intervention group) or after a 12-week wait (control group). Participants were assessed at baseline, 12 weeks, and 24 weeks. Thirty-five survivors were enrolled and randomized. Results indicate that 89% of intervention calls were delivered, and most participants felt that intervention goals and the number and duration of intervention calls were appropriate. Satisfaction ratings indicate that the intervention was acceptable, and 100% of participants would recommend it to others. Comparison of the intervention and control groups at the 12-week assessment (i.e., before controls received the intervention) revealed that the intervention group was performing more minutes of at least moderate intensity PA/week (p = 0.002; M = 113.8, SE = 23.5 vs. M = -8.7, SE = 27.1) and outperformed controls on a test of cardiovascular fitness (p = 0.008; M = -1.76, SE = 0.41 vs. M = -0.03, SE = 0.45). When data from the intervention and control groups were pooled, pre- to post-intervention analyses indicated a trend toward improved mood. This theory-based intervention for young adult cancer survivors was feasible and acceptable, and may have helped survivors increase PA, improve fitness, and enhance mood.

Atomoxetine Treatment Strengthens an Anti-Correlated Relationship between Functional Brain Networks in Medication-Naïve Adults with Attention-Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Clinical Trial

PubMed Central

Lin, Hsiang-Yuan

2016-01-01

Background: Although atomoxetine demonstrates efficacy in individuals with attention-deficit hyperactivity disorder, its treatment effects on brain resting-state functional connectivity remain unknown. Therefore, we aimed to investigate major brain functional networks in medication-naïve adults with attention-deficit hyperactivity disorder and the efficacy of atomoxetine treatment on resting-state functional connectivity. Methods: After collecting baseline resting-state functional MRI scans from 24 adults with attention-deficit hyperactivity disorder (aged 18–52 years) and 24 healthy controls (matched in demographic characteristics), the participants with attention-deficit hyperactivity disorder were randomly assigned to atomoxetine (n=12) and placebo (n=12) arms in an 8-week, double-blind, placebo-controlled trial. The primary outcome was functional connectivity assessed by a resting-state functional MRI. Seed-based functional connectivity was calculated and compared for the affective, attention, default, and cognitive control networks. Results: At baseline, we found atypical cross talk between the default, cognitive control, and dorsal attention networks and hypoconnectivity within the dorsal attention and default networks in adults with attention-deficit hyperactivity disorder. Our first-ever placebo-controlled clinical trial incorporating resting-state functional MRI showed that treatment with atomoxetine strengthened an anticorrelated relationship between the default and task-positive networks and modulated all major brain networks. The strengthened anticorrelations were associated with improving clinical symptoms in the atomoxetine-treated adults. Conclusions: Our results support the idea that atypical default mode network task-positive network interaction plays an important role in the pathophysiology of adult attention-deficit hyperactivity disorder. Strengthening this atypical relationship following atomoxetine treatment suggests an important pathway to treat attention-deficit hyperactivity disorder. PMID:26377368

Atomoxetine Treatment Strengthens an Anti-Correlated Relationship between Functional Brain Networks in Medication-Naïve Adults with Attention-Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

PubMed

Lin, Hsiang-Yuan; Gau, Susan Shur-Fen

2015-09-16

Although atomoxetine demonstrates efficacy in individuals with attention-deficit hyperactivity disorder, its treatment effects on brain resting-state functional connectivity remain unknown. Therefore, we aimed to investigate major brain functional networks in medication-naïve adults with attention-deficit hyperactivity disorder and the efficacy of atomoxetine treatment on resting-state functional connectivity. After collecting baseline resting-state functional MRI scans from 24 adults with attention-deficit hyperactivity disorder (aged 18-52 years) and 24 healthy controls (matched in demographic characteristics), the participants with attention-deficit hyperactivity disorder were randomly assigned to atomoxetine (n=12) and placebo (n=12) arms in an 8-week, double-blind, placebo-controlled trial. The primary outcome was functional connectivity assessed by a resting-state functional MRI. Seed-based functional connectivity was calculated and compared for the affective, attention, default, and cognitive control networks. At baseline, we found atypical cross talk between the default, cognitive control, and dorsal attention networks and hypoconnectivity within the dorsal attention and default networks in adults with attention-deficit hyperactivity disorder. Our first-ever placebo-controlled clinical trial incorporating resting-state functional MRI showed that treatment with atomoxetine strengthened an anticorrelated relationship between the default and task-positive networks and modulated all major brain networks. The strengthened anticorrelations were associated with improving clinical symptoms in the atomoxetine-treated adults. Our results support the idea that atypical default mode network task-positive network interaction plays an important role in the pathophysiology of adult attention-deficit hyperactivity disorder. Strengthening this atypical relationship following atomoxetine treatment suggests an important pathway to treat attention-deficit hyperactivity disorder. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Targeted spine strengthening exercise and posture training program to reduce hyperkyphosis in older adults: results from the study of hyperkyphosis, exercise, and function (SHEAF) randomized controlled trial.

PubMed

Katzman, W B; Vittinghoff, E; Lin, F; Schafer, A; Long, R K; Wong, S; Gladin, A; Fan, B; Allaire, B; Kado, D M; Lane, N E

2017-10-01

A 6-month randomized controlled trial of spine-strengthening exercise and posture training reduced both radiographic and clinical measures of kyphosis. Participants receiving the intervention improved self-image and satisfaction with their appearance. Results suggest that spine-strengthening exercise and postural training may be an effective treatment option for older adults with hyperkyphosis. The purpose of the present study is to determine in a randomized controlled trial whether spine-strengthening exercises improve Cobb angle of kyphosis in community-dwelling older adults. We recruited adults ≥60 years with kyphosis ≥40° and enrolled 99 participants (71 women, 28 men), mean age 70.6 ± 0.6 years, range 60-88, with baseline Cobb angle 57.4 ± 12.5°. The intervention included group spine-strengthening exercise and postural training, delivered by a physical therapist, 1-h, three times weekly for 6 months. Controls received four group health education meetings. The primary outcome was change in the gold standard Cobb angle of kyphosis measured from standing lateral spine radiographs. Secondary outcomes included change in kyphometer-measured kyphosis, physical function (modified Physical Performance Test, gait speed, Timed Up and Go, Timed Loaded Standing, 6-Min Walk), and health-related quality of life (HRQoL) (PROMIS global health and physical function indexes, SRS-30 self-image domain). ANCOVA was used to assess treatment effects on change from baseline to 6 months in all outcomes. There was a -3.0° (95% CI -5.2, -0.8) between-group difference in change in Cobb angle, p = 0.009, favoring the intervention and approximating the magnitude of change from an incident vertebral fracture. Kyphometer-measured kyphosis (p = 0.03) and SRS-30 self-esteem (p < 0.001) showed favorable between-group differences in change, with no group differences in physical function or additional HRQoL outcomes, p > 0.05. Spine-strengthening exercise and posture training over 6 months reduced kyphosis compared to control. Our randomized controlled trial results suggest that a targeted kyphosis-specific exercise program may be an effective treatment option for older adults with hyperkyphosis. ClinicalTrials.gov; identifier NCT01751685.

Interpersonal Skills Training: Evaluation of a Program with Adult Male Offenders.

ERIC Educational Resources Information Center

Bornstein, Philip H.; And Others

1979-01-01

To assess the efficacy of an interpersonal skill training program, adult offenders were randomly assigned to either interpersonal effectiveness training or waiting-list control. Results indicated interpersonal effectiveness training group superiority on Interpersonal Behavior Role-Play Test training and generalization assessment items. Findings…

Effect of Footwear on Joint Pain and Function in Older Adults With Lower Extremity Osteoarthritis.

PubMed

Wagner, Amy; Luna, Sarah

Lower extremity osteoarthritis (OA) is a common condition among older adults; given the risks of surgical and pharmaceutical interventions, conservative, lower-cost management options such as footwear warrant further investigation. This systematic review investigated the effects of footwear, including shoe inserts, in reducing lower extremity joint pain and improving gait, mobility, and quality of life in older adults with OA. The CINAHL, SPORTDiscus, PubMed, RECAL, and Web of Knowledge databases were searched for publications from January 1990 to September 2014, using the terms "footwear," "shoes," "gait," "pain," and "older adult." Participants who were 50 years or older and those who had OA in at least one lower extremity joint narrowed the results. Outcomes of interest included measures of pain, comfort, function, gait, or quality of life. Exclusion criteria applied to participants with rheumatoid arthritis, amputation, diabetes, multiple sclerosis, use of modified footwear or custom orthotics, purely biomechanical studies, and outcomes of balance or falls only. Single-case studies, qualitative narrative descriptions, and expert opinions were also excluded. The initial search resulted in a total of 417 citations. Eleven articles met inclusion criteria. Two randomized controlled trials and 3 quasiexperimental studies reported lateral wedge insoles may have at least some pain-relieving effects and improved functional mobility in older adults at 4 weeks to 2 years' follow-up, particularly when used with subtalar and ankle strapping. Three randomized controlled trials with large sample sizes reported that lateral wedges provided no knee pain relief compared with flat insoles. Hardness of shoe soles did not significantly affect joint comfort in the foot in a quasiexperimental study. A quasiexperimental designed study investigating shock-absorbing insoles showed reduction in knee joint pain with 1 month of wear. Finally, a cross-sectional prognostic study indicated poor footwear at early ages exhibits an association with hindfoot pain later in life. Because of the limited number of randomized control trials, it is not possible to make a definitive conclusion about the long-term effects of footwear on lower extremity joint pain caused by OA. There is mounting evidence that shock-absorbing insoles, subtalar strapping, and avoidance of high heels and sandals early in life may prevent lower extremity joint pain in older adults, but no conclusive evidence exists to show that lateral wedge insoles will provide long-term relief from knee joint pain and improved mobility in older adults with OA. More high-quality randomized control trials are needed to study the effectiveness of footwear and shoe inserts on joint pain and function in older adults with OA.

The effect of music listening on older adults undergoing cardiovascular surgery.

PubMed

Twiss, Elizabeth; Seaver, Jean; McCaffrey, Ruth

2006-01-01

The purpose of this study was to determine the effect of music listening on postoperative anxiety and intubation time in patients undergoing cardiovascular surgery. Coronary artery disease and valvular heart disease affect approximately 15 million Americans and 5 million persons in the U.K. annually, with the majority of these patients being older adults. The anxiety experienced before, during and after surgery increases cardiovascular workload, thereby prolonging recovery time. Music listening as a nursing intervention has shown an ability to reduce anxiety. The study used a randomized control trial design. Sixty adults older than 65 years were randomly assigned to the control and the experimental groups. The experimental group listened to music during and after surgery, while the control group received standard postoperative care. The Spielberger State Trait Anxiety Inventory was administered to both groups before surgery and 3 days postoperatively. The mean of the differences between scores was compared using analysis of variance. Differences in mean intubation time were measured in both groups. Older adults who listened to music had lower scores on the state anxiety test (F = 5.57, p = .022) and had significantly fewer minutes of postoperative intubation (F = 5.45, p = .031) after cardiovascular surgery. Older adults undergoing cardiovascular surgery who listen to music had less anxiety and reduced intubation time than those who did not.

Systematic review and meta-analysis of Saccharomyces boulardii in adult patients.

PubMed

McFarland, Lynne V

2010-05-14

This article reviews the evidence for efficacy and safety of Saccharomyces boulardii (S. boulardii) for various disease indications in adults based on the peer-reviewed, randomized clinical trials and pre-clinical studies from the published medical literature (Medline, Clinical Trial websites and meeting abstracts) between 1976 and 2009. For meta-analysis, only randomized, blinded controlled trials unrestricted by language were included. Pre-clinical studies, volunteer studies and uncontrolled studies were excluded from the review of efficacy and meta-analysis, but included in the systematic review. Of 31 randomized, placebo-controlled treatment arms in 27 trials (encompassing 5029 study patients), S. boulardii was found to be significantly efficacious and safe in 84% of those treatment arms. A meta-analysis found a significant therapeutic efficacy for S. boulardii in the prevention of antibiotic-associated diarrhea (AAD) (RR = 0.47, 95% CI: 0.35-0.63, P < 0.001). In adults, S. boulardii can be strongly recommended for the prevention of AAD and the traveler's diarrhea. Randomized trials also support the use of this yeast probiotic for prevention of enteral nutrition-related diarrhea and reduction of Helicobacter pylori treatment-related symptoms. S. boulardii shows promise for the prevention of C. difficile disease recurrences; treatment of irritable bowel syndrome, acute adult diarrhea, Crohn's disease, giardiasis, human immunodeficiency virus-related diarrhea; but more supporting evidence is recommended for these indications. The use of S. boulardii as a therapeutic probiotic is evidence-based for both efficacy and safety for several types of diarrhea.

Systematic review and meta-analysis of Saccharomyces boulardii in adult patients

PubMed Central

McFarland, Lynne V

2010-01-01

This article reviews the evidence for efficacy and safety of Saccharomyces boulardii (S. boulardii) for various disease indications in adults based on the peer-reviewed, randomized clinical trials and pre-clinical studies from the published medical literature (Medline, Clinical Trial websites and meeting abstracts) between 1976 and 2009. For meta-analysis, only randomized, blinded controlled trials unrestricted by language were included. Pre-clinical studies, volunteer studies and uncontrolled studies were excluded from the review of efficacy and meta-analysis, but included in the systematic review. Of 31 randomized, placebo-controlled treatment arms in 27 trials (encompassing 5029 study patients), S. boulardii was found to be significantly efficacious and safe in 84% of those treatment arms. A meta-analysis found a significant therapeutic efficacy for S. boulardii in the prevention of antibiotic-associated diarrhea (AAD) (RR = 0.47, 95% CI: 0.35-0.63, P < 0.001). In adults, S. boulardii can be strongly recommended for the prevention of AAD and the traveler’s diarrhea. Randomized trials also support the use of this yeast probiotic for prevention of enteral nutrition-related diarrhea and reduction of Heliobacter pylori treatment-related symptoms. S. boulardii shows promise for the prevention of C. difficile disease recurrences; treatment of irritable bowel syndrome, acute adult diarrhea, Crohn’s disease, giardiasis, human immunodeficiency virus-related diarrhea; but more supporting evidence is recommended for these indications. The use of S. boulardii as a therapeutic probiotic is evidence-based for both efficacy and safety for several types of diarrhea. PMID:20458757

A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

DTIC Science & Technology

2013-10-01

Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder PRINCIPAL INVESTIGATOR: John Gabrieli...SUBTITLE A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder 5a. CONTRACT NUMBER...dysfunctions and (2) oxytocin (OT) administration prior to CBT sessions will each enhance social function in young adults with autism spectrum disorders

Improved functions and reduced length of stay after inpatient rehabilitation programs in older adults with stroke: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Bindawas, Saad M; Vennu, Vishal; Moftah, Emad

2017-01-01

to examine the effects of inpatient rehabilitation programs on function and length of stay in older adults with strokeMETHODS: A total of five electronic databases were searched for relevant randomized controlled trials that examined the effects of inpatient rehabilitation programs on functional recovery, as measured by the functional independence measure and length of stay, which was measured in days. We included full-text articles written in English, and no time limit. The methodological quality and risk of bias were assessed using the Physiotherapy Evidence Database Scale and the Cochrane collaboration tools respectively. The effect sizes and confidence intervals were estimated using fixed-effect modelsRESULTS: Eight randomized controlled trials involving 1,910 patients with stroke were included in the meta-analysis showed that patients who participated in the inpatient rehabilitation programs had significantly (p less than 0.05) higher functional independence measure scores (effect size = 0.10; 95 percent confidence interval = 0.01, 0.22) and shorter length of stay (effect size = 0.14; 95 percent confidence interval = 0.03, 0.22). This systematic review provided evidence that inpatient rehabilitation programs have beneficial effects, improving functionality and reducing length of stay for older adults with stroke.

The Transfer of Cognitive Speed of Processing Training to Older Adults' Driving Mobility Across 5 Years.

PubMed

Ross, Lesley A; Edwards, Jerri D; O'Connor, Melissa L; Ball, Karlene K; Wadley, Virginia G; Vance, David E

2016-01-01

Multilevel models assessed the effects of cognitive speed of processing training (SPT) on older adults' self-reported driving using intention-to-treat (ITT, randomization to training or control conditions) and dosage (treatment-received via number of training sessions) analyses across 5 years. Participants randomized to SPT (n = 598) were compared with those randomized to either the no-contact control (n = 598) or memory training, which served as an active control (n = 610). Driving mobility (frequency, exposure, and space) was assessed over time. No significant effects were found within the ITT analyses. However, number of SPT sessions did affect driving mobility outcomes. In the full sample (N = 1,806), higher SPT doses were associated with maintained driving frequency as compared with both control groups, but no effects were found for driving exposure or space. Subsample analyses (n = 315) revealed that persons at-risk for mobility declines (i.e., poor initial processing speed) who received additional booster SPT sessions reported greater maintenance of both driving frequency and exposure over time as compared with the no-contact and active control groups. These results and prior research indicate that cognitive SPT transfers to prolonged driving mobility among older adults. Future research should investigate the mechanisms behind transfer effects to real-world activities, such as driving. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Randomized controlled trial of a web-based indoor tanning intervention: Acceptability and preliminary outcomes.

PubMed

Stapleton, Jerod L; Manne, Sharon L; Darabos, Katie; Greene, Kathryn; Ray, Anne E; Turner, Amber L; Coups, Elliot J

2015-12-01

This article describes the acceptability and preliminary behavioral outcomes of a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning users' perceptions of the benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre- and postintervention assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants' evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6 weeks postintervention. Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared with control participants on the postintervention assessment. No differences were found for sunburns. The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Effectiveness of cognitive-behavioural therapy on glycaemic control and psychological outcomes in adults with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Uchendu, C; Blake, H

2017-03-01

Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes. An electronic search was conducted in PubMed, Embase, MEDLINE, PsycINFO, CINAHL, Web of Knowledge, Cochrane Central Register of Controlled Trials and references in reviews. Twelve randomized controlled trials (RCTs) were identified that evaluated the effectiveness of CBT on at least one of: glycaemic control, diabetes-related distress, anxiety, depression or quality of life in adults with Type 1 or Type 2 diabetes. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias assessment and meta-analysis, respectively. CBT is effective in reducing short-term and medium-term glycaemic control, although no significant effect was found for long-term glycaemic control. CBT improved short- and medium-term anxiety and depression, and long-term depression. Mixed results were found for diabetes-related distress and quality of life. CBT is beneficial in improving depression for adults with diabetes. It may have benefits for improving glycaemic control and other aspects of psychological health, although the findings are inconclusive. © 2016 Diabetes UK.

Brief Treatments for Cannabis Dependence: Findings From a Randomized Multisite Trial

ERIC Educational Resources Information Center

Babor, Thomas F.

2004-01-01

This study evaluated the efficacy of 2 brief interventions for cannabis-dependent adults. A multisite randomized controlled trial compared cannabis use outcomes across 3 study conditions: (a) 2 sessions of motivational enhancement therapy (MET); (b) 9 sessions of multicomponent therapy that included MET, cognitive-behavioral therapy, and case…

Educational and Skills-Based Interventions to Prevent Relationship Violence in Young People

ERIC Educational Resources Information Center

Fellmeth, Gracia; Heffernan, Catherine; Nurse, Joanna; Habibula, Shakiba; Sethi, Dinesh

2015-01-01

Objectives: To assess the efficacy of educational and skills-based interventions to prevent relationship and dating violence in adolescents and young adults. Methods: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, and other databases for randomized, cluster-randomized, and quasi-randomized…

Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial

USDA-ARS?s Scientific Manuscript database

As populations shift to include a larger proportion of older adults, the necessity of research targeting older populations is becoming increasingly apparent. Changes in motor coordination during ‘normal’ aging, in animals and humans, include decrements in balance and locomotion. Parallel to alterati...

Dietary strawberry improves cognition in older adults: a randomized, double-blind, placebo-controlled study

USDA-ARS?s Scientific Manuscript database

Older adults experience a variety of functional changes that decrease their quality of life with age-related cognitive decline and reduced mobility being of particular concern. Pre-clinical research indicates that berry fruit offer a promising dietary approach to preserving nervous system function, ...

Problem-Solving Therapy for Depression in Adults: A Systematic Review

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie

2008-01-01

Objectives: This article presents a systematic review of the evidence on problem-solving therapy (PST) for depressive disorders in noninstitutionalized adults. Method: Intervention studies using randomized controlled designs are included and methodological quality is assessed using a standard set of criteria from the Cochrane Collaborative Review…

Spatial and Temporal Lingual Coarticulation and Motor Control in Preadolescents

ERIC Educational Resources Information Center

Zharkova, Natalia; Hewlett, Nigel; Hardcastle, William J.; Lickley, Robin J.

2014-01-01

Purpose: In this study, the authors compared coarticulation and lingual kinematics in preadolescents and adults in order to establish whether preadolescents had a greater degree of random variability in tongue posture and whether their patterns of lingual coarticulation differed from those of adults. Method: High-speed ultrasound tongue contour…

Immunoglobulin G antibodies against indoor dampness-related microbes and adult-onset asthma: a population-based incident case–control study

PubMed Central

JAAKKOLA, M S; LAITINEN, S; PIIPARI, R; UITTI, J; NORDMAN, H; HAAPALA, A-M; JAAKKOLA, J J K

2002-01-01

Immunoglobulin G (IgG) antibodies against microbes related to indoor dampness problems have been used as potential biomarkers of fungal exposure in clinical investigations. There is limited information on their relation to asthma. We conducted a population-based incident case–control study to assess the risk of asthma in relation to specific IgG antibodies to eight dampness-related microbes: Aspergillus fumigatus, A. versicolor, Cladosporium cladosporioides, Fusarium oxysporum, Sporobolomyces salmonicolor, Stachybotrys chartarum, Streptomyces albus and Trichoderma citrinoviride. We recruited systematically all new cases of asthma during a 2·5-year study period and randomly selected controls from a source population of adults 21–63 years of age living in the Pirkanmaa Hospital District, South Finland. The clinically diagnosed case series consisted of 521 adults with newly diagnosed asthma and the control series of 932 controls selected randomly from the source population. IgG antibodies were analysed with ELISA. An increased risk of developing asthma in adulthood was significantly related to IgG antibodies to T. citrinoviride, but not to the other moulds. There was no evidence of a dose–response relation between the IgG antibody level and the risk of asthma. T. citrinoviride may play a role in the aetiology of adult-onset asthma or serve as an indicator of other causal factors. PMID:12100029

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

ERIC Educational Resources Information Center

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

Attitudinal and Psychosocial Outcomes of a Fitness and Health Education Program on Adults with Down Syndrome

ERIC Educational Resources Information Center

Heller, Tamar; Hsieh, Kelly; Rimmer, James H.

2004-01-01

Attitudinal and psychosocial outcomes of a fitness and health education program for adults with Down syndrome were examined. Participants were 53 adults with Down syndrome ages 30 years and older (29 females, 24 males, M age = 39.72 years) who were randomized into a training (n = 32) or control group (n = 21). The training group participated in a…

Elastic Band Exercises Improved Activities of Daily Living and Functional Fitness of Wheelchair-bound Older Adults with Cognitive Impairment: A Cluster Randomized Controlled Trial.

PubMed

Chen, Meng-Chun; Chen, Kuei-Min; Chang, Chu-Lin; Chang, Ya-Hui; Cheng, Yin-Yin; Huang, Hsin-Ting

2016-11-01

The purpose of this study was to test the effects of a 6-month Wheelchair-bound Senior Elastic Band (WSEB) exercise program on the activities of daily living (ADL) and functional fitness of wheelchair-bound older adults with cognitive impairment. Cluster randomized controlled trial was used. A convenience sample of 138 wheelchair-bound older adults with cognitive impairment were recruited from 8 nursing homes in southern Taiwan and were randomly assigned based on the nursing homes they lived to the experimental (4 nursing homes; n = 73) or the control group (4 nursing homes; n = 65). The experimental group performed WSEB exercises 3 times per week and 40 minutes per session for 6 months. The ADL and functional fitness (cardiopulmonary function, body flexibility, range of joint motion, and muscle strength and endurance) were examined at baseline, 3 months, and the end of 6-month study. The ADL and functional fitness indicators of participants in the experimental group showed significant improvements compared to the control group (all P < 0.05). The WSEB exercises have positive benefits for the ADL and functional fitness of wheelchair-bound older adults with cognitive impairment. It is suggested that WSEB exercises be included as a routine activity in nursing homes. Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCMECME OBJECTIVES:: Upon completion of this article the reader should be able to: (1) Understand the risk factors for functional decline in older adults with dementia; (2) Articulate the benefits of structured activities and exercises in the older adult with dementia; and (3) Incorporate elastic band exercises into the treatment plan of wheelchair bound older adults with dementia. AdvancedACCREDITATION:: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Association of Academic Physiatrists designates this activity for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

A systematic review and meta-analysis: Effectiveness of internet empowerment-based self-management interventions on adults with metabolic diseases.

PubMed

Kuo, Chia-Chi; Su, Yu-Jen; Lin, Chiu-Chu

2018-03-25

To synthesize the effects of Internet empowerment-based self-management interventions on adults with metabolic diseases. Metabolic diseases are prevalent and burden healthcare systems; they have become a major health problem worldwide. The effects of IESMIs on lifestyle changes have been shown to improve adults' physiological and psychological conditions. However, we found no systematic review evaluating these effects. Systematic review and meta-analysis of randomized and non-randomized controlled trials, conducted according to the Cochrane handbook. A literature search was conducted using the Airiti Library, Association for Computing Machinery, CINAHL, Cochrane Library, Embase, ProQuest, PubMed/MEDLINE and Index of the Taiwan Periodical Literature System databases (earliest-June 2016). Two reviewers used the Cochrane Collaboration bias assessment tool to assess the methodological quality of included studies. Extracted data were entered and analysed using RevMan 5.3.5 software. Inverse variance was used to estimate effect sizes. Weighted and standardized mean differences with 95% confidence intervals were calculated using a random effects model. Subgroup and sensitivity analyses were performed. Twenty-one randomized controlled trials were reviewed. Meta-analysis showed that the intervention significantly improved adults' exercise habits, glycated haemoglobin (HbA1c) levels, body weight, empowerment levels and quality of life. The intervention significantly improve the health status of adults with metabolic diseases, in particular their exercise habits, HbA1c levels, body weight, empowerment and quality of life. The intervention provides more convenient and faster access to healthcare for busy individuals with time constraints. These results suggest that healthcare professionals could develop accessible and friendly interactive online interfaces for patients to expand the use of these interventions in the clinical setting. © 2018 John Wiley & Sons Ltd.

Review of yoga therapy during cancer treatment.

PubMed

Danhauer, Suzanne C; Addington, Elizabeth L; Sohl, Stephanie J; Chaoul, Alejandro; Cohen, Lorenzo

2017-04-01

Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Studies were identified via research databases and reference lists. Inclusion criteria were the following: (1) children or adults undergoing cancer treatment, (2) intervention stated as yoga or component of yoga, and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria were the following: (1) samples receiving hormone therapy only, (2) interventions involving meditation only, and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results of non-randomized (adult n = 8, pediatric n = 4) and randomized controlled trials (adult n = 13, pediatric n = 0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines.

Community-wide promotion of physical activity in middle-aged and older Japanese: a 3-year evaluation of a cluster randomized trial.

PubMed

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Harada, Kazuhiro; Lee, I-Min; Bauman, Adrian; Miyachi, Motohiko

2015-06-23

Promotion of physical activity (PA) is a key strategy to prevent non-communicable diseases. However, evidence on the effectiveness of community-wide interventions (CWIs) for promoting PA is limited. To evaluate the effectiveness of a 3-year CWI for promoting PA in middle-aged and older adults compared with usual public health services. This study is an extension to an original 1-year investigation study. Cluster randomized controlled trial with community as unit of randomization and individual as unit of analysis. 12 communities in Unnan, Japan were randomly allocated to the intervention (9) or the control (3). Additionally intervention communities were randomly allocated to aerobic activity promotion (Group A), flexibility and muscle-strengthening activities promotion (Group FM), or aerobic, flexibility, and muscle-strengthening activities promotion (Group AFM), each consisting of three communities. Randomly-sampled 4414 residents aged 40 to 79 years responded to the baseline survey (74%), and were analyzed in 2013-2014. A 3-year CWI based on social marketing, to promote PA from 2009 to 2012. The primary outcome was a change in regular aerobic, flexibility, and/or muscle-strengthening activities, defined by (1) engaging in 150 mins/week or more of walking, (2) engaging in daily flexibility activity, or (3) engaging 2 or more days/week in muscle-strengthening activities, evaluated at the individual level. Secondary outcomes were changes in specific types of PA and musculoskeletal pain. Outcomes were measured at baseline and at 1 and 3 years (2009, 2010, and 2012). The CWI did not significantly increase the proportion of adults who reached recommended levels of aerobic, flexibility, and/or muscle-strengthening activities (adjusted change difference = 1.6% [95% CI: -3.5, 6.6]). In the subgroup analysis, compared to the controls, adults doing flexibility activity daily significantly increased in Group FM (6.3% [95% CI: 1.9, 10.7]). In Group A and AFM for PA outcomes and in all groups for pain outcomes, there was no significant change compared to controls. The CWI did not achieve significant increase in the proportion of adults who reached recommended PA levels. However, it might be effective in promoting flexibility activity in middle-aged and older Japanese. UMIN-CTR UMIN000002683 .

Elearning approaches to prevent weight gain in young adults: A randomized controlled study.

PubMed

Nikolaou, Charoula Konstantia; Hankey, Catherine Ruth; Lean, Michael Ernest John

2015-12-01

Preventing obesity among young adults should be a preferred public health approach given the limited efficacy of treatment interventions. This study examined whether weight gain can be prevented by online approaches using two different behavioral models, one overtly directed at obesity and the other covertly. A three-group parallel randomized controlled intervention was conducted in 2012-2013; 20,975 young adults were allocated a priori to one control and two "treatment" groups. Two treatment groups were offered online courses over 19 weeks on (1) personal weight control ("Not the Ice Cream Van," NTICV) and, (2) political, environmental, and social issues around food ("Goddess Demetra," "GD"). Control group received no contact. The primary outcome was weight change over 40 weeks. Within-group 40-week weight changes were different between groups (P < 0.001): Control (n = 2,134): +2.0 kg (95% CI = 1.5, 2.3 kg); NTICV (n = 1,810): -1.0 kg (95% CI = -1.3, -0.5); and GD (n = 2,057): -1.35 kg (95% CI = -1.4 to -0.7). Relative risks for weight gain vs. NTICV = 0.13 kg (95% CI = 0.10, 0.15), P < 0.0001; GD = 0.07 kg (95% CI = 0.05, 0.10), P < 0.0001. Both interventions were associated with prevention of the weight gain observed among control subjects. This low-cost intervention could be widely transferable as one tool against the obesity epidemic. Outside the randomized controlled trial setting, it could be enhanced using supporting advertising and social media. © 2015 The Obesity Society.

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial.

PubMed

Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

2017-08-04

Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. This will be analyzed by negative binomial regression, yielding density ratios. This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources. Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial.

PubMed

Sosnoff, Jacob J; Finlayson, Marcia; McAuley, Edward; Morrison, Steve; Motl, Robert W

2014-03-01

To determine the feasibility, safety, and efficacy of a home-based exercise intervention targeting fall risk in older adults with multiple sclerosis. A randomized controlled pilot trial. A home-based exercise program. Participants were randomly allocated to either a home-based exercise intervention group (n = 13) or a waiting list control group (n = 14). The exercise group completed exercises targeting lower muscle strength and balance three times a week for 12 weeks. The control group continued normal activity. Fall risk (Physiological Profile Assessment scores), balance (Berg Balance Scale), and walking testing prior to and immediately following the 12-week intervention. Each outcome measure was placed in an analysis of covariance with group as the between-subject factor and baseline values as the covariate. Effect sizes were calculated. Twelve participants from the control group and ten from the exercise group completed the study. There were no related adverse events. Fall risk was found to decrease in the exercise group following the intervention (1.1 SD 1.0 vs. 0.6 SD 0.6) while there was an increase in fall risk in the control group (1.9 SD 1.5 vs. 2.2 SD 1.9). Effect sizes for most outcomes were large (η(2) > 0.15). Home-based exercise was found to be feasible, safe, and effective for reducing physiological fall risk in older adults with multiple sclerosis. Our findings support the implementation of a larger trial to reduce fall risk in persons with multiple sclerosis.

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

PubMed

Carlson, Mike; Vigen, Cheryl Lp; Rubayi, Salah; Blanche, Erna Imperatore; Blanchard, Jeanine; Atkins, Michal; Bates-Jensen, Barbara; Garber, Susan L; Pyatak, Elizabeth A; Diaz, Jesus; Florindez, Lucia I; Hay, Joel W; Mallinson, Trudy; Unger, Jennifer B; Azen, Stanley Paul; Scott, Michael; Cogan, Alison; Clark, Florence

2017-04-17

Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. ClinicalTrials.gov NCT01999816.

Post-traumatic stress disorder in older adults: a systematic review of the psychotherapy treatment literature.

PubMed

Dinnen, Stephanie; Simiola, Vanessa; Cook, Joan M

2015-01-01

Older adults represent the fastest growing segment of the US and industrialized populations. However, older adults have generally not been included in randomized clinical trials of psychotherapy for post-traumatic stress disorder (PTSD). This review examined reports of psychological treatment for trauma-related problems, primarily PTSD, in studies with samples of at least 50% adults aged 55 and older using standardized measures. A systematic review of the literature was conducted on psychotherapy for PTSD with older adults using PubMed, Medline, PsychInfo, CINAHL, PILOTS, and Google Scholar. A total of 42 studies were retrieved for full review; 22 were excluded because they did not provide at least one outcome measure or results were not reported by age in the case of mixed-age samples. Of the 20 studies that met review criteria, there were: 13 case studies or series, three uncontrolled pilot studies, two randomized clinical trials, one non-randomized concurrent control study and one post hoc effectiveness study. Significant methodological limitations in the current older adult PTSD treatment outcome literature were found reducing its internal validity and generalizability, including non-randomized research designs, lack of comparison conditions and small sample sizes. Select evidence-based interventions validated in younger and middle-aged populations appear acceptable and efficacious with older adults. There are few treatment studies on subsets of the older adult population including cultural and ethnic minorities, women, the oldest old (over 85), and those who are cognitively impaired. Implications for clinical practice and future research directions are discussed.

Tai Chi Improves Sleep Quality in Healthy Adults and Patients with Chronic Conditions: A Systematic Review and Meta-analysis

PubMed Central

Raman, Gowri; Zhang, Yuan; Minichiello, Vincent J; D'Ambrosio, Carolyn M.; Wang, Chenchen

2017-01-01

Background Physical activity and exercise appear to improve sleep quality. However, the quantitative effects of Tai Chi on sleep quality in the adult population have rarely been examined. We conducted a systematic review and meta-analysis evaluating the effects of Tai Chi on sleep quality in healthy adults and disease populations. Methods Medline, Cochrane Central databases, and review of references were searched through July 31, 2013. English-language studies of all designs evaluating Tai Chi’s effect on sleep outcomes in adults were examined. Data were extracted and verified by 2 reviewers. Extracted information included study setting and design, population characteristics, type and duration of interventions, outcomes, risk of bias and main results. Random effect models meta-analysis was used to assess the magnitude of treatment effect when at least 3 trials reported on the same sleep outcomes. Results Eleven studies (9 randomized and 2 non-randomized trials) totaling 994 subjects published between 2004 and 2012 were identified. All studies except one reported Pittsburg Sleep Quality Index. Nine randomized trials reported that 1.5 to 3 hour each week for a duration of 6 to 24 weeks of Tai Chi significantly improved sleep quality (Effect Size, 0.89; 95% confidence interval [CI], 0.28 to 1.50), in community-dwelling healthy participants and in patients with chronic conditions. Improvement in health outcomes including physical performance, pain reduction, and psychological well-being occurred in the Tai Chi group compared with various controls. Limitations Studies were heterogeneous and some trials were lacking in methodological rigor. Conclusions Tai Chi significantly improved sleep quality in both healthy adults and patients with chronic health conditions, which suggests that Tai Chi may be considered as an alternative behavioral therapy in the treatment of insomnia. High-quality, well-controlled randomized trials are needed to better inform clinical decisions. PMID:28845367

Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

PubMed Central

2010-01-01

Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT00357877 PMID:20923557

Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial Study Protocol

PubMed Central

Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

2015-01-01

Background Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. Objective The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. Methods A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as “On the Road to Quitting” (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. Results This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. Conclusions This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that drive change in smoking behavior using an app, and improve the design of cessation apps. This trial is among the first to assess the effect of a comprehensive and evidence-informed mHealth smoking cessation app on a large sample of young adult smokers. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the intervention. If effective, the trial has the potential to demonstrate that including mHealth technology as a population-based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit. Trial Registration ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i). PMID:25599695

Effect of a mobile phone intervention on quitting smoking in a young adult population of smokers: randomized controlled trial study protocol.

PubMed

Baskerville, Neill Bruce; Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

2015-01-19

Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as "On the Road to Quitting" (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that drive change in smoking behavior using an app, and improve the design of cessation apps. This trial is among the first to assess the effect of a comprehensive and evidence-informed mHealth smoking cessation app on a large sample of young adult smokers. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the intervention. If effective, the trial has the potential to demonstrate that including mHealth technology as a population-based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit. ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i).

A randomized trial to measure the impact of a community-based cognitive training intervention on balance and gait in cognitively intact Black older adults.

PubMed

Smith-Ray, Renae L; Makowski-Woidan, Beth; Hughes, Susan L

2014-10-01

Fall prevention is important for maintaining mobility and independence into old age. Approaches for reducing falls include exercise, tai chi, and home modifications; however, causes of falling are multifactorial and include not just physical but cognitive factors. Cognitive decline occurs with age, but older adults with the greatest declines in executive function experience more falls. The purpose of this study was twofold: to demonstrate the feasibility of a community-based cognitive training program for cognitively intact Black older adults and to analyze its impact on gait and balance in this population. This pilot study used a pretest/posttest randomized trial design with assignment to an intervention or control group. Participants assigned to the intervention completed a computer-based cognitive training class that met 2 days a week for 60 min over 10 weeks. Classes were held at senior/community centers. Primary outcomes included balance as measured by the Berg Balance Scale (BBS), 10-meter gait speed, and 10-meter gait speed under visuospatial dual-task condition. All measures were assessed at baseline and immediately post-intervention. Participants were community-dwelling Black adults with a mean age of 72.5 and history of falls (N = 45). Compared to controls, intervention participants experienced statistically significant improvements in BBS and gait speed. Mean performance on distracted gait speed also improved more for intervention participants compared to controls. Findings from this pilot randomized trial demonstrate the feasibility of a community-based cognitive training intervention. They provide initial evidence that cognitive training may be an efficacious approach toward improving balance and gait in older adults known to have a history of falls. © 2014 Society for Public Health Education.

Effects of a Lutein and Zeaxanthin Intervention on Cognitive Function: A Randomized, Double-Masked, Placebo-Controlled Trial of Younger Healthy Adults.

PubMed

Renzi-Hammond, Lisa M; Bovier, Emily R; Fletcher, Laura M; Miller, L Stephen; Mewborn, Catherine M; Lindbergh, Cutter A; Baxter, Jeffrey H; Hammond, Billy R

2017-11-14

Background: Past studies have suggested that higher lutein (L) and zeaxanthin (Z) levels in serum and in the central nervous system (as quantified by measuring macular pigment optical density, MPOD) are related to improved cognitive function in older adults. Very few studies have addressed the issue of xanthophylls and cognitive function in younger adults, and no controlled trials have been conducted to date to determine whether or not supplementation with L + Z can change cognitive function in this population. Objective: The purpose of this study was to determine whether or not supplementation with L + Z could improve cognitive function in young (age 18-30), healthy adults. Design: A randomized, double-masked, placebo-controlled trial design was used. Fifty-one young, healthy subjects were recruited as part of a larger study on xanthophylls and cognitive function. Subjects were randomized into active supplement ( n = 37) and placebo groups ( n = 14). MPOD was measured psychophysically using customized heterochromatic flicker photometry. Cognitive function was measured using the CNS Vital Signs testing platform. MPOD and cognitive function were measured every four months for a full year of supplementation. Results: Supplementation increased MPOD significantly over the course of the year, vs. placebo ( p < 0.001). Daily supplementation with L + Z and increases in MPOD resulted in significant improvements in spatial memory ( p < 0.04), reasoning ability ( p < 0.05) and complex attention ( p < 0.04), above and beyond improvements due to practice effects. Conclusions: Supplementation with L + Z improves CNS xanthophyll levels and cognitive function in young, healthy adults. Magnitudes of effects are similar to previous work reporting correlations between MPOD and cognition in other populations.

Effects of a multimodal exercise program on balance, functional mobility and fall risk in older adults with cognitive impairment: a randomized controlled single-blind study.

PubMed

Kovács, E; Sztruhár Jónásné, I; Karóczi, C K; Korpos, A; Gondos, T

2013-10-01

Exercise programs have important role in prevention of falls, but to date, there are conflicting findings about the effects of exercise programs on balance, functional performance and fall risk among cognitively impaired older adults. AIM. To investigate the effects of a multimodal exercise program on static and dynamic balance, and risk of falls in older adults with mild or moderate cognitive impairment. A randomized controlled study. A long-term care institute. Cognitively impaired individuals aged over 60 years. Eighty-six participants were randomized to an exercise group providing multimodal exercise program for 12 months or a control group which did not participate in any exercise program. The Performance Oriented Mobility Assessment scale, Timed Up and Go test, and incidence of falls were measured at baseline, at 6 months and at 12 months. There was a significant improvement in balance-related items of Performance Oriented Mobility Assessment scale in the exercise group both at 6 month and 12 month (P<0.0001, P=0.002; respectively). There was no statistically significant increase in gait-related items of Performance Oriented Mobility Assessment scale after the first 6-month treatment period (P=0.210), but in the second 6-month treatment period the POMA-G score improved significantly (P=0.001). There was no significant difference between groups regarding falls. Our results confirmed that a 12-month multimodal exercise program can improve the balance in cognitively impaired older adults. Based on our results, the multimodal exercise program may be a promising fall prevention exercise program for older adults with mild or moderate cognitive impairment improving static balance but it is supposed that more emphasis should be put on walking component of exercise program and environmental fall risk assessment.

Using music to reduce anxiety among older adults in the emergency department: a randomized pilot study.

PubMed

Belland, Laura; Rivera-Reyes, Laura; Hwang, Ula

2017-11-01

An emergency department (ED) visit may be distressing and anxiety-provoking for older adults (age > 65 years). No studies have specifically evaluated the effect of music listening on anxiety in older adults in the ED. The objective of this pilot study was to evaluate the effect of music listening on anxiety levels in older ED patients. This was a randomized pilot study in the geriatric ED of an urban academic tertiary medical center. This was a sample of English-speaking adults (age > 65 years) who were not deaf (n = 35). Subjects consented to participate and were randomized to receive up to 60 min of music listening with routine care, while the control group received routine care with no music. Subjects in the music treatment group received headphones and an electronic tablet with pre-downloaded music, and were allowed to choose from 5 selections. The primary outcome was change in anxiety levels, measured by the state-trait anxiety inventory (STAI), at enrollment and 1 h later. A total of 35 participants were enrolled: 74% were female, 40% were white, and 40% were black; of these, 32 subjects completed the study protocol. When comparing control (n = 18) against intervention subjects (n = 17), there were no significant differences in enrollment STAI scores (43.00 ± 15.00 vs. 40.30 ± 12.80, P = 0.57). STAI scores 1 hour after enrollment (after the music intervention) were significantly reduced in the intervention subjects compared to the control subjects (with reduction of 10.00 ± 12.29 vs. 1.88 ± 7.97, P = 0.03). These pilot results suggest that music listening may be an effective tool for reducing anxiety among older adults in the ED.

Neuropsychological Profiles on the WAIS-IV of Adults With ADHD.

PubMed

Theiling, Johanna; Petermann, Franz

2016-11-01

The aim of the study was to investigate the pattern of neuropsychological profiles on the Wechsler Adult Intelligence Scale-IV (WAIS-IV) for adults With ADHD relative to randomly matched controls and to assess overall intellectual ability discrepancies of the Full Scale Intelligence Quotient (FSIQ) and the General Ability Index (GAI). In all, 116 adults With ADHD and 116 controls between 16 and 71 years were assessed. Relative to controls, adults With ADHD show significant decrements in subtests with working memory and processing speed demands with moderate to large effect sizes and a higher GAI in comparison with the FSIQ. This suggests first that deficits identified with previous WAIS versions are robust in adults With ADHD and remain deficient when assessed with the WAIS-IV; second that the WAIS-IV reliably differentiates between patients and controls; and third that a reduction of the FSIQ is most likely due to a decrement in working memory and processing speed abilities. The findings have essential implications for the diagnostic process. © The Author(s) 2014.

Nitrofurantoin vs other prophylactic agents in reducing recurrent urinary tract infections in adult women: a systematic review and meta-analysis.

PubMed

Price, Jameca Renee; Guran, Larissa A; Gregory, W Thomas; McDonagh, Marian S

2016-11-01

The clinical and financial burden from bladder infections is significant. Daily antibiotic use is the recommended strategy for recurrent urinary tract infection prevention. Increasing antibiotic resistance rates, however, require immediate identification of innovative alternative prophylactic therapies. This systematic review aims to provide guidance on gaps in evidence to guide future research. The objective of this review was to provide current pooled estimates of randomized control trials comparing the effects of nitrofurantoin vs other agents in reducing recurrent urinary tract infections in adult, nonpregnant women and assess relative adverse side effects. Data sources included the following: MEDLINE, Jan. 1, 1946, to Jan. 31, 2015; Cochrane Central Register of Controlled Trials the Cochrane Database of Systematic Reviews, and web sites of the National Institute for Clinical Excellence, and the National Guideline Clearinghouse from 2000 to 2015. Randomized control trials of women with recurrent urinary tract infections comparing nitrofurantoin with any other treatment were included. A protocol for the study was developed a priori. Published guidance was followed for assessment of study quality. All meta-analyses were performed using random-effects models with Stats Direct Software. Dual review was used for all decisions and data abstraction. Twelve randomized control trials involving 1063 patients were included. One study that had a serious flaw was rated poor in quality, one study rated good, and the remainder fair. No significant differences in prophylactic antibiotic treatment with nitrofurantoin and norfloxacin, trimethoprim, sulfamethoxazole/trimethoprim, methamine hippurate, estriol, or cefaclor were found in clinical or microbiological cure in adult nonpregnant women with recurrent urinary tract infections (9 randomized control trials, 673 patients, relative risk ratio, 1.06; 95% confidence interval, 0.89-1.27; I 2 , 65%; and 12 randomized control trials, 1063 patients, relative risk ratio, 1.06; 95% confidence interval, 0.90-1.26; I 2 , 76%, respectively). Duration of prophylaxis also did not have a significant impact on outcomes. There was a statistically significant difference in overall adverse effects, with nitrofurantoin resulting in greater risk than other prophylactic treatments (10 randomized control trials, 948 patients, relative risk ratio, 2.17; 95% confidence interval, 1.34-3.50; I 2 , 61%). Overall, the majority of nitrofurantoin adverse effects were gastrointestinal, with a significant difference for withdrawals (12 randomized control trials, 1063 patients, relative risk ratio, 2.14; 95% confidence interval, 1.28-3.56; I 2 , 8%). Nitrofurantoin had similar efficacy but a greater risk of adverse events than other prophylactic treatments. Balancing the risks of adverse events, particularly gastrointestinal symptoms, with potential benefits of decreasing collateral ecological damage should be considered if selecting nitrofurantoin. Copyright © 2016 Elsevier Inc. All rights reserved.

Age-Related Corresponding Relationships of Controlled Force Exertion Measured by a Computer-Generated Sinusoidal and Quasi-Random Display

ERIC Educational Resources Information Center

Nagasawa, Yoshinori; Demura, Shinichi

2011-01-01

This study examined age-group corresponding relationships of the controlled force exertion based on sinusoidal and quasi-random waveforms in 175 right-handed male adults aged 20 to 86 years. The subjects were divided into 3 groups based on age-level: 53 young (mean age 24.6, SD = 3.3 years), 71 middle aged (mean age 44.3, SD = 8.7 years), and 51…

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

PubMed

Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

2015-11-01

To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults.

PubMed

Kolmodin MacDonell, Karen; Naar, Sylvie; Gibson-Scipio, Wanda; Lam, Phebe; Secord, Elizabeth

2016-10-01

To conduct a randomized controlled pilot of a multicomponent, technology-based intervention promoting adherence to controller medication in African-American emerging adults with asthma. The intervention consisted of two computer-delivered sessions based on motivational interviewing combined with text messaged reminders between sessions. Participants (N = 49) were 18-29 years old, African-American, with persistent asthma requiring controller medication. Participants had to report poor medication adherence and asthma control. Youth were randomized to receive the intervention or an attention control. Data were collected through computer-delivered self-report questionnaires at baseline, 1, and 3 months. Ecological Momentary Assessment via two-way text messaging was also used to collect "real-time" data on medication use and asthma control. The intervention was feasible and acceptable to the target population, as evidenced by high retention rates and satisfaction scores. Changes in study outcomes from pre- to postintervention favored the intervention, particularly for decrease in asthma symptoms, t (42) = 2.22, p < .05 (Cohen's d = .071). Results suggest that the intervention is feasible and effective. However, findings are preliminary and should be replicated with a larger sample and more sophisticated data analyses. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Randomized Crossover Study of the Natural Restorative Environment Intervention to Improve Attention and Mood in Heart Failure.

PubMed

Jung, Miyeon; Jonides, John; Northouse, Laurel; Berman, Marc G; Koelling, Todd M; Pressler, Susan J

In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results

PubMed Central

2012-01-01

Background The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here. Methods The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. Results There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys. Conclusions Randomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012. Trial registration Current Controlled Trials ISRCTN68175121 PMID:22769971

Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Heavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown. Methods/Design We will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (≥4 drinks for women; ≥5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months. Discussion This study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change. Trial registration Clinicaltrials.gov NCT01688245 PMID:23552023

The effect of a trunk release maneuver on Peak Pressure Index, trunk displacement and perceived discomfort in older adults seated in a High Fowler's position: a randomized controlled trial.

PubMed

Best, Krista L; Desharnais, Guylaine; Boily, Jeanette; Miller, William C; Camp, Pat G

2012-11-16

Pressure ulcers pose significant negative individual consequences and financial burden on the healthcare system. Prolonged sitting in High Fowler's position (HF) is common clinical practice for older adults who spend extended periods of time in bed. While HF aids in digestion and respiration, being placed in a HF may increase perceived discomfort and risk of pressure ulcers due to increased pressure magnitude at the sacral and gluteal regions. It is likely that shearing forces could also contribute to risk of pressure ulcers in HF. The purpose of this study was to evaluate the effect of a low-tech and time-efficient Trunk Release Manuever (TRM) on sacral and gluteal pressure, trunk displacement and perceived discomfort in ambulatory older adults. A randomized controlled trial was used. We recruited community-living adults who were 60 years of age and older using posters, newspaper advertisements and word-of-mouth. Participants were randomly allocated to either the intervention or control group. The intervention group (n = 59) received the TRM, while the control group (n = 58) maintained the standard HF position. The TRM group had significantly lower mean (SD) PPI values post-intervention compared to the control group, 59.6 (30.7) mmHg and 79.9 (36.5) mmHg respectively (p = 0.002). There was also a significant difference in trunk displacement between the TRM and control groups, +3.2 mm and -5.8 mm respectively (p = 0.005). There were no significant differences in perceived discomfort between the groups. The TRM was effective for reducing pressure in the sacral and gluteal regions and for releasing the trunk at the point of contact between the skin and the support surface, but did not have an effect on perceived discomfort. The TRM is a simple method of repositioning which may have important clinical application for the prevention of pressure ulcers that may occur as a result of HF.

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

PubMed

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults. ClinicalTrials.gov, NCT02662192 . Registered on 14 January 2016.

Mechanisms in Psychosocial Interventions for Adults Living with Cancer: Opportunity for Integration of Theory, Research, and Practice

ERIC Educational Resources Information Center

Stanton, Annette L.; Luecken, Linda J.; MacKinnon, David P.; Thompson, Elizabeth H.

2013-01-01

Objective: The diagnosis and treatment of cancer are highly stressful experiences that can profoundly affect emotional and physical well-being. Hundreds of longitudinal investigations that identify risk and protective factors for psychological and physical adjustment in adults living with cancer and numerous randomized controlled psychosocial…

Impact of the Fit and Strong Intervention on Older Adults with Osteoarthritis

ERIC Educational Resources Information Center

Hughes, Susan L.; Seymour, Rachel B.; Campbell, Richard; Pollak, Naomi; Huber, Gail; Sharma, Leena

2004-01-01

Purpose: This study assessed the impact of a low cost, multicomponent physical activity intervention for older adults with lower extremity osteoarthritis. Design and Methods: A randomized controlled trial compared the effects of a facility-based multiple-component training program followed by home-based adherence (n = 80) to a wait list control…

Morpho-Phonemic Analysis Boosts Word Reading for Adult Struggling Readers

ERIC Educational Resources Information Center

Gray, Susan H.; Ehri, Linnea C.; Locke, John L.

2018-01-01

A randomized control trial compared the effects of two kinds of vocabulary instruction on component reading skills of adult struggling readers. Participants seeking alternative high school diplomas received 8 h of scripted tutoring to learn forty academic vocabulary words embedded within a civics curriculum. They were matched for language…

Validation of Geriatric Depression Scale--5 Scores among Sedentary Older Adults

ERIC Educational Resources Information Center

Marquez, David X.; McAuley, Edward; Motl, Robert W.; Elavsky, Steriani; Konopack, James F.; Jerome, Gerald J.; Kramer, Arthur F.

2006-01-01

This study examined the validity of Geriatric Depression Scale--5 (GDS-5) scores among older sedentary adults based on its structural properties and relationship with external criteria. Participants from two samples (Ns = 185 and 93; M ages = 66 and 67 years) completed baseline assessments as part of randomized controlled exercise trials.…

Simulated Driving Changes in Young Adults with ADHD Receiving Mixed Amphetamine Salts Extended Release and Atomoxetine

ERIC Educational Resources Information Center

Kay, Gary G.; Michaels, M. Alex; Pakull, Barton

2009-01-01

Background: Psychostimulant treatment may improve simulated driving performance in young adults with attention-deficit/hyperactivity disorder (ADHD). Method: This was a randomized, double-blind, placebo-controlled, crossover study of simulated driving performance with mixed amphetamine salts--extended release (MAS XR) 50 mg/day (Cohort 1) and…

Outcome Benchmarks for Adaptations of Research-Supported Treatments for Adult Traumatic Stress

ERIC Educational Resources Information Center

Rubin, Allen; Parrish, Danielle E.; Washburn, Micki

2016-01-01

This article provides benchmark data on within-group effect sizes from published randomized controlled trials (RCTs) that evaluated the efficacy of research-supported treatments (RSTs) for adult traumatic stress. Agencies can compare these benchmarks to their treatment group effect size to inform their decisions as to whether the way they are…

Measuring Perceived Barriers to Healthful Eating in Obese, Treatment-Seeking Adults

ERIC Educational Resources Information Center

Welsh, Ericka M.; Jeffery, Robert W.; Levy, Rona L.; Langer, Shelby L.; Flood, Andrew P.; Jaeb, Melanie A.; Laqua, Patricia S.

2012-01-01

Objective: To characterize perceived barriers to healthful eating in a sample of obese, treatment-seeking adults and to examine whether changes in barriers are associated with energy intake and body weight. Design: Observational study based on findings from a randomized, controlled behavioral weight-loss trial. Participants: Participants were 113…

Healthy Youth Places: A Randomized Controlled Trial to Determine the Effectiveness of Facilitating Adult and Youth Leaders to Promote Physical Activity and Fruit and Vegetable Consumption in Middle Schools

ERIC Educational Resources Information Center

Dzewaltowski, David A.; Estabrooks, Paul A.; Welk, Greg; Hill, Jennie; Milliken, George; Karteroliotis, Kostas; Johnston, Judy A.

2009-01-01

The Healthy Youth Places (HYP) intervention targeted increased fruit and vegetable consumption (FV) and physical activity (PA) through building the environmental change skills and efficacy of adults and youth. HYP included group training for adult school site leaders, environmental change skill curriculum, and youth-led FV and PA environment…

A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

PubMed Central

Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

2014-01-01

Objective To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods Randomized controlled trial. We hypothesized that Koru, compared to a wait-list control group, would reduce perceived stress and sleep problems, and increase mindfulness, self-compassion, and gratitude. Results As hypothesized, results showed significant Group (Koru, wait-list) X Time (pre, post) interactions for improvements in perceived stress (F=4.50, df [1, 76.40], p=.037, d=.45), sleep problems (F= 4.71, df [1,79.49], p=.033, d=.52), mindfulness (F=26.80, df [1, 79.09], p<.001, d=.95), and self-compassion (F=18.08, df [1, 74.77], p<.001, d=.75). All significant effects were replicated in the wait-list group. Significant correlations were observed among changes in perceived stress, sleep problems, mindfulness, and self-compassion. Conclusions Results support the effectiveness of the Koru program for emerging adults in the university setting. PMID:24499130

Leisure education reduces stress among older adults.

PubMed

Chang, Liang-Chih

2014-01-01

The objectives of this study were to examine whether a leisure education program could facilitate leisure competence among older adults and whether it could also reduce their stress. A pre-test-post-test randomized experimental design was conducted. Subjects were randomly assigned to either an experimental group (n = 30) or a control group (n = 30). A leisure education program was used to serve as the intervention. A day before this experiment was carried out, pre-test data were collected using leisure competence and stress scales. Thirty minutes after this experiment ended, post-test data were collected using the same scales. These data were analyzed using an analysis of covariance. The results indicated that the average post-test scores of leisure competence in the experimental group were significantly higher than those in the control group and that the average post-test scores of stress in the experimental group were significantly lower than those in the control group. Healthcare practitioners should adopt the provision of leisure education as a priority to facilitate leisure competence and reduce stress among older adults.

Efficacy of Acupuncture for Bell's Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Li, Pingping; Qiu, Tangmeng; Qin, Chao

2015-01-01

Acupuncture has emerged as an alternative therapy for Bell's palsy in both adults and children. However, the use of acupuncture is controversial. We conducted a systematic review and meta-analysis to assess the efficacy of acupuncture for Bell's palsy. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, irrespective of any language restrictions. Randomized controlled trials comparing acupuncture with other therapies for Bell's palsy in adults or children were included. Fourteen randomized controlled trials involving 1541 individuals were included in this meta-analysis. Significant association was observed in acupuncture with a higher effective response rate for Bell's palsy (relative risk, 1.14; 95% confidence interval, 1.04-1.25; P = 0.005) but there was a heterogeneity among the studies (I2 = 87%). An assessment of the included studies revealed a high risk of bias in methodological quality. An evaluation of the incidence of complications was not available, owing to incomplete data. Acupuncture seems to be an effective therapy for Bell's palsy, but there was insufficient evidence to support the efficacy and safety of acupuncture. However, the results should be interpreted cautiously, because of the poor quality and heterogeneity of the included studies.

Mobile Phone Intervention and Weight Loss Among Overweight and Obese Adults: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Liu, Fangchao; Kong, Xiaomu; Cao, Jie; Chen, Shufeng; Li, Changwei; Huang, Jianfeng; Gu, Dongfeng; Kelly, Tanika N.

2015-01-01

We conducted a meta-analysis of randomized controlled trials to examine the association of mobile phone intervention with net change in weight-related measures among overweight and obese adults. We searched electronic databases and conducted a bibliography review to identify articles published between the inception date of each database and March 27, 2014. Fourteen trials (including 1,337 participants in total) that met the eligibility criteria were included. Two investigators independently abstracted information on study characteristics and study outcomes. Net change estimates comparing the intervention group with the control group were pooled across trials using random-effects models. Compared with the control group, mobile phone intervention was associated with significant changes in body weight and body mass index (weight (kg)/height (m)2) of −1.44 kg (95% confidence interval (CI): −2.12, −0.76) and −0.24 units (95% CI: −0.40, −0.08), respectively. Subgroup analyses revealed that the associations were consistent across study-duration and intervention-type subgroups. For example, net body weight changes were −0.92 kg (95% CI: −1.58, −0.25) and −1.85 kg (95% CI: −2.99, −0.71) in trials of shorter (<6 months) and longer (≥6 months) duration, respectively. These findings provide evidence that mobile phone intervention may be a useful tool for promoting weight loss among overweight and obese adults. PMID:25673817

Consumption of protein-enriched milk has minor effects on inflammation in older adults-A 12-week double-blind randomized controlled trial.

PubMed

Gjevestad, Gyrd O; Ottestad, Inger; Biong, Anne Sofie; Iversen, Per Ole; Retterstøl, Kjetil; Raastad, Truls; Skålhegg, Bjørn S; Ulven, Stine M; Holven, Kirsten B

2017-03-01

Aging is associated with increased levels of circulating inflammatory markers and reduced muscle mass and strength. We investigated whether intake of protein-enriched milk for 12 weeks would influence markers of inflammation among adults ≥70years of age with reduced physical strength. In a double-blind randomized controlled intervention study, subjects were randomly allocated into two groups, receiving a protein-enriched milk (2×20g protein/d, n=14, mean (±SD) age 76.9±4.9 yrs) or an isocaloric carbohydrate drink (n=17, age 77.7±4.8 yrs) for 12 weeks. We measured serum and mRNA expression levels of inflammatory markers in PBMCs. Significant differences in the mRNA expression of nuclear receptor subfamily, group H, member 3 (NR1H3, encoding the LXRα transcription factor) and interferon gamma (INFG) were observed between groups. The mRNA level of TNFRSF1A was significantly reduced, while the mRNA level of dipeptidyl-peptidase 4 (DPP4) was significantly increased, in the control group. The serum level of TNFα increased significantly in the control group, while sTNFRSF1A increased significantly in both groups, but with no significant differences between groups. Consumption of a low-fat, protein-enriched milk for 12 weeks had minor effects on inflammatory related markers in older adults compared to an isocaloric carbohydrate drink. Copyright © 2017 Elsevier B.V. All rights reserved.

Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial.

PubMed

Lee, Kyeongjin; Lee, Yong Woo

2017-09-01

[Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per week for 4 weeks. The main outcome measures, including the Berg balance scale; the functional reach test and one leg stance test for postural balance; and the timed up-and-go test and 10-meter walking test for gait ability, were assessed at baseline and after 4 weeks of training. [Results] The postural balance and gait ability in the ACBT group improved significantly compared to those in the control group, except BBS. [Conclusion] The results of this study showed improved postural balance and gait abilities after ACBT and that ACBT is a feasible method for improving postural balance and gait ability in community-dwelling older adults.

Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial

PubMed Central

Lee, Kyeongjin; Lee, Yong Woo

2017-01-01

[Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per week for 4 weeks. The main outcome measures, including the Berg balance scale; the functional reach test and one leg stance test for postural balance; and the timed up-and-go test and 10-meter walking test for gait ability, were assessed at baseline and after 4 weeks of training. [Results] The postural balance and gait ability in the ACBT group improved significantly compared to those in the control group, except BBS. [Conclusion] The results of this study showed improved postural balance and gait abilities after ACBT and that ACBT is a feasible method for improving postural balance and gait ability in community-dwelling older adults. PMID:28931994

Effects of Tai Chi on Cognition and Fall Risk in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial.

PubMed

Sungkarat, Somporn; Boripuntakul, Sirinun; Chattipakorn, Nipon; Watcharasaksilp, Kanokwan; Lord, Stephen R

2017-04-01

To examine whether combined center- and home-based Tai Chi training can improve cognitive ability and reduce physiological fall risk in older adults with amnestic mild cognitive impairment (a-MCI). Randomized controlled trial. Chiang Mai, Thailand. Adults aged 60 and older who met Petersen's criteria for multiple-domain a-MCI (N = 66). Three weeks center-based and 12 weeks home-based Tai Chi (50 minutes per session, 3 times per week). Cognitive tests, including Logical Memory (LM) delayed recall, Block Design, Digit Span forward and backward, and Trail-Making Test Part B-A (TMT B-A), and fall risk index using the Physiological Profile Assessment (PPA). At the end of the trial, performance on LM, Block Design, and TMT B-A were significantly better for the Tai Chi group than the control group after adjusting for baseline test performance. The Tai Chi group also had significantly better composite PPA score and PPA parameter scores: knee extension strength, reaction time, postural sway, and lower limb proprioception. Combined center- and home-based Tai Chi training three times per week for 15 weeks significantly improved cognitive function and moderately reduced physiological fall risk in older adults with multiple-domain a-MCI. Tai Chi may be particularly beneficial to older adults with this condition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Effects of mind-body interventions on depressive symptoms among older Chinese adults: a systematic review and meta-analysis.

PubMed

Bo, Ai; Mao, Weiyu; Lindsey, Michael A

2017-05-01

To determine the efficacy of mind-body interventions in depressive symptoms treatment among older Chinese adults (>60 years of age). We searched MEDLINE, PsycINFO (Ovid), Embase (Ovid), CINAHL, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Data, Chinese Biomedical Literature Database, and Chongqing VIP for eligible studies until September 2016. We reviewed randomized controlled trials investigating the efficacy of mind-body interventions for depressive symptoms among Chinese older adults. Two authors independently conducted screening, and risk of bias assessment. Data were extracted by one author and crosschecked by the research team. Cohen's d standardized mean differences were calculated to represent intervention effects. A comprehensive search yielded 926 records; 14 articles met inclusion criteria. Relative to the control groups, mind-body interventions had large short-term effects in reducing depressive symptoms in older Chinese adults (standardized mean differences = -1.41; 95% CI [-1.82, -0.99]). Most studies did not report the long-term effects of mind-body interventions. Subgroup analyses by type of mind-body interventions, participants' age group, and control condition yielded different effect sizes; however, these differences did not all reach a statistically significant level. The interpretation of the subgroup analysis should be considered with caution given its observational nature and a small number of included studies. This systematic review suggests that mind-body interventions had short-term effects in alleviating depressive symptoms among older Chinese adults. Further research (randomized controlled trials with active controls and follow-up tests) are needed to assess the effects of mind-body interventions on depressive symptoms among this population. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Effects of a 10-Day Intensive Health Promotion Program Combining Diet and Physical Activity on Body Composition, Physical Fitness, and Blood Factors of Young Adults: A Randomized Pilot Study

PubMed Central

Lee, Kyoung Soon; Lee, Jae Koo; Yeun, Young Ran

2017-01-01

Background A lifestyle characterized by poor eating habits and physical inactivity is a risk factor for multiple lifestyle diseases in young adults. This study assessed the effects of implementing an intensive 10-day health promotion program combining diet and physical activities on body composition, physical fitness, and biochemical parameters of young adults. Material/Methods In this randomized pilot study, 30 female undergraduate students were randomly allocated to an intervention and a control group. The health promotion program consisted of unlimited amounts of vegetarian food; aerobic, flexibility, and strength exercises (3 hours/day); lectures on health (3 hours/day); massage practice (2 hours/day); and healthy cooking practice (1 hour/day). The effects of the intervention were analyzed using the Mann-Whitney U test and the Wilcoxon signed-rank test. Results The intensive 10-day health promotion program significantly reduced body weight, body mass index, triglyceride, total cholesterol, low-density lipoprotein cholesterol, blood glucose, and the homeostasis model assessment of insulin resistance. At the same time, participants demonstrated increased back muscle, leg muscle, and grip strength; waist and shoulder flexibility; balance; and cardiorespiratory endurance. Conclusions The intensive 10-day health promotion program is a viable intervention for improving body composition, physical fitness, glycemic control, and blood lipid levels in young adults. PMID:28399076

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study

PubMed Central

Anton, Stephen D.; Embry, Chelsea; Marsiske, Michael; Lud, Xiaomin; Doss, Hani; Leeuwenburgh, Christiaan; Manini, Todd M.

2014-01-01

Resveratrol has been found to have potent antioxidant, anti-inflammatory, and anticarcinogenic effects. The safety and efficacy of resveratrol supplementation in older adults are currently unknown. We conducted a double-blind, randomized, placebo-controlled trial to examine the safety and metabolic outcomes in 32 overweight, older adults (mean age, 73 ± 7 years). Participants were randomized into one of three treatment groups: (1) placebo, (2) moderate dose resveratrol (300 mg/day), and (3) high dose resveratrol (1000 mg/day). Both resveratrol and placebo were orally ingested in capsule form twice daily for 90 days. Blood chemistry values remained within the normal range, and there were no significant differences in the number of participants reporting adverse events across conditions. Compared to placebo, glucose levels were significantly lower at post-treatment among participants randomized to both resveratrol conditions, with and without adjustment for the corresponding baseline values (ps < 0.05). Glucose values of participants in the treatment groups, however, were not significantly different from baseline levels. These findings suggest that short-term resveratrol supplementation at doses of 300 mg/day and 1000 mg/day does not adversely affect blood chemistries and is well tolerated in overweight, older individuals. These findings support the study of resveratrol for improving cardio-metabolic health in older adults in larger clinical trials. PMID:24866496

The optimal blood glucose level for critically ill adult patients.

PubMed

Lv, Shaoning; Ross, Paul; Tori, Kathleen

2017-09-01

Glycaemic control is recognized as one of the important aspects in managing critically ill patients. Both hyperglycaemia and hypoglycaemia independently increase the risk of patient mortality. Hence, the identification of optimal glycaemic control is of paramount importance in the management of critically ill patients. The aim of this literature review is to examine the current status of glycaemic control in critically ill adult patients. This literature review will focus on randomized controlled trials comparing intensive insulin therapy to conventional insulin therapy, with an objective to identify optimal blood glucose level targets for critically ill adult patients. A literature review was conducted to identify large randomized controlled trials for the optimal targeted blood glucose level for critically ill adult patients published since 2000. A total of eight studies fulfilled the selection criteria of this review. With current human and technology resources, the results of the studies support commencing glycaemic control once the blood glucose level of critically ill patients reaches 10 mmol/L and maintaining this level between 8 mmol/L and 10 mmol/L. This literature review provides a recommendation for targeting the optimal blood glucose level for critically ill patients within moderate blood glucose level target range (8-10 mmol/L). The need for uniformed glucometrics for unbiased reporting and further research for optimal blood glucose target is required, especially in light of new technological advancements in closed-loop insulin delivery and monitoring devices. This literature review has revealed a need to call for consensus in the measurement and reporting of glycaemic control using standardized glucometrics. © 2017 British Association of Critical Care Nurses.

A Block Randomized Controlled Trial of a Brief Smoking Cessation Counselling and Advice through Short Message Service on Participants Who Joined the Quit to Win Contest in Hong Kong

ERIC Educational Resources Information Center

Chan, Sophia S. C.; Wong, David C. N.; Cheung, Yee Tak Derek; Leung, Doris Y. P.; Lau, Lisa; Lai, Vienna; Lam, Tai-Hing

2015-01-01

The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking. A block randomized controlled trial allocated 1003 adult daily smokers to three groups: (i) The TEL group (n = 338) received a 5-min nurse-led telephone counselling; (ii) The SMS group (n = 335) received…

Enhancing the Career Planning Self-Determination of Young Adults with Mental Health Challenges.

PubMed

Sowers, Jo-Ann; Swank, Paul

2017-01-01

The impact of an intervention on the self-determination and career planning engagement of young adults with mental health challenges was studied. Sixty-seven young adults, 20 to 30 years of age, with mental health diagnoses (e.g., depression, bipolar disorder) were randomly assigned to intervention and control groups. Statistically significant greater increases were made by the intervention group versus the control group for self-determination and career planning engagement, and self-determination at least partially mediated increases in career planning engagement. With career planning self-determination interventions, young adults with mental health challenges might be able to achieve better career and life outcomes than is typical for this population.

Feasibility and effects of a physical exercise programme in adults with myotonic dystrophy type 1: a randomized controlled pilot study.

PubMed

Kierkegaard, Marie; Harms-Ringdahl, Karin; Edström, Lars; Widén Holmqvist, Lotta; Tollbäck, Anna

2011-07-01

To investigate the feasibility and effects of a physical exercise programme on functioning and health-related quality of life in adults with myotonic dystrophy type 1. A randomized controlled trial. Thirty-five adults with myotonic dystrophy type 1. After stratification for level of functioning, study participants were assigned by lot to either a training group or a control group. Training-group participants attended a 60-minute comprehensive group-training programme, Friskis&Svettis® Open Doors, twice a week for 14 weeks. The six-minute walk test was the primary outcome measure and the timed-stands test, the timed up-and-go test, the Epworth sleepiness scale and the Short Form-36 health survey were secondary outcome measures. Intention-to-treat analyses revealed no significant differences in any outcome measures, except for an increased between-group difference after intervention in the Short Form-36 mental health subscale and a decrease in the vitality subscale for the control group. The programme was well tolerated and many training-group participants perceived subjective changes for the better. No negative effects were reported. The Friskis&Svettis® Open Doors programme was feasible for adults with myotonic dystrophy type 1 who had been screened for cardiac involvement, had distal or mild-to-moderate proximal muscle impairment, and no severe cognitive impairments. No beneficial or detrimental effects were evident.

Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

PubMed Central

Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

2015-01-01

Objective To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. Methods This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Results Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Conclusion Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention. PMID:25926725

Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial.

PubMed

Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

2015-01-01

To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention.

A randomized controlled trial of multicomponent exercise in older adults with mild cognitive impairment.

PubMed

Suzuki, Takao; Shimada, Hiroyuki; Makizako, Hyuma; Doi, Takehiko; Yoshida, Daisuke; Ito, Kengo; Shimokata, Hiroshi; Washimi, Yukihiko; Endo, Hidetoshi; Kato, Takashi

2013-01-01

To examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment (MCI), and identify biomarkers associated with improvement of cognitive functions. Subjects were 100 older adults (mean age, 75 years) with MCI. The subjects were classified to an amnestic MCI group (n = 50) with neuroimaging measures, and other MCI group (n = 50) before the randomization. Subjects in each group were randomized to either a multicomponent exercise or an education control group using a ratio of 1∶1. The exercise group exercised for 90 min/d, 2 d/wk, 40 times for 6 months. The exercise program was conducted under multitask conditions to stimulate attention and memory. The control group attended two education classes. A repeated-measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients. A sub-analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination (p = .04) and logical memory scores (p = .04), and reducing whole brain cortical atrophy (p<.05) compared to the control group. Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores (p<.05), and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores (p<.05). The results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI. Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI. Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI. UMIN-CTR UMIN000003662 ctr.cgi?function = brows&action = brows&type = summary&recptno = R000004436&language = J.

The effect of asthma education program on knowledge of school teachers: a randomized controlled trial.

PubMed

Kawafha, Mariam M; Tawalbeh, Loai Issa

2015-04-01

The purpose of this study was to examine the effect of an asthma education program on schoolteachers' knowledge. Pre-test-post-test experimental randomized controlled design was used. A multistage-cluster sampling technique was used to randomly select governorate, primary schools, and schoolteachers. Schoolteachers were randomly assigned either to the experimental group (n = 36) and attended three educational sessions or to the control group (n = 38) who did not receive any intervention. Knowledge about asthma was measured using the Asthma General Knowledge Questionnaire for Adults (AGKQA). The results indicated that teachers in the experimental group showed significantly (p < .001) higher knowledge of asthma in the first post-test and the second post-test compared with those in the control group. Implementing asthma education enhanced schoolteachers' knowledge of asthma. The asthma education program should target schoolteachers to improve knowledge about asthma. © The Author(s) 2014.

Sleep quality and depression of nursing home older adults in wheelchairs after exercises.

PubMed

Chen, Kuei-Min; Huang, Hsin-Ting; Cheng, Yin-Yin; Li, Chun-Huw; Chang, Ya-Hui

2015-01-01

Sleep disturbances and depression are costly and potentially disabling conditions that affect a considerable proportion of older adults. The purpose of this study was to test the effectiveness of 6 months of elastic band exercises on sleep quality and depression of wheelchair-bound older adults in nursing homes. One hundred twenty-seven older adults from 10 nursing homes participated in this cluster randomized controlled trial, and 114 completed the study. Participants were randomly assigned to two groups: experimental group (five nursing homes, n = 59) and control group (five nursing homes, n = 55). A 40-minute wheelchair-bound senior elastic band exercise program was implemented 3 times per week for 6 months. Sleep quality and depression of the participants were examined at baseline, after 3 months, and at the end of the 6-month study. Participants in the experimental group had longer sleep durations, better habitual sleep efficiencies, and less depression than the control group at 3 months of the study and maintained them throughout the rest of the 6-month study. Nursing home directors could recruit volunteers to learn the program and lead the elderly residents in wheelchairs in practicing the wheelchair-bound senior elastic band exercises regularly in the facilities. Copyright © 2015 Elsevier Inc. All rights reserved.

Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial.

PubMed

Ballesteros, Soledad; Prieto, Antonio; Mayas, Julia; Toril, Pilar; Pita, Carmen; Ponce de León, Laura; Reales, José M; Waterworth, John

2014-01-01

Age-related cognitive and brain declines can result in functional deterioration in many cognitive domains, dependency, and dementia. A major goal of aging research is to investigate methods that help to maintain brain health, cognition, independent living and wellbeing in older adults. This randomized controlled study investigated the effects of 20 1-h non-action video game training sessions with games selected from a commercially available package (Lumosity) on a series of age-declined cognitive functions and subjective wellbeing. Two groups of healthy older adults participated in the study, the experimental group who received the training and the control group who attended three meetings with the research team along the study. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. All participants were assessed individually before and after the intervention, or a similar period of time, using neuropsychological tests and laboratory tasks to investigate possible transfer effects. The results showed significant improvements in the trained group, and no variation in the control group, in processing speed (choice reaction time), attention (reduction of distraction and increase of alertness), immediate and delayed visual recognition memory, as well as a trend to improve in Affection and Assertivity, two dimensions of the Wellbeing Scale. Visuospatial working memory (WM) and executive control (shifting strategy) did not improve. Overall, the current results support the idea that training healthy older adults with non-action video games will enhance some cognitive abilities but not others.

Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial

PubMed Central

Ballesteros, Soledad; Prieto, Antonio; Mayas, Julia; Toril, Pilar; Pita, Carmen; Ponce de León, Laura; Reales, José M.; Waterworth, John

2014-01-01

Age-related cognitive and brain declines can result in functional deterioration in many cognitive domains, dependency, and dementia. A major goal of aging research is to investigate methods that help to maintain brain health, cognition, independent living and wellbeing in older adults. This randomized controlled study investigated the effects of 20 1-h non-action video game training sessions with games selected from a commercially available package (Lumosity) on a series of age-declined cognitive functions and subjective wellbeing. Two groups of healthy older adults participated in the study, the experimental group who received the training and the control group who attended three meetings with the research team along the study. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. All participants were assessed individually before and after the intervention, or a similar period of time, using neuropsychological tests and laboratory tasks to investigate possible transfer effects. The results showed significant improvements in the trained group, and no variation in the control group, in processing speed (choice reaction time), attention (reduction of distraction and increase of alertness), immediate and delayed visual recognition memory, as well as a trend to improve in Affection and Assertivity, two dimensions of the Wellbeing Scale. Visuospatial working memory (WM) and executive control (shifting strategy) did not improve. Overall, the current results support the idea that training healthy older adults with non-action video games will enhance some cognitive abilities but not others. PMID:25352805

Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial.

PubMed

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Ruiz-Marquez, Eloísa; Toril, Pilar; Reales, José M

2017-01-01

Video game training with older adults potentially enhances aspects of cognition that decline with aging and could therefore offer a promising training approach. Although, previous published studies suggest that training can produce transfer, many of them have certain shortcomings. This randomized controlled trial (RCT; Clinicaltrials.gov ID: NCT02796508) tried to overcome some of these limitations by incorporating an active control group and the assessment of motivation and expectations. Seventy-five older volunteers were randomly assigned to the experimental group trained for 16 sessions with non-action video games from Lumosity , a commercial platform (http://www.lumosity.com/) or to an active control group trained for the same number of sessions with simulation strategy games. The final sample included 55 older adults (30 in the experimental group and 25 in the active control group). Participants were tested individually before and after training to assess working memory (WM) and selective attention and also reported their perceived improvement, motivation and engagement. The results showed improved performance across the training sessions. The main results were: (1) the experimental group did not show greater improvements in measures of selective attention and working memory than the active control group (the opposite occurred in the oddball task); (2) a marginal training effect was observed for the N -back task, but not for the Stroop task while both groups improved in the Corsi Blocks task. Based on these results, one can conclude that training with non-action games provide modest benefits for untrained tasks. The effect is not specific for that kind of training as a similar effect was observed for strategy video games. Groups did not differ in motivation, engagement or expectations.

Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial

PubMed Central

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Ruiz-Marquez, Eloísa; Toril, Pilar; Reales, José M.

2017-01-01

Video game training with older adults potentially enhances aspects of cognition that decline with aging and could therefore offer a promising training approach. Although, previous published studies suggest that training can produce transfer, many of them have certain shortcomings. This randomized controlled trial (RCT; Clinicaltrials.gov ID: NCT02796508) tried to overcome some of these limitations by incorporating an active control group and the assessment of motivation and expectations. Seventy-five older volunteers were randomly assigned to the experimental group trained for 16 sessions with non-action video games from Lumosity, a commercial platform (http://www.lumosity.com/) or to an active control group trained for the same number of sessions with simulation strategy games. The final sample included 55 older adults (30 in the experimental group and 25 in the active control group). Participants were tested individually before and after training to assess working memory (WM) and selective attention and also reported their perceived improvement, motivation and engagement. The results showed improved performance across the training sessions. The main results were: (1) the experimental group did not show greater improvements in measures of selective attention and working memory than the active control group (the opposite occurred in the oddball task); (2) a marginal training effect was observed for the N-back task, but not for the Stroop task while both groups improved in the Corsi Blocks task. Based on these results, one can conclude that training with non-action games provide modest benefits for untrained tasks. The effect is not specific for that kind of training as a similar effect was observed for strategy video games. Groups did not differ in motivation, engagement or expectations. PMID:29163136

Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

PubMed

Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

2017-09-01

To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

Upper Extremity Muscle Volumes and Functional Strength After Resistance Training in Older Adults

PubMed Central

Daly, Melissa; Vidt, Meghan E.; Eggebeen, Joel D.; Simpson, W. Greg; Miller, Michael E.; Marsh, Anthony P.; Saul, Katherine R.

2014-01-01

Aging leads to a decline in strength and an associated loss of independence. The authors examined changes in muscle volume, maximum isometric joint moment, functional strength, and 1-repetition maximum (1RM) after resistance training (RT) in the upper extremity of older adults. They evaluated isometric joint moment and muscle volume as predictors of functional strength. Sixteen healthy older adults (average age 75 ± 4.3 yr) were randomized to a 6-wk upper extremity RT program or control group. The RT group increased 1RM significantly (p < .01 for all exercises). Compared with controls, randomization to RT led to greater functional pulling strength (p = .003), isometric shoulder-adduction moment (p = .041), elbow-flexor volume (p = .017), and shoulder-adductor volume (p = .009). Shoulder-muscle volumes and isometric moments were good predictors of functional strength. The authors conclude that shoulder strength is an important factor for performing functional reaching and pulling tasks and a key target for upper extremity RT interventions. PMID:22952203

Motivational and mindfulness intervention for young adult female marijuana users

PubMed Central

de Dios, Marcel A.; Herman, Debra S.; Britton, Willoughby B.; Hagerty, Claire E.; Anderson, Bradley J.; Stein, Michael D.

2011-01-01

This pilot study tested the efficacy of a brief intervention using motivational interviewing (MI) plus mindfulness meditation (MM) to reduce marijuana use among young adult female. Thirty-four female marijuana users between the ages of 18–29 were randomized to either the intervention group (n = 22), consisting of 2 sessions of MI-MM or an assessment-only control group (n = 12). Participants’ marijuana use was assessed at baseline, 1, 2, and 3 months post-treatment. Fixed-effects regression modeling was used to analyze treatment effects. Participants randomized to the intervention group were found to use marijuana on 6.15 (z = −2.42, p=.015), 7.81 (z = −2.78, p=.005), and 6.83 (z = −2.23, p=.026) fewer days at months 1, 2, and 3, respectively, than controls. Findings from this pilot study provide preliminary evidence for the feasibility and effectiveness of a brief MI-MM for young adult female marijuana users. PMID:21940136

Efficacy and side-effect profiles of lactulose, docusate sodium, and sennosides compared to PEG in opioid-induced constipation: a systematic review.

PubMed

Ruston, Teresa; Hunter, Kathleen; Cummings, Greta; Lazarescu, Adriana

2013-01-01

Opioid-induced constipation (OIC) is a side effect of opioid therapy that can affect quality of life, adherence to treatment, and morbidity and possibly mortality. To investigate whether docusate sodium, sennosides, and lactulose have equal efficacy and side effect profiles compared to PEG in the management of OIC in adults. A systematic review was undertaken. Randomized controlled trials of adults taking opioids for cancer or non-cancer pain were considered if they met inclusion criteria. Statistical pooling was not possible as no studies met inclusion criteria. Large, well-powered, randomized controlled trials are feasible. Standard definitions of OIC would assist with the execution of these studies and contribute to their internal and external validity. Further research is strongly encouraged.

Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial.

PubMed

Smith, Lewis J; Kalhan, Ravi; Wise, Robert A; Sugar, Elizabeth A; Lima, John J; Irvin, Charles G; Dozor, Allen J; Holbrook, Janet T

2015-05-26

Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24. Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. The primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation. Mean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, -0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, -0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42-2.54] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, -3.48 ppb [95% CI, -5.99 to -0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, -1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL (P < .001) in participants receiving the supplement. Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication, use of a soy isoflavone supplement, compared with placebo, did not result in improved lung function or clinical outcomes. These findings suggest that this supplement should not be used for patients with poorly controlled asthma. clinicaltrials.gov Identifier: NCT01052116.

Attachment as Moderator of Treatment Outcome in Major Depression: A Randomized Control Trial of Interpersonal Psychotherapy versus Cognitive Behavior Therapy

ERIC Educational Resources Information Center

McBride, Carolina; Atkinson, Leslie; Quilty, Lena C.; Bagby, R. Michael

2006-01-01

Anxiety and avoidance dimensions of adult attachment insecurity were tested as moderators of treatment outcome for interpersonal psychotherapy (IPT) and cognitive-behavioral therapy (CBT). Fifty-six participants with major depression were randomly assigned to these treatment conditions. Beck Depression Inventory-II, Six-Item Hamilton Rating Scale…

77 FR 5850 - Notice of Random Assignment Study To Evaluate Workforce Investment Act Adult and Dislocated...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

...: One commenter was concerned about 50 percent of the participants being placed in a control group. The... impact methodology for the evaluation. The design of the study was described as follows: The evaluation... eligible for intensive services would be randomly assigned to one of three groups. The three research...

A Double-Blind, Randomized, Placebo-Controlled Trial of Escitalopram in the Treatment of Pediatric Depression

ERIC Educational Resources Information Center

Wagner, Karen Dineen; Jonas, Jeffrey; Findling, Robert L.; Ventura, Daniel; Saikali, Khalil

2006-01-01

Objective: Escitalopram is a selective serotonin reuptake inhibitor antidepressant indicated for use in adults. This trial examined the efficacy and safety of escitalopram in pediatric depression. Method: Patients (6-17 years old) with major depressive disorder were randomized to receive 8 weeks of double-blind flexibly dosed treatment with…

Chess Expertise and Memory for Chess Positions in Children and Adults.

ERIC Educational Resources Information Center

Schneider, Wolfgang; And Others

1993-01-01

A study presented four groups of chess players (child experts and novices, adult experts and novices) with short-term memory tasks involving meaningful and random chess positions, as well as a control board composed of geometric-shaped spaces and pieces. Found that child experts' immediate recall for meaningful chess positions was far superior to…

Dose Response Effects of Lisdexamfetamine Dimesylate Treatment in Adults with ADHD: An Exploratory Study

ERIC Educational Resources Information Center

Faraone, Stephen V.; Spencer, Thomas J.; Kollins, Scott H.; Glatt, Stephen J.; Goodman, David

2012-01-01

Objective: To explore dose-response effects of lisdexamfetamine dimesylate (LDX) treatment for ADHD. Method: This was a 4-week, randomized, double-blinded, placebo-controlled, parallel-group, forced-dose titration study in adult participants, aged 18 to 55 years, meeting "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.)…

Long-Term Effects of Leisure Education on Leisure Needs and Stress in Older Adults

ERIC Educational Resources Information Center

Kao, I-Chan; Chang, Liang-Chih

2017-01-01

We examined whether a 12-week leisure education program could promote leisure autonomy and leisure competence and reduce stress in older adults. Forty subjects were randomly assigned to either an experimental group or a control group. Before the experiment, pretest data were collected using leisure autonomy, leisure competence, and stress scales.…

Adult Outcomes as a Function of an Early Childhood Educational Program: An Abecedarian Project Follow-Up

ERIC Educational Resources Information Center

Campbell, Frances A.; Pungello, Elizabeth P.; Burchinal, Margaret; Kainz, Kirsten; Pan, Yi; Wasik, Barbara H.; Barbarin, Oscar A.; Sparling, Joseph J.; Ramey, Craig T.

2012-01-01

Adult (age 30) educational, economic, and social-emotional adjustment outcomes were investigated for participants in the Abecedarian Project, a randomized controlled trial of early childhood education for children from low-income families. Of the original 111 infants enrolled (98% African American), 101 took part in the age 30 follow-up. Primary…

A Placebo-Controlled Test of Cognitive-Behavioral Therapy for Comorbid Insomnia in Older Adults

ERIC Educational Resources Information Center

Rybarczyk, Bruce; Stepanski, Edward; Fogg, Louis; Lopez, Martita; Barry, Paulette; Davis, Andrew

2005-01-01

The present study tested cognitive-behavioral therapy (CBT) for insomnia in older adults with osteoarthritis, coronary artery disease, or pulmonary disease. Ninety-two participants (mean age = 69 years) were randomly assigned to classroom CBT or stress management and wellness (SMW) training, which served as a placebo condition. Compared with SMW,…

The Malleability of Working Memory and Visuospatial Skills: A Randomized Controlled Study in Older Adults

ERIC Educational Resources Information Center

Stepankova, Hana; Lukavsky, Jiri; Buschkuehl, Martin; Kopecek, Miloslav; Ripova, Daniela; Jaeggi, Susanne M.

2014-01-01

There is accumulating evidence that training on working memory (WM) generalizes to other nontrained domains, and there are reports of transfer effects extending as far as to measures of fluid intelligence. Although there have been several demonstrations of such transfer effects in young adults and children, they have been difficult to demonstrate…

Effects of the Paraphrasing Strategy on Expository Reading Comprehension of Young Adults with Intellectual Disability

ERIC Educational Resources Information Center

Hua, Youjia; Woods-Groves, Suzanne; Ford, Jeremy W.; Nobles, Kelly A.

2014-01-01

The purpose of the study was to investigate the effectiveness of teaching a three-step paraphrasing strategy on expository reading comprehension of young adults with intellectual disability. Ten learners from a postsecondary education program for individuals with disability participated in the study. They were randomly assigned to the control and…

Internet-Based Interventions Have Potential to Affect Short-Term Mediators and Indicators of Dietary Behavior of Young Adults

ERIC Educational Resources Information Center

Park, Amanda; Nitzke, Susan; Kritsch, Karen; Kattelmann, Kendra; White, Adrienne; Boeckner, Linda; Lohse, Barbara; Hoerr, Sharon; Greene, Geoffrey; Zhang, Zhumin

2008-01-01

Objective: Evaluate a theory-based, Internet-delivered nutrition education module. Design: Randomized, treatment-control design with pre-post intervention assessments. Setting and Participants: Convenience sample of 160 young adults (aged 18-24) recruited by community educators in 4 states. Study completers (n = 96) included a mix of…

Human Responding on Random-Interval Schedules of Response-Cost Punishment: The Role of Reduced Reinforcement Density

ERIC Educational Resources Information Center

Pietras, Cynthia J.; Brandt, Andrew E.; Searcy, Gabriel D.

2010-01-01

An experiment with adult humans investigated the effects of response-contingent money loss (response-cost punishment) on monetary-reinforced responding. A yoked-control procedure was used to separate the effects on responding of the response-cost contingency from the effects of reduced reinforcement density. Eight adults pressed buttons for money…

Interventions to Reduce Distress in Adult Victims of Rape and Sexual Violence: A Systematic Review

ERIC Educational Resources Information Center

Regehr, Cheryl; Alaggia, Ramona; Dennis, Jane; Pitts, Annabel; Saini, Michael

2013-01-01

Objectives: This article presents a systematic evaluation of the effectiveness of interventions aimed at reducing distress in adult victims of rape and sexual violence. Method: Studies were eligible for the review if the assignment of study participants to experimental or control groups was by random allocation or parallel cohort design. Results:…

The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

PubMed Central

Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

2014-01-01

Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight. This trial was registered at clinicaltrails.gov as NCT01781780. PMID:24898236

Effect of a perturbation-based balance training program on compensatory stepping and grasping reactions in older adults: a randomized controlled trial.

PubMed

Mansfield, Avril; Peters, Amy L; Liu, Barbara A; Maki, Brian E

2010-04-01

Compensatory stepping and grasping reactions are prevalent responses to sudden loss of balance and play a critical role in preventing falls. The ability to execute these reactions effectively is impaired in older adults. The purpose of this study was to evaluate a perturbation-based balance training program designed to target specific age-related impairments in compensatory stepping and grasping balance recovery reactions. This was a double-blind randomized controlled trial. The study was conducted at research laboratories in a large urban hospital. Thirty community-dwelling older adults (aged 64-80 years) with a recent history of falls or self-reported instability participated in the study. Participants were randomly assigned to receive either a 6-week perturbation-based (motion platform) balance training program or a 6-week control program involving flexibility and relaxation training. Features of balance reactions targeted by the perturbation-based program were: (1) multi-step reactions, (2) extra lateral steps following anteroposterior perturbations, (3) foot collisions following lateral perturbations, and (4) time to complete grasping reactions. The reactions were evoked during testing by highly unpredictable surface translation and cable pull perturbations, both of which differed from the perturbations used during training. /b> Compared with the control program, the perturbation-based training led to greater reductions in frequency of multi-step reactions and foot collisions that were statistically significant for surface translations but not cable pulls. The perturbation group also showed significantly greater reduction in handrail contact time compared with the control group for cable pulls and a possible trend in this direction for surface translations. Further work is needed to determine whether a maintenance program is needed to retain the training benefits and to assess whether these benefits reduce fall risk in daily life. Perturbation-based training shows promise as an effective intervention to improve the ability of older adults to prevent themselves from falling when they lose their balance.

Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial.

PubMed

Janse, Anthonie; Worm-Smeitink, Margreet; Bussel-Lagarde, José; Bleijenberg, Gijs; Nikolaus, Stephanie; Knoop, Hans

2015-08-12

Cognitive behavioural therapy (CBT) is an effective treatment for fatigue and disabilities in patients with chronic fatigue syndrome (CFS). However, treatment capacity is limited. Providing web-based CBT and tailoring the amount of contact with the therapist to the individual needs of the patient may increase the efficiency of the intervention. Web-based CBT for adolescents with CFS has proven to be effective in reducing fatigue and increasing school attendance. In the proposed study the efficacy of a web-based CBT intervention for adult patients with CFS will be explored. Two different formats of web-based CBT will be tested. In the first format named protocol driven feedback, patients report on their progress and receive feedback from a therapist according to a preset schedule. In the second format named support on demand, feedback and support of the therapist is only given when patients ask for it. The primary objective of the study is to determine the efficacy of a web-based CBT intervention on fatigue severity. A randomized clinical trial will be conducted. Two-hundred-forty adults who have been diagnosed with CFS according to the US Centers for Disease Control and Prevention (CDC) consensus criteria will be recruited and randomized to one of three conditions: web-based CBT with protocol driven feedback, web-based CBT with support on demand, or wait list. Feedback will be delivered by therapists specialized in CBT for CFS. Each of the web-based CBT interventions will be compared to a wait list condition with respect to its effect on the primary outcome measure; fatigue severity. Secondary outcome measures are level of disability, physical functioning, psychological distress, and the proportion of patients with clinical significant improvement in fatigue severity. Outcomes will be assessed at baseline and six months post randomization. The web-based CBT formats will be compared with respect to the time therapists need to deliver the intervention. As far as we know this is the first randomized controlled trial (RCT) that evaluates the efficacy of a web-based CBT intervention for adult patients with CFS. NTR4013.

Enhanced Medical Rehabilitation increases therapy intensity and engagement and improves functional outcomes in post-acute rehabilitation of older adults: a randomized controlled trial

PubMed Central

Lenze, Eric J.; Host, Helen H.; Hildebrand, Mary W.; Morrow-Howell, Nancy; Carpenter, Brian; Freedland, Kenneth E.; Baum, Carolyn A.; Dixon, David; Doré, Peter; Wendleton, Leah; Binder, Ellen F.

2012-01-01

Objectives For millions of disabled older adults each year, post-acute care in skilled nursing facilities (SNFs) is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly due to therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in post-acute care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Post-acute care unit of a skilled nursing facility in St Louis, MO. Participants 26 older adults admitted from a hospital for post-acute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists (PT/OT) that increase patient engagement and intensity, with the goal of improving functional outcome, through: (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and six-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 meter/sec vs. 0.08 to 0.22 in standard of care,p=0.003) and six-minute walk (from 73 to 266 feet vs. 40 to 94 feet in standard of care, p=0.026), with a trend for better improvement of Barthel Index (+43 points vs. 26 points in standard of care, p=0.087), compared to participants randomized to standard-of-care rehabilitation. Conclusion Higher intensity and patient engagement in the post-acute rehabilitation setting is achievable, with resultant better functional outcomes for older adults. Findings should be confirmed in a larger randomized controlled trial. PMID:22863663

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Andresen, Andrew A; Jones, Mark E; Lyons, Kevin J; Hondras, Maria A; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2013-01-16

Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.

Albumin in Burn Shock Resuscitation: A Meta-Analysis of Controlled Clinical Studies.

PubMed

Navickis, Roberta J; Greenhalgh, David G; Wilkes, Mahlon M

2016-01-01

Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07-0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed.

Cell phone Intervention for You (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology

PubMed Central

Svetkey, LP; Batch, BC; Lin, P-H; Intille, SS; Corsino, L; Tyson, CC; Bosworth, HB; Grambow, SC; Voils, C; Loria, C; Gallis, JA; Schwager, J; Bennett, GB

2015-01-01

Objectives To determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Methods Randomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. Results The 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months. Conclusions Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. Trial Registration ClinicalTrials.gov Identifier NCT01092364. https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3 PMID:26530929

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

PubMed

Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

PubMed Central

Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

2014-01-01

Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

Reductions of intimate partner violence resulting from supplementing children with omega-3 fatty acids: A randomized, double-blind, placebo-controlled, stratified, parallel-group trial.

PubMed

Portnoy, Jill; Raine, Adrian; Liu, Jianghong; Hibbeln, Joseph R

2018-05-20

Omega-3 supplementation has been found to reduce externalizing behavior in children. Reciprocal models of parent-child behavior suggest that improving child behavior could lead to improvements in parent behavior, however no study has examined whether omega-3 supplementation in children could reduce intimate partner violence or child maltreatment by their adult caregivers. In this randomized, double-blind, placebo-controlled, stratified, parallel group trial, a community sample of children were randomized to receive either a fruit drink containing 1 gm of omega-3 fats (Smartfish Recharge; Omega-3 group, n = 100) or the same fruit drink without omega-3's (Placebo group, n = 100). Child participants, adult caregivers, and research staff were blinded to group assignment. Adult caregivers reported inter-partner and child-directed physical assault and psychological aggression at baseline, 6 months (end of treatment) and 12 months (6 months post-treatment) using the Conflicts Tactics Scale. Caregivers of children in the omega-3 group reported long-term reductions in psychological aggression in a group × time interaction. Improvements in adult psychological aggression were correlated with improvements in child externalizing behavior scores. No differences were reported for child maltreatment. This study is the first to show that omega-3 supplementation in children can reduce inter-partner psychological aggression among adult caregivers not receiving supplements. Findings suggest that improving child behavior through omega-3 supplementation could have long-term benefits to the family system as a whole. © 2018 Wiley Periodicals, Inc.

A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

DTIC Science & Technology

2016-10-01

AWARD NUMBER: W81XWH-12-1-0543 TITLE: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism ...Therapy for Autism Spectrum Disorder 5b. GRANT NUMBER W81XWH-12-1-0543 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) John Gabrieli, Ph.D; Aude Henin...core social dysfunctions, and (2) oxytocin (OT) administration prior to CBT sessions will each enhance social function in young adults with autism

The Effects of Slackline Balance Training on Postural Control in Older Adults.

PubMed

Thomas, Monika; Kalicinski, Michael

2016-07-01

The present study investigated whether slackline training enhances postural control in older adults. Twenty-four participants were randomized into an intervention and a control group. The intervention group received 6 weeks of slackline training, two times per week. Pre-post measurement included the time of different standing positions on a balance platform with and without an external disturbance and the acceleration of the balance platform. Results showed significantly improved standing times during one-leg stance without external disturbance and a significantly reduced acceleration of the balance platform for the intervention group after the training period during tandem stance with and without an external disturbance. We conclude that slackline training in older adults has a positive impact on postural control and thus on the reduction of fall risk.

The effect of genetic counseling for adult offspring of patients with type 2 diabetes on attitudes toward diabetes and its heredity: a randomized controlled trial.

PubMed

Nishigaki, M; Tokunaga-Nakawatase, Y; Nishida, J; Kazuma, K

2014-10-01

The aim of this study is to investigate the effect of diabetes genetic counseling on attitudes toward diabetes and its heredity in relatives of type 2 diabetes patients. This study was an unmasked, randomized controlled trial at a medical check-up center in Japan. Subjects in this study are healthy adults between 30 and 60 years of age who have a family history of type 2 diabetes in their first degree relatives. Participants in the intervention group received a brief genetic counseling session for approximately 10 min. Genetic counseling was structured based on the Health Belief Model. Both intervention and control groups received a booklet for general diabetes prevention. Risk perception and recognition of diabetes, and attitude towards its prevention were measured at baseline, 1 week and 1 year after genetic counseling. Participants who received genetic counseling showed significantly higher recognition about their sense of control over diabetes onset than control group both at 1 week and 1 year after the session. On the other hand, anxiety about diabetes did not change significantly. The findings show that genetic counseling for diabetes at a medical check center helped adults with diabetes family history understand they are able to exert control over the onset of their disease through lifestyle modification.

The Well London program--a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results.

PubMed

Phillips, Gemma; Renton, Adrian; Moore, Derek G; Bottomley, Christian; Schmidt, Elena; Lais, Shahana; Yu, Ge; Wall, Martin; Tobi, Patrick; Frostick, Caroline; Clow, Angela; Lock, Karen; Petticrew, Mark; Hayes, Richard

2012-07-06

The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here. The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys. Randomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012.

The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA). Methods/Design 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during the course of treatment and across a one year follow up period. The primary outcome measure is body mass index (BMI) taken at twelve months after randomization. Discussion This multi-center study provides a large sample size, broad inclusion criteria and a follow-up period. However, the study has to contend with difficulties directly related to running a large multi-center randomized controlled trial and the psychopathology of AN. These issues are discussed. Trial Registration Current Controlled Trials ISRCTN67720902 - A Maudsley outpatient study of treatments for anorexia nervosa and related conditions. PMID:23721562

Orthotics Compared to Conventional Therapy and Other Non-Surgical Treatments for Plantar Fasciitis

PubMed Central

Lewis, Rebecca D.; Wright, Paul; McCarthy, Laine H.

2016-01-01

Clinical Question In adults with acute plantar fasciitis whose symptoms have not been relieved with the conventional regimen of NSAIDS, stretching and lifestyle modification, do the addition of orthotics (prefabricated or custom fitted) reduce pain and improve function compared with other non-surgical treatments (manipulative chiropractic, physical therapy and/or heel steroid injections)? Answer Yes. Studies have shown that orthotics, both prefabricated and custom fitted, reduce pain and improve function in adults with acute plantar fasciitis with few risks or side effects. Used alone or in addition to conventional therapy (NSAIDs, stretching, lifestyle modification), orthotics are effective and well tolerated by patients for short-term pain relief and improved function. Prefabricated orthotics are less costly and provide similar relief to more expensive custom orthotics. Level of Evidence of the Answer A Search Terms Plantar fasciitis, heel pain, treatment, orthotics, Limits Adult, human, English, Review, Randomized-Control Trials, Systematic Reviews, adults age 18 or more, publication dates 2004 to present. Date Search was Conducted January 16, 2014; updated January 20, 2015 Inclusion Criteria Recent published systematic reviews, randomized controlled, meta-analyses; adults with confirmed acute or recent diagnosis of plantar fasciitis. Exclusion Criteria Studies older than 10 years, children, adolescents less than 18 years of age, chronic or recalcitrant plantar fasciitis. PMID:26855444

Orthotics Compared to Conventional Therapy and Other Non-Surgical Treatments for Plantar Fasciitis.

PubMed

Lewis, Rebecca D; Wright, Paul; McCarthy, Laine H

2015-12-01

In adults with acute plantar fasciitis whose symptoms have not been relieved with the conventional regimen of NSAIDS, stretching and lifestyle modification, do the addition of orthotics (prefabricated or custom fitted) reduce pain and improve function compared with other non-surgical treatments (manipulative chiropractic, physical therapy and/or heel steroid injections)? Yes. Studies have shown that orthotics, both prefabricated and custom fitted, reduce pain and improve function in adults with acute plantar fasciitis with few risks or side effects. Used alone or in addition to conventional therapy (NSAIDs, stretching, lifestyle modification), orthotics are effective and well tolerated by patients for short-term pain relief and improved function. Prefabricated orthotics are less costly and provide similar relief to more expensive custom orthotics. Level of Evidence of the Answer: A Search Terms: Plantar fasciitis, heel pain, treatment, orthotics, Limits: Adult, human, English, Review, Randomized-Control Trials, Systematic Reviews, adults age 18 or more, publication dates 2004 to present. Date Search was Conducted: January 16, 2014; updated January 20, 2015 INCLUSION CRITERIA: Recent published systematic reviews, randomized controlled, meta-analyses; adults with confirmed acute or recent diagnosis of plantar fasciitis. Studies older than 10 years, children, adolescents less than 18 years of age, chronic or recalcitrant plantar fasciitis.

A randomized controlled trial to test the efficacy of the SCI Get Fit Toolkit on leisure-time physical activity behaviour and social-cognitive processes in adults with spinal cord injury.

PubMed

Arbour-Nicitopoulos, Kelly P; Sweet, Shane N; Lamontagne, Marie-Eve; Ginis, Kathleen A Martin; Jeske, Samantha; Routhier, François; Latimer-Cheung, Amy E

2017-01-01

Single blind, two-group randomized controlled trial. To evaluate the efficacy of the SCI Get Fit Toolkit delivered online on theoretical constructs and moderate-to-vigorous physical activity (MVPA) among adults with SCI. Ontario and Quebec, Canada. Inactive, English- and French-speaking Canadian adults with traumatic SCI with Internet access, and no self-reported cognitive or memory impairments. Participants ( N =90 M age =48.12±11.29 years; 79% male) were randomized to view the SCI Get Fit Toolkit or the Physical Activity Guidelines for adults with SCI (PAG-SCI) online. Primary (intentions) and secondary (outcome expectancies, self-efficacy, planning and MVPA behaviour) outcomes were assessed over a 1-month period. Of the 90 participants randomized, 77 were included in the analyses. Participants viewed the experimental stimuli only briefly, reading the 4-page toolkit for approximately 2.5 min longer than the 1-page guideline document. No condition effects were found for intentions, outcome expectancies, self-efficacy, and planning (ΔR 2 ⩽0.03). Individuals in the toolkit condition were more likely to participate in at least one bout of 20 min of MVPA behaviour at 1-week post-intervention compared to individuals in the guidelines condition (OR=3.54, 95% CI=0.95, 13.17). However, no differences were found when examining change in weekly minutes of MVPA or comparing whether participants met the PAG-SCI. No firm conclusions can be made regarding the impact of the SCI Get Fit Toolkit in comparison to the PAG-SCI on social cognitions and MVPA behaviour. The limited online access to this resource may partially explain these null findings.

A randomized study of reinforcing ambulatory exercise in older adults

PubMed Central

Petry, Nancy M.; Andrade, Leonardo F.; Barry, Danielle; Byrne, Shannon

2014-01-01

Many older adults do not meet physical activity recommendations and suffer from health-related complications. Reinforcement interventions can have pronounced effects on promoting behavior change; this study evaluated the efficacy of a reinforcement intervention to enhance walking in older adults. Forty-five sedentary adults with mild to moderate hypertension were randomized to 12-week interventions consisting of pedometers and guidelines to walk 10,000 steps/day or that same intervention with chances to win $1-$100 prizes for meeting recommendations. Patients walked an average of about 4,000 steps/day at baseline. Throughout the intervention, participants in the reinforcement intervention met walking goals on 82.5% ± 25.8% of days versus 55.3% ± 37.1% of days in the control condition, p < .01. Even though steps walked increased significantly in both groups relative to baseline, participants in the reinforcement condition walked an average of about 2,000 more steps/day than participants in the control condition, p < .02. Beneficial effects of the reinforcement condition relative to the control condition persisted at a 24-week follow-up evaluation, p < .02, although steps/day were lower than during the intervention period in both groups. Participants in the reinforcement intervention also evidenced greater reductions in blood pressure and weight over time and improvements in fitness indices, ps < .05. This reinforcement-based intervention substantially increased walking and improved clinical parameters, suggesting that larger-scale evaluations of reinforcement-based interventions for enhancing active lifestyles in older adults are warranted. Ultimately, economic analyses may reveal reinforcement interventions to be cost-effective, especially in high-risk populations of older adults. PMID:24128075

The Effectiveness of Social Robots for Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.

PubMed

Pu, Lihui; Moyle, Wendy; Jones, Cindy; Todorovic, Michael

2018-06-12

Social robots may promote the health of older adults by increasing their perceived emotional support and social interaction. This review aims to summarize the effectiveness of social robots on outcomes (psychological, physiological, quality of life, or medications) of older adults from randomized controlled trials (RCTs). A mixed-method systematic review of RCTs meeting the study inclusion criteria was undertaken. Eight databases were electronically searched up to September 2017. Participants' characteristics, intervention features, and outcome data were retrieved. The mean difference and standardized mean difference with 95% confidence intervals (CI) were synthesized to pool the effect size. A total of 13 articles from 11 RCTs were identified from 2,204 articles, of which 9 studies were included in the meta-analysis. Risk of bias was relatively high in allocation concealment and blinding. Social robots appeared to have positive impacts on agitation, anxiety, and quality of life for older adults but no statistical significance was found in the meta-analysis. However, results from a narrative review indicated that social robot interactions could improve engagement, interaction, and stress indicators, as well as reduce loneliness and the use of medications for older adults. Social robots appear to have the potential to improve the well-being of older adults, but conclusions are limited due to the lack of high-quality studies. More RCTs are recommended with larger sample sizes and rigorous study designs.

Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis123

PubMed Central

Pan, An; Willett, Walter C; Hu, Frank B

2013-01-01

Background: The relation between sugar-sweetened beverages (SSBs) and body weight remains controversial. Objective: We conducted a systematic review and meta-analysis to summarize the evidence in children and adults. Design: We searched PubMed, EMBASE, and Cochrane databases through March 2013 for prospective cohort studies and randomized controlled trials (RCTs) that evaluated the SSB-weight relation. Separate meta-analyses were conducted in children and adults and for cohorts and RCTs by using random- and fixed-effects models. Results: Thirty-two original articles were included in our meta-analyses: 20 in children (15 cohort studies, n = 25,745; 5 trials, n = 2772) and 12 in adults (7 cohort studies, n = 174,252; 5 trials, n = 292). In cohort studies, one daily serving increment of SSBs was associated with a 0.06 (95% CI: 0.02, 0.10) and 0.05 (95% CI: 0.03, 0.07)-unit increase in BMI in children and 0.22 kg (95% CI: 0.09, 0.34 kg) and 0.12 kg (95% CI: 0.10, 0.14 kg) weight gain in adults over 1 y in random- and fixed-effects models, respectively. RCTs in children showed reductions in BMI gain when SSBs were reduced [random and fixed effects: −0.17 (95% CI: −0.39, 0.05) and −0.12 (95% CI: −0.22, −0.2)], whereas RCTs in adults showed increases in body weight when SSBs were added (random and fixed effects: 0.85 kg; 95% CI: 0.50, 1.20 kg). Sensitivity analyses of RCTs in children showed more pronounced benefits in preventing weight gain in SSB substitution trials (compared with school-based educational programs) and among overweight children (compared with normal-weight children). Conclusion: Our systematic review and meta-analysis of prospective cohort studies and RCTs provides evidence that SSB consumption promotes weight gain in children and adults. PMID:23966427

A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial.

PubMed

Kuroda, Miho; Kawakubo, Yuki; Kuwabara, Hitoshi; Yokoyama, Kazuhito; Kano, Yukiko; Kamio, Yoko

2013-07-23

Adults with high-functioning autism spectrum disorders (ASD) have difficulties in social communication; thus, these individuals have trouble understanding the mental states of others. Recent research also suggests that adults with ASD are unable to understand their own mental states, which could lead to difficulties in emotion-regulation. Some studies have reported the efficacy of cognitive-behavioral therapy (CBT) in improving emotion-regulation among children with ASD. The current study will investigate the efficacy of group-based CBT for adults with ASD. The study is a randomized, waitlist controlled, single-blinded trial. The participants will be 60 adults with ASD; 30 will be assigned to a CBT group and 30 to a waitlist control group. Primary outcome measures are the 20-item Toronto Alexithymia Scale, the Coping Inventory for Stressful Situations, the Motion Picture Mind-Reading task, and an ASD questionnaire. The secondary outcome measures are the Center for Epidemiological Studies Depression Scale, the World Health Organization Quality of Life Scale 26-item version, the Global Assessment of Functioning, State-trait Anxiety Inventory, Social Phobia and Anxiety Inventory, and Liebowitz Social Anxiety Scale. All will be administered during the pre- and post-intervention, and 12 week follow-up periods. The CBT group will receive group therapy over an 8 week period (one session per week) with each session lasting approximately 100 minutes. Group therapy will consist of four or five adults with ASD and two psychologists. We will be using visual materials for this program, mainly the Cognitive Affective Training kit. This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD. This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No. UMIN000006236.

Does a multicomponent exercise program improve dual-task performance in amnestic mild cognitive impairment? A randomized controlled trial.

PubMed

Makizako, Hyuma; Doi, Takehiko; Shimada, Hiroyuki; Yoshida, Daisuke; Tsutsumimoto, Kota; Uemura, Kazuki; Suzuki, Takao

2012-12-01

There has been much interest in exercise interventions as a primary behavioral prevention strategy against cognitive decline. The aim of this study was to evaluate the effect of a multicomponent exercise program on physical and dual-task performances in community-dwelling older adults with amnestic mild cognitive impairment (aMCI). Fifty older adults (23 women) with aMCI (mean age, 76 years) were randomized to an intervention (n=25) or a control group (n=25). The intervention group received a multicomponent exercise program for 90 minutes/day, 2 days/week, or 40 times over six months. The multicomponent exercises included aerobic exercise, muscle strength training and postural balance retraining, which was conducted under multi-task conditions to stimulate attention and memory. Participants in the control group attended two health promotion education classes within six months. Physical and dual-task performances were measured before randomization and after six months. Dual-task performances using reaction times with balance and cognitive demands were measured. The improvement effects on dual-task performances with both balance and cognitive demands were not statistically significant: reaction time with balance demand F1,45=3.3, p=0.07, and cognitive demand F1,45=2.6, p=0.12. However, there was a significant group-by-time interaction on maximal walking speed, which decreased significantly in the control group (F1,45=5.9, p=0.02). This six-month multicomponent exercise program improved maximal walking speed in older adults with aMCI; however, it did not improve dual-task performances assessed by reaction times.

Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

PubMed

Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

2017-03-01

To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

Effect of nitrate supplementation on hepatic blood flow and glucose homeostasis: a double-blind, placebo-controlled, randomized control trial.

PubMed

Shepherd, Anthony I; Wilkerson, Daryl P; Fulford, Jon; Winyard, Paul G; Benjamin, Nigel; Shore, Angela C; Gilchrist, Mark

2016-09-01

Nitric oxide alters gastric blood flow, improves vascular function, and mediates glucose uptake within the intestines and skeletal muscle. Dietary nitrate, acting as a source of nitric oxide, appears to be a potential low-cost therapy that may help maintain glucose homeostasis. In a randomized, double-blind, placebo-controlled crossover study, 31 young and older adult participants had a standardized breakfast, supplemented with either nitrate-rich beetroot juice (11.91 mmol nitrate) or nitrate-depleted beetroot juice as placebo (0.01 mmol nitrate). MRI was used to assess apparent diffusion coefficient (ADC), portal vein flux, and velocity. Plasma glucose, incretin, and C-peptide concentrations and blood pressure were assessed. Outcome variables were measured at baseline and hourly for 3 h. Compared with a placebo, beetroot juice resulted in a significant elevation in plasma nitrate and plasma nitrite concentration. No differences were seen for the young or older adult cohorts between placebo and beetroot juice for ADC, or portal vein flux. There was an interaction effect in the young adults between visits for portal vein velocity. Nitrate supplementation did not reduce plasma glucose, active GLP-1, total GLP-1, or plasma C-peptide concentrations for the young or older adult cohorts. Despite a significant elevation in plasma nitrite concentration following an acute dose of (11.91 mmol) nitrate, there was no effect on hepatic blood flow, plasma glucose, C-peptide, or incretin concentration in healthy adults. Copyright © 2016 the American Physiological Society.

Effect of nitrate supplementation on hepatic blood flow and glucose homeostasis: a double-blind, placebo-controlled, randomized control trial

PubMed Central

Wilkerson, Daryl P.; Fulford, Jon; Winyard, Paul G.; Benjamin, Nigel; Shore, Angela C.

2016-01-01

Nitric oxide alters gastric blood flow, improves vascular function, and mediates glucose uptake within the intestines and skeletal muscle. Dietary nitrate, acting as a source of nitric oxide, appears to be a potential low-cost therapy that may help maintain glucose homeostasis. In a randomized, double-blind, placebo-controlled crossover study, 31 young and older adult participants had a standardized breakfast, supplemented with either nitrate-rich beetroot juice (11.91 mmol nitrate) or nitrate-depleted beetroot juice as placebo (0.01 mmol nitrate). MRI was used to assess apparent diffusion coefficient (ADC), portal vein flux, and velocity. Plasma glucose, incretin, and C-peptide concentrations and blood pressure were assessed. Outcome variables were measured at baseline and hourly for 3 h. Compared with a placebo, beetroot juice resulted in a significant elevation in plasma nitrate and plasma nitrite concentration. No differences were seen for the young or older adult cohorts between placebo and beetroot juice for ADC, or portal vein flux. There was an interaction effect in the young adults between visits for portal vein velocity. Nitrate supplementation did not reduce plasma glucose, active GLP-1, total GLP-1, or plasma C-peptide concentrations for the young or older adult cohorts. Despite a significant elevation in plasma nitrite concentration following an acute dose of (11.91 mmol) nitrate, there was no effect on hepatic blood flow, plasma glucose, C-peptide, or incretin concentration in healthy adults. PMID:27418682

Improving early relationships: a randomized, controlled trial of an age-paced parenting newsletter.

PubMed

Waterston, Tony; Welsh, Brenda; Keane, Brigid; Cook, Margaret; Hammal, Donna; Parker, Louise; McConachie, Helen

2009-01-01

Parenting is recognized as a key mediator in both health and educational outcomes. Much is known on the value of support and group work in benefiting parenting, but little is known on the effect of written information. A randomized, controlled trial was conducted to evaluate the effect of a parenting newsletter, sent monthly to the parents' home from birth to 1 year, on maternal well-being and parenting style. We tested the hypothesis that mothers receiving the newsletter would show less stress and better parenting characteristics than controls. Parents of first infants born in a North East England District General Hospital between February and October 2003 who consented to take part in the study were randomly allocated to either the intervention or control arm. Those in the intervention arm were sent 12 monthly issues of an age-paced parenting newsletter containing information on emotional development, parent-child interaction, and play. Both the intervention and control group received normal parenting support. Mothers in both groups completed the Well-being Index, Parenting Daily Hassles Scale, and the Adult-Adolescent Parenting Inventory at birth and at 1 year. One hundred eighty-five mothers were recruited, with 94 randomly assigned to the intervention group, and 91 controls. Allowing for differences at recruitment, there were significant differences between the groups at 1 year: the intervention mothers had lower frequency and intensity of perceived hassles and fewer inappropriate expectations of the infant on the Adult-Adolescent Parenting Inventory than the control mothers. A monthly parenting newsletter sent directly to the home in the first year of life seems to help parents to understand their infant better and feel less hassled. This intervention is low cost and can be applied to all parents, so it is nonstigmatizing.

What is the evidence for rest, ice, compression, and elevation therapy in the treatment of ankle sprains in adults?

PubMed

van den Bekerom, Michel P J; Struijs, Peter A A; Blankevoort, Leendert; Welling, Lieke; van Dijk, C Niek; Kerkhoffs, Gino M M J

2012-01-01

Ankle sprains are common problems in acute medical care. The variation in treatment observed for the acutely injured lateral ankle ligament complex in the first week after the injury suggests a lack of evidence-based management strategies for this problem. To analyze the effectiveness of applying rest, ice, compression, and elevation (RICE) therapy begun within 72 hours after trauma for patients in the initial period after ankle sprain. Eligible studies were published original randomized or quasi-randomized controlled trials concerning at least 1 of the 4 subtreatments of RICE therapy in the treatment of acute ankle sprains in adults. MEDLINE, Cochrane Clinical Trial Register, CINAHL, and EMBASE. The lists of references of retrieved publications also were checked manually. We extracted relevant data on treatment outcome (pain, swelling, ankle mobility or range of motion, return to sports, return to work, complications, and patient satisfaction) and assessed the quality of included studies. If feasible, the results of comparable studies were pooled using fixed- or random-effects models. After deduction of the overlaps among the different databases, evaluation of the abstracts, and contact with some authors, 24 potentially eligible trials remained. The full texts of these articles were retrieved and thoroughly assessed as described. This resulted in the inclusion of 11 trials involving 868 patients. The main reason for exclusion was that the authors did not describe a well-defined control group without the intervention of interest. Insufficient evidence is available from randomized controlled trials to determine the relative effectiveness of RICE therapy for acute ankle sprains in adults. Treatment decisions must be made on an individual basis, carefully weighing the relative benefits and risks of each option, and must be based on expert opinions and national guidelines.

Brief Intervention in the Emergency Department Among Mexican-Origin Young Adults at the US-Mexico Border: Outcomes of a Randomized Controlled Clinical Trial Using Promotores.

PubMed

Cherpitel, Cheryl J; Ye, Yu; Bond, Jason; Woolard, Robert; Villalobos, Susana; Bernstein, Judith; Bernstein, Edward; Ramos, Rebeca

2016-03-01

A randomized controlled trial of brief intervention (BI), for drinking and related problems, using peer health promotion advocates (promotores), was conducted among at-risk and alcohol-dependent Mexican-origin young adult emergency department (ED) patients, aged 18-30. Six hundred and ninety-eight patients were randomized to: screened only (n = 78), assessed (n = 310) and intervention (n = 310). Primary outcomes were at-risk drinking and Rapid Alcohol Problems Screen (RAPS4) scores. Secondary outcomes were drinking days per week, drinks per drinking day, maximum drinks in a day and negative consequences of drinking. At 3- and 12-month follow-up the intervention condition showed significantly lower values or trends on all outcome variables compared to the assessed condition, with the exception of the RAPS4 score; e.g. at-risk drinking days dropped from 2.9 to 1.7 at 3 months for the assessed condition and from 3.2 to 1.2 for the intervention condition. Using random effects modeling controlling for demographics and baseline values, the intervention condition showed significantly greater improvement in all consumption measures at 12 months, but not in the RAPS4 or negative consequences of drinking. Improvements in outcomes were significantly more evident for non-injured patients, those reporting drinking prior to the event, and those lower on risk taking disposition. At 12-month follow-up this study demonstrated significantly improved drinking outcomes for Mexican-origin young adults in the ED who received a BI delivered by promotores compared to those who did not. ClinicalTrials.gov. NCT02056535. © The Author 2015. Medical Council on Alcohol and Oxford University Press. All rights reserved.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial

PubMed Central

Song, Yeonsu; Hughes, Jaime; Jouldjian, Stella; Dzierzewski, Joseph M.; Fung, Constance H; Rodriguez Tapia, Juan Carlos; Mitchell, Michael N.; Alessi, Cathy A

2017-01-01

Abstract Study Objective To test the effectiveness of a 4-week behavioral Sleep Intervention Program (SIP: sleep compression, modified stimulus control, and sleep hygiene) compared to a 4-week information-only control (IC) among older adults attending a VA Adult Day Health Care (ADHC) program in a double-blind, randomized, clinical trial. Methods Forty-two individuals (mean age: 77 years, 93% male) enrolled in a VA ADHC program were randomized to receive SIP or IC. All completed in-person sleep and health assessments at baseline, post-treatment and 4-months follow-up that included 3 days/nights of wrist actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). Mixed repeated measures analysis was used to compare sleep outcomes at post-treatment and 4-months follow-up, with baseline values as covariates. Results SIP participants (n = 21) showed significant improvement on actigraphy sleep efficiency (p = .007), number of nighttime awakenings (p = .016), and minutes awake at night (p = .001) at post-treatment, compared to IC participants (n = 21). Benefits were slightly attenuated but remained significant at 4-month follow-up (all p’s < .05). There were no differences in total sleep time between groups. There was significant improvement on PSQI factor 3 (daily disturbances) at 4-month follow-up (p = .016), but no differences were observed between SIP and IC on other PSQI components or ISI scores at post-treatment or 4-month follow-up. Conclusions A short behavioral sleep intervention may have important benefits in improving objectively measured sleep in older adults participating in ADHC. Future studies are needed to study implementation of this intervention into routine clinical care within ADHC. PMID:28482053

A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial.

PubMed

Pothier, Kristell; Soriano, G; Lussier, M; Naudin, A; Costa, N; Guyonnet, S; Piau, A; Ousset, P J; Nourhashemi, F; Vellas, B; de Souto Barreto, P

2018-01-24

Multidomain interventions composed of nutritional counseling, exercise and cognitive trainings have shown encouraging results as effective preventive strategies delaying age-related declines. However, these interventions are time- and resource-consuming. The use of Information and Communication Technologies (ICT) might facilitate the translation from research into real-world practice and reach a massive number of people. This article describes the protocol of the eMIND study, a randomized controlled trial (RCT) using a web-based multidomain intervention for older adults. One hundred and twenty older adults (≥ 65 years), with a spontaneous memory complaint, will be randomly assigned to a six-month web-based multidomain (nutritional counseling, physical and cognitive trainings) intervention group with a connected accelerometer (number of steps, energy expenditure), or to a control group with access to general information on healthy aging plus the accelerometer, but no access to the multidomain intervention. The main outcome is the feasibility/acceptability of the web-based intervention. Secondary clinical outcomes include: cognitive functions, physical performance, nutritional status and cost-effectiveness. We expect a high amount of adherers (ie, > 75% compliance to the protocol) to reflect the feasibility. Acceptability, assessed through interviews, should allow us to understand motivators and barriers to this ICT intervention. We also expect to provide data on its effects on various clinical outcomes and efficiency. The eMIND study will provide crucial information to help developing a future and larger web-based multidomain lifestyle RCT, which should facilitate the translation of this ICT intervention from the research world into real-life clinical practice for the healthcare of older adults.

Randomized, Double-Blind, Placebo-Controlled Trial of Asenapine Maintenance Therapy in Adults With an Acute Manic or Mixed Episode Associated With Bipolar I Disorder.

PubMed

Szegedi, Armin; Durgam, Suresh; Mackle, Mary; Yu, Sung Yun; Wu, Xiao; Mathews, Maju; Landbloom, Ronald P

2018-01-01

The authors determined the efficacy and safety of asenapine in preventing recurrence of any mood episode in adults with bipolar I disorder. Adults with an acute manic or mixed episode per DSM-IV-TR criteria were enrolled in this randomized, placebo-controlled trial consisting of an initial 12- to 16-week open-label period and a 26-week double-blind randomized withdrawal period. The target asenapine dosage was 10 mg b.i.d. in the open-label period but could be titrated down to 5 mg b.i.d. After completing the open-label period, subjects meeting stabilization/stable-responder criteria were randomized to asenapine or placebo treatment in the double-blind period. The primary efficacy endpoint was time to recurrence of any mood event during the double-blind period. Kaplan-Meier estimation was performed, and 95% confidence intervals were determined. Safety was assessed throughout. A total of 549 subjects entered the open-label period, of whom 253 enrolled in the double-blind randomized withdrawal period (127 in the placebo group; 126 in the asenapine group). Time to recurrence of any mood episode was statistically significantly longer for asenapine- than placebo-treated subjects. In post hoc analyses, significant differences in favor of asenapine over placebo were seen in time to recurrence of manic and depressive episodes. The most common treatment-emergent adverse events were somnolence (10.0%), akathisia (7.7%), and sedation (7.7%) in the open-label period and mania (11.9% of the placebo group compared with 4.0% of the asenapine group) and bipolar I disorder (6.3% compared with 1.6%) in the double-blind period. Long-term treatment with asenapine was more effective than placebo in preventing recurrence of mood events in adults with bipolar I disorder and was generally well-tolerated.

Efficacy of standardized extract of Hibiscus sabdariffa L. (Malvaceae) in improving iron status of adults in malaria endemic area: A randomized controlled trial.

PubMed

Peter, Emanuel L; Rumisha, Susan F; Mashoto, Kijakazi O; Minzi, Omary Ms; Mfinanga, Sayoki

2017-09-14

Indigenous community of Mkuranga district have been using aqueous extract of H. sabdariffa L. for treating anemia. However, there have been neither safety nor efficacy studies to validate this medicinal product in anemia. The purpose of this study was to establish efficacy and safety of standardized aqueous extract of H. sabdariffa L. in anemic adults. This was a randomized controlled clinical trial in which 130 adults' men and women aged 18-50 years were involved after meeting the inclusion criteria. Initially, standardized aqueous extract of H. sabdariffa L. was prepared using optimized extraction parameters. Stratified randomization was used to randomize participants into four fixed dose groups. The first group received oral dose of 1000ml while the 2nd group was randomized to receive 1500ml orally. The last two groups were given a dose of 2000ml of extract and 200mg ferrous sulphate tablet respectively. Primary endpoint was the actual change of iron status indicators at the end of 30 days follow up period as compared to those recorded at baseline. Adverse effects were assessed at every 10th day scheduled visit. In all arms, HB and hematopoietic parameters were measured using HemoCue hemoglobinometer® (HemoCue, Ängelholm, Sweden) and hematology analyzer® respectively at the trial site. Follow up was done for 30 days. A total of 82 participants were included for analysis. A standardized aqueous extract of H. sabdariffa L. did not improve iron status in anemic adults in malaria endemic region (P>0.005). However, there was evidence to support the safety of the extract for human consumptions as herbal supplement. Iron and organic acids contents of H. sabdariffa L. extract showed the potential of improving hematopoietic parameters. Studies with bigger sample size are therefore needed to establish the efficacy of the extract when concurrently used with malaria chemoprophylaxis in malaria endemic areas. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Prevention of Relapse and Recurrence in Major Depression

ERIC Educational Resources Information Center

Dobson, Keith S.; Hollon, Steven D.; Dimidjian, Sona; Schmaling, Karen B.; Kohlenberg, Robert J.; Gallop, Robert J.; Rizvi, Shireen L.; Gollan, Jackie K.; Dunner, David L.; Jacobson, Neil S.

2008-01-01

This study followed treatment responders from a randomized controlled trial of adults with major depression. Patients treated with medication but withdrawn onto pill-placebo had more relapse through 1 year of follow-up compared to patients who received prior behavioral activation, prior cognitive therapy, or continued medication. Prior…

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

ERIC Educational Resources Information Center

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

Efficacy of Creative Clay Work for Reducing Negative Mood: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Kimport, Elizabeth R.; Robbins, Steven J.

2012-01-01

Clay work has long been used in art therapy to achieve therapeutic goals. However, little empirical evidence exists to document the efficacy of such work. The present study randomly assigned 102 adult participants to one of four conditions following induction of a negative mood: (a) handling clay with instructions to create a pinch pot, (b)…

Impact of Exposure to Electronic Cigarette Advertising on Susceptibility and Trial of Electronic Cigarettes and Cigarettes in US Young Adults: A Randomized Controlled Trial.

PubMed

Villanti, Andrea C; Rath, Jessica M; Williams, Valerie F; Pearson, Jennifer L; Richardson, Amanda; Abrams, David B; Niaura, Raymond S; Vallone, Donna M

2016-05-01

This study assessed the impact of brief exposure to four electronic cigarette (e-cigarette) print advertisements (ads) on perceptions, intention, and subsequent use of e-cigarettes and cigarettes in US young adults. A randomized controlled trial was conducted in a national sample of young adults from an online panel survey in 2013. Participants were randomized to ad exposure or control. Curiosity, intentions, and perceptions regarding e-cigarettes were assessed post-exposure and e-cigarette and cigarette use at 6-month follow-up. Analyses were conducted in 2014. Approximately 6% of young adults who had never used an e-cigarette at baseline tried an e-cigarette at 6-month follow-up, half of whom were current cigarette smokers at baseline. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette (18.3% exposed vs. 11.3% unexposed, AOR = 1.63, 95% CI = 1.18, 2.26) among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up (3.6% exposed vs. 1.2% unexposed, AOR = 2.85; 95% CI = 1.07, 7.61) among never users of cigarettes and e-cigarettes. Exploratory analyses did not find an association between ad exposure and cigarette trial or past 30-day use among never users, nor cigarette use among smokers over time. Curiosity mediated the relationship between ad exposure and e-cigarette trial among e-cigarette never users. Exposure to e-cigarette ads may enhance curiosity and limited trial of e-cigarettes in never users. Future studies are needed to examine the net effect of curiosity and trial of e-cigarettes on longer-term patterns of tobacco use. This randomized trial provides the first evidence of the effect of e-cigarette advertising on a behavioral outcome in young adults. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up in a small number of never e-cigarette users and greater likelihood of e-cigarette trial at follow-up among never users of cigarettes and e-cigarettes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Brief Report: Vocational Outcomes for Young Adults with Autism Spectrum Disorders at Six Months after Virtual Reality Job Interview Training

ERIC Educational Resources Information Center

Smith, Matthew J.; Fleming, Michael F.; Wright, Michael A.; Losh, Molly; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D.

2015-01-01

Young adults with high-functioning autism spectrum disorder (ASD) have low employment rates and job interviewing presents a critical barrier to employment for them. Results from a prior randomized controlled efficacy trial suggested virtual reality job interview training (VR-JIT) improved interviewing skills among trainees with ASD, but not…

A Randomized Controlled Trial to Improve Social Skills in Young Adults with Autism Spectrum Disorder: The UCLA PEERS® Program

ERIC Educational Resources Information Center

Laugeson, Elizabeth A.; Gantman, Alexander; Kapp, Steven K.; Orenski, Kaely; Ellingsen, Ruth

2015-01-01

Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young…

Effects of Dog-Assisted Therapy on Communication and Basic Social Skills of Adults with Intellectual Disabilities: A Pilot Study

ERIC Educational Resources Information Center

Scorzato, Ivano; Zaninotto, Leonardo; Romano, Michela; Menardi, Chiara; Cavedon, Lino; Pegoraro, Alessandra; Socche, Laura; Zanetti, Piera; Coppiello, Deborah

2017-01-01

Thirty-nine adults with severe to profound intellectual disability (ID) were randomly assigned to either an experimental group (n = 21) or a control group (n = 18). Assessment was blinded and included selected items from the International Classification of Functioning, Disability and Health (ICF), the Behavioral Assessment Battery (BAB), and the…

Feasibility study design and methods for a home-based, square-stepping exercise program among older adults with multiple sclerosis: The SSE-MS project.

PubMed

Sebastião, Emerson; McAuley, Edward; Shigematsu, Ryosuke; Motl, Robert W

2017-09-01

We propose a randomized controlled trial (RCT) examining the feasibility of square-stepping exercise (SSE) delivered as a home-based program for older adults with multiple sclerosis (MS). We will assess feasibility in the four domains of process, resources, management and scientific outcomes. The trial will recruit older adults (aged 60 years and older) with mild-to-moderate MS-related disability who will be randomized into intervention or attention control conditions. Participants will complete assessments before and after completion of the conditions delivered over a 12-week period. Participants in the intervention group will have biweekly meetings with an exercise trainer in the Exercise Neuroscience Research Laboratory and receive verbal and visual instruction on step patterns for the SSE program. Participants will receive a mat for home-based practice of the step patterns, an instruction manual, and a logbook and pedometer for monitoring compliance. Compliance will be further monitored through weekly scheduled Skype calls. This feasibility study will inform future phase II and III RCTs that determine the actual efficacy and effectiveness of a home-based exercise program for older adults with MS.

Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial

PubMed Central

Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

2015-01-01

[Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static stretching per week for 12 weeks. The following evaluations were performed before and after the interventions: isokinetic torque of knee extensors and flexors at 300°/s, the Timed Up and Go (TUG) test, the Berg Balance Scale, and the Health Survey assessment (SF-36). [Results] In the intra-group analysis, the EG demonstrated significant improvement in all variables. In the inter-group analysis, the EG demonstrated significant improvement in most variables. [Conclusion] Pilates exercises led to significant improvement in isokinetic torque of the knee extensors and flexors, postural balance and aspects of the health-related quality of life of older adults. PMID:25931749

A Randomized, Controlled Trial of Meditation for Work Stress, Anxiety and Depressed Mood in Full-Time Workers

PubMed Central

Manocha, R.; Black, D.; Sarris, J.; Stough, C.

2011-01-01

Objective. To assess the effect of meditation on work stress, anxiety and mood in full-time workers. Methods. 178 adult workers participated in an 8-week, 3-arm randomized controlled trial comparing a “mental silence” approach to meditation (n = 59) to a “relaxation” active control (n = 56) and a wait-list control (n = 63). Participants were assessed before and after using Psychological Strain Questionnaire (PSQ), a subscale of the larger Occupational Stress Inventory (OSI), the State component of the State/Trait Anxiety Inventory for Adults (STAI), and the depression-dejection (DD) subscale of the Profile of Mood States (POMS). Results. There was a significant improvement for the meditation group compared to both the relaxation control and the wait-list groups the PSQ (P = .026), and DD (P = .019). Conclusions. Mental silence-orientated meditation, in this case Sahaja Yoga meditation, is a safe and effective strategy for dealing with work stress and depressive feelings. The findings suggest that “thought reduction” or “mental silence” may have specific effects relevant to work stress and hence occupational health. PMID:21716708

Efficacy of Acupuncture for Bell’s Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Li, Pingping; Qiu, Tangmeng; Qin, Chao

2015-01-01

Acupuncture has emerged as an alternative therapy for Bell’s palsy in both adults and children. However, the use of acupuncture is controversial. We conducted a systematic review and meta-analysis to assess the efficacy of acupuncture for Bell’s palsy. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, irrespective of any language restrictions. Randomized controlled trials comparing acupuncture with other therapies for Bell’s palsy in adults or children were included. Fourteen randomized controlled trials involving 1541 individuals were included in this meta-analysis. Significant association was observed in acupuncture with a higher effective response rate for Bell’s palsy (relative risk, 1.14; 95% confidence interval, 1.04–1.25; P = 0.005) but there was a heterogeneity among the studies (I 2 = 87%). An assessment of the included studies revealed a high risk of bias in methodological quality. An evaluation of the incidence of complications was not available, owing to incomplete data. Acupuncture seems to be an effective therapy for Bell’s palsy, but there was insufficient evidence to support the efficacy and safety of acupuncture. However, the results should be interpreted cautiously, because of the poor quality and heterogeneity of the included studies. PMID:25974022

Endurance exercise beneficially affects ambulatory blood pressure: a systematic review and meta-analysis.

PubMed

Cornelissen, Véronique A; Buys, Roselien; Smart, Neil A

2013-04-01

Exercise is widely recommended as one of the key preventive lifestyle changes to reduce the risk of hypertension and to manage high blood pressure (BP), but individual studies investigating the effect of exercise on ambulatory BP have remained inconclusive. Therefore, the primary purpose of this systematic review and meta-analysis was to determine the effect of aerobic endurance training on daytime and night-time BP in healthy adults. A systematic literature search was conducted using PubMed and Cochrane Controlled Clinical trial registry from their inception to May 2012. Randomized controlled trials of at least 4 weeks investigating the effects of aerobic endurance training on ambulatory BP in healthy adults were included. Inverse weighted random effects models were used for analyses, with data reported as weighted means and 95% confidence limits. We included 15 randomized controlled trials, involving 17 study groups and 633 participants (394 exercise participants and 239 control participants). Overall, endurance training induced a significant reduction in daytime SBP [-3.2 mmHg, 95% confidence interval (CI), -5.0 to-1.3] and daytime DBP (-2.7 mmHg, 95% CI, -3.9 to -1.5). No effect was observed on night-time BP. The findings from this meta-analysis suggest that aerobic endurance exercise significantly decreases daytime, but not night-time, ambulatory BP.

Setting the stage for chronic health problems: cumulative childhood adversity among homeless adults with mental illness in Vancouver, British Columbia.

PubMed

Patterson, Michelle L; Moniruzzaman, Akm; Somers, Julian M

2014-04-12

It is well documented that childhood abuse, neglect and household dysfunction are disproportionately present in the backgrounds of homeless adults, and that these experiences adversely impact child development and a wide range of adult outcomes. However, few studies have examined the cumulative impact of adverse childhood experiences on homeless adults with mental illness. This study examines adverse events in childhood as predictors of duration of homelessness, psychiatric and substance use disorders, and physical health in a sample of homeless adults with mental illness. This study was conducted using baseline data from a randomized controlled trial in Vancouver, British Columbia for participants who completed the Adverse Childhood Experiences (ACE) scale at 18 months follow-up (n=364). Primary outcomes included current mental disorders; substance use including type, frequency and severity; physical health; duration of homelessness; and vocational functioning. In multivariable regression models, ACE total score independently predicted a range of mental health, physical health, and substance use problems, and marginally predicted duration of homelessness. Adverse childhood experiences are overrepresented among homeless adults with complex comorbidities and chronic homelessness. Our findings are consistent with a growing body of literature indicating that childhood traumas are potent risk factors for a number of adult health and psychiatric problems, particularly substance use problems. Results are discussed in the context of cumulative adversity and self-trauma theory. This trial has been registered with the International Standard Randomized Control Trial Number Register and assigned ISRCTN42520374.

Prevention of sexually transmitted infections in urban communities (Peru PREVEN): a multicomponent community-randomised controlled trial.

PubMed

García, Patricia J; Holmes, King K; Cárcamo, César P; Garnett, Geoff P; Hughes, James P; Campos, Pablo E; Whittington, William L H

2012-03-24

Previous community-randomised trials of interventions to control sexually transmitted infections (STIs) have involved rural settings, were rarely multicomponent, and had varying results. We aimed to assess the effect of a multicomponent intervention on curable STIs in urban young adults and female sex workers (FSWs). In this community-randomised trial, baseline STI screening was done between August, and November, 2002, in random household samples of young adults (aged 18-29 years) and in FSWs in Peruvian cities with more than 50,000 inhabitants. Geographically separate cities were selected, matched into pairs, and randomly allocated to intervention or control groups with an S-PLUS program. Follow-up surveys of random samples were done after 2 years and 3 years. The intervention comprised four modalities: strengthened STI syndromic management by pharmacy workers and clinicians; mobile-team outreach to FSWs for STI screening and pathogen-specific treatment; periodic presumptive treatment of FSWs for trichomoniasis; and condom promotion for FSWs and the general population. Individuals in control cities received standard care. The composite primary endpoint was infection of young adults with Chlamydia trachomatis, Trichomonas vaginalis, or Neisseria gonorrhoeae, or syphilis seroreactivity. Laboratory workers and the data analyst were masked, but fieldworkers, the Peruvian study team, and participants in the outcome surveys were not. All analyses were done by intention to treat. This trial is registered, ISRCTN43722548. We did baseline surveys of 15,261 young adults in 24 Peruvian cities. Of those, 20 geographically separate cities were matched into pairs, in each of which one city was assigned to intervention and the other to standard of care. In the 2006 follow-up survey, data for the composite primary outcome were available for 12,930 young adults. We report a non-significant reduction in prevalence of STIs in young adults, adjusted for baseline prevalence, in intervention cities compared with control cities (relative risk 0·84, 95% CI 0·69-1·02; p=0·096). In subgroup analyses, significant reductions were noted in intervention cities in young adult women and FSWs. Syndromic management of STIs, mobile-team outreach to FSWs, presumptive treatment for trichomoniasis in FSWs, and condom promotion might reduce the composite prevalence of any of the four curable STIs investigated in this trial. Wellcome Trust and Burroughs Wellcome Fund, National Institutes of Health, Center for AIDS Research, CIPRA, and USAID-Peru. Copyright © 2012 Elsevier Ltd. All rights reserved.

Facilitating change in health-related behaviors and intentions: a randomized controlled trial of a multidimensional memory program for older adults.

PubMed

Wiegand, Melanie A; Troyer, Angela K; Gojmerac, Christina; Murphy, Kelly J

2013-01-01

Many older adults are concerned about memory changes with age and consequently seek ways to optimize their memory function. Memory programs are known to be variably effective in improving memory knowledge, other aspects of metamemory, and/or objective memory, but little is known about their impact on implementing and sustaining lifestyle and healthcare-seeking intentions and behaviors. We evaluated a multidimensional, evidence-based intervention, the Memory and Aging Program, that provides education about memory and memory change, training in the use of practical memory strategies, and support for implementation of healthy lifestyle behavior changes. In a randomized controlled trial, 42 healthy older adults participated in a program (n = 21) or a waitlist control (n = 21) group. Relative to the control group, participants in the program implemented more healthy lifestyle behaviors by the end of the program and maintained these changes 1 month later. Similarly, program participants reported a decreased intention to seek unnecessary medical attention for their memory immediately after the program and 1 month later. Findings support the use of multidimensional memory programs to promote healthy lifestyles and influence healthcare-seeking behaviors. Discussion focuses on implications of these changes for maximizing cognitive health and minimizing impact on healthcare resources.

Enhanced visual statistical learning in adults with autism

PubMed Central

Roser, Matthew E.; Aslin, Richard N.; McKenzie, Rebecca; Zahra, Daniel; Fiser, József

2014-01-01

Individuals with autism spectrum disorder (ASD) are often characterized as having social engagement and language deficiencies, but a sparing of visuo-spatial processing and short-term memory, with some evidence of supra-normal levels of performance in these domains. The present study expanded on this evidence by investigating the observational learning of visuospatial concepts from patterns of covariation across multiple exemplars. Child and adult participants with ASD, and age-matched control participants, viewed multi-shape arrays composed from a random combination of pairs of shapes that were each positioned in a fixed spatial arrangement. After this passive exposure phase, a post-test revealed that all participant groups could discriminate pairs of shapes with high covariation from randomly paired shapes with low covariation. Moreover, learning these shape-pairs with high covariation was superior in adults with ASD than in age-matched controls, while performance in children with ASD was no different than controls. These results extend previous observations of visuospatial enhancement in ASD into the domain of learning, and suggest that enhanced visual statistical learning may have arisen from a sustained bias to attend to local details in complex arrays of visual features. PMID:25151115

Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials.

PubMed

Matteson, Michelle L; Russell, Cynthia

2010-10-01

Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

Would transcranial direct current stimulation (tDCS) enhance the effects of working memory training in older adults with mild neurocognitive disorder due to Alzheimer's disease: study protocol for a randomized controlled trial.

PubMed

Cheng, Calvin P W; Chan, Sandra S M; Mak, Arthur D P; Chan, Wai Chi; Cheng, Sheung Tak; Shi, Lin; Wang, Defeng; Lam, Linda Chiu-Wa

2015-10-24

There has been longstanding interesting in cognitive training for older adults with cognitive impairment. In this study, we will investigate the effects of working memory training, and explore augmentation strategies that could possibly consolidate the effects in older adults with mild neurocognitive disorder. Transcranial direct current stimulation (tDCS) has been demonstrated to affect the neuronal excitability and reported to enhance memory performance. As tDCS may also modulate cognitive function through changes in neuroplastic response, it would be adopted as an augmentation strategy for working memory training in the present study. This is a 4-week intervention double-blind randomized controlled trial (RCT) of tDCS. Chinese older adults (aged 60 to 90 years) with mild neurocognitive disorder due to Alzheimer's disease (DSM-5 criteria) would be randomized into a 4-week intervention of either tDCS-working memory (DCS-WM), tDCS-control cognitive training (DCS-CC), and sham tDCS-working memory (WM-CD) groups. The primary outcome would be working memory test - the n-back task performance and the Chinese version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). Secondary outcomes would be test performance of specific cognitive domains and mood. Intention-to-treat analysis would be carried out. Changes of efficacy indicators with time and intervention would be tested with mixed effect models. This study adopts the theory of neuroplasticity to evaluate the potential cognitive benefits of non-invasive electrical brain stimulation, working memory training and dual stimulation in older adults at risk of cognitive decline. It would also examine the tolerability, program adherence and adverse effects of this novel intervention. Information would be helpful for further research of dementia prevention studies. ChiCTR-TRC- 14005036 Date of registration: 31 July 2014.

Effects of the visual-feedback-based force platform training with functional electric stimulation on the balance and prevention of falls in older adults: a randomized controlled trial.

PubMed

Li, Zhen; Wang, Xiu-Xia; Liang, Yan-Yi; Chen, Shu-Yan; Sheng, Jing; Ma, Shao-Jun

2018-01-01

Force platform training with functional electric stimulation aimed at improving balance may be effective in fall prevention for older adults. Aim of the study is to evaluate the effects of the visual-feedback-based force platform balance training with functional electric stimulation on balance and fall prevention in older adults. A single-centre, unblinded, randomized controlled trial was conducted. One hundred and twenty older adults were randomly allocated to two groups: the control group ( n  = 60, one-leg standing balance exercise, 12 min/d) or the intervention group ( n  = 60, force platform training with functional electric stimulation, 12 min/d). The training was provided 15 days a month for 3 months by physical therapists. Medial-lateral and anterior-posterior maximal range of sway with eyes open and closed, the Berg Balance Scale, the Barthel Index, the Falls Efficacy scale-International were assessed at baseline and after the 3-month intervention. A fall diary was kept by each participant during the 6-month follow-up. On comparing the two groups, the intervention group showed significantly decreased ( p  < 0.01) medial-lateral and anterior-posterior maximal range of sway with eyes open and closed. There was significantly higher improvement in the Berg Balance Scale ( p  < 0.05), the Barthel Index ( p  < 0.05) and the Falls Efficacy Scale-International ( p  < 0.05), along with significantly lesser number of injurious fallers ( p  < 0.05), number of fallers ( p  < 0.05), and fall rates ( p  < 0.05) during the 6-month follow-up in the intervention group. This study showed that the visual feedback-based force platform training with functional electric stimulation improved balance and prevented falls in older adults.

A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up

PubMed Central

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M.; Waterworth, John A.

2015-01-01

This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary. PMID:25926790

A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up.

PubMed

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M; Waterworth, John A

2015-01-01

This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary.

Wheelchair skills training to improve confidence with using a manual wheelchair among older adults: A pilot study

PubMed Central

Sakakibara, Brodie M.; Miller, William C.; Souza, Melanie; Nikolova, Viara; Best, Krista L.

2014-01-01

Objectives To examine the effects of wheelchair skills training on confidence in older adults who are inexperienced with using a wheelchair. Design Parallel group, single blind randomized controlled trial Setting Vancouver, Canada Participants Participants (N=20) who were community-living older adults at least 65 years old (mean = 70 years), 50% female, and who had no prior experience using a wheelchair were randomly allocated to an intervention (n=10) or control (n=10) group. Intervention The intervention group received two 1-hour training sessions that followed the Wheelchair Skills Training Program (WSTP) protocol. The control group received a single socialization contact. Main Outcome Measure The Wheelchair Use Confidence Scale-Manual (WheelCon-M) was used to evaluate confidence with using a manual wheelchair. The WheelCon-M is a self-report questionnaire comprised of 65 items in 6 conceptual areas. Results A 1-way between groups analysis of covariance revealed a significant difference in post-intervention WheelCon-M scores between the intervention and control groups [F(1,17) = 10.9, p = 0.004] after controlling for baseline WheelCon-M scores. A large effect size was also observed (partial eta squared = 0.39). Secondary analyses revealed the WSTP had greater effects on confidence in areas related to maneuvering around the physical environment, knowledge and problem solving, advocacy, and managing emotions, than in areas related to performing activities and behaving in social situations. Conclusion Two 1-hour WSTP sessions improves confidence with using a manual wheelchair among older adults, inexperienced with using a wheelchair. PMID:23385110

V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial.

PubMed

Mirelman, Anat; Rochester, Lynn; Reelick, Miriam; Nieuwhof, Freek; Pelosin, Elisa; Abbruzzese, Giovanni; Dockx, Kim; Nieuwboer, Alice; Hausdorff, Jeffrey M

2013-02-06

Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk. Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson's disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function. This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit. (NIH)-NCT01732653.

V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial

PubMed Central

2013-01-01

Background Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk. Methods/Design Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson’s disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function. Discussion This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit. Trial Registration (NIH)–NCT01732653 PMID:23388087

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

PubMed Central

Shinnar, Shlomo; Gloss, David; Alldredge, Brian; Arya, Ravindra; Bainbridge, Jacquelyn; Bare, Mary; Bleck, Thomas; Dodson, W. Edwin; Garrity, Lisa; Jagoda, Andy; Lowenstein, Daniel; Pellock, John; Riviello, James; Sloan, Edward; Treiman, David M.

2016-01-01

CONTEXT: The optimal pharmacologic treatment for early convulsive status epilepticus is unclear. OBJECTIVE: To analyze efficacy, tolerability and safety data for anticonvulsant treatment of children and adults with convulsive status epilepticus and use this analysis to develop an evidence-based treatment algorithm. DATA SOURCES: Structured literature review using MEDLINE, Embase, Current Contents, and Cochrane library supplemented with article reference lists. STUDY SELECTION: Randomized controlled trials of anticonvulsant treatment for seizures lasting longer than 5 minutes. DATA EXTRACTION: Individual studies were rated using predefined criteria and these results were used to form recommendations, conclusions, and an evidence-based treatment algorithm. RESULTS: A total of 38 randomized controlled trials were identified, rated and contributed to the assessment. Only four trials were considered to have class I evidence of efficacy. Two studies were rated as class II and the remaining 32 were judged to have class III evidence. In adults with convulsive status epilepticus, intramuscular midazolam, intravenous lorazepam, intravenous diazepam and intravenous phenobarbital are established as efficacious as initial therapy (Level A). Intramuscular midazolam has superior effectiveness compared to intravenous lorazepam in adults with convulsive status epilepticus without established intravenous access (Level A). In children, intravenous lorazepam and intravenous diazepam are established as efficacious at stopping seizures lasting at least 5 minutes (Level A) while rectal diazepam, intramuscular midazolam, intranasal midazolam, and buccal midazolam are probably effective (Level B). No significant difference in effectiveness has been demonstrated between intravenous lorazepam and intravenous diazepam in adults or children with convulsive status epilepticus (Level A). Respiratory and cardiac symptoms are the most commonly encountered treatment-emergent adverse events associated with intravenous anticonvulsant drug administration in adults with convulsive status epilepticus (Level A). The rate of respiratory depression in patients with convulsive status epilepticus treated with benzodiazepines is lower than in patients with convulsive status epilepticus treated with placebo indicating that respiratory problems are an important consequence of untreated convulsive status epilepticus (Level A). When both are available, fosphenytoin is preferred over phenytoin based on tolerability but phenytoin is an acceptable alternative (Level A). In adults, compared to the first therapy, the second therapy is less effective while the third therapy is substantially less effective (Level A). In children, the second therapy appears less effective and there are no data about third therapy efficacy (Level C). The evidence was synthesized into a treatment algorithm. CONCLUSIONS: Despite the paucity of well-designed randomized controlled trials, practical conclusions and an integrated treatment algorithm for the treatment of convulsive status epilepticus across the age spectrum (infants through adults) can be constructed. Multicenter, multinational efforts are needed to design, conduct and analyze additional randomized controlled trials that can answer the many outstanding clinically relevant questions identified in this guideline. PMID:26900382

Physical activity and nutrition behaviour outcomes of a cluster-randomized controlled trial for adults with metabolic syndrome in Vietnam.

PubMed

Tran, Van Dinh; Lee, Andy H; Jancey, Jonine; James, Anthony P; Howat, Peter; Mai, Le Thi Phuong

2017-01-13

Metabolic syndrome is prevalent among Vietnamese adults, especially those aged 50-65 years. This study evaluated the effectiveness of a 6 month community-based lifestyle intervention to increase physical activity levels and improve dietary behaviours for adults with metabolic syndrome in Vietnam. Ten communes, involving participants aged 50-65 years with metabolic syndrome, were recruited from Hanam province in northern Vietnam. The communes were randomly allocated to either the intervention (five communes, n = 214) or the control group (five communes, n = 203). Intervention group participants received a health promotion package, consisting of an information booklet, education sessions, a walking group, and a resistance band. Control group participants received one session of standard advice during the 6 month period. Data were collected at baseline and after the intervention to evaluate programme effectiveness. The International Physical Activity Questionnaire - Short Form and a modified STEPS questionnaire were used to assess physical activity and dietary behaviours, respectively, in both groups. Pedometers were worn by the intervention participants only for 7 consecutive days at baseline and post-intervention testing. To accommodate the repeated measures and the clustering of individuals within communes, multilevel mixed regression models with random effects were fitted to determine the impacts of intervention on changes in outcome variables over time and between groups. With a retention rate of 80.8%, the final sample comprised 175 intervention and 162 control participants. After controlling for demographic and other confounding factors, the intervention participants showed significant increases in moderate intensity activity (P = 0.018), walking (P < 0.001) and total physical activity (P = 0.001), as well as a decrease in mean sitting time (P < 0.001), relative to their control counterparts. Significant improvements in dietary behaviours were also observed, particularly reductions in intake of animal internal organs (P = 0.001) and in using cooking oil for daily meal preparation (P = 0.001). The prescribed community-based physical activity and nutrition intervention programme successfully improved physical activity and dietary behaviours for adults with metabolic syndrome in Vietnam. Australian New Zealand Clinical Trials Registry, ACTRN12614000811606 . Registered on 31 July 2014.

Long-term effects of three multicomponent exercise interventions on physical performance and fall-related psychological outcomes in community-dwelling older adults: a randomized controlled trial.

PubMed

Freiberger, Ellen; Häberle, Lothar; Spirduso, Waneen W; Zijlstra, G A Rixt

2012-03-01

To determine the long-term effects of three strength and balance exercise interventions on physical performance, fall-related psychological outcomes, and falls in older people. A single-blinded, four-group, randomized controlled trial. Community, Germany. Community-dwelling adults aged 70 to 90 who had fallen in the past 6 months or reported fear of falling. After baseline assessment, 280 participants were randomly assigned to the control group (CG; no intervention; n = 80) or one of three strength and balance exercise interventions (the strength and balance group (SBG; strength and balance only; n = 63), the fitness group (FG; strength and balance plus endurance training; n = 64), or the multifaceted group (MG; strength and balance plus fall risk education; n = 73). The interventions consisted of 32 one-hour group sessions in 16 weeks. Data on physical performance, fall-related psychological outcomes, and falls were collected for 24 months. Mixed-effects regression analyses showed improved short- and long-term (12 and 24 months, respectively) physical performance for the SBG and FG, particularly regarding mobility, balance, and walking speed (P < .05). The improvements in physical performance outcomes were most prominent in the FG. Fall-related psychological outcomes, number of falls, and injurious falls were not significantly different from in the control group. Training focusing on strength, balance, and endurance can enhance physical performance for up to 24 months in community-dwelling older adults. These findings did not translate to improved fall-related psychological outcomes or reduced incidence of falls. This demonstrates the need for a different approach (e.g., regarding intervention dose and components) to gain intervention benefits in the multiple domains that contribute to independence and well-being in older adults. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

Effect of the adapted Virtual Reality cognitive training program among Chinese older adults with chronic schizophrenia: a pilot study.

PubMed

Chan, Christopher L F; Ngai, Elena K Y; Leung, Paul K H; Wong, Stephen

2010-06-01

To examine the effect of the adapted virtual reality cognitive training program in older adults with chronic schizophrenia. Older adults with chronic schizophrenia were recruited from a long-stay care setting and were randomly assigned into intervention (n = 12) and control group (n = 15). The intervention group received 10-session of VR program that consisted of 2 VR activities using IREX. The control group attended the usual programs in the setting. After the 10-session intervention, older adults with chronic schizophrenia preformed significantly better than control in overall cognitive function (p .000), and in two cognitive subscales: repetition (p .001) and memory (p .040). These participants engaged in the VR activities volitionally. No problem of cybersickness was observed. The results of the current study indicate that engaging in the adapted virtual reality cognitive training program offers the potential for significant gains in cognitive function of the older adults with chronic schizophrenia.

Effects of Meditation versus Music Listening on Perceived Stress, Mood, Sleep, and Quality of Life in Adults with Early Memory Loss: A Pilot Randomized Controlled Trial.

PubMed

Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

2016-04-08

Older adults with subjective cognitive decline (SCD) are at increased risk not only for Alzheimer's disease, but for poor mental health, impaired sleep, and diminished quality of life (QOL), which in turn, contribute to further cognitive decline, highlighting the need for early intervention. In this randomized controlled trial, we assessed the effects of two 12-week relaxation programs, Kirtan Kriya Meditation (KK) and music listening (ML), on perceived stress, sleep, mood, and health-related QOL in older adults with SCD. Sixty community-dwelling older adults with SCD were randomized to a KK or ML program and asked to practice 12 minutes daily for 12 weeks, then at their discretion for the following 3 months. At baseline, 12 weeks, and 26 weeks, perceived stress, mood, psychological well-being, sleep quality, and health-related QOL were measured using well-validated instruments. Fifty-three participants (88%) completed the 6-month study. Participants in both groups showed significant improvement at 12 weeks in psychological well-being and in multiple domains of mood and sleep quality (p's≤0.05). Relative to ML, those assigned to KK showed greater gains in perceived stress, mood, psychological well-being, and QOL-Mental Health (p's≤0.09). Observed gains were sustained or improved at 6 months, with both groups showing marked and significant improvement in all outcomes. Changes were unrelated to treatment expectancies. Findings suggest that practice of a simple meditation or ML program may improve stress, mood, well-being, sleep, and QOL in adults with SCD, with benefits sustained at 6 months and gains that were particularly pronounced in the KK group.

Effects of Meditation versus Music Listening on Perceived Stress, Mood, Sleep, and Quality of Life in Adults with Early Memory Loss: A Pilot Randomized Controlled Trial

PubMed Central

Innes, Kim E.; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

2017-01-01

Background Older adults with subjective cognitive decline (SCD) are at increased risk not only for Alzheimer’s disease, but for poor mental health, impaired sleep, and diminished quality of life (QOL), which in turn, contribute to further cognitive decline, highlighting the need for early intervention. Objective In this randomized controlled trial, we assessed the effects of two 12-week relaxation programs, Kirtan Kriya Meditation (KK) and music listening (ML), on perceived stress, sleep, mood, and health-related QOL in older adults with SCD. Methods Sixty community-dwelling older adults with SCD were randomized to a KK or ML program and asked to practice 12 minutes daily for 12 weeks, then at their discretion for the following 3 months. At baseline, 12 weeks, and 26 weeks, perceived stress, mood, psychological well-being, sleep quality, and health-related QOL were measured using well-validated instruments. Results Fifty-three participants (88%) completed the 6-month study. Participants in both groups showed significant improvement at 12 weeks in psychological well-being and in multiple domains of mood and sleep quality (p’s ≤ 0.05). Relative to ML, those assigned to KK showed greater gains in perceived stress, mood, psychological well-being, and QOL-Mental Health (p’s ≤ 0.09). Observed gains were sustained or improved at 6 months, with both groups showing marked and significant improvement in all outcomes. Changes were unrelated to treatment expectancies. Conclusions Findings suggest that practice of a simple meditation or ML program may improve stress, mood, well-being, sleep, and QOL in adults with SCD, with benefits sustained at 6 months and gains that were particularly pronounced in the KK group. PMID:27079708

Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

PubMed

Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

2015-11-01

One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults.

PubMed

Gray, Kevin M; Sonne, Susan C; McClure, Erin A; Ghitza, Udi E; Matthews, Abigail G; McRae-Clark, Aimee L; Carroll, Kathleen M; Potter, Jennifer S; Wiest, Katharina; Mooney, Larissa J; Hasson, Albert; Walsh, Sharon L; Lofwall, Michelle R; Babalonis, Shanna; Lindblad, Robert W; Sparenborg, Steven; Wahle, Aimee; King, Jacqueline S; Baker, Nathaniel L; Tomko, Rachel L; Haynes, Louise F; Vandrey, Ryan G; Levin, Frances R

2017-08-01

Cannabis use disorder (CUD) is a prevalent and impairing condition, and established psychosocial treatments convey limited efficacy. In light of recent findings supporting the efficacy of N-acetylcysteine (NAC) for CUD in adolescents, the objective of this trial was to evaluate its efficacy in adults. In a 12-week double-blind randomized placebo-controlled trial, treatment-seeking adults ages 18-50 with CUD (N=302), enrolled across six National Drug Abuse Treatment Clinical Trials Network-affiliated clinical sites, were randomized in a 1:1 ratio to a 12-week course of NAC 1200mg (n=153) or placebo (n=149) twice daily. All participants received contingency management (CM) and medical management. The primary efficacy measure was the odds of negative urine cannabinoid tests during treatment, compared between NAC and placebo participants. There was not statistically significant evidence that the NAC and placebo groups differed in cannabis abstinence (odds ratio=1.00, 95% confidence interval 0.63-1.59, p=0.984). Overall, 22.3% of urine cannabinoid tests in the NAC group were negative, compared with 22.4% in the placebo group. Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group. In contrast with prior findings in adolescents, there is no evidence that NAC 1200mg twice daily plus CM is differentially efficacious for CUD in adults when compared to placebo plus CM. This discrepant finding between adolescents and adults with CUD may have been influenced by differences in development, cannabis use profiles, responses to embedded behavioral treatment, medication adherence, and other factors. Copyright © 2017 Elsevier B.V. All rights reserved.

Randomized controlled trial of oatmeal consumption versus noodle consumption on blood lipids of urban Chinese adults with hypercholesterolemia

PubMed Central

2012-01-01

Background Cardiovascular disease (CVD) is the leading cause of death in China and worldwide. Whole grain oats can reduce risk of CVD by reducing total and LDL-cholesterol, major risk factors for CVD. While this association has been established in many populations, data from Asian populations is limited. Thus, this study investigated the impact of oat consumption on cholesterol levels in Chinese adults. Male and female data from this work were previously published separately in mandarin in two Chinese journals. The combined male and female data were reanalyzed and are presented here. Methods A randomized, controlled, parallel-arm study was conducted at Beijing Hospital, Beijing china. Subjects were adults (men and women) with mild to moderate hypercholesterolemia. The oat group (n=85) consumed 100grams of instant oat cereal versus the control group (n=81) who consumed 100grams of wheat flour-based noodles daily for 6weeks. Laboratory and anthropometric measurements were conducted at baseline and at the end of the 6-week intervention. Results Dietary fiber intake increased significantly in the oat group compared to the control group at the end of the 6-week intervention. Total-, LDL-cholesterol and waist circumference decreased significantly in the oat group compared to the control. HDL-cholesterol decreased significantly in the control group versus the oat group. There were no significant changes in blood pressure, other anthropometric or laboratory measures between the two groups at the end of the intervention. Conclusions Instant oatmeal consumed daily for 6 weeks significantly increased fiber intake and decreased major risk factors for CVD in Chinese adults with hypercholesterolemia. Increased consumption of whole grains, including oats, should continue to be encouraged. PMID:22866937

Randomized controlled trial of oatmeal consumption versus noodle consumption on blood lipids of urban Chinese adults with hypercholesterolemia.

PubMed

Zhang, Jian; Li, Lixiang; Song, Pengkun; Wang, Chunrong; Man, Qingqing; Meng, Liping; Cai, Jenny; Kurilich, Anne

2012-08-06

Cardiovascular disease (CVD) is the leading cause of death in China and worldwide. Whole grain oats can reduce risk of CVD by reducing total and LDL-cholesterol, major risk factors for CVD. While this association has been established in many populations, data from Asian populations is limited. Thus, this study investigated the impact of oat consumption on cholesterol levels in Chinese adults. Male and female data from this work were previously published separately in mandarin in two Chinese journals. The combined male and female data were reanalyzed and are presented here. A randomized, controlled, parallel-arm study was conducted at Beijing Hospital, Beijing china. Subjects were adults (men and women) with mild to moderate hypercholesterolemia. The oat group (n=85) consumed 100 grams of instant oat cereal versus the control group (n=81) who consumed 100 grams of wheat flour-based noodles daily for 6 weeks. Laboratory and anthropometric measurements were conducted at baseline and at the end of the 6-week intervention. Dietary fiber intake increased significantly in the oat group compared to the control group at the end of the 6-week intervention. Total-, LDL-cholesterol and waist circumference decreased significantly in the oat group compared to the control. HDL-cholesterol decreased significantly in the control group versus the oat group. There were no significant changes in blood pressure, other anthropometric or laboratory measures between the two groups at the end of the intervention. Instant oatmeal consumed daily for 6 weeks significantly increased fiber intake and decreased major risk factors for CVD in Chinese adults with hypercholesterolemia. Increased consumption of whole grains, including oats, should continue to be encouraged.

Effects of nurse-led child- and parent-focused violence intervention on mentally ill adult patients and victimized parents: A randomized controlled trial.

PubMed

Sun, Gwo-Ching; Hsu, Mei-Chi

2016-08-01

Child-to-parent violence is an often hidden serious problem for parental caregivers of mentally ill adult children who experience violence toward them. To date, the comprehensive dyadic parent-adult child intervention to manage child-to-parent violence is scarce. To evaluate the effect of Child- and Parent-focused Violence Program, an adjunctive intervention involved with both violent adult children with mental illness and their victimized biological parent (parent-adult child dyads) on violence management. Open-label randomized controlled trial. A psychiatric ward in a teaching hospital and two mental hospitals in Southern Taiwan. Sixty-nine patients aged ≥20 years, with thought or mood disorders, having violent behavior in the past 6 months toward their biological parent of either gender were recruited. The violent patients' victimized biological parents who had a major and ongoing role in provision of care to these patients, living together with and being assaulted by their violent children were also recruited. The parent-adult child dyads were selected. The intervention was carried out from 2011 to 2013. The parent-adult child dyads were randomly assigned to either the experimental group (36 dyads), which received Child- and Parent-focused Violence Intervention Program, or to the control group (33 dyads), which received only routine psychiatric care. The intervention included two individualized sessions for each patient and parent, separately, and 2 conjoint sessions for each parental-child dyad for a total of 6 sessions. Each session lasted for at least 60-min. Data collection was conducted at 3 different time frames: pre-treatment, post-treatment, and treatment follow-up (one month after the completion of the intervention). Occurrence of violence prior to intervention was comparable between two groups: 88.9% (n=32) parents in the experimental group versus 93.9% (n=31) in the control group experienced verbal attack, and 50% (n=18) versus 48.5% (n=16) received body attack and were injured. The intervention significantly reduced violence, improved impulsivity, changed patients' and parents' violence attributions, and fostering active coping processes in the experimental group as compared to the control group (p<0.05). No significant reductions were found in verbal aggression, cognitive and social reactions in the parent's reactions to assault, attentional subscale of impulsivity and wishful thinking (p>0.05). Child- and Parent-focused Violence Intervention Program is effective on child-to-parent violence management in parent-adult child dyads. Thus, the intervention can be helpful for patients who have just been diagnosed with mental illness and had an episode of violence toward their parents within a narrow time frame. Copyright © 2016 Elsevier Ltd. All rights reserved.

Musical dual-task training in patients with mild-to-moderate dementia: a randomized controlled trial.

PubMed

Chen, Yu-Ling; Pei, Yu-Cheng

2018-01-01

Dual-task training may improve dual-task gait performance, balance, and cognition in older adults with and without cognitive impairment. Although music has been widely utilized in dementia management, there are no existing protocols for music-based dual-task training. This randomized controlled study developed a Musical Dual-Task Training (MDTT) protocol that patients with dementia can use to practice walking and making music simultaneously, to enhance attention control in patients during dual-tasking. Twenty-eight adults diagnosed with mild-to-moderate dementia were assigned to the MDTT (n=15) or control groups (n=13). The MDTT group received MDTT, while the control group participated in non-musical cognitive and walking activities. The effects of MDTT were evaluated through the primary outcome of attention control, and secondary outcomes of dual-task performance, balance, falls efficacy, and agitation. The MDTT group showed a significant improvement in attention control, while the control group did not ( P <0.001). A significant effect favored MDTT over control treatment for the secondary outcome of falls efficacy ( P =0.02) and agitation ( P <0.01). MDTT, a music therapy intervention that demands a high level of cognitive processing, enhances attention control, falls efficacy, and helps alleviate agitation in patients with mild-to-moderate dementia.

Musical dual-task training in patients with mild-to-moderate dementia: a randomized controlled trial

PubMed Central

Chen, Yu-Ling; Pei, Yu-Cheng

2018-01-01

Background/aims Dual-task training may improve dual-task gait performance, balance, and cognition in older adults with and without cognitive impairment. Although music has been widely utilized in dementia management, there are no existing protocols for music-based dual-task training. This randomized controlled study developed a Musical Dual-Task Training (MDTT) protocol that patients with dementia can use to practice walking and making music simultaneously, to enhance attention control in patients during dual-tasking. Methods Twenty-eight adults diagnosed with mild-to-moderate dementia were assigned to the MDTT (n=15) or control groups (n=13). The MDTT group received MDTT, while the control group participated in non-musical cognitive and walking activities. The effects of MDTT were evaluated through the primary outcome of attention control, and secondary outcomes of dual-task performance, balance, falls efficacy, and agitation. Results The MDTT group showed a significant improvement in attention control, while the control group did not (P<0.001). A significant effect favored MDTT over control treatment for the secondary outcome of falls efficacy (P=0.02) and agitation (P<0.01). Conclusion MDTT, a music therapy intervention that demands a high level of cognitive processing, enhances attention control, falls efficacy, and helps alleviate agitation in patients with mild-to-moderate dementia. PMID:29881275

Cognitive Behaviour therapy for Older Adults with Insomnia and Depression: A Randomized Controlled Trial in Community Mental Health Services.

PubMed

Sadler, Paul; McLaren, Suzanne; Klein, Britt; Harvey, Jack; Jenkins, Megan

2018-05-24

To investigate whether cognitive behaviour therapy was effective for older adults with comorbid insomnia and depression in a community mental health setting, and explore whether an advanced form of cognitive behaviour therapy for insomnia produced better outcomes compared to a standard form of cognitive behaviour therapy for insomnia. An 8 week randomized controlled clinical trial was conducted within community mental health services, Victoria, Australia. Seventy-two older adults (56% female, M age 75 years ± 7) with diagnosed comorbid insomnia and depression participated. Three conditions were tested using a group therapy format: cognitive behaviour therapy for insomnia (CBT-I, standard), cognitive behaviour therapy for insomnia plus positive mood strategies (CBT-I+, advanced), psychoeducation control group (PCG, control). The primary outcomes were insomnia severity (Insomnia Severity Index) and depression severity (Geriatric Depression Scale). Primary and secondary measures were collected at pre (week 0), post (week 8), and follow-up (week 20). CBT-I and CBT-I+ both generated significantly greater reductions in insomnia and depression severity compared to PCG from pre to post (p < .001), which were maintained at follow-up. Although the differences between outcomes of the two treatment conditions were not statistically significant, the study was not sufficiently powered to detect either superiority of one treatment or equivalence of the two treatment conditions. CBT-I and CBT-I+ were both effective at reducing insomnia and depression severity for older adults. Mental health services that deliver treatment for comorbid insomnia with cognitive behaviour therapy may improve recovery outcomes for older adults with depression. Australian and New Zealand Clinical Trials Registry (ANZCTR) URL: https://www.anzctr.org.au Trial ID: ACTRN12615000067572 Date Registered: 12th December 2014.

Effects of a 12-week, short-interval, intermittent, low-intensity, slow-jogging program on skeletal muscle, fat infiltration, and fitness in older adults: randomized controlled trial.

PubMed

Ikenaga, Masahiro; Yamada, Yosuke; Kose, Yujiro; Morimura, Kazuhiro; Higaki, Yasuki; Kiyonaga, Akira; Tanaka, Hiroaki

2017-01-01

We developed a short-interval, low-intensity, slow-jogging (SJ) program consisting of sets of 1 min of SJ at walking speed and 1 min of walking. We aimed to examine the effects of an easily performed SJ program on skeletal muscle, fat infiltration, and fitness in older adults. A total of 81 community-dwelling, independent, older adults (70.8 ± 4.0 years) were randomly assigned to the SJ or control group. The SJ group participants were encouraged to perform 90 min of SJ at their anaerobic threshold (AT) intensity and 90 min of walking intermittently per week. Aerobic capacity at the AT and sit-to-stand (STS) scores were measured. Intracellular water (ICW) in the legs was assessed by segmental multi-frequency bioelectrical impedance analysis. Subcutaneous (SAT) and intermuscular (IMAT) adipose tissue and muscle cross-sectional area (CSA) were measured at the mid-thigh using computed tomography. A total of 75 participants (37 SJ group, 38 controls) completed the 12-week intervention. The AT and STS improved in the SJ group compared with the controls (AT 15.7 vs. 4.9 %, p < 0.01; STS 12.9 vs. 4.5 %, p < 0.05). ICW in the upper leg increased only in the SJ group (9.7 %, p < 0.05). SAT and IMAT were significantly decreased only in the SJ group (p < 0.01). The 12-week SJ program was easily performed by older adults with low skeletal muscle mass, improved aerobic capacity, muscle function, and muscle composition in older adults.

Short stick exercises for fall prevention among older adults: a cluster randomized trial.

PubMed

Yokoi, Katsushi; Yoshimasu, Kouichi; Takemura, Shigeki; Fukumoto, Jin; Kurasawa, Shigeki; Miyashita, Kazuhisa

2015-01-01

To investigate the effects of short stick exercise (SSEs) on fall prevention and improvement of physical function in older adults. A cluster randomized trial was conducted in five residential care facilities. The intervention group (n = 51) practiced SSEs for six months, followed by routine care for six more months. The control group (n = 54) received ordinary care for 12 months. The primary outcome measure was the number of fallers, taking into account the time to first fall using the Kaplan-Meier method. The secondary outcome measures were physical and mental functions. The number of fallers was significantly lower in the intervention group (n = 6) than in the control group (n = 16) during the 12 months. The adjusted hazard ratio for a first fall in the intervention group compared with the control group was 0.15 (CI, 0.03 to 0.74, p = 0.02). The fall-free period was significantly longer in the intervention group than in controls (mean ± SD, 10.1 ± 3.0 versus 9.0 ± 4.1 months, p = 0.027). The functional reach and sit and reach tests were significantly improved at three and six months. The SSEs appeared effective for fall prevention and improvement of physical function in older adults. Implications for Rehabilitation The newly developed short stick exercises appear an effective means of reducing falls among older adults in residential care facilities. The short stick exercises seem to have an immediate effect on improving physical functions. Effects gained by performing the short stick exercises, such as static balance, flexibility and agility may last for six months. The short stick exercises were found to be easy for older adults to practice continuously in residential care facilities.

A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis.

PubMed

Watson, Helen; Bilton, Diana; Truby, Helen

2008-05-01

Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population.

Comparing Tailored and Untailored Text Messages for Smoking Cessation: A Randomized Controlled Trial among Adolescent and Young Adult Smokers

ERIC Educational Resources Information Center

Skov-Ettrup, L. S.; Ringgaard, L. W.; Dalum, P.; Flensborg-Madsen, T.; Thygesen, L. C.; Tolstrup, J. S.

2014-01-01

The aim was to compare the effectiveness of untailored text messages for smoking cessation to tailored text messages delivered at a higher frequency. From February 2007 to August 2009, 2030 users of an internet-based smoking cessation program with optional text message support aged 15-25 years were consecutively randomized to versions of the…

Environmental Tobacco Smoke and Adult-Onset Asthma: A Population-Based Incident Case–Control Study

PubMed Central

Jaakkola, Maritta S.; Piipari, Ritva; Jaakkola, Niina; Jaakkola, Jouni J. K.

2003-01-01

Objectives. The authors assessed the effects of environmental tobacco smoke (ETS) on the development of asthma in adults. Methods. In the Pirkanmaa district of South Finland, all 21- to 63-year-old adults with new cases of asthma diagnosed during a 2.5-year period (n = 521 case patients, out of 441 000 inhabitants) and a random sample of control subjects from the source population (932 control subjects) participated in a population-based incident case–control study. Results. Risk of asthma was related to workplace ETS exposure (adjusted odds ratio [OR] = 2.16; 95% confidence interval [CI] = 1.26, 3.72) and home exposure (OR = 4.77; 95% CI = 1.29, 17.7) in the past year. Cumulative ETS exposure over a lifetime at work and at home increased the risk. Conclusions. This study indicates for the first time that both cumulative lifetime and recent ETS exposures increase the risk of adult-onset asthma. PMID:14652334

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

PubMed

Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

2014-02-26

Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927. PMID:24568299

An Implementation Study of Two Evidence-Based Exercise and Health Education Programmes for Older Adults with Osteoarthritis of the Knee and Hip

ERIC Educational Resources Information Center

de Jong, O. R. W.; Hopman-Rock, M.; Tak, E. C. M. P.; Klazinga, N. S.

2004-01-01

Implementation studies are recommended to assess the feasibility and effectiveness in real-life of programmes which have been tested in randomized controlled trials (RCTs). We report on an implementation study of two evidence-based exercise and health education programmes for older adults with osteoarthritis (OA) of the knee or hip. Three types of…

A STUDY OF THE EFFECTS OF PRESENTING INFORMATIVE SPEECHES WITH AND WITHOUT THE USE OF VISUAL AIDS TO VOLUNTARY ADULT AUDIENCES.

ERIC Educational Resources Information Center

BODENHAMER, SCHELL H.

TO DETERMINE THE COMPARATIVE AMOUNT OF LEARNING THAT OCCURRED AND THE AUDIENCE REACTION TO MEETING EFFECTIVENESS, A 20-MINUTE INFORMATIVE SPEECH, "THE WEATHER," WAS PRESENTED WITH VISUAL AIDS TO 23 AND WITHOUT VISUAL AIDS TO 23 INFORMAL, VOLUNTARY, ADULT AUDIENCES. THE AUDIENCES WERE RANDOMLY DIVIDED, AND CONTROLS WERE USED TO ASSURE IDENTICAL…

The effects of an 8-week computerized cognitive training program in older adults: a study protocol for a randomized controlled trial.

PubMed

Ten Brinke, Lisanne F; Best, John R; Crockett, Rachel A; Liu-Ambrose, Teresa

2018-01-30

Given the world's aging population, it is important to identify strategies that promote healthy cognitive aging and minimize cognitive decline. Currently, no curative pharmaceutical therapy exists for cognitive impairment and dementia. As a result, there is much interest in lifestyle approaches. Specifically, complex mental activity, such as cognitive training, may be a promising method to combat cognitive decline in older adults. As such, the industry of commercial computerized cognitive training (CCT) applications has rapidly grown in the last decade. However, the efficacy of these commercial products is largely not established. Moreover, exercise is a recognized strategy for promoting cognitive outcomes in older adults and may augment the efficacy of computerized cognitive training applications. Therefore, we propose a proof-of-concept randomized controlled trial (RCT) to examine the effect of a commercial CCT program in community-dwelling older adults. An 8-week RCT to examine the effect of a commercial CCT program, alone and preceded by a 15-min brisk walk, on cognitive function and explore the underlying neural mechanisms in adults aged 65-85 years old. Participants will be randomized to one of three intervention groups: 1) Computerized cognitive training (FBT); 2) A 15-min brisk walk followed by computerized cognitive training (Ex-FBT); or 3) A combination of educational classes, sham cognitive training, and balanced and tone exercises (active control, BAT). Participants in all intervention groups will attend three one-hour classes per week over the course of the intervention. Participants will be assessed at baseline, trial completion, and 1-year post study completion (1-year follow-up). If results from this study show benefits for cognition at trial completion, CCT programs, alone or in combination with walking, might be a strategy to promote healthy cognitive aging in older adults. In addition, results from the 1-year follow-up measurement could provide important information regarding the long-term benefits of these CCT programs. ClinicalTrials.gov Protocol Registration System: NCT02564809; registered September 1, 2015.

Video game training to improve selective visual attention in older adults

PubMed Central

Belchior, Patrícia; Marsiske, Michael; Sisco, Shannon M.; Yam, Anna; Bavelier, Daphne; Ball, Karlene; Mann, William C.

2013-01-01

The current study investigated the effect of video game training on older adult’s useful field of view performance (the UFOV® test). Fifty-eight older adult participants were randomized to receive practice with the target action game (Medal of Honor), a placebo control arcade game (Tetris), a clinically validated UFOV training program, or into a no contact control group. Examining pretest–posttest change in selective visual attention, the UFOV improved significantly more than the game groups; all three intervention groups improved significantly more than no-contact controls. There was a lack of difference between the two game conditions, differing from findings with younger adults. Discussion considers whether games posing less challenge might still be effective interventions for elders, and whether optimal training dosages should be higher. PMID:24003265

The Development and Evaluation of a Life Skills Programme for Young Adult Offenders.

PubMed

Jordaan, Jacques; Beukes, Roelf; Esterhuyse, Karel

2017-10-01

The purpose of this research project was to develop, implement, and evaluate a Life Skills programme for young adult male long-term offenders with the aim of improving their life skills that, in turn, could enable them to adjust more effectively in the correctional environment. Experimental research was used to investigate the effectiveness of the programme. In this study, 96 literate young adult male offenders between the ages of 21 and 25 years, with long sentences, were selected randomly. The participants were assigned randomly into an experimental and a control group. The Solomon four-group design was utilized to control for the effect of pretest sensitization. The measurements of the effectiveness of the programme were conducted before the programme commenced, directly (short term) after, 3 months (medium term) after, and 6 months (long term) after. The findings indicated that the programme had limited success in equipping the offenders with the necessary skills crucial to their survival in a correctional centre. The programme did, however, have significant effects, especially on problem solving and anger management in the short and medium term. These improvements were not long lived.

A Peer-Led HIV Mediation Adherence Intervention Targeting Adults Linked to Medical Care but without a Suppressed Viral Load

PubMed Central

Enriquez, Maithe; Cheng, An-Lin; Banderas, Julie; Farnan, Rose; Chertoff, Keyna; Hayes, Deana; Ortego, Gerry; Moreno, Jose; Peterson, Jane; McKinsey, David

2017-01-01

Background Non-adherence to antiretroviral (ART) treatment remains a prevalent problem even among the segment of the U.S. HIV population that is ‘linked’ to medical care. Methods Controlled pilot feasibility study with ART experienced adult patients (n=20) linked to HIV medical care without suppressed viral load. Patients were randomized to a peer-led HIV medication adherence intervention named ‘Ready’ or a time equivalent ‘healthy eating’ control arm. Lay individuals living with HIV were trained to facilitate ‘Ready’. Results Patients had been prescribed a mean of three prior ART regimens. The group randomized to ‘Ready’ had significantly improved adherence. MEMS and pharmacy refill data correlated with viral load log drop. Higher readiness for healthful behavior change correlated with viral load drop and approached significance. Conclusion A peer-led medication adherence intervention had a positive impact among adults who had experienced repeated non-adherence to HIV treatment. A larger study is needed to examine intervention dissemination and efficacy. PMID:25412724

Efficacy of Percutaneous Electrical Nerve Stimulation and Therapeutic Exercise for Older Adults with Chronic Low Back Pain: A Randomized Controlled Trial

PubMed Central

Weiner, Debra K.; Perera, Subashan; Rudy, Thomas E.; Glick, Ronald M.; Shenoy, Sonali; Delitto, Anthony

2008-01-01

Chronic low back pain (CLBP) in older adults may be disabling and therapeutically challenging, largely because of the inefficacy and/or morbidity associated with traditional pain treatment. We conducted a randomized controlled trial in 200 men and women ≥ age 65 with CLBP to evaluate the efficacy of percutaneous electrical nerve stimulation (PENS) with and without general conditioning and aerobic exercise (GCAE), for reducing pain and improving physical function. Participants were randomized to receive 1) PENS, 2) control-PENS (brief electrical stimulation to control for treatment expectancy), 3) PENS + GCAE, or 4) control-PENS + GCAE, twice a week for 6 weeks. All four groups experienced significantly reduced pain (range −2.3 to −4.1 on the McGill Pain Questionnaire short form), improved self-reported disability (range −2.1 to −3.0 on Roland scale) and improved gait velocity (0.04–0.07 m/sec), sustained at 6 months. The GCAE groups experienced significantly fewer fear avoidance beliefs immediately post-intervention and at 6 months than non-GCAE groups. There were no significant side effects. Since brief electrical stimulation (i.e., control-PENS) facilitated comparably reduced pain and improved function at 6 months as compared with PENS, the exact dose of electrical stimulation required for analgesia cannot be determined. GCAE was more effective than PENS alone in reducing fear avoidance beliefs, but not in reducing pain or improving physical function. PMID:18930352

Health-social partnership intervention programme for community-dwelling older adults: a research protocol for a randomized controlled trial.

PubMed

Wong, Kwan Ching; Wong, Frances Kam Yuet; Chang, Katherine Ka Pik

2015-11-01

This paper aims to describe the research protocol that will be used to determine the effectiveness of a health-social partnership intervention programme among community-dwelling older adults. Ageing in place is a preferred option for overcoming challenges of the increasing prevalence of chronic diseases and the risk for hospitalization associated with the ageing population. Nevertheless, our knowledge of how to implement this concept is limited. The integrated efforts of health and social services may help to enable older adults to live with a sense of control over their daily life and to be independent to the fullest extent possible in the community. This is a randomized, controlled trial. Participants are community-dwelling older adults referred from a community centre. Sample size calculation was based on power analysis. The intervention group will receive the programme with the standard protocols guided by a comprehensive assessment-intervention-evaluation framework. Home visits and telephones follow-up will be employed as means of conducting the interventions and monitoring their progress. The customary care group will receive placebo social calls. The duration of the interventions will be 3 months. The study was funded by the School of Nursing in Hong Kong. Research Ethics Committee approval was obtained in September 2014. The results of this research are expected to enable older adults to stay in the community with optimal health and well-being. Health and social sciences are integrated into the practice in this research protocol. The scarce literature on this topic means that this study can also provide an opportunity to bridge the caring gap among older adults. © 2015 John Wiley & Sons Ltd.

Will Exercise Advice Be Sufficient for Treatment of Young Adults With Prehypertension and Hypertension? A Systematic Review and Meta-Analysis.

PubMed

Williamson, Wilby; Foster, Charlie; Reid, Hamish; Kelly, Paul; Lewandowski, Adam James; Boardman, Henry; Roberts, Nia; McCartney, David; Huckstep, Odaro; Newton, Julia; Dawes, Helen; Gerry, Stephen; Leeson, Paul

2016-07-01

Previous studies report benefits of exercise for blood pressure control in middle age and older adults, but longer-term effectiveness in younger adults is not well established. We performed a systematic review and meta-analysis of published randomized control trials with meta-regression of potential effect modifiers. An information specialist completed a comprehensive search of available data sources, including studies published up to June 2015. Authors applied strict inclusion and exclusion criteria to screen 9524 titles. Eligible studies recruited younger adults with a cardiovascular risk factor (with at least 25% of cohort aged 18-40 years); the intervention had a defined physical activity strategy and reported blood pressure as primary or secondary outcome. Meta-analysis included 14 studies randomizing 3614 participants, mean age 42.2±6.3 (SD) years. At 3 to 6 months, exercise was associated with a reduction in systolic blood pressure of -4.40 mm Hg (95% confidence interval, -5.78 to -3.01) and in diastolic blood pressure of -4.17 mm Hg (95% confidence interval, -5.42 to -2.93). Intervention effect was not significantly influenced by baseline blood pressure, body weight, or subsequent weight loss. Observed intervention effect was lost after 12 months of follow-up with no reported benefit over control, mean difference in systolic blood pressure -1.02 mm Hg (95% confidence interval, -2.34 to 0.29), and in diastolic blood pressure -0.91 mm Hg (95% confidence interval, -1.85 to 0.02). Current exercise guidance provided to reduce blood pressure in younger adults is unlikely to benefit long-term cardiovascular risk. There is need for continued research to improve age-specific strategies and recommendations for hypertension prevention and management in young adults. © 2016 The Authors.

Indoor dampness and molds and development of adult-onset asthma: a population-based incident case-control study.

PubMed Central

Jaakkola, Maritta S; Nordman, Henrik; Piipari, Ritva; Uitti, Jukka; Laitinen, Jukka; Karjalainen, Antti; Hahtola, Paula; Jaakkola, Jouni J K

2002-01-01

Previous cross-sectional and prevalent case-control studies have suggested increased risk of asthma in adults related to dampness problems and molds in homes. We conducted a population-based incident case-control study to assess the effects of indoor dampness problems and molds at work and at home on development of asthma in adults. We recruited systematically all new cases of asthma during a 2.5-year study period (1997-2000) and randomly selected controls from a source population consisting of adults 21-63 years old living in the Pirkanmaa Hospital district, South Finland. The clinically diagnosed case series consisted of 521 adults with newly diagnosed asthma and the control series of 932 controls, after we excluded 76 (7.5%) controls with a history of asthma. In logistic regression analysis adjusting for confounders, the risk of asthma was related to the presence of visible mold and/or mold odor in the workplace (odds ratio, 1.54; 95% confidence interval, 1.01-2.32) but not to water damage or damp stains alone. We estimated the fraction of asthma attributable to workplace mold exposure to be 35.1% (95% confidence interval, 1.0-56.9%) among the exposed. Present results provide new evidence of the relation between workplace exposure to indoor molds and adult-onset asthma. PMID:12003761

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses.

PubMed

Khankari, Nikhil K; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I; Easton, Douglas; Eeles, Rosalind A; Gruber, Stephen B; Haiman, Christopher A; Hunter, David J; Chanock, Stephen J; Pierce, Brandon L; Zheng, Wei

2016-09-01

Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers.

Pharmacokinetics and Analgesic Effects of Methadone in Children and Adults with Sickle Cell Disease

PubMed Central

Horst, Jennifer; Frei-Jones, Melissa; Deych, Elena; Shannon, William; Kharasch, Evan D.

2017-01-01

Background Vaso-occlusive episodes (VOE) are a significant source of morbidity among children and adults with sickle cell disease (SCD). There is little information on methadone use for SCD pain. This investigation evaluated methadone pharmacokinetics in children and adults with SCD, with a secondary aim to assess pain relief and opioid consumption. Procedure Participants included children (<18 yr) and adults with a VOE requiring hospitalization. Patients were randomly assigned to receive standard care (opioid patient controlled analgesia; control group) or one dose of intravenous methadone (0.1–0.125 mg/kg) in addition to standard care (methadone group). Venous methadone and metabolite concentrations were measured. Pain scores, pain relief scores, and opioid consumption were recorded. Results Twenty-four children (12 methadone, 12 controls) and twenty-three adults (11 methadone, 12 controls) were studied. In children, the half-life of R-and S-methadone enantiomers was 34±16 and 24±9 hr, respectively. In adults, R- and S-methadone half-lives were 52±17 and 38±12 hr. Pain scores were lower (p=0.002) and pain relief scores were higher (p=0.0396) in children receiving methadone vs controls. There was no difference in pain scores and pain relief in adults receiving methadone vs controls. There was no difference in opioid consumption between methadone and control groups, in both adults and children. Conclusions Intravenous methadone disposition in children and adults with SCD was comparable to subjects without SCD from prior studies. Methadone produced more pain relief than standard care in children with SCD. Higher methadone doses may be more effective and should be evaluated in both children and adults with SCD. PMID:27572136

Almond consumption and processing affects the composition of the gastrointestinal microbiota of healthy adult men and women: a randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Almond processing has been shown to differentially impact metabolizable energy; however, the effect of food form on the gastrointestinal microbiota is under-investigated. We aimed to assess the interrelationship of almond consumption and processing on the gastrointestinal microbiota. A controlled-fe...

A randomized controlled trial of a nursing psychotherapeutic intervention for anxiety in adult psychiatric outpatients.

PubMed

Sampaio, Francisco Miguel Correia; Araújo, Odete; Sequeira, Carlos; Lluch Canut, María Teresa; Martins, Teresa

2018-05-01

To evaluate the short-term efficacy of a psychotherapeutic intervention in nursing on Portuguese adult psychiatric outpatients with the nursing diagnosis "anxiety." Several efficacious forms of treatment for anxiety are available, including different forms of psychotherapy and pharmacotherapy. However, literature tends to favour findings from studies on the efficacy of psychotherapies and therapies provided by nurses to the detriment of those arising from studies on the efficacy of nursing psychotherapeutic interventions (interventions which are classified, for instance, on Nursing Interventions Classification). Randomized controlled trial. The study was performed, between November 2016 - April 2017, at a psychiatry outpatient ward. Participants were randomly allocated to an intervention group (N = 29) or a treatment-as-usual control group (N = 31). Patients in the intervention group received psychopharmacotherapy with interventions integrated in the Nursing Interventions Classification for the nursing diagnosis "anxiety." A treatment-as-usual control group received only psychopharmacotherapy (if applicable). Anxiety level and anxiety self-control were the primary outcomes. Patients from both groups had reduced anxiety levels, between the pre-test and the posttest assessment; however, according to analysis of means, patients in the intervention group displayed significantly better results than those of the control group. Furthermore, only patients in the intervention group presented significant improvements in anxiety self-control. This study demonstrated the short-term efficacy of this psychotherapeutic intervention model in nursing in the decrease of anxiety level and improvement of anxiety self-control in a group of psychiatric outpatients with pathological anxiety. NCT02930473. © 2017 John Wiley & Sons Ltd.

Plant-Based Nutraceutical Increases Plasma Catalase Activity in Healthy Participants: A Small Double-Blind, Randomized, Placebo-Controlled, Proof of Concept Trial.

PubMed

Sweazea, Karen L; Johnston, Carol S; Knurick, Jessica; Bliss, Courtney D

2017-03-04

Oxidative stress resulting from dietary, lifestyle and environmental factors is strongly associated with tissue damage and aging. It occurs when there is either an overproduction of reactive oxygen species (i.e., oxidants) or decreased bioavailability of antioxidants that can scavenge them. The objective of this 12-week double-blind placebo-controlled study was to assess the efficacy of a nutraceutical at augmenting antioxidant status. Healthy adults (25-45 y) were randomized to either a treatment group (Product B, n = 23) or a placebo group (control, n = 20). No significant effect of Product B was observed for anthropometric variables or markers of glucose and lipid regulation. Biomarkers of oxidative stress were likewise not altered following the 12-week intervention. Plasma catalase concentrations were significantly elevated following 12 weeks of Product B as compared to the control group (+6.1 vs. -10.3 nmol/min/mL, p = 0.038), whereas other measures of antioxidant capacity were not significantly different between the groups. Product B effectively augmented concentrations of the anti-aging antioxidant catalase in healthy adults.

Effects of music videos on sleep quality in middle-aged and older adults with chronic insomnia: a randomized controlled trial.

PubMed

Lai, Hui-Ling; Chang, En-Ting; Li, Yin-Ming; Huang, Chiung-Yu; Lee, Li-Hua; Wang, Hsiu-Mei

2015-05-01

Listening to soothing music has been used as a complementary therapy to improve sleep quality. However, there is no empirical evidence for the effects of music videos (MVs) on sleep quality in adults with insomnia as assessed by polysomnography (PSG). In this randomized crossover controlled trial, we compared the effects of a peaceful Buddhist MV intervention to a usual-care control condition before bedtime on subjective and objective sleep quality in middle-aged and older adults with chronic insomnia. The study was conducted in a hospital's sleep laboratory. We randomly assigned 38 subjects, aged 50-75 years, to an MV/usual-care sequence or a usual-care/MV sequence. After pretest data collection, testing was held on two consecutive nights, with subjects participating in one condition each night according to their assigned sequence. Each intervention lasted 30 min. Sleep was assessed using PSG and self-report questionnaires. After controlling for baseline data, sleep-onset latency was significantly shorter by approximately 2 min in the MV condition than in the usual-care condition (p = .002). The MV intervention had no significant effects relative to the usual care on any other sleep parameters assessed by PSG or self-reported sleep quality. These results suggest that an MV intervention may be effective in promoting sleep. However, the effectiveness of a Buddhist MV on sleep needs further study to develop a culturally specific insomnia intervention. Our findings also suggest that an MV intervention can serve as another option for health care providers to improve sleep onset in people with insomnia. © The Author(s) 2014.

Effect of patient navigation on colorectal cancer screening in a community-based randomized controlled trial of urban African American adults

PubMed Central

Phelan-Emrick, Darcy F.; Pollack, Craig E.; Markakis, Diane; Wenzel, Jennifer; Ahmed, Saifuddin; Garza, Mary A.; Shapiro, Gary R.; Bone, Lee R.; Johnson, Lawrence B.; Ford, Jean G.

2015-01-01

Purpose In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Methods Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Results Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07–2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07–2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65–69 years and those with an adequate health literacy level. Conclusions In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels. PMID:25516073

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.

PubMed

Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

2015-01-01

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

Multiple-modality exercise and mind-motor training to improve mobility in older adults: A randomized controlled trial.

PubMed

Boa Sorte Silva, Narlon C; Gill, Dawn P; Gregory, Michael A; Bocti, John; Petrella, Robert J

2018-03-01

To investigate the effects of multiple-modality exercise with or without additional mind-motor training on mobility outcomes in older adults with subjective cognitive complaints. This was a 24-week randomized controlled trial with a 28-week no-contact follow-up. Community-dwelling older adults underwent a thrice -weekly, Multiple-Modality exercise and Mind-Motor (M4) training or Multiple-Modality (M2) exercise with an active control intervention (balance, range of motion and breathing exercises). Study outcomes included differences between groups at 24weeks and after the no-contact follow-up (i.e., 52weeks) in usual and dual-task (DT, i.e., serial sevens [S7] and phonemic verbal fluency [VF] tasks) gait velocity, step length and cycle time variability, as well as DT cognitive accuracy. 127 participants (mean age 67.5 [7.3] years, 71% women) were randomized to either M2 (n=64) or M4 (n=63) groups. Participants were assessed at baseline, intervention endpoint (24weeks), and study endpoint (52weeks). At 24weeks, the M2 group demonstrated greater improvements in usual gait velocity, usual step length, and DT gait velocity (VF) compared to the M4 group, and no between- or within-group changes in DT accuracy were observed. At 52weeks, the M2 group retained the gains in gait velocity and step length, whereas the M4 group demonstrated trends for improvement (p=0.052) in DT cognitive accuracy (VF). Our results suggest that additional mind-motor training was not effective to improve mobility outcomes. In fact, participants in the active control group experienced greater benefits as a result of the intervention. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of patient navigation on colorectal cancer screening in a community-based randomized controlled trial of urban African American adults.

PubMed

Horne, Hisani N; Phelan-Emrick, Darcy F; Pollack, Craig E; Markakis, Diane; Wenzel, Jennifer; Ahmed, Saifuddin; Garza, Mary A; Shapiro, Gary R; Bone, Lee R; Johnson, Lawrence B; Ford, Jean G

2015-02-01

In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07-2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07-2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65-69 years and those with an adequate health literacy level. In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels.

Effects of Cable News Watching on Older Adults' Physiological and Self-Reported Stress and Cognitive Function.

PubMed

Deal, Caroline; Bogdan, Ryan; Miller, J Phil; Rodebaugh, Tom; Caburnay, Charlene; Yingling, Mike; Hershey, Tammy; Schweiger, Julia; Lenze, Eric J

2017-01-01

Older adults are the largest consumer of cable news, which includes negative and politicized content and may constitute a daily stressor. As older adults are also vulnerable to the negative consequences of stress, we hypothesized that cable news watching could induce a stress reaction and impair cognitive function. We tested exposures to cable news (i.e., Fox News and MSNBC) in a within-subject randomized controlled design in 34 healthy older adults. We also included negative (Public Broadcasting Station) and positive (trier social stress test) controls. Cable news watching had no effect on psychological stress, physiological stress, or cognitive function. This remained true even if the news exposures were discordant with participants' political affiliation. We conclude that brief cable news watching does not induce a physiological or subjective stress response or cognitive impairment among healthy older adults.

A high whey protein-, leucine-, and vitamin D-enriched supplement preserves muscle mass during intentional weight loss in obese older adults: a double-blind randomized controlled trial.

PubMed

Verreijen, Amely M; Verlaan, Sjors; Engberink, Mariëlle F; Swinkels, Sophie; de Vogel-van den Bosch, Johan; Weijs, Peter J M

2015-02-01

Intentional weight loss in obese older adults is a risk factor for muscle loss and sarcopenia. The objective was to examine the effect of a high whey protein-, leucine-, and vitamin D-enriched supplement on muscle mass preservation during intentional weight loss in obese older adults. We included 80 obese older adults in a double-blind randomized controlled trial. During a 13-wk weight loss program, all subjects followed a hypocaloric diet (-600 kcal/d) and performed resistance training 3×/wk. Subjects were randomly allocated to a high whey protein-, leucine-, and vitamin D-enriched supplement including a mix of other macro- and micronutrients (150 kcal, 21 g protein; 10×/wk, intervention group) or an isocaloric control. The primary outcome was change in appendicular muscle mass. The secondary outcomes were body composition, handgrip strength, and physical performance. Data were analyzed by using ANCOVA and mixed linear models with sex and baseline value as covariates. At baseline, mean ± SD age was 63 ± 5.6 y, and body mass index (in kg/m(2)) was 33 ± 4.4. During the trial, protein intake was 1.11 ± 0.28 g · kg body weight(-1) · d(-1) in the intervention group compared with 0.85 ± 0.24 g · kg body weight(-1) · d(-1) in the control group (P < 0.001). Both intervention and control groups decreased in body weight (-3.4 ± 3.6 kg and -2.8 ± 2.8 kg; both P < 0.001) and fat mass (-3.2 ± 3.1 kg and -2.5 ± 2.4 kg; both P < 0.001), with no differences between groups. The 13-wk change in appendicular muscle mass, however, was different in the intervention and control groups [+0.4 ± 1.2 kg and -0.5 ± 2.1 kg, respectively; β = 0.95 kg (95% CI: 0.09, 1.81); P = 0.03]. Muscle strength and function improved over time without significant differences between groups. A high whey protein-, leucine-, and vitamin D-enriched supplement compared with isocaloric control preserves appendicular muscle mass in obese older adults during a hypocaloric diet and resistance exercise program and might therefore reduce the risk of sarcopenia. This trial was registered at the Dutch Trial Register (http://www.trialregister.nl) as NTR2751. © 2015 American Society for Nutrition.

[Effects of rare earth compounds on human peripheral mononuclear cell telomerase and apoptosis].

PubMed

Yu, Li; Dai, Yu-Cheng; Yuan, Zhao-Kang; Li, Jie

2004-07-01

To study the effects of rare earth exposure on human telomerase and apoptosis of human peripheral mononuclear cells (PBMNs). Rare earth mine lot in Xunwu county, the biggest ion absorptive rare earth mine lot of China, was selected as the study site. Another village of Xunwu county, with comparable geological structure and social environment was selected as the control site. Thirty healthy adults were randomly selected from the study site as exposure group and another 30 healthy adults randomly selected from the control site as control group. The blood content of 15 rare earth elements, including La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb, Lu and Y, were determined by inductive coupled plasma-source mass spectrometry (ICP-MS). The total contents of rare earth elements in the blood were calculated. The TRAP and FCM assays were carried out to analyse the telomerase and apoptosis of human PBMNCs respectively. In the exposure group, the concentration of La, Ce, Dy and Y were significantly higher (P<0.001), and Pr, Nd, Sm, Gd and Yb were higher than those in the control group (P<0.05). The total content of rare earth in the blood of exposure group showed significant difference compared with control group (P<0.001). Telomerase activity in PBMNs of the exposure group was higher than that in the control group (P<0.05); there were 11 adults in the exposure group (30 adults) and 5 adults in control group (30 adults) showed positive telomerase activity. The average age of the exposure group was (38.69 +/- 8.02) years-old, while the control group was (40.45 +/- 9.02) years-old (P >0.05). It was found that there was a significant relationship between telomerase activity and the total content of rare earth elements (P <0.01). 3. The proportion of apoptosis was not different between the two groups (P >0.05), but the cells in the S-phase and G2-M phase were increased (P <0.01) in the exposed group. The telomerase activity of PBMNs in the rare earth elements exposed group was higher than that of the control group, and there is no effect on apoptotic rate of PBMNs, but may promote the diploid DNA replication, and increase the percentage of G2/M and S phase cells.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. Discussion This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain. Trial registration This trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233. PMID:23324133

A Randomized, Double-Blinded, Placebo-Controlled Study to Compare the Safety and Efficacy of Low Dose Enhanced Wild Blueberry Powder and Wild Blueberry Extract (ThinkBlue™) in Maintenance of Episodic and Working Memory in Older Adults.

PubMed

Whyte, Adrian R; Cheng, Nancy; Fromentin, Emilie; Williams, Claire M

2018-05-23

Previous research has shown beneficial effects of polyphenol-rich diets in ameliorating cognitive decline in aging adults. Here, using a randomized, double blinded, placebo-controlled chronic intervention, we investigated the effect of two proprietary blueberry formulations on cognitive performance in older adults; a whole wild blueberry powder at 500 mg (WBP500) and 1000 mg (WBP1000) and a purified extract at 100 mg (WBE111). One hundred and twenty-two older adults (65⁻80 years) were randomly allocated to a 6-month, daily regimen of either placebo or one of the three interventions. Participants were tested at baseline, 3, and 6 months on a battery of cognitive tasks targeting episodic memory, working memory and executive function, alongside mood and cardiovascular health parameters. Linear mixed model analysis found intervention to be a significant predictor of delayed word recognition on the Reys Auditory Verbal Learning Task (RAVLT), with simple contrast analysis revealing significantly better performance following WBE111 at 3 months. Similarly, performance on the Corsi Block task was predicted by treatment, with simple contrast analysis revealing a trend for better performance at 3 months following WBE111. Treatment also significantly predicted systolic blood pressure (SBP) with simple contrast analysis revealing lower SBP following intervention with WBE111 in comparison to placebo. These results indicate 3 months intervention with WBE111 can facilitate better episodic memory performance in an elderly population and reduce cardiovascular risk factors over 6 months.

Mindfulness Based Relapse Prevention for Stimulant Dependent Adults: A Pilot Randomized Clinical Trial.

PubMed

Glasner-Edwards, Suzette; Mooney, Larissa J; Ang, Alfonso; Garneau, Hélène Chokron; Hartwell, Emily; Brecht, Mary-Lynn; Rawson, Richard A

2017-02-01

In light of the known associations between stress, negative affect, and relapse, mindfulness strategies hold promise as a means of reducing relapse susceptibility. In a pilot randomized clinical trial, we evaluated the effects of Mindfulness Based Relapse Prevention (MBRP), relative to a health education control condition (HE) among stimulant dependent adults receiving contingency management. All participants received a 12-week contingency management (CM) intervention. Following a 4-week CM-only lead in phase, participants were randomly assigned to concurrently receive MBRP (n=31) or HE (n=32). Stimulant dependent adults age 18 and over. A university based clinical research center. The primary outcomes were stimulant use, measured by urine drug screens weekly during the intervention and at 1-month post-treatment, negative affect, measured by the Beck Depression Inventory and Beck Anxiety Inventory, and psychiatric severity, measured by the Addiction Severity Index. Medium effect sizes favoring MBRP were observed for negative affect and overall psychiatric severity outcomes. Depression severity changed differentially over time as a function of group, with MBRP participants reporting greater reductions through follow-up (p=0.03; Effect Size=0.58). Likewise, the MBRP group evidenced greater declines in psychiatric severity, (p=0.01; Effect Size=0.61 at follow-up). Among those with depressive and anxiety disorders, MBRP was associated with lower odds of stimulant use relative to the control condition (Odds Ratio= 0.78, p=0.03 and OR=0.68, p=0.04). MBRP effectively reduces negative affect and psychiatric impairment, and is particularly effective in reducing stimulant use among stimulant dependent adults with mood and anxiety disorders.

Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

PubMed Central

Côté, José

2016-01-01

Background Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that less than half of people with type 2 diabetes in Canada are sufficiently active to meet the Canadian Diabetes Association's guidelines, effective programs targeting the adoption of regular physical activity are in demand for this population. Many researchers have argued that Web-based interventions targeting physical activity are a promising avenue for insufficiently active populations; however, it remains unclear if this type of intervention is effective among people with type 2 diabetes. Objective This research project aims to evaluate the effectiveness of two Web-based interventions targeting the adoption of regular aerobic physical activity among insufficiently active adult Canadian Francophones with type 2 diabetes. Methods A 3-arm, parallel randomized controlled trial with 2 experimental groups and 1 control group was conducted in the province of Quebec, Canada. A total of 234 participants were randomized at a 1:1:1 ratio to receive an 8-week, fully automated, computer-tailored, Web-based intervention (experimental group 1); an 8-week peer support (ie, Facebook group) Web-based intervention (experimental group 2); or no intervention (control group) during the study period. Results The primary outcome of this study is self-reported physical activity level (total min/week of moderate-intensity aerobic physical activity). Secondary outcomes are attitude, social influence, self-efficacy, type of motivation, and intention. All outcomes are assessed at baseline and 3 and 9 months after baseline with a self-reported questionnaire filled directly on the study websites. Conclusions By evaluating and comparing the effectiveness of 2 Web-based interventions characterized by different behavior change perspectives, findings of this study will contribute to advances in the field of physical activity promotion in adult populations with type 2 diabetes. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN15747108; http://www.isrctn.com/ISRCTN15747108 (Archived by WebCite at http://www.webcitation.org/6eJTi0m3r) PMID:26869015

Fall Preventive Exercise With or Without Behavior Change Support for Community-Dwelling Older Adults: A Randomized Controlled Trial With Short-Term Follow-up.

PubMed

Arkkukangas, Marina; Söderlund, Anne; Eriksson, Staffan; Johansson, Ann-Christin

2017-02-27

In Western countries, falls and fall-related injuries are a well-known threat to health in the aging population. Studies indicate that regular exercise improves strength and balance and can therefore decrease the incidence of falls and fall-related injuries. The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population. The aim of this study was to investigate the short-term effect of a home-based exercise program with or without motivational interviewing (MI) compared with standard care on physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency. A total of 175 older adults participated in this randomized controlled study. They were randomly allocated for the Otago Exercise Program (OEP) (n = 61), OEP combined with MI (n = 58), or a control group (n = 56). The participants' mean age was 83 years. The recruitment period was from October 2012 to May 2015. Measurements of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency were done before and 12 weeks after randomization. A total of 161 participants were followed up, and there were no significant differences between groups after a period of 12 weeks of regular exercise. Within the OEP + MI group, physical performance, fall self-efficacy, physical activity level, and handgrip strength improved significantly; likewise, improved physical performance and fall self-efficacy were found in the control group. A corresponding difference did not occur in the OEP group. Adherence to the exercise was generally high in both exercise groups. In the short-term perspective, there were no benefits of an exercise program with or without MI regarding physical performance, fall self-efficacy, activity level, handgrip strength, adherence to the exercise, and fall frequency in comparison to a control group. However, some small effects occurred within the OEP + MI group, indicating that there may be some possible value in behavioral change support combined with exercise in older adults that requires further evaluation in both short- and long-term studies.

Safety and Allele-Specific Immunogenicity of a Malaria Vaccine in Malian Adults: Results of a Phase I Randomized Trial

PubMed Central

Thera, Mahamadou A; Doumbo, Ogobara K; Coulibaly, Drissa; Diallo, Dapa A; Sagara, Issaka; Dicko, Alassane; Diemert, David J; Heppner, D. Gray; Stewart, V. Ann; Angov, Evelina; Soisson, Lorraine; Leach, Amanda; Tucker, Kathryn; Lyke, Kirsten E; Plowe, Christopher V

2006-01-01

Objectives: The objectives were to evaluate the safety, reactogenicity, and allele-specific immunogenicity of the blood-stage malaria vaccine FMP1/AS02A in adults exposed to seasonal malaria and the impact of natural infection on vaccine-induced antibody levels. Design: We conducted a randomized, double-blind, controlled phase I clinical trial. Setting: Bandiagara, Mali, West Africa, is a rural town with intense seasonal transmission of Plasmodium falciparum malaria. Participants: Forty healthy, malaria-experienced Malian adults aged 18–55 y were enrolled. Interventions: The FMP1/AS02A malaria vaccine is a 42-kDa recombinant protein based on the carboxy-terminal end of merozoite surface protein-1 (MSP-142) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The control vaccine was a killed rabies virus vaccine (Imovax). Participants were randomized to receive either FMP1/AS02A or rabies vaccine at 0, 1, and 2 mo and were followed for 1 y. Outcome Measures: Solicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-142 and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured. Results: Transient local pain and swelling were more common in the malaria vaccine group than in the control group (11/20 versus 3/20 and 10/20 versus 6/20, respectively). MSP-142 antibody levels rose during the malaria transmission season in the control group, but were significantly higher in malaria vaccine recipients after the second immunization and remained higher after the third immunization relative both to baseline and to the control group. Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-142 alleles and their subunits. Conclusions: FMP1/AS02A was well tolerated and highly immunogenic in adults exposed to intense seasonal malaria transmission and elicited immune responses to genetically diverse parasite clones. Anti-MSP-142 antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine. PMID:17124530

Cluster randomized controlled trial of a multilevel physical activity intervention for older adults.

PubMed

Kerr, Jacqueline; Rosenberg, Dori; Millstein, Rachel A; Bolling, Khalisa; Crist, Katie; Takemoto, Michelle; Godbole, Suneeta; Moran, Kevin; Natarajan, Loki; Castro-Sweet, Cynthia; Buchner, David

2018-04-02

Older adults are the least active population group. Interventions in residential settings may support a multi-level approach to behavior change. In a cluster randomized control trial, 11 San Diego retirement communities were assigned to a physical activity (PA) intervention or a healthy aging attention control condition. Participants were 307 adults over 65 years old. The multilevel PA intervention was delivered with the assistance of peer leaders, who were trained older adult from the retirement communities. Intervention components included individual counseling & self-monitoring with pedometers, group education sessions, group walks, community advocacy and pedestrian community change projects. Intervention condition by time interactions were tested using generalized mixed effects regressions. The primary outcomes was accelerometer measured physical activity. Secondary outcomes were blood pressure and objectively measured physical functioning. Over 70% of the sample were 80 years or older. PA significantly increased in the intervention condition (56 min of moderate-vigorous PA per week; 119 min of light PA) compared with the control condition and remained significantly higher across the 12 month study. Men and participants under 84 years old benefited most from the intervention. There was a significant decrease in systolic (p < .007) and diastolic (p < .02) blood pressure at 6 months. Physical functioning improved but the changes were not statistically significant. Intervention fidelity was high demonstrating feasibility. Changes in PA and blood pressure achieved were comparable to other studies with much younger participants. Men, in particular, avoided a year-long decline in PA. clincialtrials.gov Identifier: NCT01155011 .

Nurse care coordination and technology effects on health status of frail older adults via enhanced self-management of medication: randomized clinical trial to test efficacy.

PubMed

Marek, Karen Dorman; Stetzer, Frank; Ryan, Polly A; Bub, Linda Denison; Adams, Scott J; Schlidt, Andrea; Lancaster, Rachelle; O'Brien, Anne-Marie

2013-01-01

Self-management of complex medication regimens for chronic illness is challenging for many older adults. The purpose of this study was to evaluate health status outcomes of frail older adults receiving a home-based support program that emphasized self-management of medications using both care coordination and technology. This study used a randomized controlled trial with three arms and longitudinal outcome measurement. Older adults having difficulty in self-managing medications (n = 414) were recruited at discharge from three Medicare-certified home healthcare agencies in a Midwestern urban area. All participants received baseline pharmacy screens. The control group received no further intervention. A team of advanced practice nurses and registered nurses coordinated care for 12 months to two intervention groups who also received either an MD.2 medication-dispensing machine or a medplanner. Health status outcomes (the Geriatric Depression Scale, Mini Mental Status Examination, Physical Performance Test, and SF-36 Physical Component Summary and Mental Component Summary) were measured at baseline and at 3, 6, 9, and 12 months. After covariate and baseline health status adjustment, time × group interactions for the MD.2 and medplanner groups on health status outcomes were not significant. Time × group interactions were significant for the medplanner and control group comparisons. Participants with care coordination had significantly better health status outcomes over time than those in the control group, but addition of the MD.2 machine to nurse care coordination did not result in better health status outcomes.

Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial.

PubMed

Jorgensen, Martin G; Laessoe, Uffe; Hendriksen, Carsten; Nielsen, Ole Bruno Faurholt; Aagaard, Per

2013-07-01

Older adults show increased risk of falling and major risk factors include impaired lower extremity muscle strength and postural balance. However, the potential positive effect of biofeedback-based Nintendo Wii training on muscle strength and postural balance in older adults is unknown. This randomized controlled trial examined postural balance and muscle strength in community-dwelling older adults (75±6 years) pre- and post-10 weeks of biofeedback-based Nintendo Wii training (WII, n = 28) or daily use of ethylene vinyl acetate copolymer insoles (controls [CON], n = 30). Primary end points were maximal muscle strength (maximal voluntary contraction) and center of pressure velocity moment during bilateral static stance. Intention-to-treat analysis with adjustment for age, sex, and baseline level showed that the WII group had higher maximal voluntary contraction strength (18%) than the control group at follow up (between-group difference = 269 N, 95% CI = 122; 416, and p = .001). In contrast, the center of pressure velocity moment did not differ (1%) between WII and CON at follow-up (between-group difference = 0.23 mm(2)/s, 95% CI = -4.1; 4.6, and p = .92). For secondary end points, pre-to-post changes favoring the WII group were evident in the rate of force development (p = .03), Timed Up and Go test (p = .01), short Falls Efficacy Scale-International (p = .03), and 30-second repeated Chair Stand Test (p = .01). Finally, participants rated the Wii training highly motivating at 5 and 10 weeks into the intervention. Biofeedback-based Wii training led to marked improvements in maximal leg muscle strength (maximal voluntary contraction; rate of force development) and overall functional performance in community-dwelling older adults. Unexpectedly, static bilateral postural balance remained unaltered with Wii training. The high level of participant motivation suggests that biofeedback-based Wii exercise may ensure a high degree of compliance to home- and/or community-based training in community-dwelling older adults.

Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST): A Pilot Randomized Trial.

PubMed

Kosa, S Daisy; Gafni, Amiram; House, Andrew A; Lawrence, JulieAnn; Moist, Louise; Nathoo, Bharat; Tam, Paul; Sarabia, Alicia; Thabane, Lehana; Wu, George; Lok, Charmaine E

2017-03-01

We developed the Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST) to permit hemodialysis (HD) patients with central venous catheters (catheters) to shower without additional infection risk. Our primary objective was to determine the feasibility of conducting a parallel randomized controlled trial (RCT) to evaluate the impact of HIPPO-ST on catheter-related bacteremia (CRB) in adult HD patients. Adult HD patients using catheters were recruited from 11 HD units. Patients were randomized to receive HIPPO-ST or standard care and were followed up for 6 months. Only CRB-outcome assessors were blinded. For the study to be considered feasible, 4 of 5 feasibility outcomes, each with its own statistical threshold for success, must have been achieved. A total of 68 patients were randomized (33 HIPPO-ST and 35 control) and were followed up to 6 months. Of 5 measures of feasibility, 4 were achieved: (1) accurate CRB rate documented (threshold: κ level >0.80); (2) 97.8% (279/285) of satellite HD patients with catheters were screened (threshold: >95%); (3) 88% (23/26) in the HIPPO-ST arm were successfully educated by 6 months (threshold: >80%); and (4) 0% (0/29) patients in the control arm were "contaminated," that is, using HIPPO-ST (threshold: <5%). However, only 44.2% (72/163) of eligible patients consented to participate (threshold: >80%). The rate of CRB was similarly low in HIPPO-ST and control groups (0.68 vs. 0.88/1000 catheter days). This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Objective: Determine whole-body protein turnover responses to high protein diets during weight loss. Design: Thirty-nine adults (age, 21 ± 1 yr; VO2peak, 48 ± 1 ml'kg-1'min-1; body mass index, 25 ± 1 kg•m2) were randomized to diets providing protein at the recommend dietary allowance (RDA), 2X-RD...

Effectiveness of Nurse-Practitioner-Delivered Brief Motivational Intervention for Young Adult Alcohol and Drug Use in Primary Care in South Africa: A Randomized Clinical Trial

PubMed Central

Mertens, Jennifer R.; Ward, Catherine L.; Bresick, Graham F.; Broder, Tina; Weisner, Constance M.

2014-01-01

Aims: To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country. Methods: A randomized controlled trial in a public-sector clinic in Delft, a township in the Western Cape, South Africa recruited 403 patients who were randomized to either single-session, nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list, and followed up at 3 months. Results: Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up, patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) for alcohol—the most prevalent substance. Conclusion: Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients; additional research is needed to examine long-term outcomes. PMID:24899076

Efficacy and Safety of Oral and Transdermal Opioid Analgesics for Musculoskeletal Pain in Older Adults: A Systematic Review of Randomized, Placebo-Controlled Trials.

PubMed

Megale, Rodrigo Z; Deveza, Leticia A; Blyth, Fiona M; Naganathan, Vasi; Ferreira, Paulo H; McLachlan, Andrew J; Ferreira, Manuela L

2018-05-01

This systematic review with meta-analysis was performed to evaluate the efficacy and safety of using opioid analgesics in older adults with musculoskeletal pain. We searched Cochrane Library, MEDLINE, EMBASE, Web of Science, AMED, CINAHL, and LILACS for randomized controlled trials with mean population age of 60 years or older, comparing the efficacy and safety of opioid analgesics with placebo for musculoskeletal pain conditions. Reviewers extracted data, assessed risk of bias, and evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. Random effects models were used to calculate standardized mean differences (when different scales were used across trials), mean differences and odds ratios with respective 95% confidence intervals (CIs). Meta-regressions were carried out to assess the influence of opioid analgesic daily dose and treatment duration on our main outcomes. We included 23 randomized placebo-controlled trials in the meta-analysis. Opioid analgesics had a small effect on decreasing pain intensity (standardized mean difference = -.27; 95% CI = -.33 to -.20) and improving function (standardized mean difference = -.27, 95% CI = -.36 to -.18), which was not associated with daily dose or treatment duration. The odds of adverse events were 3 times higher (odds ratio = 2.94; 95% CI = 2.33-3.72) and the odds of treatment discontinuation due to adverse events 4 times higher (odds ratio = 4.04; 95% CI = 3.10-5.25) in patients treated with opioid analgesics. The results show that in older adults suffering from musculoskeletal pain, using opioid analgesics had only a small effect on pain and function at the cost of a higher odds of adverse events and treatment discontinuation. For this specific population, the opioid-related risks may outweigh the benefits. The systematic review shows that, in older adults suffering from musculoskeletal conditions, opioid analgesics have only a small effect on pain and disability. Conversely, this population is at higher risk of adverse events. The results may reflect age-related physiological changes in pain processing, pharmacokinetics, and pharmacodynamics. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands.

PubMed

Gessner, Bradford D; Jiang, Qin; Van Werkhoven, Cornelis H; Sings, Heather L; Webber, Chris; Scott, Daniel; Neuzil, Kathleen M; O'Brien, Katherine L; Wunderink, Richard G; Grobbee, Diederick E; Bonten, Marc J M; Jodar, Luis

2018-05-31

We conducted a post-hoc analysis of a double blind, randomized, placebo-controlled trial of 13-valent pneumococcal conjugate vaccine (PCV13) among adults aged 65 years or older to assess public health impact. For all outcomes, we included all randomized subjects, using a modified intention-to-treat (mITT) approach to determine vaccine efficacy (VE), vaccine preventable disease incidence (VPDI) defined as control minus vaccinated group incidence, and numbers needed to vaccinate (NNV) (based on a five-year duration of protection). Results are reported for, in order, clinical, adjudicated (clinical plus radiologic infiltrate determined by committee), pneumococcal, and vaccine-type pneumococcal (VT-Sp) community-acquired pneumonia; invasive pneumococcal disease (IPD) and VT-IPD. VEs (95% CI) for all hospital episodes were 8.1% (-0.6%, 16.1%), 6.7% (-4.1%, 16.3%), 22.2% (2.0%, 38.3%), 37.5% (14.3%, 54.5%), 49.3% (23.2%, 66.5%), and 75.8% (47.6%, 88.8%). VPDIs per 100,000 person-years of observation (PYOs) were 72, 37, 25, 25, 20, and 15 with NNVs of 277, 535, 816, 798, 1016, and 1342. For clinical CAP, PCV13 was associated with a reduction of 909 (-115, 2013) hospital days per 100,000 PYOs translating to a reduction over 5 years of one hospital day for every 22 people vaccinated. When comparing at-risk persons (defined by self-report of diabetes, chronic lung disease, or other underlying conditions) to not at-risk persons, VEs were similar or lower, but because baseline incidences were higher the VPDIs were approximately 2-10 times higher and NNVs 50-90% lower. A public health analysis of pneumonia and IPD outcomes in a randomized controlled trial found substantial burden reduction following adult PCV13 immunization implemented in a setting with an ongoing infant PCV7-PCV10 program. VPDIs were higher among at-risk adults. The original study and the current analysis were funded by Pfizer. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial.

PubMed

Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Sarang, Aseefa; Connelly, Jo; Whisler, Adam; McKenzie, Kwame

2016-10-21

Little is known about the effectiveness of Housing First (HF) among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135) or usual care (n = 102) and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81) vs. 41 % (95 % CI 35 to 48), respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3). Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72). Housing First enhanced with anti-racism and anti-oppression practices can improve housing stability and community functioning among ethnically diverse homeless adults with mental illness. International Standard Randomized Control Trial Number Register Identifier: ISRCTN42520374 , assigned August 18, 2009.

Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults.

PubMed

Porter Starr, Kathryn N; Pieper, Carl F; Orenduff, Melissa C; McDonald, Shelley R; McClure, Luisa B; Zhou, Run; Payne, Martha E; Bales, Connie W

2016-10-01

Obesity is a significant cause of functional limitations in older adults; yet, concerns that weight reduction could diminish muscle along with fat mass have impeded progress toward an intervention. Meal-based enhancement of protein intake could protect function and/or lean mass but has not been studied during geriatric obesity reduction. In this 6-month randomized controlled trial, 67 obese (body mass index ≥30kg/m(2)) older (≥60 years) adults with a Short Physical Performance Battery score of 4-10 were randomly assigned to a traditional (Control) weight loss regimen or one with higher protein intake (>30g) at each meal (Protein). All participants were prescribed a hypo-caloric diet, and weighed and provided dietary guidance weekly. Physical function (Short Physical Performance Battery) and lean mass (BOD POD), along with secondary measures, were assessed at 0, 3, and 6 months. At the 6-month endpoint, there was significant (p < .001) weight loss in both the Control (-7.5±6.2kg) and Protein (-8.7±7.4kg) groups. Both groups also improved function but the increase in the Protein (+2.4±1.7 units; p < .001) was greater than in the Control (+0.9±1.7 units; p < .01) group (p = .02). Obese, functionally limited older adults undergoing a 6-month weight loss intervention with a meal-based enhancement of protein quantity and quality lost similar amounts of weight but had greater functional improvements relative to the Control group. If confirmed, this dietary approach could have important implications for improving the functional status of this vulnerable population (ClinicalTrials.gov identifier: NCT01715753). © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America.

Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults

PubMed Central

Pieper, Carl F.; Orenduff, Melissa C.; McDonald, Shelley R.; McClure, Luisa B.; Zhou, Run; Payne, Martha E.; Bales, Connie W.

2016-01-01

Abstract Background: Obesity is a significant cause of functional limitations in older adults; yet, concerns that weight reduction could diminish muscle along with fat mass have impeded progress toward an intervention. Meal-based enhancement of protein intake could protect function and/or lean mass but has not been studied during geriatric obesity reduction. Methods: In this 6-month randomized controlled trial, 67 obese (body mass index ≥30kg/m2) older (≥60 years) adults with a Short Physical Performance Battery score of 4–10 were randomly assigned to a traditional (Control) weight loss regimen or one with higher protein intake (>30g) at each meal (Protein). All participants were prescribed a hypo-caloric diet, and weighed and provided dietary guidance weekly. Physical function (Short Physical Performance Battery) and lean mass (BOD POD), along with secondary measures, were assessed at 0, 3, and 6 months. Results: At the 6-month endpoint, there was significant (p < .001) weight loss in both the Control (−7.5±6.2kg) and Protein (−8.7±7.4kg) groups. Both groups also improved function but the increase in the Protein (+2.4±1.7 units; p < .001) was greater than in the Control (+0.9±1.7 units; p < .01) group (p = .02). Conclusion: Obese, functionally limited older adults undergoing a 6-month weight loss intervention with a meal-based enhancement of protein quantity and quality lost similar amounts of weight but had greater functional improvements relative to the Control group. If confirmed, this dietary approach could have important implications for improving the functional status of this vulnerable population (ClinicalTrials.gov identifier: NCT01715753). PMID:26786203

Effects of a Televised Two-City Safer Sex Mass Media Campaign Targeting High-Sensation-Seeking and Impulsive-Decision-Making Young Adults

ERIC Educational Resources Information Center

Zimmerman, Rick S.; Palmgreen, Philip M.; Noar, Seth M.; Lustria, Mia Liza A.; Lu, Hung-Yi; Horosewski, Mary Lee

2007-01-01

This study evaluates the ability of a safer sex televised public service announcement (PSA) campaign to increase safer sexual behavior among at-risk young adults. Independent, monthly random samples of 100 individuals were surveyed in each city for 21 months as part of an interrupted-time-series design with a control community. The 3-month…

The effects of vitamin D and calcium supplementation on pancreatic beta cell function, insulin sensitivity and glycemia in adults at high risk for diabetes. The CaDDM Randomized Controlled Trial

USDA-ARS?s Scientific Manuscript database

Suboptimal vitamin D and calcium status has been associated with higher risk of type 2 diabetes in observational studies but evidence from trials is lacking. The objective of this trial was to determine whether vitamin D supplementation, with or without calcium, improves glucose homeostasis in adult...

Building research in diet and cognition: The BRIDGE randomized controlled trial.

PubMed

Tussing-Humphreys, Lisa; Lamar, Melissa; Blumenthal, James A; Babyak, Michael; Fantuzzi, Giamila; Blumstein, Lara; Schiffer, Linda; Fitzgibbon, Marian L

2017-08-01

Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers. Copyright © 2017. Published by Elsevier Inc.

Efficacy of L-carnitine supplementation on frailty status and its biomarkers, nutritional status, and physical and cognitive function among prefrail older adults: a double-blind, randomized, placebo-controlled clinical trial.

PubMed

Badrasawi, M; Shahar, Suzana; Zahara, A M; Nor Fadilah, R; Singh, Devinder Kaur Ajit

2016-01-01

Frailty is a biological syndrome of decreased reserve and resistance to stressors due to decline in multiple physiological systems. Amino acid deficiency, including L-carnitine, has been proposed to be associated with its pathophysiology. Nevertheless, the efficacy of L-carnitine supplementation on frailty status has not been documented. Thus, this study aimed to determine the effect of 10-week L-carnitine supplement (1.5 g/day) on frailty status and its biomarkers and also physical function, cognition, and nutritional status among prefrail older adults in Klang Valley, Malaysia. This study is a randomized, double-blind, placebo-controlled clinical trial conducted among 50 prefrail subjects randomized into two groups (26 in L-carnitine group and 24 in placebo group). Outcome measures include frailty status using Fried criteria and Frailty Index accumulation of deficit, selected frailty biomarkers (interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor-1), physical function, cognitive function, nutritional status and biochemical profile. The results indicated that the mean scores of Frailty Index score and hand grip test were significantly improved in subjects supplemented with L-carnitine ( P <0.05 for both parameters) as compared to no change in the placebo group. Based on Fried criteria, four subjects (three from the L-carnitine group and one from the control group) transited from prefrail status to robust after the intervention. L-carnitine supplementation has a favorable effect on the functional status and fatigue in prefrail older adults.

Efficacy of L-carnitine supplementation on frailty status and its biomarkers, nutritional status, and physical and cognitive function among prefrail older adults: a double-blind, randomized, placebo-controlled clinical trial

PubMed Central

Badrasawi, M; Shahar, Suzana; Zahara, AM; Nor Fadilah, R; Singh, Devinder Kaur Ajit

2016-01-01

Background Frailty is a biological syndrome of decreased reserve and resistance to stressors due to decline in multiple physiological systems. Amino acid deficiency, including L-carnitine, has been proposed to be associated with its pathophysiology. Nevertheless, the efficacy of L-carnitine supplementation on frailty status has not been documented. Thus, this study aimed to determine the effect of 10-week L-carnitine supplement (1.5 g/day) on frailty status and its biomarkers and also physical function, cognition, and nutritional status among prefrail older adults in Klang Valley, Malaysia. Methodology This study is a randomized, double-blind, placebo-controlled clinical trial conducted among 50 prefrail subjects randomized into two groups (26 in L-carnitine group and 24 in placebo group). Outcome measures include frailty status using Fried criteria and Frailty Index accumulation of deficit, selected frailty biomarkers (interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor-1), physical function, cognitive function, nutritional status and biochemical profile. Results The results indicated that the mean scores of Frailty Index score and hand grip test were significantly improved in subjects supplemented with L-carnitine (P<0.05 for both parameters) as compared to no change in the placebo group. Based on Fried criteria, four subjects (three from the L-carnitine group and one from the control group) transited from prefrail status to robust after the intervention. Conclusion L-carnitine supplementation has a favorable effect on the functional status and fatigue in prefrail older adults. PMID:27895474

Traditional Chinese Mind and Body Exercises for Promoting Balance Ability of Old Adults: A Systematic Review and Meta-Analysis

PubMed Central

Zhang, Yanjie; Wang, Yong Tai; Liu, Xiao Lei

2016-01-01

The purpose of this study was to provide a quantitative evaluation of the effectiveness of traditional Chinese mind and body exercises in promoting balance ability for old adults. The eligible studies were extensively searched from electronic databases (Medline, CINAHL, SportDicus, and Web of Science) until 10 May 2016. Reference lists of relevant publications were screened for future hits. The trials used randomized controlled approaches to compare the effects of traditional Chinese mind and body exercise (TCMBE) on balance ability of old adults that were included. The synthesized results of Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and static balance with 95% confidence intervals were counted under a random-effects model. Ten studies were selected based on the inclusion criteria, and a total of 1,798 participants were involved in this review. The results of the meta-analysis showed that TCMBE had no significant improvement on BBS and TUG, but the BBS and TUG could be obviously improved by prolonging the intervention time. In addition, the results showed that TCMBE could significantly improve the static balance compared to control group. In conclusion, old adults who practiced TCMBE with the time not less than 150 minutes per week for more than 15 weeks could promote the balance ability. PMID:27990168

Traditional Chinese Mind and Body Exercises for Promoting Balance Ability of Old Adults: A Systematic Review and Meta-Analysis.

PubMed

Chen, Shihui; Zhang, Yanjie; Wang, Yong Tai; Liu, Xiao Lei

2016-01-01

The purpose of this study was to provide a quantitative evaluation of the effectiveness of traditional Chinese mind and body exercises in promoting balance ability for old adults. The eligible studies were extensively searched from electronic databases (Medline, CINAHL, SportDicus, and Web of Science) until 10 May 2016. Reference lists of relevant publications were screened for future hits. The trials used randomized controlled approaches to compare the effects of traditional Chinese mind and body exercise (TCMBE) on balance ability of old adults that were included. The synthesized results of Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and static balance with 95% confidence intervals were counted under a random-effects model. Ten studies were selected based on the inclusion criteria, and a total of 1,798 participants were involved in this review. The results of the meta-analysis showed that TCMBE had no significant improvement on BBS and TUG, but the BBS and TUG could be obviously improved by prolonging the intervention time. In addition, the results showed that TCMBE could significantly improve the static balance compared to control group. In conclusion, old adults who practiced TCMBE with the time not less than 150 minutes per week for more than 15 weeks could promote the balance ability.

Effects of resistance and functional-skills training on habitual activity and constipation among older adults living in long-term care facilities: a randomized controlled trial.

PubMed

Chin A Paw, Marijke J M; van Poppel, Mireille N M; van Mechelen, Willem

2006-07-31

Large-scale RCTs comparing different types of exercise training in institutionalised older people are scarce, especially regarding effects on habitual physical activity and constipation. This study investigated the effects of different training protocols on habitual physical activity and constipation of older adults living in long-term care facilities. A randomized controlled trial with 157 participants, aged 64 to 94 years, who were randomly assigned to 1) resistance training; 2) all-round functional-skills training; 3) both; or 4) an 'educational' control condition. Habitual physical activity was assessed with a physical activity questionnaire and accelerometers. Constipation was assessed by a questionnaire. Measurements were performed at baseline and after six months of training. At baseline the median time spent sitting was 8.2 hr/d, the median time spent on activity of at least moderate intensity was 32 min/d. At baseline, about 22% of the subjects were diagnosed with constipation and 23% were taking laxatives. There were no between-group differences for changes in habitual physical activity or constipation over 6-months. Six months of moderate intensity exercise training neither enhances habitual physical activity nor affects complaints of constipation among older people living in long-term care facilities.

Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes.

PubMed

Gucciardi, Enza; Demelo, Margaret; Lee, Ruth N; Grace, Sherry L

2007-04-01

To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period. The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence. Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months. Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to determine the most efficacious education method to sustain long-term nutrition adherence and glycemic control.

Soy provides modest benefits on endothelial function without affecting inflammatory biomarkers in adults at cardiometabolic risk

PubMed Central

Reverri, Elizabeth J.; LaSalle, Colette D.; Franke, Adrian A.; Steinberg, Francene M.

2015-01-01

Scope Systemic inflammation, endothelial dysfunction, and oxidative stress are involved in the pathogenesis of the metabolic syndrome (MetS). Epidemiological evidence supports an association between whole soy food consumption and reduced risk of cardiovascular disease (CVD). The objective of this randomized, controlled, crossover study was to evaluate the effects of soy nut consumption on inflammatory biomarkers and endothelial function and to assess whether isoflavone metabolism to secondary products, equol and/or O-desmethylangolensin (ODMA), modifies these responses. Methods and Results n=17 adults at cardiometabolic risk were randomly assigned to the order of two snack interventions, soy nuts and macronutrient-matched control snack, for four weeks each, separated by a two week washout period. Outcome measures included biomarkers of inflammation, oxidative stress, and glycemic control (ELISA and clinical analyzers), endothelial function and arterial stiffness (peripheral arterial tonometry (PAT)), and isoflavone metabolites (LC-MS/MS). Results revealed that consuming soy nuts improved arterial stiffness as assessed by the augmentation index using PAT (P=0.03), despite lack of improvement in inflammatory biomarkers. Addition of equol and/ODMA production status as covariates did not significantly change these results. Conclusions Soy nuts when added to a usual diet for one month provide some benefit on arterial stiffness in adults at cardiometabolic risk. PMID:25351805

Working memory training in healthy young adults: Support for the null from a randomized comparison to active and passive control groups.

PubMed

Clark, Cameron M; Lawlor-Savage, Linette; Goghari, Vina M

2017-01-01

Training of working memory as a method of increasing working memory capacity and fluid intelligence has received much attention in recent years. This burgeoning field remains highly controversial with empirically-backed disagreements at all levels of evidence, including individual studies, systematic reviews, and even meta-analyses. The current study investigated the effect of a randomized six week online working memory intervention on untrained cognitive abilities in a community-recruited sample of healthy young adults, in relation to both a processing speed training active control condition, as well as a no-contact control condition. Results of traditional null hypothesis significance testing, as well as Bayesian factor analyses, revealed support for the null hypothesis across all cognitive tests administered before and after training. Importantly, all three groups were similar at pre-training for a variety of individual variables purported to moderate transfer of training to fluid intelligence, including personality traits, motivation to train, and expectations of cognitive improvement from training. Because these results are consistent with experimental trials of equal or greater methodological rigor, we suggest that future research re-focus on: 1) other promising interventions known to increase memory performance in healthy young adults, and; 2) examining sub-populations or alternative populations in which working memory training may be efficacious.

Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

2014-01-01

Background An increasing number of studies have documented the effectiveness of qigong exercise in helping people reduce psychological stress and anxiety, but there is a scarcity of systematic reviews evaluating evidence from randomized controlled trials (RCTs) conducted among healthy subjects. Methods Thirteen databases were searched for RCTs from their inception through June 2013. Effects of qigong exercise were pooled across trials. Standardized mean differences (SMDs) were calculated for the pooled effects. Heterogeneity was assessed using the I 2 test. The risk of bias was assessed using the Cochrane criteria. Results Seven RCTs met the inclusion criteria. Two RCTs suggested that qigong exercise immediately relieved anxiety among healthy adults, compared to lecture attendance and structured movements only. Four RCTs suggested qigong exercise relieved anxiety (pooled SMD = -0.75; 95% CI, -1.11 to -0.40), and three RCTs suggested that qigong exercise reduced stress (pooled SMD = -0.88; 95% CI, -1.22 to -0.55) among healthy subjects following one to three months of qigong practice, compared to wait-list controls. Conclusions The available evidence suggests that qigong exercise reduces stress and anxiety in healthy adults. However, given the limited number of RCTs and their methodological flaws, further rigorously designed RCTs are needed. PMID:24400778

Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

PubMed Central

Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; Cho, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

2016-01-01

Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Mini-Mental State Examination, and the Clock Drawing Test. Physical performance was evaluated by exercise time, the number of pedal rotation, total load, grip strength, and the Berg Balance Scale (BBS). Results In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements. Conclusion This study indicates that it is possible to improve cognitive function in older adults with moderate to severe AD through 6-month physical exercise with a multicomponent cognitive intervention. PMID:27403134

The Detroit Young Adult Asthma Project: Proposal for a Multicomponent Technology Intervention for African American Emerging Adults With Asthma.

PubMed

MacDonell, Karen; Naar, Sylvie; Gibson-Scipio, Wanda; Bruzzese, Jean-Marie; Wang, Bo; Brody, Aaron

2018-05-07

Racial and ethnic minority youth have poorer asthma status than white youth, even after controlling for socioeconomic variables. Proper use of asthma controller medications is critical in reducing asthma mortality and morbidity. The clinical consequences of poor asthma management include increased illness complications, excessive functional morbidity, and fatal asthma attacks. There are significant limitations in research on interventions to improve asthma management in racial minority populations, particularly minority adolescents and young adults, although illness management tends to deteriorate after adolescence during emerging adulthood, the unique developmental period beyond adolescence but before adulthood. The objective of the pilot study was to test the feasibility, acceptability, and signals of efficacy of an intervention targeting adherence to controller medication in African American youth (ages 18-29) with asthma. All elements of the protocol were piloted in a National Heart, Lung, and Blood Institute (NHLBI)-funded pilot study (1R34HL107664 MacDonell). Results suggested feasibility and acceptability of the protocol as well as proof of concept. We are now ready to test the intervention in a larger randomized clinical trial. The proposed study will include 192 African American emerging adults with moderate to severe persistent asthma and low controller medication adherence recruited from clinic, emergency department, and community settings. Half of the sample will be randomized to receive a multicomponent technology-based intervention targeting adherence to daily controller medication. The multicomponent technology-based intervention consists of 2 components: (1) 2 sessions of computer-delivered motivational interviewing targeting medication adherence and (2) individualized text messaging focused on medication adherence between the sessions. Text messages will be individualized based on ecological momentary assessment. The remaining participants will complete a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants will also receive text messages between intervention sessions. Message content will be the same for all control participants and contain general facts about asthma (not tailored). It is hypothesized that youth randomized to multicomponent technology-based intervention will show improvements in medication adherence (primary outcome) and asthma control (secondary outcome) compared with comparison condition at all postintervention follow-ups (3, 6, 9, and 12 months). The proposed study was funded by NHLBI from September 1, 2016 through August 31, 2021. This project will test a brief, technology-based intervention specifically targeting adherence to asthma controller medications in an under-researched population, African American emerging adults. If successful, our multicomponent technology-based intervention aimed at improving adherence to asthma medications has the potential to improve quality of life of minority emerging adults with asthma at relatively low cost. It could eventually be integrated into clinical settings and practice to reach a large number of emerging adults with asthma. ClinicalTrials.gov NCT03121157; https://clinicaltrials.gov/ct2/show/NCT03121157 (Archived by WebCite at http://www.webcitation.org/6wq4yWHPv). ©Karen MacDonell, Sylvie Naar, Wanda Gibson-Scipio, Jean-Marie Bruzzese, Bo Wang, Aaron Brody. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.05.2018.

The connecting health and technology study: a 6-month randomized controlled trial to improve nutrition behaviours using a mobile food record and text messaging support in young adults.

PubMed

Kerr, Deborah A; Harray, Amelia J; Pollard, Christina M; Dhaliwal, Satvinder S; Delp, Edward J; Howat, Peter A; Pickering, Mark R; Ahmad, Ziad; Meng, Xingqiong; Pratt, Iain S; Wright, Janine L; Kerr, Katherine R; Boushey, Carol J

2016-04-21

Early adulthood represents the transition to independent living which is a period when changes in diet and body weight are likely to occur. This presents an ideal time for health interventions to reduce the effect of health problems and risk factors for chronic disease in later life. As young adults are high users of mobile devices, interventions that use this technology may improve engagement. The Connecting Health and Technology study aimed to evaluate the effectiveness of tailored dietary feedback and weekly text messaging to improve dietary intake of fruit, vegetables and junk food over 6 months among a population-based sample of men and women (aged 18-30 years). A three-arm, parallel, randomized control trial was conducted. After baseline assessments, participants were randomized to one of three groups: A) dietary feedback and weekly text messages, B) dietary feedback only or C) control group. Dietary intake was assessed using a mobile food record App (mFR) where participants captured images of foods and beverages consumed over 4-days at baseline and post-intervention. The primary outcomes were changes in serves of fruits, vegetables, energy-dense nutrient-poor (EDNP) foods and sugar-sweetened beverages (SSB). The intervention effects were assessed using linear mixed effect models for change in food group serves. Young adults (n = 247) were randomized to group A (n = 82), group B (n = 83), or group C (n = 82). Overall, no changes in food group serves for either intervention groups were observed. An unanticipated outcome was a mean weight reduction of 1.7 kg (P = .02) among the dietary feedback only. Men who received dietary feedback only, significantly reduced their serves of EDNP foods by a mean of 1.4 serves/day (P = .02). Women who received dietary feedback only significantly reduced their intake of SSB (P = .04) by an average of 0.2 serves/day compared with controls. Tailored dietary feedback only resulted in a decrease in EDNP foods in men and SSB in women, together with a reduction in body weight. Using a mobile food record for dietary assessment and tailored feedback has great potential for future health promotion interventions targeting diet and weight in young adults. Australian Clinical Trials Registry Registration number: ACTRN12612000250831 .

Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study.

PubMed

Chen, Shulin; Conwell, Yeates; Xue, Jiang; Li, Lydia W; Tang, Wan; Bogner, Hillary R; Dong, Hengjin

2018-05-29

Depression and hypertension are common, costly, and destructive conditions among the rapidly aging population of China. The two disorders commonly coexist and are poorly recognized and inadequately treated, especially in rural areas. The Chinese Older Adult Collaborations in Health (COACH) Study is a cluster randomized controlled trial (RCT) designed to test the hypotheses that the COACH intervention, designed to manage comorbid depression and hypertension in older adult, rural Chinese primary care patients, will result in better treatment adherence and greater improvement in depressive symptoms and blood pressure control, and better quality of life, than enhanced Care-as-Usual (eCAU). Based on chronic disease management and collaborative care principles, the COACH model integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW) from the village's Aging Association, supervised by a psychiatrist consultant. One hundred sixty villages, each of which is served by one PCP, will be randomly selected from two counties in Zhejiang Province and assigned to deliver eCAU or the COACH intervention. Approximately 2400 older adult residents from the selected villages who have both clinically significant depressive symptoms and a diagnosis of hypertension will be recruited into the study, randomized by the villages in which they live and receive primary care. After giving informed consent, they will undergo a baseline research evaluation; receive treatment for 12 months with the approach to which their village was assigned; and be re-evaluated at 3, 6, 9, and 12 months after entry. Depression and HTN control are the primary outcomes. Treatment received, health care utilization, and cost data will be obtained from the subjects' electronic medical records (EMR) and used to assess adherence to care recommendations and, in a preliminary manner, to establish cost and cost effectiveness of the intervention. The COACH intervention is designed to serve as a model for primary care-based management of common mental disorders that occur in tandem with common chronic conditions of later life. It leverages existing resources in rural settings, integrates social interventions with the medical model, and is consistent with the cultural context of rural life. ClinicalTrials.gov ID: NCT01938963 ; First posted: September 10, 2013.

Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India.

PubMed

Goel, Sonu; Kathiresan, Jeyashree; Singh, Preeti; Singh, Rana J

2017-09-01

An association between smoking and poor tuberculosis (TB) treatment outcomes has been globally established. Various smoking cessation interventions (SCIs) have been proven worldwide to curb smoking behavior. There is a need for evidence to assess if SCI increases the chance of successful treatment outcome among TB patients. To assess the effectiveness of a brief SCI; The Ask, Brief, Cessation support (ABC) package, on treatment outcomes and smoking cessation in smear-positive adult pulmonary TB patients. A cluster, randomized controlled trial was conducted wherein 17 designated microscopic centers of Chandigarh, India were randomly assigned using a computer-generated randomization sequence to receive SCI within directly observed treatment, short (DOTS) services, or existing standard of care. Eligible and consenting smokers (15 + years) registered as smear-positive pulmonary TB for DOTS (n = 156) between January and June 2013 were enrolled. Smoking cessation (self-reported) was assessed at intervals till the end of treatment. End TB treatment outcomes were extracted from patient records. Treatment success was lower in intervention arm (83.6%) as compared control arm (88.2%), but the difference was statistically insignificant (P = 0.427). Smoking cessation was higher in intervention arm (80.2%) compared to comparison arm (57.5%) (adjusted incidence risk ratio = 1.56; 95% confidence interval = 1.24-1.93; P < 0.0001). SCI is effective in inducing smoking cessation among TB patients. No association of SCI with TB treatment outcomes could be detected.

Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

PubMed

Wong, Charlene A; Miller, Victoria A; Murphy, Kathryn; Small, Dylan; Ford, Carol A; Willi, Steven M; Feingold, Jordyn; Morris, Alexander; Ha, Yoonhee P; Zhu, Jingsan; Wang, Wenli; Patel, Mitesh S

2017-12-01

Glycemic control often deteriorates during adolescence and the transition to young adulthood for patients with type 1 diabetes. The inability to manage type 1 diabetes effectively during these years is associated with poor glycemic control and complications from diabetes in adult life. To determine the effect of daily financial incentives on glucose monitoring adherence and glycemic control in adolescents and young adults with type 1 diabetes. The Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes (BE IN CONTROL) study was an investigator-blinded, 6-month, 2-arm randomized clinical trial conducted between January 22 and November 2, 2016, with 3-month intervention and follow-up periods. Ninety participants (aged 14-20) with suboptimally controlled type 1 diabetes (hemoglobin A1c [HbA1c] >8.0%) were recruited from the Diabetes Center for Children at the Children's Hospital of Philadelphia. All participants were given daily blood glucose monitoring goals of 4 or more checks per day with 1 or more level within the goal range (70-180 mg/dL) collected with a wireless glucometer. The 3-month intervention consisted of a $60 monthly incentive in a virtual account, from which $2 was subtracted for every day of nonadherence to the monitoring goals. During a 3-month follow-up period, the intervention was discontinued. The primary outcome was change in HbA1c levels at 3 months. Secondary outcomes included adherence to glucose monitoring and change in HbA1c levels at 6 months. All analyses were by intention to treat. Of the 181 participants screened, 90 (52 [57.8%] girls) were randomized to the intervention (n = 45) or control (n = 45) arms. The mean (SD) age was 16.3 (1.9) years. The intervention group had significantly greater adherence to glucose monitoring goals in the incentive period (50.0% vs 18.9%; adjusted difference, 27.2%; 95% CI, 9.5% to 45.0%; P = .003) but not in the follow-up period (15.3% vs 8.7%; adjusted difference, 3.9%; 95% CI, -2.0% to 9.9%; P = .20). The change in HbA1c levels from baseline did not differ significantly between groups at 3 months (adjusted difference, -0.08%; 95% CI, -0.69% to 0.54%; P = .80) or 6 months (adjusted difference, 0.03%; 95% CI, -0.55% to 0.60%; P = .93). Among adolescents and young adults with type 1 diabetes, daily financial incentives improved glucose monitoring adherence during the incentive period but did not significantly improve glycemic control. clinicaltrials.gov Identifier: NCT02568501.

Education, Employment, Income, and Marital Status Among Adults Diagnosed With Inflammatory Bowel Diseases During Childhood or Adolescence.

PubMed

El-Matary, Wael; Dufault, Brenden; Moroz, Stan P; Schellenberg, Jeannine; Bernstein, Charles N

2017-04-01

We aimed to assess levels of education attained, employment, and marital status of adults diagnosed with inflammatory bowel diseases (IBD) during childhood or adolescence, compared with healthy individuals in Canada. We performed a cross-sectional study of adults diagnosed with IBD in childhood or adolescence at Children's Hospital in Winnipeg, Manitoba from January 1978 through December 2007. Participants (n = 112) answered a semi-structured questionnaire on educational achievements, employment, and marital status. Patients were matched for age and sex with random healthy individuals from the 2012 Canadian Community Health Survey (controls, 5 per patient). Conditional binary logistic regression and random-effects ordinal logistic regression models were used for analysis. Patients were followed for a mean duration of 14.3 years (range, 3.1-34.5 years). Persons with IBD were more likely to earn more money per annum and attain a post-secondary school degree or receive a diploma than controls (odds ratio, 1.72; 95% confidence interval, 1.13-2.60; P < .01 and odds ratio, 2.73; 95% confidence interval, 1.48-5.04; P < .01, respectively). There was no significant difference between patients and controls in employment or marital status. Adults diagnosed with IBD during childhood seem to achieve higher education levels than individuals without IBD. This observation should provide reassurance to children with IBD and their parents. ClinicalTrials.gov number: NCT02152241. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Changing Throwing Pattern: Instruction and Control Parameter

ERIC Educational Resources Information Center

Southard, Dan

2006-01-01

The purpose of this study was to determine the effects of instruction and scaling up a control parameter (velocity of throw) on changes in throwing pattern. Sixty adult female throwers (ages 20-26 years) were randomly placed into one of four practice conditions: (a) scale up on velocity with no instruction, (b) maintain constant velocity with no…

HIV Prevention for Adults With Criminal Justice Involvement: A Systematic Review of HIV Risk-Reduction Interventions in Incarceration and Community Settings

PubMed Central

Dumont, Dora; Operario, Don

2014-01-01

We summarized and appraised evidence regarding HIV prevention interventions for adults with criminal justice involvement. We included randomized and quasi-randomized controlled trials that evaluated an HIV prevention intervention, enrolled participants with histories of criminal justice involvement, and reported biological or behavioral outcomes. We used Cochrane methods to screen 32 271 citations from 16 databases and gray literature. We included 37 trials enrolling n = 12 629 participants. Interventions were 27 psychosocial, 7 opioid substitution therapy, and 3 HIV-testing programs. Eleven programs significantly reduced sexual risk taking, 4 reduced injection drug risks, and 4 increased testing. Numerous interventions may reduce HIV-related risks among adults with criminal justice involvement. Future research should consider process evaluations, programs involving partners or families, and interventions integrating biomedical, psychosocial, and structural approaches. PMID:25211725

Cardiorespiratory benefits of group exercise among adults with serious mental illness.

PubMed

Jerome, Gerald J; Young, Deborah Rohm; Dalcin, Arlene T; Wang, Nae-Yuh; Gennusa, Joseph; Goldsholl, Stacy; Appel, Lawrence J; Daumit, Gail L

2017-10-01

This study examined cardiorespiratory fitness (CRF) among adults with serious mental illness (SMI) participating in group exercise classes. Overweight and obese adults with SMI were randomized to either a control condition or a weight management condition with group exercise classes (n = 222). Submaximal bicycle ergometry was used to assess CRF at baseline, 6 and 18 months. Those with ≥ 66% participation in the exercise classes had a lower heart rate response at 6 and 18 month follow-up. Participation in group exercise classes was associated with improved short and long term cardiovascular fitness among adults with SMI. Copyright © 2017 Elsevier B.V. All rights reserved.

The Effect of Interference on Temporal Order Memory for Random and Fixed Sequences in Nondemented Older Adults

ERIC Educational Resources Information Center

Tolentino, Jerlyn C.; Pirogovsky, Eva; Luu, Trinh; Toner, Chelsea K.; Gilbert, Paul E.

2012-01-01

Two experiments tested the effect of temporal interference on order memory for fixed and random sequences in young adults and nondemented older adults. The results demonstrate that temporal order memory for fixed and random sequences is impaired in nondemented older adults, particularly when temporal interference is high. However, temporal order…

Aromatherapy for the treatment of PONV in children: a pilot RCT.

PubMed

Kiberd, Mathew B; Clarke, Suzanne K; Chorney, Jill; d'Eon, Brandon; Wright, Stuart

2016-11-09

Postoperative nausea and vomiting (PONV) is one of the most common postoperative complications of general anesthesia in pediatrics. Aromatherapy has been shown to be effective in treating PONV in adults. Given the encouraging results of the adult studies, we planned to determine feasibility of doing a large-scale study in the pediatric population. Our group conducted a pilot randomized controlled trial examining the effect of aromatherapy on post-operative nausea and vomiting in patients 4-16 undergoing ambulatory surgery at a single center. Nausea was defined as a score of 4/10 on the Baxter Retching Faces Scale (BARF scale). A clinically significant reduction was defined as a two-point reduction in Nausea. Post operatively children were administered the BARF scale in 15 min internals until discharge home or until nausea score of 4/10 or greater. Children with nausea were randomized to saline placebo group or aromatherapy QueaseEase™ (Soothing Scents, Inc, Enterprise, AL: blend of ginger, lavender, mint and spearmint). Nausea scores were recorded post intervention. A total of 162 subjects were screened for inclusion in the study. Randomization occurred in 41 subjects of which 39 were included in the final analysis. For the primary outcome, 14/18 (78 %) of controls reached primary outcome compared to 19/21 (90 %) in the aromatherapy group (p = 0.39, Eta 0.175). Other outcomes included use of antiemetic in PACU (control 44 %, aromatherapy 52 % P = 0.75, Eta 0.08), emesis (Control 11 %, 9 % aromatherapy, P = 0.87, Eta = 0.03). There was a statistically significant difference in whether subjects continued to use the intervention (control 28 %, aromatherapy 66 %, p-value 0.048, Eta 0.33). Aromatherapy had a small non-significant effect size in treating postoperative nausea and vomiting compared with control. A large-scale randomized control trial would not be feasible at our institution and would be of doubtful utility. ClinicalTrials.gov NCT02663154 .

Increasing older adults’ walking through primary care: results of a pilot randomized controlled trial

PubMed Central

Mutrie, Nanette

2012-01-01

Background. Physical activity can positively influence health for older adults. Primary care is a good setting for physical activity promotion. Objective. To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations. Methods. Design: Two-arm (intervention/control) 12-week randomized controlled trial with a 12-week follow-up for the intervention group. Setting: One general practice in Glasgow, UK. Participants: Participants were aged ≥65 years. The intervention group received two 30-minute physical activity consultations from a trained practice nurse, a pedometer and a walking programme. The control group continued as normal for 12 weeks and then received the intervention. Both groups were followed up at 12 and 24 weeks. Outcome measures: Step counts were measured by sealed pedometers and an activPALTM monitor. Psychosocial variables were assessed and focus groups conducted. Results. The response rate was 66% (187/284), and 90% of those randomized (37/41) completed the study. Qualitative data suggested that the pedometer and nurse were helpful to the intervention. Step counts (activPAL) showed a significant increase from baseline to week 12 for the intervention group, while the control group showed no change. Between weeks 12 and 24, step counts were maintained in the intervention group, and increased for the control group after receiving the intervention. The intervention was associated with improved quality of life and reduced sedentary time. Conclusions. It is feasible to recruit and retain older adults from primary care and help them increase walking. A larger trial is necessary to confirm findings and consider cost-effectiveness. PMID:22843637

ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

PubMed Central

Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

2016-01-01

Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial.

PubMed

Shah, Krupa N; Majeed, Zahraa; Yoruk, Yilmaz B; Yang, Hongmei; Hilton, Tiffany N; McMahon, James M; Hall, William J; Walck, Donna; Luque, Amneris E; Ryan, Richard M

2016-06-01

HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. In total, 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to 1 of 2 groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p < .05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared with the control group (p < .05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p < .05). Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Improving late life depression and cognitive control through the use of therapeutic video game technology: A proof-of-concept randomized trial.

PubMed

Anguera, Joaquin A; Gunning, Faith M; Areán, Patricia A

2017-06-01

Existing treatments for depression are known to have only modest effects, are insufficiently targeted, and are inconsistently utilized, particularly in older adults. Indeed, older adults with impaired cognitive control networks tend to demonstrate poor response to a majority of existing depression interventions. Cognitive control interventions delivered using entertainment software have the potential to not only target the underlying cerebral dysfunction associated with depression, but to do so in a manner that is engaging and engenders adherence to treatment protocol. In this proof-of-concept trial (Clinicaltrials.gov #: NCT02229188), individuals with late life depression (LLD) (22; 60+ years old) were randomized to either problem solving therapy (PST, n = 10) or a neurobiologically inspired digital platform designed to enhance cognitive control faculties (Project: EVO™, n = 12). Given the overlapping functional neuroanatomy of mood disturbances and executive dysfunction, we explored the impact of an intervention targeting cognitive control abilities, functional disability, and mood in older adults suffering from LLD, and how those outcomes compare to a therapeutic gold standard. EVO participants demonstrated similar improvements in mood and self-reported function after 4 weeks of treatment to PST participants. The EVO participants also showed generalization to untrained measures of working memory and attention, as well as negativity bias, a finding not evident in the PST condition. Individuals assigned to EVO demonstrated 100% adherence. This study provides preliminary findings that this therapeutic video game targeting cognitive control deficits may be an efficacious LLD intervention. Future research is needed to confirm these findings. © 2016 Wiley Periodicals, Inc.

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis.

PubMed

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-02-08

We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A₁(C)) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A₁(C) levels (pooled standardized mean difference between intervention and control groups -0.38 [95% confidence interval -0.47 to -0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A₁(C) levels (standardized mean difference -0.60 v. -0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A₁(C) levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference -0.56 v. -0.30, p = 0.03). Disease-management programs had a clinically moderate but significant impact on hemoglobin A₁(C) levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval.

Effectiveness of disease-management programs for improving diabetes care: a meta-analysis

PubMed Central

Pimouguet, Clément; Le Goff, Mélanie; Thiébaut, Rodolphe; Dartigues, Jean François; Helmer, Catherine

2011-01-01

Background We conducted a meta-analysis of randomized controlled trials to assess the effectiveness of disease-management programs for improving glycemic control in adults with diabetes mellitus and to study which components of programs are associated with their effectiveness. Methods We searched several databases for studies published up to December 2009. We included randomized controlled trials involving adults with type 1 or 2 diabetes that evaluated the effect of disease-management programs on glycated hemoglobin (hemoglobin A1C) concentrations. We performed a meta-regression analysis to determine the effective components of the programs. Results We included 41 randomized controlled trials in our review. Across these trials, disease-management programs resulted in a significant reduction in hemoglobin A1C levels (pooled standardized mean difference between intervention and control groups −0.38 [95% confidence interval −0.47 to −0.29], which corresponds to an absolute mean difference of 0.51%). The finding was robust in the sensitivity analyses based on quality assessment. Programs in which the disease manager was able to start or modify treatment with or without prior approval from the primary care physician resulted in a greater improvement in hemoglobin A1C levels (standardized mean difference −0.60 v. −0.28 in trials with no approval to do so; p < 0.001). Programs with a moderate or high frequency of contact reported a significant reduction in hemoglobin A1C levels compared with usual care; nevertheless, only programs with a high frequency of contact led to a significantly greater reduction compared with low-frequency contact programs (standardized mean difference −0.56 v. −0.30, p = 0.03). Interpretation Disease-management programs had a clinically moderate but significant impact on hemoglobin A1C levels among adults with diabetes. Effective components of programs were a high frequency of patient contact and the ability for disease managers to adjust treatment with or without prior physician approval. PMID:21149524

Computer Enabled Neuroplasticity Treatment: A Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD

PubMed Central

Cowley, Benjamin; Holmström, Édua; Juurmaa, Kristiina; Kovarskis, Levas; Krause, Christina M.

2016-01-01

Background: We report a randomized controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods: Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved ~40 h-long sessions 2–5 times per week. Training involved either theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel “inverse-training” condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting: Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomization: We randomly allocated half the sample then adaptively allocated the remainder to minimize baseline differences in prognostic variables. Blinding: Waiting-list control design meant trial was not blinded. Participants: Fifty-four adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. Forty-four had ADHD diagnoses, 10 had ADD. Measurements: Symptoms were assessed by computerized attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results: Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive analysis will be reported elsewhere. Trial Registration: “Computer Enabled Neuroplasticity Treatment (CENT),” ISRCTN13915109. PMID:27242472

Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial.

PubMed

Kurz, Ilan; Gimmon, Yoav; Shapiro, Amir; Debi, Ronen; Snir, Yoram; Melzer, Itshak

2016-03-04

Falls are common among elderly, most of them occur while slipping or tripping during walking. We aimed to explore whether a training program that incorporates unexpected loss of balance during walking able to improve risk factors for falls. In a double-blind randomized controlled trial 53 community dwelling older adults (age 80.1±5.6 years), were recruited and randomly allocated to an intervention group (n = 27) or a control group (n = 26). The intervention group received 24 training sessions over 3 months that included unexpected perturbation of balance exercises during treadmill walking. The control group performed treadmill walking with no perturbations. The primary outcome measures were the voluntary step execution times, traditional postural sway parameters and Stabilogram-Diffusion Analysis. The secondary outcome measures were the fall efficacy Scale (FES), self-reported late life function (LLFDI), and Performance-Oriented Mobility Assessment (POMA). Compared to control, participation in intervention program that includes unexpected loss of balance during walking led to faster Voluntary Step Execution Times under single (p = 0.002; effect size [ES] =0.75) and dual task (p = 0.003; [ES] = 0.89) conditions; intervention group subjects showed improvement in Short-term Effective diffusion coefficients in the mediolateral direction of the Stabilogram-Diffusion Analysis under eyes closed conditions (p = 0.012, [ES] = 0.92). Compared to control there were no significant changes in FES, LLFDI, and POMA. An intervention program that includes unexpected loss of balance during walking can improve voluntary stepping times and balance control, both previously reported as risk factors for falls. This however, did not transferred to a change self-reported function and FES. ClinicalTrials.gov NCT01439451 .

An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial.

PubMed

Chen, Kuei-Min; Li, Chun-Huw; Chang, Ya-Hui; Huang, Hsin-Ting; Cheng, Yin-Yin

2015-01-01

The number of older adults using wheelchairs in nursing homes is over 50% of that population, and many of them use wheelchairs due to muscle weakness in the lower extremities. Muscles of older adults are trainable, and progressive resistance exercises using elastic bands can increase muscle strength in older adults. To test the effectiveness of six-month Wheelchair-bound Senior Elastic Band exercises on the functional fitness of older adults in nursing homes. Cluster randomized trial. Ten nursing homes, southern Taiwan. 127 participants were recruited, and 114 of them completed the study. Inclusion criteria were: (1) aged 65 and over, (2) using wheelchairs for mobility, (3) living in the facility for at least three months, (4) cognitively intact, and (5) heavily or moderate dependency in their activities of daily living. The mean age of the participants was 79.15 (7.03) years, and 98.20% of them had chronic illnesses. Participants were randomly assigned to the experimental (five nursing homes, n=59) or the control (five nursing homes, n=55) group based on the nursing homes where they stayed. A 40-min Wheelchair-bound Senior Elastic Band exercise program was implemented three times per week for six months for the experimental group participants. The functional fitness (activities of daily living, lung capacity, body flexibilities, muscle power and endurance) of the participants was examined at baseline, after three months, and at the end of the six months study. The mixed-design, two-way analysis of variance was used to detect the interaction effects, and one-way repeated measures analysis of variance and analysis of covariance were performed to analyze the within-group and between-group differences. At the end of the six-month study, the Wheelchair-bound Senior Elastic Band group had better performances in all of the functional fitness indicators than the control group (all p<0.05). The Wheelchair-bound Senior Elastic Band exercises significantly improved the functional fitness of the older adults in wheelchairs. It is suggested that the program be incorporated as a part of daily activities for nursing home older adults in wheelchairs. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.

PubMed

Cadorna-Carlos, Josefina B; Nolan, Terry; Borja-Tabora, Charissa Fay; Santos, Jaime; Montalban, M Cecilia; de Looze, Ferdinandus J; Eizenberg, Peter; Hall, Stephen; Dupuy, Martin; Hutagalung, Yanee; Pépin, Stéphanie; Saville, Melanie

2015-05-15

Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate. This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination. 1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains. In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults. NCT01481454. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

What Is the Evidence for Rest, Ice, Compression, and Elevation Therapy in the Treatment of Ankle Sprains in Adults?

PubMed Central

van den Bekerom, Michel P.J; Struijs, Peter A.A; Blankevoort, Leendert; Welling, Lieke; van Dijk, C. Niek; Kerkhoffs, Gino M.M.J

2012-01-01

Context: Ankle sprains are common problems in acute medical care. The variation in treatment observed for the acutely injured lateral ankle ligament complex in the first week after the injury suggests a lack of evidence-based management strategies for this problem. Objective: To analyze the effectiveness of applying rest, ice, compression, and elevation (RICE) therapy begun within 72 hours after trauma for patients in the initial period after ankle sprain. Study Selection: Eligible studies were published original randomized or quasi-randomized controlled trials concerning at least 1 of the 4 subtreatments of RICE therapy in the treatment of acute ankle sprains in adults. Data Sources: MEDLINE, Cochrane Clinical Trial Register, CINAHL, and EMBASE. The lists of references of retrieved publications also were checked manually. Data Extraction: We extracted relevant data on treatment outcome (pain, swelling, ankle mobility or range of motion, return to sports, return to work, complications, and patient satisfaction) and assessed the quality of included studies. If feasible, the results of comparable studies were pooled using fixed- or random-effects models. Data Synthesis: After deduction of the overlaps among the different databases, evaluation of the abstracts, and contact with some authors, 24 potentially eligible trials remained. The full texts of these articles were retrieved and thoroughly assessed as described. This resulted in the inclusion of 11 trials involving 868 patients. The main reason for exclusion was that the authors did not describe a well-defined control group without the intervention of interest. Conclusions: Insufficient evidence is available from randomized controlled trials to determine the relative effectiveness of RICE therapy for acute ankle sprains in adults. Treatment decisions must be made on an individual basis, carefully weighing the relative benefits and risks of each option, and must be based on expert opinions and national guidelines. PMID:22889660

Effects of whole-body vibration on balance and mobility in institutionalized older adults: a randomized controlled trial.

PubMed

Lam, Freddy Mh; Chan, Philip Fl; Liao, L R; Woo, Jean; Hui, Elsie; Lai, Charles Wk; Kwok, Timothy Cy; Pang, Marco Yc

2018-04-01

To investigate whether a comprehensive exercise program was effective in improving physical function among institutionalized older adults and whether adding whole-body vibration to the program conferred additional therapeutic benefits. A single-blinded randomized controlled trial was conducted. This study was carried out in residential care units. In total, 73 older adults (40 women, mean age: 82.3 ± 7.3 years) were enrolled into this study. Participants were randomly allocated to one of the three groups: strength and balance program combined with whole-body vibration, strength and balance program without whole-body vibration, and social and recreational activities consisting of upper limb exercises only. All participants completed three training sessions per week for eight weeks. Assessment of mobility, balance, lower limb strength, walking endurance, and self-perceived balance confidence were conducted at baseline and immediately after the eight-week intervention. Incidences of falls requiring medical attention were recorded for one year after the end of the training period. A significant time × group interaction was found for lower limb strength (five-times-sit-to-stand test; P = 0.048), with the exercise-only group showing improvement (pretest: 35.8 ± 16.1 seconds; posttest: 29.0 ± 9.8 seconds), compared with a decline in strength among controls (pretest: 27.1 ± 10.4 seconds; posttest: 28.7 ± 12.3 seconds; P = 0.030). The exercise with whole-body vibration group had a significantly better outcome in balance confidence (pretest: 39.2 ± 29.0; posttest: 48.4 ± 30.6) than the exercise-only group (pretest: 35.9 ± 24.8; posttest: 38.2 ± 26.5; P = 0.033). The exercise program was effective in improving lower limb strength among institutionalized older adults but adding whole-body vibration did not enhance its effect. Whole-body vibration may improve balance confidence without enhancing actual balance performance.

A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial.

PubMed

Lewis, Carmen L; Kistler, Christine E; Dalton, Alexandra F; Morris, Carolyn; Ferrari, Renée; Barclay, Colleen; Brewer, Noel T; Dolor, Rowena; Harris, Russell; Vu, Maihan; Golin, Carol E

2018-07-01

Concerns have been raised about both over- and underutilization of colorectal cancer (CRC) screening in older patients and the need to align screening behavior with likelihood of net benefit. The purpose of this study was to test a novel use of a patient decision aid (PtDA) to promote appropriate CRC screening in older adults. A total of 424 patients ages 70 to 84 y who were not up to date with CRC screening participated in a double-blinded randomized controlled trial of a PtDA targeted to older adults making decisions about whether to undergo CRC screening from March 2012 to February 2015. Patients were randomized to a targeted PtDA or an attention control. The PtDA was designed to facilitate individualized decision making-helping patients understand the potential risks, benefits, and uncertainties of CRC screening given advanced age, health state, preferences, and values. Two composite outcomes, appropriate CRC screening behavior 6 mo after the index visit and appropriate screening intent immediately after the visit, were defined as completed screening or intent for patients in good health, discussion about screening with their provider for patients in intermediate health, and no screening or intent for patients in poor health. Health state was determined by age and Charlson Comorbidity Index. Four hundred twelve (97%) and 421 (99%) patients were analyzed for the primary and secondary outcomes, respectively. Appropriate screening behavior at 6 mo was higher in the intervention group (55% v. 45%, P = 0.023) as was appropriate screening intent following the provider visit (61% v. 47%, P = 0.003). The study took place in a single geographic region. The appropriate CRC screening classification system used in this study has not been formally validated. A PtDA for older adults promoted appropriate CRC screening behavior and intent. Clinicaltrials.gov, registration number NCT01575990. https://clinicaltrials.gov/ct2/show/NCT01575990?term=epic-d&rank=1.

A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial.

PubMed

Martin, Jennifer L; Song, Yeonsu; Hughes, Jaime; Jouldjian, Stella; Dzierzewski, Joseph M; Fung, Constance H; Rodriguez Tapia, Juan Carlos; Mitchell, Michael N; Alessi, Cathy A

2017-08-01

To test the effectiveness of a 4-week behavioral Sleep Intervention Program (SIP: sleep compression, modified stimulus control, and sleep hygiene) compared to a 4-week information-only control (IC) among older adults attending a VA Adult Day Health Care (ADHC) program in a double-blind, randomized, clinical trial. Forty-two individuals (mean age: 77 years, 93% male) enrolled in a VA ADHC program were randomized to receive SIP or IC. All completed in-person sleep and health assessments at baseline, post-treatment and 4-months follow-up that included 3 days/nights of wrist actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). Mixed repeated measures analysis was used to compare sleep outcomes at post-treatment and 4-months follow-up, with baseline values as covariates. SIP participants (n = 21) showed significant improvement on actigraphy sleep efficiency (p = .007), number of nighttime awakenings (p = .016), and minutes awake at night (p = .001) at post-treatment, compared to IC participants (n = 21). Benefits were slightly attenuated but remained significant at 4-month follow-up (all p's < .05). There were no differences in total sleep time between groups. There was significant improvement on PSQI factor 3 (daily disturbances) at 4-month follow-up (p = .016), but no differences were observed between SIP and IC on other PSQI components or ISI scores at post-treatment or 4-month follow-up. A short behavioral sleep intervention may have important benefits in improving objectively measured sleep in older adults participating in ADHC. Future studies are needed to study implementation of this intervention into routine clinical care within ADHC. Published by Oxford University Press on behalf of Sleep Research Society (SRS) 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Music as an adjuvant therapy in control of pain and symptoms in hospitalized adults: a systematic review.

PubMed

Cole, Linda C; LoBiondo-Wood, Geri

2014-03-01

The objective of this review is to evaluate the evidence regarding the use of music as an adjuvant therapy for pain control in hospitalized adults. The search terms music, music therapy, pain, adults, inpatient, and hospitalized were used to search the Cochrane Library, Cinahl, Medline, Natural Standard, and Scopus databases from January 2005 to March 2011. (A systematic review conducted by the Cochrane Collaboration has extensively covered the time frame from 1966 to 2004.) Seventeen randomized controlled trials met criteria for review and inclusion. Seven of the research studies were conducted with surgical patients, three with medical patients, one with medical-surgical patients, four with intensive care patients, and two with pregnant patients. The combined findings of these studies provide support for the use of music as an adjuvant approach to pain control in hospitalized adults. The use of music is safe, inexpensive, and an independent nursing function that can be easily incorporated into the routine care of patients. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial.

PubMed

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

2018-04-01

Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40-79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78-83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3-3.4%, P ≥ 0.138). Linear dose-response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. The 5-year CWI using the focused social marketing strategy increased the population-level of PA.

Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial

PubMed Central

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

2018-01-01

Abstract Background Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. Methods We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40–79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78–83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3–3.4%, P ≥ 0.138). Linear dose–response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. Conclusions The 5-year CWI using the focused social marketing strategy increased the population-level of PA. PMID:29228255

Randomized controlled trial of group cognitive behavioral therapy compared to a discussion group for co-morbid anxiety and depression in older adults.

PubMed

Wuthrich, V M; Rapee, R M; Kangas, M; Perini, S

2016-03-01

Co-morbid anxiety and depression in older adults is associated with worse physical and mental health outcomes and poorer response to psychological and pharmacological treatments in older adults. However, there is a paucity of research focused on testing the efficacy of the co-morbid treatment of anxiety and depression in older adults using psychological interventions. Accordingly, the primary objective of the current study was to test the effects of a group cognitive behavior therapy (CBT) program in treating co-morbid anxiety and depression in a sample of older age adults. A total of 133 community-dwelling participants aged ⩾60 years (mean age = 67.35, s.d. = 5.44, male = 59) with both an anxiety disorder and unipolar mood disorder, as assessed on the Anxiety Disorder Interview Schedule (ADIS), were randomly allocated to an 11-week CBT group or discussion group. Participants with Mini-Mental State Examination scores <26 were excluded. Participants were assessed pre-treatment, post-treatment and at 6 months follow-up on the ADIS, a brief measure of well-being, Geriatric Anxiety Inventory and Geriatric Depression Scale. Both conditions resulted in significant improvements over time on all diagnostic, symptom and wellbeing measures. Significant group × time interaction effects emerged at post-treatment only for diagnostic severity of the primary disorder, mean severity of all anxiety disorders, mood disorders, and all disorders, and recovery rates on primary disorder. Group CBT produced faster and sustained improvements in anxiety and depression on diagnostic severity and recovery rates compared to an active control in older adults.

Perturbation training can reduce community-dwelling older adults' annual fall risk: a randomized controlled trial.

PubMed

Pai, Yi-Chung; Bhatt, Tanvi; Yang, Feng; Wang, Edward

2014-12-01

Previous studies indicated that a single session of repeated-slip exposure can reduce over 40% of laboratory-induced falls among older adults. The purpose of this study was to determine to what degree such perturbation training translated to the reduction of older adults' annual falls risk in their everyday living. Two hundred and twelve community-dwelling older adults (≥65 years old) were randomly assigned to either the training group (N = 109), who then were exposed to 24 unannounced repeated slips, or the control group (N = 103), who merely experienced one slip during the same walking in the same protective laboratory environment. We recorded their falls in the preceding year (through self-reported history) and during the next 12 months (through falls diary and monitored with phone calls). With this single session of repeated-slip exposure, training cut older adults' annual risk of falls by 50% (from 34% to 15%, p < .05). Those who experienced merely a single slip were 2.3 times more likely to fall during the same 12-month follow-up period (p < .05) than those who experienced the 24 repeated slips. Such training effect was especially prominent among those who had history of falls. A single session of repeated-slip exposure could improve community-dwelling older adults' resilience to postural disturbances and, hence, significantly reduce their annual risk of falls. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial.

PubMed

de Vries, Nienke M; Staal, J Bart; Teerenstra, Steven; Adang, Eddy M M; Rikkert, Marcel G M Olde; Nijhuis-van der Sanden, Maria W G

2013-12-17

Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention ('Coach2Move') delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined. The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices. Randomization will take place at the individual patient level. The study population consists of older adults, ≥70 years of age, with decreased physical functioning and mobility and/or a physically inactive lifestyle. The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy. The control group will receive the usual physiotherapy care. Measurements will be performed by research assistants not aware of group assignment. The results will be evaluated on the amount of physical activity (LASA Physical Activity Questionnaire), mobility (modified 'get up and go' test, walking speed and six-minute walking test), quality of life (SF-36), degree of frailty (Evaluative Frailty Index for Physical Activity), fatigue (NRS-fatigue), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire) and health care costs. Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating factor in evaluating a new approach is that it may not be automatically adopted by clinicians. Specific actions are undertaken to optimize implementation of the Coach2Move strategy during the trial. Whether or not these will be sufficient is a matter we will consider subsequently, using quality indicators and process analysis. The Netherlands National Trial Register: NTR3527.

Night-to-Night Sleep Variability in Older Adults With Chronic Insomnia: Mediators and Moderators in a Randomized Controlled Trial of Brief Behavioral Therapy (BBT-I)

PubMed Central

Chan, Wai Sze; Williams, Jacob; Dautovich, Natalie D.; McNamara, Joseph P.H.; Stripling, Ashley; Dzierzewski, Joseph M.; Berry, Richard B.; McCoy, Karin J.M.; McCrae, Christina S.

2017-01-01

Study Objectives: Sleep variability is a clinically significant variable in understanding and treating insomnia in older adults. The current study examined changes in sleep variability in the course of brief behavioral therapy for insomnia (BBT-I) in older adults who had chronic insomnia. Additionally, the current study examined the mediating mechanisms underlying reductions of sleep variability and the moderating effects of baseline sleep variability on treatment responsiveness. Methods: Sixty-two elderly participants were randomly assigned to either BBT-I or self-monitoring and attention control (SMAC). Sleep was assessed by sleep diaries and actigraphy from baseline to posttreatment and at 3-month follow-up. Mixed models were used to examine changes in sleep variability (within-person standard deviations of weekly sleep parameters) and the hypothesized mediation and moderation effects. Results: Variabilities in sleep diary-assessed sleep onset latency (SOL) and actigraphy-assessed total sleep time (TST) significantly decreased in BBT-I compared to SMAC (Pseudo R2 = .12, .27; P = .018, .008). These effects were mediated by reductions in bedtime and wake time variability and time in bed. Significant time × group × baseline sleep variability interactions on sleep outcomes indicated that participants who had higher baseline sleep variability were more responsive to BBT-I; their actigraphy-assessed TST, SOL, and sleep efficiency improved to a greater degree (Pseudo R2 = .15 to .66; P < .001 to .044). Conclusions: BBT-I is effective in reducing sleep variability in older adults who have chronic insomnia. Increased consistency in bedtime and wake time and decreased time in bed mediate reductions of sleep variability. Baseline sleep variability may serve as a marker of high treatment responsiveness to BBT-I. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT02967185 Citation: Chan WS, Williams J, Dautovich ND, McNamara JP, Stripling A, Dzierzewski JM, Berry RB, McCoy KJ, McCrae CS. Night-to-night sleep variability in older adults with chronic insomnia: mediators and moderators in a randomized controlled trial of brief behavioral therapy (BBT-I). J Clin Sleep Med. 2017;13(11):1243–1254. PMID:28992829

Randomized controlled drug trials on very elderly subjects: descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adults.

PubMed

Le Quintrec, Jean-Laurent; Bussy, Caroline; Golmard, Jean-Louis; Hervé, Christian; Baulon, Alain; Piette, François

2005-03-01

Very elderly subjects (VES; aged 80 years or older) constitute a special population as they frequently present multiple diseases (polypathology). Results from trials on general adult populations therefore cannot be extrapolated to VES. We performed a census of randomized controlled trials (RCT) on VES published between 1990 and 2002, and carried out a descriptive and methodological analysis of these RCT/VES, comparing them with matched RCT on general adult populations (control RCT, RCT/C). We searched for RCT/VES in two international databases (EMBASE and MEDLINE) and then manually. RCT/C were matched to RCT/VES for disease area and year of publication. The methodological quality of each RCT was assessed with Chalmers' scale. We identified 84 RCT/VES, 63 of which were conclusive and 21, inconclusive. Subjects were institutionalized in 48 RCT, and community dwelling in 11 RCT (unspecified in 25 RCT). Efficacy was the main criterion in 75 RCT; tolerance in 9 RCT. Twenty-six RCT were published by geriatrics journals, and 58 by general medical journals. The RCT/VES covered most of the disease areas of geriatrics. The 84 RCT/VES had a mean methodological quality score of 0.578 +/- 0.157. The matched 84 RCT/C had a mean methodological quality score of 0.592 +/- 0.116 (p = .466). The methodological quality score of RCT/VES increased with the number of included subjects (p = .004) and the year of publication (p = .001). The methodological quality of RCT/VES is equivalent to that of RCT in general adult populations. Nevertheless, RCT/VES remain very scarce, and neglect certain diseases. RCT/VES and the inclusion of very elderly subjects in RCT on adults should be strongly encouraged.

Randomized controlled resistance training based physical activity trial for central European nursing home residing older adults.

PubMed

Barthalos, Istvan; Dorgo, Sandor; Kopkáné Plachy, Judit; Szakály, Zsolt; Ihász, Ferenc; Ráczné Németh, Teodóra; Bognár, József

2016-10-01

Nursing home residing older adults often experience fear of sickness or death, functional impairment and pain. It is difficult for these older adults to maintain a physically active lifestyle and to keep a positive outlook on life. This study evaluated the changes in quality of life, attitude to aging, assertiveness, physical fitness and body composition of nursing home residing elderly through a 15-week organized resistance training based physical activity program. Inactive older adults living in a state financed nursing home (N.=45) were randomly divided into two intervention groups and a control group. Both intervention groups were assigned to two physical activity sessions a week, but one of these groups also had weekly discussions on health and quality of life (Mental group). Data on anthropometric measures, fitness performance, as well as quality of life and attitudes to aging survey data were collected. Due to low attendance rate 12 subjects were excluded from the analyses. Statistical analysis included Paired Samples t-tests and Repeated Measures Analysis of Variance. Both intervention groups significantly improved their social participation, and their upper- and lower-body strength scores. Also, subjects in the Mental group showed improvement in agility fitness test and certain survey scales. No positive changes were detected in attitude towards aging and body composition measures in any groups. The post-hoc results suggest that Mental group improved significantly more than the Control group. Regular physical activity with discussions on health and quality of life made a more meaningful difference for the older adults living in nursing home than physical activity alone. Due to the fact that all participants were influenced by the program, it is suggested to further explore this area for better understanding of enhanced quality of life.

Exergaming and older adult cognition: a cluster randomized clinical trial.

PubMed

Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

2012-02-01

Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Avatar-based depression self-management technology: promising approach to improve depressive symptoms among young adults.

PubMed

Pinto, Melissa D; Hickman, Ronald L; Clochesy, John; Buchner, Marc

2013-02-01

Major depressive disorder is prevalent among American young adults and predisposes young adults to serious impairments in psychosocial functioning. Without intervention, young adults with depressive symptoms are at high risk for worsening of depressive symptoms and developing major depressive disorder. Young adults are not routinely taught effective depression self management skills to reduce depressive symptoms and preempt future illness. This study reports initial results of a randomized controlled trial among young adults (18-25 years of age) with depressive symptoms who were exposed to an avatar-based depression self-management intervention, eSMART-MH. Participants completed self-report measures of depressive symptoms at baseline and at 4, 8, and 12 weeks follow-up. Participants who received eSMART-MH had a significant reduction in depressive symptoms over 3 months, while individuals in the attention-control condition had no change in symptoms. In this study, eSMART-MH demonstrated initial efficacy and is a promising developmentally appropriate depression self-management intervention for young adults. Copyright © 2013 Elsevier Inc. All rights reserved.

Viewing Our Aged Selves: Age Progression Simulations Increase Young Adults' Aging Anxiety and Negative Stereotypes of Older Adults.

PubMed

Rittenour, Christine E; Cohen, Elizabeth L

2016-04-01

This experiment tests the effect of an old-age progression simulation on young adults' (N = 139) reported aging anxiety and perceptions about older adults as a social group. College students were randomly assigned to one of three conditions: self-aged simulation, stranger-aged simulation, or a control group. Compared with the control group, groups exposed to an age progression experienced more negative affect, and individuals in the self-aged condition reported greater aging anxiety. In accordance with stereotype activation theorizing, the self-age simulation group also perceived older adults as less competent and expressed more pity and less envy for older adults. Compared to the stranger-aged group, participants who observed their own age progression were also the more likely to deny the authenticity of their transformed image.These findings highlight potential negative social and psychological consequences of using age simulations to affect positive health outcomes, and they shed light on how virtual experiences can affect stereotyping of older adults. © The Author(s) 2016.

Internet-Delivered Cognitive Behavioral Therapy to Treat Insomnia: A Systematic Review and Meta-Analysis.

PubMed

Seyffert, Michael; Lagisetty, Pooja; Landgraf, Jessica; Chopra, Vineet; Pfeiffer, Paul N; Conte, Marisa L; Rogers, Mary A M

2016-01-01

Insomnia is of major public health importance. While cognitive behavioral therapy is beneficial, in-person treatment is often unavailable. We assessed the effectiveness of internet-delivered cognitive behavioral therapy for insomnia. The primary objectives were to determine whether online cognitive behavioral therapy for insomnia could improve sleep efficiency and reduce the severity of insomnia in adults. Secondary outcomes included sleep quality, total sleep time, time in bed, sleep onset latency, wake time after sleep onset, and number of nocturnal awakenings. We searched PubMed/MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, PsycInfo, Cochrane Library, Embase, and the Web of Science for randomized trials. Studies were eligible if they were randomized controlled trials in adults that reported application of cognitive behavioral therapy for insomnia via internet delivery. Mean differences in improvement in sleep measures were calculated using the Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis. We found 15 trials, all utilizing a pretest-posttest randomized control group design. Sleep efficiency was 72% at baseline and improved by 7.2% (95% CI: 5.1%, 9.3%; p<0.001) with internet-delivered cognitive behavioral therapy versus control. Internet-delivered cognitive behavioral therapy resulted in a decrease in the insomnia severity index by 4.3 points (95% CI: -7.1, -1.5; p = 0.017) compared to control. Total sleep time averaged 5.7 hours at baseline and increased by 20 minutes with internet-delivered therapy versus control (95% CI: 9, 31; p = 0.004). The severity of depression decreased by 2.3 points (95% CI: -2.9, -1.7; p = 0.013) in individuals who received internet-delivered cognitive behavioral therapy compared to control. Improvements in sleep efficiency, the insomnia severity index and depression scores with internet-delivered cognitive behavioral therapy were maintained from 4 to 48 weeks after post-treatment assessment. There were no statistically significant differences between sleep efficiency, total sleep time, and insomnia severity index for internet-delivered versus in-person therapy with a trained therapist. In conclusion, internet-delivered cognitive behavioral therapy is effective in improving sleep in adults with insomnia. Efforts should be made to educate the public and expand access to this therapy. Registration Number, Prospero: CRD42015017622.

Internet-Delivered Cognitive Behavioral Therapy to Treat Insomnia: A Systematic Review and Meta-Analysis

PubMed Central

Seyffert, Michael; Lagisetty, Pooja; Landgraf, Jessica; Chopra, Vineet; Pfeiffer, Paul N.; Conte, Marisa L.; Rogers, Mary A. M.

2016-01-01

Background Insomnia is of major public health importance. While cognitive behavioral therapy is beneficial, in-person treatment is often unavailable. We assessed the effectiveness of internet-delivered cognitive behavioral therapy for insomnia. Objectives The primary objectives were to determine whether online cognitive behavioral therapy for insomnia could improve sleep efficiency and reduce the severity of insomnia in adults. Secondary outcomes included sleep quality, total sleep time, time in bed, sleep onset latency, wake time after sleep onset, and number of nocturnal awakenings. Data Sources We searched PubMed/MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, PsycInfo, Cochrane Library, Embase, and the Web of Science for randomized trials. Methods Studies were eligible if they were randomized controlled trials in adults that reported application of cognitive behavioral therapy for insomnia via internet delivery. Mean differences in improvement in sleep measures were calculated using the Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis. Results We found 15 trials, all utilizing a pretest-posttest randomized control group design. Sleep efficiency was 72% at baseline and improved by 7.2% (95% CI: 5.1%, 9.3%; p<0.001) with internet-delivered cognitive behavioral therapy versus control. Internet-delivered cognitive behavioral therapy resulted in a decrease in the insomnia severity index by 4.3 points (95% CI: -7.1, -1.5; p = 0.017) compared to control. Total sleep time averaged 5.7 hours at baseline and increased by 20 minutes with internet-delivered therapy versus control (95% CI: 9, 31; p = 0.004). The severity of depression decreased by 2.3 points (95% CI: -2.9, -1.7; p = 0.013) in individuals who received internet-delivered cognitive behavioral therapy compared to control. Improvements in sleep efficiency, the insomnia severity index and depression scores with internet-delivered cognitive behavioral therapy were maintained from 4 to 48 weeks after post-treatment assessment. There were no statistically significant differences between sleep efficiency, total sleep time, and insomnia severity index for internet-delivered versus in-person therapy with a trained therapist. Conclusion In conclusion, internet-delivered cognitive behavioral therapy is effective in improving sleep in adults with insomnia. Efforts should be made to educate the public and expand access to this therapy. Registration Number, Prospero: CRD42015017622 PMID:26867139

Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials

PubMed Central

Innes, Kim E.; Selfe, Terry Kit

2016-01-01

A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. PMID:26788520

Testing self-regulation interventions to increase walking using factorial randomized N-of-1 trials.

PubMed

Sniehotta, Falko F; Presseau, Justin; Hobbs, Nicola; Araújo-Soares, Vera

2012-11-01

To investigate the suitability of N-of-1 randomized controlled trials (RCTs) as a means of testing the effectiveness of behavior change techniques based on self-regulation theory (goal setting and self-monitoring) for promoting walking in healthy adult volunteers. A series of N-of-1 RCTs in 10 normal and overweight adults ages 19-67 (M = 36.9 years). We randomly allocated 60 days within each individual to text message-prompted daily goal-setting and/or self-monitoring interventions in accordance with a 2 (step-count goal prompt vs. alternative goal prompt) × 2 (self-monitoring: open vs. blinded Omron-HJ-113-E pedometer) factorial design. Aggregated data were analyzed using random intercept multilevel models. Single cases were analyzed individually. The primary outcome was daily pedometer step counts over 60 days. Single-case analyses showed that 4 participants significantly increased walking: 2 on self-monitoring days and 2 on goal-setting days, compared with control days. Six participants did not benefit from the interventions. In aggregated analyses, mean step counts were higher on goal-setting days (8,499.9 vs. 7,956.3) and on self-monitoring days (8,630.3 vs. 7,825.9). Multilevel analyses showed a significant effect of the self-monitoring condition (p = .01), the goal-setting condition approached significance (p = .08), and there was a small linear increase in walking over time (p = .03). N-of-1 randomized trials are a suitable means to test behavioral interventions in individual participants.

Mental Health Professionals and Behavioral Interventions for Obesity: A Systematic Literature Review.

PubMed

Prost, Stephanie Grace; Ai, Amy L; Ainsworth, Sarah E; Ayers, Jaime

2016-01-01

Adult obesity in the United States has risen to epidemic proportions, and mental health professionals must be called to action. The objectives of this article were to (a) synthesize outcomes of behavioral health interventions for adult obesity in recent meta-analyses and systematic reviews (MAs/SRs) as well as randomized controlled trials (RCTs) and further, (b) evaluate the role of mental health professionals in these behavioral health interventions. Articles were included if published in English between January 1, 2004, and May 1, 2014, in peer-reviewed journals examining behavioral health interventions for adults with obesity. Data were subsequently extracted and independently checked by two authors. Included MAs/SRs utilized motivational interviewing, financial incentives, multicomponent behavioral weight management programs, as well as dietary and lifestyle interventions. Behavioral health interventions in randomized controlled trials (RCTs) were discussed across 3 major intervention types (educational, modified caloric intake, cognitive-based). Regarding the 1st study objective, multiple positive primary (e.g., weight loss) and secondary outcomes (e.g., quality of life) were found in both MAs/SRs and RCTs. However, the majority of included studies made no mention of interventionist professional background and little inference could be made regarding the effects of professional background on behavioral health intervention outcomes for adults facing obesity; an important limitation and direction for future research. Future studies should assess the effects of interventionist profession in addition to primary and secondary outcomes for adults facing obesity. Implications for mental health professionals' educational curricula, assessment, and treatment strategies are discussed.

Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

PubMed Central

Ragni, Margaret V

2011-01-01

A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

Temporal trends in inflammatory bowel disease publications over a 19-years period.

PubMed

Weintraub, Yael; Mimouni, Francis B; Cohen, Shlomi

2014-11-28

To determine whether temporal changes occurred in the pediatric vs adult inflammatory bowel disease (IBD), both in terms of number and type of yearly published articles. We aimed to evaluate all PubMed-registered articles related to the field of IBD from January 1, 1993 and until December 31, 2011. We searched for articles using the key words "inflammatory bowel disease" or "Crohn's disease" or "ulcerative colitis" or "undetermined colitis", using the age filters of "child" or "adult". We repeated the search according to the total number per year of articles per type of article, for each year of the specified period. We studied randomized controlled trials, clinical trials, case reports, meta-analyses, letters to the editor, reviews, systematic reviews, practice guidelines, and editorials. We identified 44645 articles over the 19 year-period. There were 8687 pediatric-tagged articles vs 19750 adult-tagged articles. Thus 16208 articles were unaccounted and not assigned a "pediatric" or "adult" tag by PubMed. There was an approximately 3-fold significant increase in all articles recorded both in pediatric and adult articles. This significant increase was true for nearly every category of article but the number of clinical trials, meta-analysis, and randomized controlled trials increased proportionally more than the number of "lower quality" articles such as editorials or letters to the editor. Very few guidelines were published every year. There is a yearly linear increase in publications related to IBD. Relatively, there are more and more clinical trials and higher quality articles.

Randomized Controlled Trial Comparing Tailoring Methods of Multimedia-Based Fall Prevention Education for Community-Dwelling Older Adults

PubMed Central

Schepens, Stacey L.; Panzer, Victoria; Goldberg, Allon

2012-01-01

OBJECTIVE We attempted to determine whether multimedia fall prevention education using different instructional strategies increases older adults’ knowledge of fall threats and their fall prevention behaviors. METHOD Fifty-three community-dwelling older adults were randomized to two educational groups or a control group. Multimedia-based educational interventions to increase fall threats knowledge and encourage fall prevention behaviors had two tailoring strategies: (1) improve content realism for individual learners (authenticity group) and (2) highlight program goals and benefits while using participants’ content selections (motivation group). Knowledge was measured at baseline and 1-mo follow-up. Participants recorded prevention behaviors for 1 mo. RESULTS Intervention group participants showed greater knowledge gains and posttest knowledge than did control group participants. The motivation group engaged in more prevention behaviors over 1 mo than did the other groups. CONCLUSION Tailoring fall prevention education by addressing authenticity and motivation successfully improved fall threats knowledge. Combining motivational strategies with multimedia education increased the effectiveness of the intervention in encouraging fall prevention behaviors. PMID:22214115

Psychological, behavioral, and clinical effects of intra-oral camera: a randomized control trial on adults with gingivitis.

PubMed

Araújo, Mário-Rui; Alvarez, Maria-João; Godinho, Cristina A; Pereira, Cícero

2016-12-01

To evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral, and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework. A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control. Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy, and planning) and IOC opinion were evaluated 1 week before or during the appointment and 4 months later. Repeated-measures anova was used to compare groups over time. Almost all the patients brushed their teeth daily, while 78% either never or hardly ever used dental floss. The IOC group showed significant improvements in BOMP index (P < 0.001), self-reported flossing (P < 0.05), and self-efficacy (P < 0.05) compared to the control group. The use of IOC significantly improves clinical, behavioral, and psychological determinants of periodontal health 4 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Positive effects of resistant starch supplementation on bowel function in healthy adults: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Shen, Deqiang; Bai, Hao; Li, Zhaoping; Yu, Yue; Zhang, Huanhuan; Chen, Liyong

2017-03-01

Animal experimental studies have found that resistant starch can significantly improve bowel function, but the outcomes are mixed while conducting human studies. Thus, we conducted a systematic review and meta-analysis of randomized controlled trials to evaluate the relationship between resistant starch supplementation and large intestinal function. Three electronic databases (PubMed, Embase, Scopus) were searched to identify eligible studies. The standardized mean difference (SMD) or weighted mean difference (WMD) was calculated using a fixed-effects model or a random-effects model. The pooled findings revealed that resistant starch significantly increased fecal wet weight (WMD 35.51 g/d, 95% CI 1.21, 69.82) and butyrate concentration (SMD 0.61, 95% CI 0.32, 0.89). Also, it significantly reduced fecal PH (WMD -0.19, 95% CI -0.35, -0.03), but the increment of defecation frequency were not statistically significant (WMD 0.04stools/g, 95% CI -0.08, 0.16). To conclude, our study found that resistant starch elicited a beneficial effect on the function of large bowel in healthy adults.[Formula: see text].

Biofeedback therapy for dyssynergic defecation

PubMed Central

Chiarioni, Giuseppe; Heymen, Steve; Whitehead, William E

2006-01-01

Dyssynergic defecation is one of the most common forms of functional constipation both in children and adults; it is defined by incomplete evacuation of fecal material from the rectum due to paradoxical contraction or failure to relax pelvic floor muscles when straining to defecate. This is believed to be a behavioral disorder because there are no associated morphological or neurological abnormalities, and consequently biofeedback training has been recommended for treatment. Biofeedback involves the use of pressure measurements or averaged electromyographic activity within the anal canal to teach patients how to relax pelvic floor muscles when straining to defecate. This is often combined with teaching the patient more appropriate techniques for straining (increasing intra-abdominal pressure) and having the patient practice defecating a water filled balloon. In adults, randomized controlled trials show that this form of biofeedback is more effective than laxatives, general muscle relaxation exercises (described as sham biofeedback), and drugs to relax skeletal muscles. Moreover, its effectiveness is specific to patients who have dyssynergic defecation and not slow transit constipation. However, in children, no clear superiority for biofeedback compared to laxatives has been demonstrated. Based on three randomized controlled studies in the last two years, biofeedback appears to be the preferred treatment for dyssynergic defecation in adults. PMID:17131466

Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies

PubMed Central

Wayne, Peter M.; Gow, Brian J.; Costa, Madalena D.; Peng, C.-K.; Lipsitz, Lewis A.; Hausdorff, Jeffrey M.; Davis, Roger B.; Walsh, Jacquelyn N.; Lough, Matthew; Novak, Vera; Yeh, Gloria Y.; Ahn, Andrew C.; Macklin, Eric A.; Manor, Brad

2014-01-01

Background Diminished control of standing balance, traditionally indicated by greater postural sway magnitude and speed, is associated with falls in older adults. Tai Chi (TC) is a multisystem intervention that reduces fall risk, yet its impact on sway measures vary considerably. We hypothesized that TC improves the integrated function of multiple control systems influencing balance, quantifiable by the multi-scale “complexity” of postural sway fluctuations. Objectives To evaluate both traditional and complexity-based measures of sway to characterize the short- and potential long-term effects of TC training on postural control and the relationships between sway measures and physical function in healthy older adults. Methods A cross-sectional comparison of standing postural sway in healthy TC-naïve and TC-expert (24.5±12 yrs experience) adults. TC-naïve participants then completed a 6-month, two-arm, wait-list randomized clinical trial of TC training. Postural sway was assessed before and after the training during standing on a force-plate with eyes-open (EO) and eyes-closed (EC). Anterior-posterior (AP) and medio-lateral (ML) sway speed, magnitude, and complexity (quantified by multiscale entropy) were calculated. Single-legged standing time and Timed-Up–and-Go tests characterized physical function. Results At baseline, compared to TC-naïve adults (n = 60, age 64.5±7.5 yrs), TC-experts (n = 27, age 62.8±7.5 yrs) exhibited greater complexity of sway in the AP EC (P = 0.023), ML EO (P<0.001), and ML EC (P<0.001) conditions. Traditional measures of sway speed and magnitude were not significantly lower among TC-experts. Intention-to-treat analyses indicated no significant effects of short-term TC training; however, increases in AP EC and ML EC complexity amongst those randomized to TC were positively correlated with practice hours (P = 0.044, P = 0.018). Long- and short-term TC training were positively associated with physical function. Conclusion Multiscale entropy offers a complementary approach to traditional COP measures for characterizing sway during quiet standing, and may be more sensitive to the effects of TC in healthy adults. Trial Registration ClinicalTrials.gov NCT01340365 PMID:25494333

Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies.

PubMed

Wayne, Peter M; Gow, Brian J; Costa, Madalena D; Peng, C-K; Lipsitz, Lewis A; Hausdorff, Jeffrey M; Davis, Roger B; Walsh, Jacquelyn N; Lough, Matthew; Novak, Vera; Yeh, Gloria Y; Ahn, Andrew C; Macklin, Eric A; Manor, Brad

2014-01-01

Diminished control of standing balance, traditionally indicated by greater postural sway magnitude and speed, is associated with falls in older adults. Tai Chi (TC) is a multisystem intervention that reduces fall risk, yet its impact on sway measures vary considerably. We hypothesized that TC improves the integrated function of multiple control systems influencing balance, quantifiable by the multi-scale "complexity" of postural sway fluctuations. To evaluate both traditional and complexity-based measures of sway to characterize the short- and potential long-term effects of TC training on postural control and the relationships between sway measures and physical function in healthy older adults. A cross-sectional comparison of standing postural sway in healthy TC-naïve and TC-expert (24.5±12 yrs experience) adults. TC-naïve participants then completed a 6-month, two-arm, wait-list randomized clinical trial of TC training. Postural sway was assessed before and after the training during standing on a force-plate with eyes-open (EO) and eyes-closed (EC). Anterior-posterior (AP) and medio-lateral (ML) sway speed, magnitude, and complexity (quantified by multiscale entropy) were calculated. Single-legged standing time and Timed-Up-and-Go tests characterized physical function. At baseline, compared to TC-naïve adults (n = 60, age 64.5±7.5 yrs), TC-experts (n = 27, age 62.8±7.5 yrs) exhibited greater complexity of sway in the AP EC (P = 0.023), ML EO (P<0.001), and ML EC (P<0.001) conditions. Traditional measures of sway speed and magnitude were not significantly lower among TC-experts. Intention-to-treat analyses indicated no significant effects of short-term TC training; however, increases in AP EC and ML EC complexity amongst those randomized to TC were positively correlated with practice hours (P = 0.044, P = 0.018). Long- and short-term TC training were positively associated with physical function. Multiscale entropy offers a complementary approach to traditional COP measures for characterizing sway during quiet standing, and may be more sensitive to the effects of TC in healthy adults. ClinicalTrials.gov NCT01340365.

Varied overground walking training versus body-weight-supported treadmill training in adults within 1 year of stroke: a randomized controlled trial.

PubMed

DePaul, Vincent G; Wishart, Laurie R; Richardson, Julie; Thabane, Lehana; Ma, Jinhui; Lee, Timothy D

2015-05-01

Although task-related walking training has been recommended after stroke, the theoretical basis, content, and impact of interventions vary across the literature. There is a need for a comparison of different approaches to task-related walking training after stroke. To compare the impact of a motor-learning-science-based overground walking training program with body-weight-supported treadmill training (BWSTT) in ambulatory, community-dwelling adults within 1 year of stroke onset. In this rater-blinded, 1:1 parallel, randomized controlled trial, participants were stratified by baseline gait speed. Participants assigned to the Motor Learning Walking Program (MLWP) practiced various overground walking tasks under the supervision of 1 physiotherapist. Cognitive effort was encouraged through random practice and limited provision of feedback and guidance. The BWSTT program emphasized repetition of the normal gait cycle while supported on a treadmill and assisted by 1 to 3 therapy staff. The primary outcome was comfortable gait speed at postintervention assessment (T2). In total, 71 individuals (mean age = 67.3; standard deviation = 11.6 years) with stroke (mean onset = 20.9 [14.1] weeks) were randomized (MLWP, n = 35; BWSTT, n = 36). There was no significant between-group difference in gait speed at T2 (0.002 m/s; 95% confidence interval [CI] = -0.11, 0.12; P > .05). The MLWP group improved by 0.14 m/s (95% CI = 0.09, 0.19), and the BWSTT group improved by 0.14 m/s (95% CI = 0.08, 0.20). In this sample of community-dwelling adults within 1 year of stroke, a 15-session program of varied overground walking-focused training was not superior to a BWSTT program of equal frequency, duration, and in-session step activity. © The Author(s) 2014.

EFFECTS OF A DIETARY SUPPLEMENT ON THE INCIDENCE OF ACUTE RESPIRATORY INFECTIONS IN SUSCEPTIBLE ADULTS: A RANDOMIZED CONTROLLED TRIAL.

PubMed

Bernal-Orozco, María Fernanda; Posada-Falomir, Margarita; Ortega-Orozco, Rafael; Silva-Villanueva, Elvia Elaonor; Macedo-Ojeda, Gabriela; Márquez-Sandoval, Yolanda Fabiola; Vizmanos-Lamotte, Barbara

2015-08-01

although supplementation of specific micronutrients may improve immunologic factors, few studies about the combination of micronutrients with plant extracts on the occurrence of acute respiratory infections (ARI) have been published. to assess the effect of a nutritional supplement with micronutrients and plant extracts on the incidence of ARI in susceptible adults between January and April, 2012. a randomized, double-blind, parallel, placebo- controlled clinical trial was performed. Participants were adults susceptible to ARI who were healthy at the time of evaluation, signed informed consent forms and were not taking medication. They completed a medical history; weight, height, vital signs and laboratory analyses were assessed. Subjects were randomly assigned for consumption of the supplement or a placebo, for a 90 days period. Subjects made daily diary entries indicating the presence ARI symptoms. Those who became ill notified researchers and the attending physician confirmed the presence of an infection. Fisher's exact test was used to compare the proportion of ill subjects between groups. Relative risk and risk difference were also calculated (p < 0.05 significant). of 59 included subjects, 45 (25 women) completed the study (21 in the supplemented group and 24 in the placebo group). There were no significant differences at baseline between groups. After the intervention, the supplemented group had a lower incidence of ARI compared with the placebo group (57.1% vs. 91.7%, p = 0.013, RR = 0.62, 95%CI 0.42, 0.92). the consumption of a supplement with vitamins, minerals and plant extracts may decrease the incidence of ARI in susceptible adults. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Vitamin D supplementation reduces insulin resistance in Japanese adults: a secondary analysis of a double-blind, randomized, placebo-controlled trial.

PubMed

Sun, Xiaomin; Cao, Zhen-Bo; Tanisawa, Kumpei; Ito, Tomoko; Oshima, Satomi; Higuchi, Mitsuru

2016-10-01

Higher circulating 25-hydroxyvitamin D (25[OH]D) concentration has been linked to a lower prevalence of insulin resistance and type 2 diabetes mellitus. However, randomized controlled trials have not clarified the effect of vitamin D supplementation on insulin resistance in healthy adults. The objective of this study was to assess the effect of vitamin D supplementation for 1 year on insulin resistance; the study was a secondary analysis of a clinical trial. We hypothesized that increased 25(OH)D concentration after vitamin D supplementation for 1 year would significantly improve insulin resistance. Ninety-six healthy adults participated in this study, of whom 81 completed the study. The participants randomly received daily either 420 IU vitamin D 3 or placebo in a double-blind manner for 1 year. The levels of fasting insulin, glucose, and other parameters were assessed at baseline and after 1 year of intervention. Homeostasis model assessment of insulin resistance index was calculated from insulin and glucose levels. Visceral fat area and physical activity were also investigated. Serum 25(OH)D and 1,25-dihydroxyvitamin D concentrations were significantly increased by approximately 29.5 nmol/L and 7.0 pg/mL, respectively, after 1-year vitamin D supplementation. After vitamin D supplementation, fasting glucose levels and values of homeostasis model assessment of insulin resistance index significantly decreased from 88.3 to 85.3 mg/dL (P < .01) and 1.17 to 0.84 (P < .01), respectively, and the results were independent of physical activity and visceral fat accumulation. In conclusion, the present study showed that vitamin D supplementation for 1 year effectively improves fasting glucose level and insulin resistance in healthy Japanese adults. Copyright © 2016 Elsevier Inc. All rights reserved.

Booster influenza vaccination does not improve immune response in adult inflammatory bowel disease patients treated with immunosuppressives: a randomized controlled trial.

PubMed

Matsumoto, Hiroko; Ohfuji, Satoko; Watanabe, Kenji; Yamagami, Hirokazu; Fukushima, Wakaba; Maeda, Kazuhiro; Kamata, Noriko; Sogawa, Mitsue; Shiba, Masatsugu; Tanigawa, Tetsuya; Tominaga, Kazunari; Watanabe, Toshio; Fujiwara, Yasuhiro; Hirota, Yoshio; Arakawa, Tetsuo

2015-08-01

This research was conducted is to assess the effect of booster doses of the trivalent influenza vaccine in adult inflammatory bowel disease (IBD) patients treated with anti-tumor necrosis factor (TNF)-α agents and/or immunomodulators. Adult IBD patients and healthy individuals were subcutaneously administered the trivalent influenza vaccine. They were randomized into two groups: the single vaccination group and the two vaccination booster group. Blood samples were collected, and the antibody titers against each influenza strain were determined by hemagglutination inhibition at 3 different time points (pre-vaccination, 3 weeks post-vaccination, and after the flu season) in the single vaccination group and at 4 time points (pre-vaccination, 3 weeks post-first vaccination, 3 weeks post-second vaccination, and after the flu season) in the booster vaccination group. Seventy-eight IBD patients and 11 healthy controls were randomized into the single vaccination group and the booster vaccination group. Twenty-nine patients received immunomodulators; 21 received anti-TNF-α agents; and 28 received a combination of both. No significant differences were observed in the evaluated immune response parameters between 3 weeks post-vaccination in the single vaccination group and 3 weeks post-second vaccination in the booster vaccination group (geometric mean titers: H1N1, p = 0.09; H3N2: p = 0.99; B: p = 0.94). A higher pre-vaccination titer was significantly associated with sufficient seroprotection rate after vaccination for the H1N1 strain (odds ratio 11.93, p = 0.03). The second booster of trivalent influenza vaccination did not improve the immune response in adult IBD patients who were treated with immunomodulators and/or anti-TNF-α agents.

Atomoxetine could improve intra-individual variability in drug-naïve adults with attention-deficit/hyperactivity disorder comparably with methylphenidate: A head-to-head randomized clinical trial.

PubMed

Ni, Hsing-Chang; Hwang Gu, Shoou-Lian; Lin, Hsiang-Yuan; Lin, Yu-Ju; Yang, Li-Kuang; Huang, Hui-Chun; Gau, Susan Shur-Fen

2016-05-01

Intra-individual variability in reaction time (IIV-RT) is common in individuals with attention-deficit/hyperactivity disorder (ADHD). It can be improved by stimulants. However, the effects of atomoxetine on IIV-RT are inconclusive. We aimed to investigate the effects of atomoxetine on IIV-RT, and directly compared its efficacy with methylphenidate in adults with ADHD. An 8-10 week, open-label, head-to-head, randomized clinical trial was conducted in 52 drug-naïve adults with ADHD, who were randomly assigned to two treatment groups: immediate-release methylphenidate (n=26) thrice daily (10-20 mg per dose) and atomoxetine once daily (n=26) (0.5-1.2 mg/kg/day). IIV-RT, derived from the Conners' continuous performance test (CCPT), was represented by the Gaussian (reaction time standard error, RTSE) and ex-Gaussian models (sigma and tau). Other neuropsychological functions, including response errors and mean of reaction time, were also measured. Participants received CCPT assessments at baseline and week 8-10 (60.4±6.3 days). We found comparable improvements in performances of CCPT between the immediate-release methylphenidate- and atomoxetine-treated groups. Both medications significantly improved IIV-RT in terms of reducing tau values with comparable efficacy. In addition, both medications significantly improved inhibitory control by reducing commission errors. Our results provide evidence to support that atomoxetine could improve IIV-RT and inhibitory control, of comparable efficacy with immediate-release methylphenidate, in drug-naïve adults with ADHD. Shared and unique mechanisms underpinning these medication effects on IIV-RT awaits further investigation. © The Author(s) 2016.

A randomized controlled trial to evaluate the feasibility of the Wii Fit for improving walking in older adults with lower limb amputation.

PubMed

Imam, Bita; Miller, William C; Finlayson, Heather; Eng, Janice J; Jarus, Tal

2017-01-01

To assess the feasibility of Wii.n.Walk for improving walking capacity in older adults with lower limb amputation. A parallel, evaluator-blind randomized controlled feasibility trial. Community-living. Individuals who were ⩾50 years old with a unilateral lower limb amputation. Wii.n.Walk consisted of Wii Fit training, 3x/week (40 minute sessions), for 4 weeks. Training started in the clinic in groups of 3 and graduated to unsupervised home training. Control group were trained using cognitive games. Feasibility indicators: trial process (recruitment, retention, participants' perceived benefit from the Wii.n.Walk intervention measured by exit questionnaire), resources (adherence), management (participant processing, blinding), and treatment (adverse event, and Cohen's d effect size and variance). Primary clinical outcome: walking capacity measured using the 2 Minute Walk Test at baseline, end of treatment, and 3-week retention. Of 28 randomized participants, 24 completed the trial (12/arm). Median (range) age was 62.0 (50-78) years. Mean (SD) score for perceived benefit from the Wii.n.Walk intervention was 38.9/45 (6.8). Adherence was 83.4%. The effect sizes for the 2 Minute Walk Test were 0.5 (end of treatment) and 0.6 (3-week retention) based on intention to treat with imputed data; and 0.9 (end of treatment) and 1.2 (3-week retention) based on per protocol analysis. The required sample size for a future larger RCT was deemed to be 72 (36 per arm). The results suggested the feasibility of the Wii.n.Walk with a medium effect size for improving walking capacity. Future larger randomized controlled trials investigating efficacy are warranted.

Impact of oral care with versus without toothbrushing on the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

2012-01-01

Introduction Ventilator-associated pneumonia (VAP) remains a common hazardous complication in mechanically ventilated patients and is associated with increased morbidity and mortality. We undertook a systematic review and meta-analysis of randomized controlled trials to assess the effect of toothbrushing as a component of oral care on the prevention of VAP in adult critically ill patients. Methods A systematic literature search of PubMed and Embase (up to April 2012) was conducted. Eligible studies were randomized controlled trials of mechanically ventilated adult patients receiving oral care with toothbrushing. Relative risks (RRs), weighted mean differences (WMDs), and 95% confidence intervals (CIs) were calculated and heterogeneity was assessed with the I2 test. Results Four studies with a total of 828 patients met the inclusion criteria. Toothbrushing did not significantly reduce the incidence of VAP (RR, 0.77; 95% CI, 0.50 to 1.21) and intensive care unit mortality (RR, 0.88; 95% CI, 0.70 to 1.10). Toothbrushing was not associated with a statistically significant reduction in duration of mechanical ventilation (WMD, -0.88 days; 95% CI, -2.58 to 0.82), length of intensive care unit stay (WMD, -1.48 days; 95% CI, -3.40 to 0.45), antibiotic-free day (WMD, -0.52 days; 95% CI, -2.82 to 1.79), or mechanical ventilation-free day (WMD, -0.43 days; 95% CI, -1.23 to 0.36). Conclusions Oral care with toothbrushing versus without toothbrushing does not significantly reduce the incidence of VAP and alter other important clinical outcomes in mechanically ventilated patients. However, the results should be interpreted cautiously since relevant evidence is still limited, although accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed. PMID:23062250

The Development of the Control of Adult Instructions Over Non-Verbal Behavior.

ERIC Educational Resources Information Center

Van Duyne, H. John

The purpose of the study was (1) to examine the results from a two-association perceptual-motor task as to their implications for Luria's theory about the development of verbal control of non-verbal behavior; (2) to explore the effects of various learning experiences upon this development. The sample consisted of 20 randomly selected children in…

A Meta-Analysis of Depressive Symptom Outcomes in Randomized, Controlled Trials for PTSD.

PubMed

Ronconi, Julia McDougal; Shiner, Brian; Watts, Bradley V

2015-07-01

Posttraumatic stress disorder (PTSD) often co-occurs with depression. Current PTSD practice guidelines lack specific guidance for clinicians regarding the treatment of depressive symptoms. We conducted a meta-analysis of all randomized, placebo-controlled trials for PTSD therapies focusing on depression outcomes to inform clinicians about effective treatment options for depressive symptoms associated with PTSD. We searched literature databases for randomized, controlled clinical trials of any treatment for PTSD published between 1980 and 2013. We selected articles in which all subjects were adults with a diagnosis of PTSD based on the Diagnostic and Statistical Manual of Mental Disorders criteria, and valid PTSD and depressive symptom measures were reported. The sample consisted of 116 treatment comparisons drawn from 93 manuscripts. Evidence-based PTSD treatments are effective for comorbid depressive symptoms. Existing PTSD treatments work as well for comorbid depressive symptoms as they do for PTSD symptoms.

Randomized controlled trial of expressive writing for psychological and physical health: the moderating role of emotional expressivity.

PubMed

Niles, Andrea N; Haltom, Kate E Byrne; Mulvenna, Catherine M; Lieberman, Matthew D; Stanton, Annette L

2014-01-01

The current study assessed main effects and moderators (including emotional expressiveness, emotional processing, and ambivalence over emotional expression) of the effects of expressive writing in a sample of healthy adults. Young adult participants (N=116) were randomly assigned to write for 20 minutes on four occasions about deepest thoughts and feelings regarding their most stressful/traumatic event in the past five years (expressive writing) or about a control topic (control). Dependent variables were indicators of anxiety, depression, and physical symptoms. No significant effects of writing condition were evident on anxiety, depressive symptoms, or physical symptoms. Emotional expressiveness emerged as a significant moderator of anxiety outcomes, however. Within the expressive writing group, participants high in expressiveness evidenced a significant reduction in anxiety at three-month follow-up, and participants low in expressiveness showed a significant increase in anxiety. Expressiveness did not predict change in anxiety in the control group. These findings on anxiety are consistent with the matching hypothesis, which suggests that matching a person's naturally elected coping approach with an assigned intervention is beneficial. These findings also suggest that expressive writing about a stressful event may be contraindicated for individuals who do not typically express emotions.

Feasibility, acceptability, and preliminary effectiveness of patient advocates for improving adult asthma outcomes

PubMed Central

Apter, Andrea J.; Wan, Fei; Reisine, Susan; Bogen, Daniel K.; Rand, Cynthia; Bender, Bruce; Bennett, Ian M.; Gonzalez, Rodalyn; Priolo, Chantel; Sonnad, Seema S.; Bryant-Stephens, Tyra; Ferguson, Monica; Boyd, Rhonda C.; Have, Thomas Ten; Roy, Jason

2014-01-01

Background Asthmatic adults from low-income urban neighborhoods have inferior health outcomes which in part may be due to barriers accessing care and with patient-provider communication. We adapted a patient advocate (PA) intervention to overcome these barriers. Objective To conduct a pilot study to assess feasibility, acceptability, and preliminary evidence of effectiveness. Methods A prospective randomized design was employed with mixed methods evaluation. Adults with moderate or severe asthma were randomized to 16 weeks of PA or a minimal intervention (MI) comparison condition. The PA, a nonprofessional, modeled preparations for a medical visit, attended the visit, and confirmed understanding. The PA facilitated scheduling, obtaining insurance coverage, and overcoming barriers to implementing medical advice. Outcomes included electronically-monitored inhaled corticosteroid adherence, asthma control, quality of life, FEV1, ED visits, and hospitalizations. Mixed-effects models guided an intention-to-treat analysis. Results 100 adults participated: age 47±14 years, 75% female, 71% African American, 16% white, baseline FEV1 69% ± 18%, 36% experiencing hospitalizations and 56% ED visits for asthma in the prior year. Ninety-three subjects completed all visits; 36 of 53 PA-assigned had a PA visit. Adherence declined significantly in the control (p= 0.001) but not significantly in the PA group (p=.30). Both PA and MI groups demonstrated improved asthma control (p=0.01 in both) and quality of life (p=0.001, p=0.004). Hospitalizations and ED visits for asthma did not differ between groups. The observed changes over time tended to favor the PA group, but this study was underpowered to detect differences between groups. Conclusion The PA intervention was feasible and acceptable and demonstrated potential for improving asthma control and quality of life. PMID:23800333

Web-based Intervention to Promote Physical Activity by Sedentary Older Adults: Randomized Controlled Trial

PubMed Central

Gelatt, Vicky A; Seeley, John R; Macfarlane, Pamela; Gau, Jeff M

2013-01-01

Background Physical activity (PA) for older adults has well-documented physical and cognitive benefits, but most seniors do not meet recommended guidelines for PA, and interventions are lacking. Objectives This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen. Methods A total of 368 sedentary men and women (M=60.3; SD 4.9) were recruited, screened, and assessed online. They were randomized into treatment and control groups and assessed at pretest, at 12 weeks, and at 6 months. After treatment group participants rated their fitness level, activity goals, and barriers to exercise, the Internet intervention program helped them select exercise activities in the areas of endurance, flexibility, strengthening, and balance enhancement. They returned to the program weekly for automated video and text support and education, with the option to change or increase their exercise plan. The program also included ongoing problem solving to overcome user-identified barriers to exercise. Results The multivariate model indicated significant treatment effects at posttest (P=.001; large effect size) and at 6 months (P=.001; medium effect size). At posttest, intervention participation showed significant improvement on 13 of 14 outcome measures compared to the control participants. At 6 months, treatment participants maintained large gains compared to the control participants on all 14 outcome measures. Conclusions These results suggest that an online PA program has the potential to positively impact the physical activity of sedentary older adult participants. More research is needed to replicate the study results, which were based on self-report measures. Research is also needed on intervention effects with older populations. PMID:23470322

Balance training with multi-task exercises improves fall-related self-efficacy, gait, balance performance and physical function in older adults with osteoporosis: a randomized controlled trial.

PubMed

Halvarsson, Alexandra; Franzén, Erika; Ståhle, Agneta

2015-04-01

To evaluate the effects of a balance training program including dual- and multi-task exercises on fall-related self-efficacy, fear of falling, gait and balance performance, and physical function in older adults with osteoporosis with an increased risk of falling and to evaluate whether additional physical activity would further improve the effects. Randomized controlled trial, including three groups: two intervention groups (Training, or Training+Physical activity) and one Control group, with a 12-week follow-up. Stockholm County, Sweden. Ninety-six older adults, aged 66-87, with verified osteoporosis. A specific and progressive balance training program including dual- and multi-task three times/week for 12 weeks, and physical activity for 30 minutes, three times/week. Fall-related self-efficacy (Falls Efficacy Scale-International), fear of falling (single-item question - 'In general, are you afraid of falling?'), gait speed with and without a cognitive dual-task at preferred pace and fast walking (GAITRite®), balance performance tests (one-leg stance, and modified figure of eight), and physical function (Late-Life Function and Disability Instrument). Both intervention groups significantly improved their fall-related self-efficacy as compared to the controls (p ≤ 0.034, 4 points) and improved their balance performance. Significant differences over time and between groups in favour of the intervention groups were found for walking speed with a dual-task (p=0.003), at fast walking speed (p=0.008), and for advanced lower extremity physical function (p=0.034). This balance training program, including dual- and multi-task, improves fall-related self-efficacy, gait speed, balance performance, and physical function in older adults with osteoporosis. © The Author(s) 2014.

The effect of interference on temporal order memory for random and fixed sequences in nondemented older adults.

PubMed

Tolentino, Jerlyn C; Pirogovsky, Eva; Luu, Trinh; Toner, Chelsea K; Gilbert, Paul E

2012-05-21

Two experiments tested the effect of temporal interference on order memory for fixed and random sequences in young adults and nondemented older adults. The results demonstrate that temporal order memory for fixed and random sequences is impaired in nondemented older adults, particularly when temporal interference is high. However, temporal order memory for fixed sequences is comparable between older adults and young adults when temporal interference is minimized. The results suggest that temporal order memory is less efficient and more susceptible to interference in older adults, possibly due to impaired temporal pattern separation.

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.

PubMed

Tingey, Lauren; Chambers, Rachel; Goklish, Novalene; Larzelere, Francene; Lee, Angelita; Suttle, Rosemarie; Rosenstock, Summer; Lake, Kristin; Barlow, Allison

2017-02-27

American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens. The proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants. Currently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents. Clinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.

Omega-3 Fatty Acid and Nutrient Deficits in Adverse Neurodevelopment and Childhood Behaviors

PubMed Central

Hibbeln, Joseph. R.; Gow, Rachel V.

2014-01-01

Synopsis Nutritional insufficiencies of omega-3 highly unsaturated fatty acids (HUFAs) may have adverse effects on brain development and neurodevelopmental outcomes. A recent meta-analysis of ten randomized controlled trials of omega-3 HUFAs reported a small to modest effect size for the efficacy of omega-3 for treating symptoms of ADHD in youth. Several controlled trials of omega-3 HUFAs combined with micronutrients (vitamins, minerals) show sizeable reductions in aggressive, antisocial, and violent behavior in youth and in young adult prisoners. Meta-analyses report efficacy for depressive symptoms in adults, and preliminary findings suggest anti-suicidal properties in adults, but studies in youth are insufficient to draw any conclusions regarding mood. Dietary adjustments to increase omega-3 and reduce omega-6 HUFA consumption are sensible recommendations for youth and adults based on general health considerations, while the evidence base for omega-3 HUFAs as potential psychiatric treatments develops. PMID:24975625

The effect of aquatic exercise and education on lowering fall risk in older adults with hip osteoarthritis.

PubMed

Arnold, Cathy M; Faulkner, Robert A

2010-07-01

To evaluate the effect of aquatic exercise and education on fall risk factors in older adults with hip osteoarthritis (OA). Seventy-nine adults, 65 years of age or older with hip OA and at least 1 fall risk factor, were randomly assigned to 1 of 3 groups: aquatics and education (AE; aquatic exercise twice a wk with once-a-wk group education), aquatics only (A; 2 wk aquatic exercise) and control (C; usual activity). Balance, falls efficacy, dual-task function, functional performance (chair stands), and walking performance were measured pre- and postintervention or control period. There was a significant improvement in fall risk factors (full-factorial MANCOVA, baseline values as covariates; p = .038); AE improved in falls efficacy compared with C and in functional performance compared with A and C. The combination of aquatic exercise and education was effective in improving fall risk factors in older adults with arthritis.

Brief Report: Vocational Outcomes for Young Adults with Autism Spectrum Disorders at Six Months After Virtual Reality Job Interview Training

PubMed Central

Fleming, Michael F.; Wright, Michael A.; Losh, Molly; Boteler Humm, Laura; Olsen, Dale; Bell, Morris D.

2016-01-01

Young adults with high-functioning autism spectrum disorder (ASD) have low employment rates and job interviewing presents a critical barrier to employment for them. Results from a prior randomized controlled efficacy trial suggested virtual reality job interview training (VR-JIT) improved interviewing skills among trainees with ASD, but not controls with ASD. We conducted a brief survey with 23 of 26 participants from this study to evaluate their vocational outcomes at 6-month follow-up with a focus on whether or not they attained a competitive position (employment or competitive volunteering). Logistic regression indicated VR-JIT trainees had greater odds of attaining a competitive position than controls (OR 7.82, p < 0.05). Initial evidence suggests VR-JIT is a promising intervention that enhances vocational outcomes among young adults with high-functioning ASD. PMID:25986176

Brief report: vocational outcomes for young adults with autism spectrum disorders at six months after virtual reality job interview training.

PubMed

Smith, Matthew J; Fleming, Michael F; Wright, Michael A; Losh, Molly; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D

2015-10-01

Young adults with high-functioning autism spectrum disorder (ASD) have low employment rates and job interviewing presents a critical barrier to employment for them. Results from a prior randomized controlled efficacy trial suggested virtual reality job interview training (VR-JIT) improved interviewing skills among trainees with ASD, but not controls with ASD. We conducted a brief survey with 23 of 26 participants from this study to evaluate their vocational outcomes at 6-month follow-up with a focus on whether or not they attained a competitive position (employment or competitive volunteering). Logistic regression indicated VR-JIT trainees had greater odds of attaining a competitive position than controls (OR 7.82, p < 0.05). Initial evidence suggests VR-JIT is a promising intervention that enhances vocational outcomes among young adults with high-functioning ASD.

Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

PubMed Central

Haas, Marilyn C.; Bodner, Eric V.; Brown, Cynthia J.; Bryan, David; Buys, David R.; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S.; Roth, David L.; Wingo, Brooks C.; Ard, Jamy; Locher, Julie L.

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling, obese, older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue (VAT)), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article. PMID:25424512

Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

PubMed

Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

Shamba Maisha: Randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes in Kenya

PubMed Central

WEISER, Sheri D.; BUKUSI, Elizabeth A.; STEINFELD, Rachel L.; FRONGILLO, Edward A.; WEKE, Elly; DWORKIN, Shari L.; PUSATERI, Kyle; SHIBOSKI, Stephen; SCOW, Kate; BUTLER, Lisa M.; COHEN, Craig R.

2015-01-01

Objectives Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. Design Pilot cluster randomized controlled trial Methods The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for one year. Data were collected on nutritional parameters, CD4 T lymphocyte counts, and HIV RNA. Difference in difference fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. Results We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/mm3, p<0.001) and proportion virologically suppressed in the intervention arm compared to the control arm (comparative improvement in proportion of 0.33 suppressed, OR 7.6, 95% CI: 2.2–26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, p<0.001) and frequency of food consumption (9.4 times per week greater frequency, p=0.013) compared to controls. Conclusion Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity. PMID:26214684

Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

PubMed

Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R

2015-09-10

Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P < 0.001) and proportion virologically suppressed in the intervention arm compared with the control arm (comparative improvement in proportion of 0.33 suppressed, odds ratio 7.6, 95% confidence interval: 2.2-26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

Panax ginseng and Salvia miltiorrhiza supplementation during eccentric resistance training in middle-aged and older adults: A double-blind randomized control trial.

PubMed

Lin, Hsin-Fu; Chou, Chun-Chung; Chao, Hsiao-Han; Tanaka, Hirofumi

2016-12-01

Muscle damage induced by an acute bout of eccentric exercise results in transient arterial stiffening. In this study, we sought to determine the effects of progressive eccentric resistance exercise training on vascular functions, and whether herb supplementation would enhance training adaptation by ameliorating the arterial stiffening effects. By using a double-blinded randomized placebo-controlled design, older adults were randomly assigned to either the Panax ginseng and Salvia miltiorrhiza supplementation group (N=12) or the placebo group (N=11). After pre-training testing, all subjects underwent 12 weeks of unilateral eccentric-only exercise training on knee extensor. Maximal leg strength and muscle quality increased in both groups (P<0.05). Relative increases in muscle mass were significantly greater in the placebo group than in the herb supplement group. Eccentric exercise training did not elicit any significant changes in muscle damage, oxidative and inflammatory biomarkers. There were no significant changes in blood pressure or endothelium-dependent vasodilation. None of the measures of arterial stiffness changed significantly with eccentric resistance training in both groups. These results suggest that Chinese herb supplementation does not appear to modulate vascular, and inflammatory adaptations to eccentric exercise training in middle-aged and older adults. However, Chinese herb supplementation abolished the increase in muscle mass induced by eccentric resistance training. (Trial registration: ClinicalTrials.gov: NCT02007304. Registered Dec. 5, 2013). Copyright © 2016 Elsevier Ltd. All rights reserved.

Time course of upper limb function and return-to-work post-radiotherapy in young adults with breast cancer: a pilot randomized control trial on effects of targeted exercise program.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2017-12-01

Breast cancer (BC) diagnosis in young adults (YA) is rising, and both disease and treatments are aggressive in this population. Evidence supports the use of physical activity in reducing shoulder dysfunction, which is common among BC survivors. A pilot randomized clinical trial was performed to determine the effectiveness of a 12-week post-radiation exercise program in minimizing upper extremity dysfunction in YA with BC. Participants were randomized to either an exercise arm or a control arm receiving standard care. Data was collected over six time points using: the Disability of Arm, Shoulder, and Hand (DASH); the Metabolic Equivalent of Task-hours per week (MET-hours/week), and a post hoc questionnaire on return to work. In total, 59 young women participated in the study (n = 29 exercise; n = 30 control). No statistically significant differences were found in overall DASH results between groups; however, those who underwent total mastectomy had residual upper limb dysfunction (p < 0.05). Both groups returned to pre-diagnosis activity levels by 18 months. Final evaluation showed that 86% of the women returned to work, and 89% resumed prior work activities with a decrease of 8.5 h/week. Although the short-term targeted exercise program had no effect on long-term upper limb function post-radiation, timing and program specificity may require consideration of tissue healing post-radiation and surgery type. The majority of participants returned to work, however not returning to pre-diagnosis work hours. Exercise interventions alone may not reverse the long-term sequelae of breast cancer treatment and allow young adult patients to return to work.

Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

PubMed

Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

2015-10-09

The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial.

PubMed

Czaja, Sara J; Boot, Walter R; Charness, Neil; Rogers, Wendy A; Sharit, Joseph

2018-05-08

Information and communication technology holds promise in terms of providing support and reducing isolation among older adults. We evaluated the impact of a specially designed computer system for older adults, the Personal Reminder Information and Social Management (PRISM) system. The trial was a multisite randomized field trial conducted at 3 sites. PRISM was compared to a Binder condition wherein participants received a notebook that contained paper content similar to that contained in PRISM. The sample included 300 older adults at risk for social isolation who lived independently in the community (Mage = 76.15 years). Primary outcome measures included indices of social isolation, social support, loneliness, and well-being. Secondary outcome measures included indices of computer proficiency and attitudes toward technology. Data were collected at baseline and at 6 and 12 months post-randomization. The PRISM group reported significantly less loneliness and increased perceived social support and well-being at 6 months. There was a trend indicating a decline in social isolation. Group differences were not maintained at 12 months, but those in the PRISM condition still showed improvements from baseline. There was also an increase in computer self-efficacy, proficiency, and comfort with computers for PRISM participants at 6 and 12 months. The findings suggest that access to technology applications such as PRISM may enhance social connectivity and reduce loneliness among older adults and has the potential to change attitudes toward technology and increase technology self-efficacy.

Preserving mobility in older adults.

PubMed Central

Buchner, D M

1997-01-01

Age-related loss of strength contributes to impaired mobility and increases the risk of falls. Recent research has focused on 2 approaches to preventing age-related loss of strength--promoting physical activity and exercise (especially strength training) and using trophic factors to enhance muscle performance. Epidemiologic evidence strongly supports a role of regular physical activity in successful aging by preserving muscle performance, promoting mobility, and reducing fall risk. Randomized controlled trials provide convincing evidence that strength and endurance training improve muscle performance in older adults. Evidence is rapidly accumulating from randomized trials that endurance, strength, and balance training promote mobility and reduce fall risk, though exercise effects differ according to the type of exercise, details of the exercise program, and the target group of older adults. Because lifetime regular physical activity is recommended for all older adults, a reasonable strategy (especially for weak adults) is an activity program that includes strength training. In contrast, insufficient evidence exists to recommend the long-term use of trophic factors to preserve muscular performance. An intervention that merits additional study is avoiding the use of psychoactive drugs because drugs like benzodiazepines appear to be risk factors for inactivity and may have unrecognized direct effects on muscular performance. Because chronic illness is a risk factor for inactivity and disuse muscle atrophy, randomized trials comparing strength training with other interventions would be useful in understanding whether strength training has advantages in preserving muscle performance and improving health-related quality of life in a variety of chronic illnesses such as depressive illness. PMID:9348757

A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India.

PubMed

Kapoor, Neha; Naufahu, Jane; Tewfik, Sundus; Bhatnagar, Sushma; Garg, Rakesh; Tewfik, Ihab

2017-03-01

Advanced cancer patients with disease progression develop cachexia. Nevertheless, cancer patients at nutritional risk have shown improved body weight and quality of life with oral nutritional supplements. This was a randomized controlled trial in adult female cancer patients (n = 63) attending palliative clinics, with symptoms of cachexia. Eligible patients were randomly distributed into control (n = 33) and intervention (n = 30) groups. Both groups were provided with nutritional and physical activity counseling, but the intervention group received an additional 100 g of Improved Atta (IAtta) for 6 months daily consumption. This study was designed to assess the efficacy of IAtta (with counseling) in enhancing the health status of cachexic patients. Anthropometric measurements, dietary intake, physical activity level and quality of life parameters were assessed at baseline, after 3 months, and at the end of 6 months. Patients in the control group (n = 15) had significantly decreased body weight ( P = .003), mid-upper-arm circumference ( P = .002), and body fat ( P = .002) by the end of intervention. A trend of body weight gain in the intervention group (n = 17; P = .08) and significant increase of body fat ( P = .002) was observed; moreover, patients reported a significant improvement in fatigue ( P = .002) and appetite scores ( P = .006) under quality-of-life domains at the end of intervention. Embedding a nutrition-sensitive intervention ( IAtta ) within Indian palliative care therapy may improve quality of life and stabilize body weight in cancer cachexia patients.

Effectiveness of educational nursing home visits on quality of life, functional status and care dependency in older adults with mobility impairments: a randomized controlled trial.

PubMed

Buss, Arne; Wolf-Ostermann, Karin; Dassen, Theo; Lahmann, Nils; Strupeit, Steve

2016-04-01

Facilitating and maintaining functional status (FS) and quality of life (QoL) and avoiding care dependency (CD) are and will increasingly become major tasks of nursing. Educational nursing home visits may have positive effects on FS and QoL in older adults. The aim of this study was to determine the effectiveness of educational home visits on FS, QoL and CD in older adults with mobility impairments. We performed a randomized controlled trial. The study was conducted in the living environments of 123 participants with functional impairments living in Hamburg, Germany. The intervention group received an additional nursing education intervention on mobility and QoL; the control group received care as usual. Data were collected from August 2011 to December 2012 at baseline, 6 months and 12 months of follow-up. The main outcomes were FS (Barthel Index), QoL (WHOQOL-BREF) and CD (Care Dependency Scale). Data were analyzed using descriptive statistics and generalized linear models. In total, 113 participants (57 in the intervention and 56 in the control group) were included in the study. The intervention had no statistical significant effect on FS, QoL and CD. The intervention did not show the benefits that we assumed. Further studies on the effects of educational nursing interventions should be performed using different concepts and rigorous research methods. © 2015 John Wiley & Sons, Ltd.

Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence.

PubMed

Palsson, Olafur S

2015-10-01

Hypnotherapy has been investigated for 30 years as a treatment for gastrointestinal (GI) disorders. There are presently 35 studies in the published empirical literature, including 17 randomized controlled trials (RCTs) that have assessed clinical outcomes of such treatment. This body of research is reviewed comprehensively in this article. Twenty-four of the studies have tested hypnotherapy for adult irritable bowel syndrome (IBS) and 5 have focused on IBS or abdominal pain in children. All IBS hypnotherapy studies have reported significant improvement in gastrointestinal symptoms, and 7 out of 10 RCTs in adults and all 3 RCTs in pediatric patient samples found superior outcomes for hypnosis compared to control groups. Collectively this body of research shows unequivocally that for both adults and children with IBS, hypnosis treatment is highly efficacious in reducing bowel symptoms and can offer lasting and substantial symptom relief for a large proportion of patients who do not respond adequately to usual medical treatment approaches. For other GI disorders the evidence is more limited, but preliminary indications of therapeutic potential can be seen in the single randomized controlled trials published to date on hypnotherapy for functional dyspepsia, functional chest pain, and ulcerative colitis. Further controlled hypnotherapy trials in those three disorders should be a high priority. The mechanisms underlying the impact of hypnosis on GI problems are still unclear, but findings from a number of studies suggest that they involve both modulation of gut functioning and changes in the brain's handling of sensory signals from the GI tract.

To Switch or Not to Switch: Role of Cognitive Control in Working Memory Training in Older Adults.

PubMed

Basak, Chandramallika; O'Connell, Margaret A

2016-01-01

It is currently not known what are the best working memory training strategies to offset the age-related declines in fluid cognitive abilities. In this randomized clinical double-blind trial, older adults were randomly assigned to one of two types of working memory training - one group was trained on a predictable memory updating task (PT) and another group was trained on a novel, unpredictable memory updating task (UT). Unpredictable memory updating, compared to predictable, requires greater demands on cognitive control (Basak and Verhaeghen, 2011a). Therefore, the current study allowed us to evaluate the role of cognitive control in working memory training. All participants were assessed on a set of near and far transfer tasks at three different testing sessions - before training, immediately after the training, and 1.5 months after completing the training. Additionally, individual learning rates for a comparison working memory task (performed by both groups) and the trained task were computed. Training on unpredictable memory updating, compared to predictable, significantly enhanced performance on a measure of episodic memory, immediately after the training. Moreover, individuals with faster learning rates showed greater gains in this episodic memory task and another new working memory task; this effect was specific to UT. We propose that the unpredictable memory updating training, compared to predictable memory updating training, may a better strategy to improve selective cognitive abilities in older adults, and future studies could further investigate the role of cognitive control in working memory training.

Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference.

PubMed

Black, Jed; Pillar, Giora; Hedner, Jan; Polo, Olli; Berkani, Ouali; Mangialaio, Sara; Hmissi, Abdel; Zammit, Gary; Hajak, Goran

2017-08-01

The orally active dual OX 1 R and OX 2 R antagonist, almorexant, targets the orexin system for the treatment of primary insomnia. This clinical trial assessed the effect of almorexant on sleep maintenance and other sleep endpoints, and its safety and tolerability in adults. Prospective, randomized, double-blind, placebo-controlled, active referenced trial in male and female adults aged 18-64 years with chronic, primary insomnia. Patients were randomized 1:1:1:1 to receive placebo, almorexant 100 mg, almorexant 200 mg, or zolpidem 10 mg (active reference) for 16 days. Primary efficacy assessments were objective (polysomnography-measured) and subjective (patient-recorded) wake time after sleep onset (WASO). Further sleep variables were also evaluated. From 709 randomized patients, 707 (mean age 45.4 years; 61.7% female) received treatment and 663 (93.8%) completed the study. A significant decrease versus placebo in median objective WASO was observed with almorexant 200 mg at the start and end of randomized treatment (-26.8 min and -19.5 min, respectively; both p < 0.0001); subjective WASO also decreased over the two-week treatment period (p = 0.0006). Objective and subjective total sleep time (TST) were increased with almorexant 200 mg (p < 0.0001). Almorexant 200 mg significantly reduced objective and subjective latency to persistent sleep and latency to sleep onset at initiation of therapy, and provided longer duration of sleep stages with no suppression of slow-wave sleep. No impaired next-day performance, rebound insomnia, or withdrawal effects were observed. Adverse events were similar with almorexant and placebo. Almorexant reduced time to sleep onset and maintained sleep without residual effects on next-day performance or safety concerns. This study provides further support for the role of the endogenous orexin system in insomnia disorder. CLINICALTRIALS. NCT00608985. Copyright © 2017 Elsevier B.V. All rights reserved.

Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.

PubMed

Adler, Elizabeth; Dhruva, Anand; Moran, Patricia J; Daubenmier, Jennifer; Acree, Michael; Epel, Elissa S; Bacchetti, Peter; Prather, Aric A; Mason, Ashley; Hecht, Frederick M

2017-03-01

Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity. This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m 2 . The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months. Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months. No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis.

PubMed

Yeh, Hsin-Chieh; Brown, Todd T; Maruthur, Nisa; Ranasinghe, Padmini; Berger, Zackary; Suh, Yong D; Wilson, Lisa M; Haberl, Elisabeth B; Brick, Jessica; Bass, Eric B; Golden, Sherita Hill

2012-09-04

Patients with diabetes mellitus need information about the effectiveness of innovations in insulin delivery and glucose monitoring. To review how intensive insulin therapy (multiple daily injections [MDI] vs. rapid-acting analogue-based continuous subcutaneous insulin infusion [CSII]) or method of monitoring (self-monitoring of blood glucose [SMBG] vs. real-time continuous glucose monitoring [rt-CGM]) affects outcomes in types 1 and 2 diabetes mellitus. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through February 2012 without language restrictions. 33 randomized, controlled trials in children or adults that compared CSII with MDI (n=19), rt-CGM with SMBG (n=10), or sensor-augmented insulin pump use with MDI and SMBG (n=4). 2 reviewers independently evaluated studies for eligibility and quality and serially abstracted data. In randomized, controlled trials, MDI and CSII showed similar effects on hemoglobin A1c (HbA1c) levels and severe hypoglycemia in children or adults with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. In adults with type 1 diabetes mellitus, HbA1c levels decreased more with CSII than with MDI, but 1 study heavily influenced these results. Compared with SMBG, rt-CGM achieved a lower HbA1c level (between-group difference of change, 0.26% [95% CI, 0.33% to 0.19%]) without any difference in severe hypoglycemia. Sensor-augmented insulin pump use decreased HbA1c levels more than MDI and SMBG did in persons with type 1 diabetes mellitus (between-group difference of change, 0.68% [CI, 0.81% to 0.54%]). Little evidence was available on other outcomes. Many studies were small, of short duration, and limited to white persons with type 1 diabetes mellitus. Continuous subcutaneous insulin infusion and MDI have similar effects on glycemic control and hypoglycemia, except CSII has a favorable effect on glycemic control in adults with type 1 diabetes mellitus. For glycemic control, rt-CGM is superior to SMBG and sensor-augmented insulin pumps are superior to MDI and SMBG without increasing the risk for hypoglycemia. Agency for Healthcare Research and Quality.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

PubMed Central

Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

2016-01-01

Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers. PMID:27598322

Do Exercise Interventions Improve Participation in Life Roles in Older Adults? A Systematic Review and Meta-Analysis

PubMed Central

Lee, Annemarie; Ward, Rachel F.; Harrison, Samantha M.; Bain, Paul A.; Goldstein, Roger S.; Brooks, Dina; Bean, Jonathan F; Jette, Alan M

2017-01-01

Abstract Background The World Health Organization recognizes participation in meaningful life roles as a key component of health. However, the evidence base for interventions to improve participation remains inconclusive. In particular, whether exercise interventions improve participation in life roles is unclear. Purpose The aim of this review was to evaluate the effect of physical exercise interventions on participation in life roles in older adults residing in the community. Data sources The PubMed, Embase, CINAHL, Cochrane, and PEDro databases were searched from inception through March 2015. Study selection Randomized controlled trials comparing the effects of an exercise intervention to usual care on participation in life roles in adults who were 60 years of age or older were included in this review. Data extraction Teams of 2 investigators independently extracted data on participation. Methodological quality was appraised using the Cochrane tool for assessing the risk of bias. The protocol was registered with Prospero (CRD42014014880). Data synthesis Eighteen randomized controlled trials with a total of 2,315 participants met the inclusion criteria. Standardized mean differences (SMDs) with 95% CIs were calculated using a random-effects model. A meta-analysis of 16 studies showed no overall effect of the exercise interventions on participation (SMD = 0.03; 95% CI = −0.10 to 0.16). Subgroup analysis showed that exercise interventions lasting 12 months or more had a small positive effect on participation (SMD = 0.15; 95% CI = 0.02 to 0.28). Limitations Limitations included variability in definitions and measures of participation. Conclusions In general, exercise interventions do not improve participation in life roles in older adults. The results do not support the implicit assumption that exercise-based interventions associated with improved function/activity also result in improved participation. Investigation of complex interventions that go beyond exercise to address participation in life roles for older adults is warranted. PMID:29029557

Effect of E-OJ-01 on Cardiac Conditioning in Young Exercising Adults: A Randomized Controlled Trial.

PubMed

Girandola, Robert N; Srivastava, Shalini

2017-05-01

Cardiac health is a determinant of athletic performance. A body of data suggests that in healthy young adults, an increase in maximal cardiac output leads to an increase in endurance. Terminalia arjuna (TA) has been studied for multiple benefits in cardiovascular health although its effects as a cardioprotective ergogenic aid require further exploration. The current trial was planned to study the effect of the proprietary TA extract (E-OJ-01) on the markers of cardiac conditioning in healthy young adults. No study has assessed the effect of TA extract on cardiac conditioning by improvement of left ventricular ejection fraction (LVEF) in young exercising individuals. A randomized, double-blind, placebo-controlled, parallel group study was conducted to determine the efficacy and safety of E-OJ-01 for use as an ergogenic supplements in young exercising adults. This trial was registered at ClinicalTrials.gov (NCT02207101) and reported according to Consolidated Standards of Reporting Trials (CONSORT) requirements. Thirty-two healthy males, aged 18-40 years performing regular endurance exercise, were randomly assigned to 400 mg of E-OJ-01 or placebo for 56 days. LVEF, right and left ventricular Myocardial Performance Index, and Borg Rated Perceived Exertion (RPE) were assessed at baseline, day 28, and day 56; creatine kinase-MB and troponin-T were assessed at baseline and at day 56. As compared with placebo, 56 days of E-OJ-01 supplementation significantly improved the LVEF (P = 0.0001) and decreased the right ventricular Myocardial Performance Index (P = 0.001). The fatigue level captured by Borg Scale after completion of exercise showed a greater decrease in the E-OJ-01 group as compared with placebo. Creatine kinase-MB and troponin-T did not change significantly. TA (E-OJ-01) significantly increased cardiovascular efficiency and improved the cardiac conditioning in young healthy adults.

Effects of Milk Proteins Supplementation in Older Adults Undergoing Resistance Training: A Meta-Analysis of Randomized Control Trials.

PubMed

Hidayat, K; Chen, G-C; Wang, Y; Zhang, Z; Dai, X; Szeto, I M Y; Qin, L-Q

2018-01-01

Older adults experience age-related physiological changes that affect body weight and body composition. In general, nutrition and exercise have been identified as potent stimulators of protein synthesis in skeletal muscle. Milk proteins are excellent sources of all the essential amino acids and may represent an ideal protein source to promote muscle anabolism in older adults undergoing resistance training. However, several randomized control trials (RCTs) have yielded mixed results on the effects of milk proteins supplementation in combination with resistance training on body weight and composition. PubMed, Web of Science and Cochrane databases were searched for literature that evaluated the effects of milk proteins supplementation on body weight and composition among older adults (age ≥ 60 years) undergoing resistance training up to September 2016. A random-effects model was used to calculate the pooled estimates and 95% confidence intervals (CIs) of effect sizes. The final analysis included 10 RCTs involving 574 participants (mean age range from 60 to 80.8 years). Overall, the combination of milk proteins supplementation and resistance training did not have significant effect on fat mass (0.30, 95% CI -0.25, 0.86 kg) or body weight (1.02, 95% CI: -0.01, 2.04 kg). However, a positive effect of milk proteins supplementation paired with resistance training on fat-free mass was observed (0.74, 95% CI 0.30, 1.17 kg). Greater fat-free mass gains were observed in studies that included more than 55 participants (0.73, 95% CI 0.30, 1.16 kg), and in studies that enrolled participants with aging-related medical conditions (1.60, 95% CI 0.92, 2.28 kg). There was no statistical evidence of publication bias among the studies. Our findings provide evidence that supplementation of milk protein, in combination with resistance training, is effective to elicit fat-free mass gain in older adults.

Do Exercise Interventions Improve Participation in Life Roles in Older Adults? A Systematic Review and Meta-Analysis.

PubMed

Beauchamp, Marla K; Lee, Annemarie; Ward, Rachel F; Harrison, Samantha M; Bain, Paul A; Goldstein, Roger S; Brooks, Dina; Bean, Jonathan F; Jette, Alan M

2017-10-01

The World Health Organization recognizes participation in meaningful life roles as a key component of health. However, the evidence base for interventions to improve participation remains inconclusive. In particular, whether exercise interventions improve participation in life roles is unclear. The aim of this review was to evaluate the effect of physical exercise interventions on participation in life roles in older adults residing in the community. The PubMed, Embase, CINAHL, Cochrane, and PEDro databases were searched from inception through March 2015. Randomized controlled trials comparing the effects of an exercise intervention to usual care on participation in life roles in adults who were 60 years of age or older were included in this review. Teams of 2 investigators independently extracted data on participation. Methodological quality was appraised using the Cochrane tool for assessing the risk of bias. The protocol was registered with Prospero (CRD42014014880). Eighteen randomized controlled trials with a total of 2,315 participants met the inclusion criteria. Standardized mean differences (SMDs) with 95% CIs were calculated using a random-effects model. A meta-analysis of 16 studies showed no overall effect of the exercise interventions on participation (SMD = 0.03; 95% CI = -0.10 to 0.16). Subgroup analysis showed that exercise interventions lasting 12 months or more had a small positive effect on participation (SMD = 0.15; 95% CI = 0.02 to 0.28). Limitations included variability in definitions and measures of participation. In general, exercise interventions do not improve participation in life roles in older adults. The results do not support the implicit assumption that exercise-based interventions associated with improved function/activity also result in improved participation. Investigation of complex interventions that go beyond exercise to address participation in life roles for older adults is warranted. © 2017 American Physical Therapy Association

Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial.

PubMed

Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Kambara, Toshimune; Sekiguchi, Atsushi; Miyauchi, Carlos Makoto; Kotozaki, Yuka; Nouchi, Haruka; Kawashima, Ryuta

2013-01-01

Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. UMIN Clinical Trial Registry 000005618.

Brain Training Game Boosts Executive Functions, Working Memory and Processing Speed in the Young Adults: A Randomized Controlled Trial

PubMed Central

Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Kambara, Toshimune; Sekiguchi, Atsushi; Miyauchi, Carlos Makoto; Kotozaki, Yuka; Nouchi, Haruka; Kawashima, Ryuta

2013-01-01

Background Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. Methods We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Results and Discussion Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Conclusions Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. Trial Registration UMIN Clinical Trial Registry 000005618. PMID:23405164

Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial.

PubMed

Guwatudde, David; Ezeamama, Amara E; Bagenda, Danstan; Kyeyune, Rachel; Wabwire-Mangen, Fred; Wamani, Henry; Mugusi, Ferdinand; Spiegelman, Donna; Wang, Molin; Manabe, Yukari C; Fawzi, Wafaie W

2012-11-15

Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578.

The Impact of the 6:3 Polyunsaturated Fatty Acid Ratio on Intermediate Markers of Breast Cancer

DTIC Science & Technology

2007-05-01

Sereika SM. Effects of a vegetarian diet and treatment preference on biological and dietary \\,ariables in overweight and obese adults: a randomized trial...combination witl standard diet or lacto-ovo- vegetarian diet on weight loss: a randomized controlled trial.(Under review at Intemational Joumal of...In press at American Joumal of Clinical Nutrition) Burke LE, Styn MA, Warziski M, Music E, Hudson AG, Sereika SM. The effects of diet preference in

Growing cell-phone population and noncoverage bias in traditional random digit dial telephone health surveys.

PubMed

Lee, Sunghee; Brick, J Michael; Brown, E Richard; Grant, David

2010-08-01

Examine the effect of including cell-phone numbers in a traditional landline random digit dial (RDD) telephone survey. The 2007 California Health Interview Survey (CHIS). CHIS 2007 is an RDD telephone survey supplementing a landline sample in California with a sample of cell-only (CO) adults. We examined the degree of bias due to exclusion of CO populations and compared a series of demographic and health-related characteristics by telephone usage. When adjusted for noncoverage in the landline sample through weighting, the potential noncoverage bias due to excluding CO adults in landline telephone surveys is diminished. Both CO adults and adults who have both landline and cell phones but mostly use cell phones appear different from other telephone usage groups. Controlling for demographic differences did not attenuate the significant distinctiveness of cell-mostly adults. While careful weighting can mitigate noncoverage bias in landline telephone surveys, the rapid growth of cell-phone population and their distinctive characteristics suggest it is important to include a cell-phone sample. Moreover, the threat of noncoverage bias in telephone health survey estimates could mislead policy makers with possibly serious consequences for their ability to address important health policy issues.

Daily Intake of Protein from Cod Residual Material Lowers Serum Concentrations of Nonesterified Fatty Acids in Overweight Healthy Adults: A Randomized Double-Blind Pilot Study.

PubMed

Vildmyren, Iselin; Cao, Huy John Vu; Haug, Lina Bowitz; Valand, Ida Ulrikke; Eng, Øyvin; Oterhals, Åge; Austgulen, Maren Hoff; Halstensen, Alfred; Mellgren, Gunnar; Gudbrandsen, Oddrun A

2018-06-05

Improved process technologies have allowed fishing vessels to utilize residuals from cod fillet production (head, backbone, skin, cuttings, and entrails) and convert this to high-quality protein powders for human consumption. In this double-blind pilot study, 42 healthy overweight or obese adults were randomized to three experimental groups consuming tablets corresponding to 6 g/day of proteins from cod residuals as presscake meal (Cod-PC), presscake and stickwater meal (Cod-PCW), or placebo tablets (control) for eight weeks. The primary outcome of this study was changes in metabolites related to glucose regulation in overweight or obese healthy adults after intake of proteins from cod residuals. Cod-PC supplementation decreased postprandial serum nonesterified fatty acids (NEFA) concentration and increased gene expressions of diglyceride acyltransferase 1 and 2 in subcutaneous adipose tissue compared with controls. Fasting insulin increased while fasting NEFA and 120-min postprandial glucose decreased within the Cod-PC group, but these changes did not differ from the other groups. In conclusion, supplementation with Cod-PC beneficially affected postprandial serum NEFA concentration compared with the other groups in overweight or obese adults. Supplementation with Cod-PCW, which contains a higher fraction of water-soluble protein compared to Cod-PC, did not affect serum markers of glucose regulation.

Effect of Probiotics and Prebiotics on Immune Response to Influenza Vaccination in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Lei, Wei-Te; Shih, Pei-Ching; Liu, Shu-Jung; Lin, Chien-Yu; Yeh, Tzu-Lin

2017-10-27

We conducted a meta-analysis to evaluate the effects of probiotics and prebiotics on the immune response to influenza vaccination in adults. We conducted a literature search of Pubmed, Embase, the Cochrane Library, the Cumulative Index to Nursing and Allied Health (CINAHL), Airiti Library, and PerioPath Index to Taiwan Periodical Literature in Taiwan. Databases were searched from inception to July 2017. We used the Cochrane Review risk of bias assessment tool to assess randomized controlled trial (RCT) quality. A total of 20 RCTs comprising 1979 adults were included in our systematic review. Nine RCTs including 623 participants had sufficient data to be pooled in a meta-analysis. Participants who took probiotics or prebiotics showed significant improvements in the H1N1 strain seroprotection rate (with an odds ratio (OR) of 1.83 and a 95% confidence interval (CI) of 1.19-2.82, p = 0.006, I ² = 0%), the H3N2 strain seroprotection rate (OR = 2.85, 95% CI = 1.59-5.10, p < 0.001, I ² = 0%), and the B strain seroconversion rate (OR = 2.11, 95% CI = 1.38-3.21, p < 0.001, I ² = 0%). This meta-analysis suggested that probiotics and prebiotics are effective in elevating immunogenicity by influencing seroconversion and seroprotection rates in adults inoculated with influenza vaccines.

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

PubMed Central

Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

The Impact of Single Session Intermittent Theta-Burst Stimulation over the Dorsolateral Prefrontal Cortex and Posterior Superior Temporal Sulcus on Adults with Autism Spectrum Disorder

PubMed Central

Ni, Hsing-Chang; Hung, June; Wu, Chen-Te; Wu, Yu-Yu; Chang, Chee-Jen; Chen, Rou-Shayn; Huang, Ying-Zu

2017-01-01

Intermittent theta burst stimulation (iTBS), a patterned repetitive transcranial magnetic stimulation, was applied over the posterior superior temporal sulcus (pSTS) or dorsolateral prefrontal cortex (DLPFC) to explore its impact in adults with autism spectrum disorder (ASD). Among 25 adults with ASD, 19 (mean age: 20.8 years) completed the randomized, sham-controlled, crossover trial. Every participant received iTBS over the bilateral DLPFC, bilateral pSTS and inion (as a sham control stimulation) in a randomized order with a 1-week interval. Neuropsychological functions were assessed using the Conners' Continuous Performance Test (CCPT) and the Wisconsin Card Sorting Test (WCST). Behavioral outcomes were measured using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Social Responsiveness Scale (SRS). In comparison to that in the sham stimulation, the reaction time in the CCPT significantly decreased following single DLPFC session (p = 0.04, effect size = 0.71) while there were no significant differences in the CCPT and WCST following single pSTS session. Besides, the results in behavioral outcomes were inconsistent and had discrepancy between reports of parents and patients. In conclusion, a single session of iTBS over the bilateral DLPFC may alter the neuropsychological function in adults with ASD. The impacts of multiple-sessions iTBS over the DLPFC or pSTS deserve further investigations. PMID:28536500

Positive effects of transcranial direct current stimulation in adult patients with attention-deficit/hyperactivity disorder - A pilot randomized controlled study.

PubMed

Cachoeira, Carolina Tosetto; Leffa, Douglas Teixeira; Mittelstadt, Suzana Doneda; Mendes, Lorenna Sena Teixeira; Brunoni, Andre R; Pinto, Jairo Vinicius; Blazius, Vtor; Machado, Vitoria; Bau, Claiton Henrique Dotto; Rohde, Luis Augusto; Grevet, Eugenio Horacio; Schestatsky, Pedro

2017-01-01

Almost 30% of adult patients with attention-deficit/hyperactivity disorder (ADHD) do not respond or tolerate standard pharmacological interventions. Few clinical investigations addressed the efficacy and tolerability of transcranial direct current stimulation (tDCS), a non-invasive neuromodulatory technique, in the disorder. We performed a double-blind, sham-controlled randomized clinical trial in 17 patients with ADHD. The set up for tDCS was the following: 2mA/20min/day for 5 days with the anode over the right dorsolateral prefrontal cortex and cathode over the left dorsolateral prefrontal cortex. ADHD symptoms were measured by the Adult ADHD Self-Report Scale (ASRS) and impairment with the Sheehan Disability Scale (SDS) in four different time points after stimulation. Participants achieved significant lower ASRS inattention and SDS scores after active tDCS in comparison with sham stimulation group. In addition, we detected a trend for a lower ASRS total score in the active tDCS group. Follow up data analysis revealed a positive interaction between time and treatment in both ASRS inattention, SDS and ASRS total scores. Short-term application of tDCS in adult patients with ADHD improved their symptoms, and this improvement persisted after the end of the stimulation. Future studies with larger sample sizes are needed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

PubMed

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-08-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.

Randomized Trial of Behavior Therapy for Adults with Tourette’s Disorder

PubMed Central

Wilhelm, Sabine; Peterson, Alan L.; Piacentini, John; Woods, Douglas W.; Deckersbach, Thilo; Sukhodolsky, Denis G.; Chang, Susanna; Liu, Haibei; Dziura, James; Walkup, John T.; Scahill, Lawrence

2013-01-01

Context Tics in Tourette syndrome begin in childhood, peak in early adolescence, and often decline by early adulthood. However, some adult patients continue to have impairing tics. Medications for tics are often effective but can cause adverse effects. Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults. Objective To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity. Design A randomized, controlled trial with posttreatment evaluations at 3 and 6 months for positive responders. Setting Three outpatient research clinics. Subjects Subjects (N = 122; 78 males, age 16 to 69 years) with Tourette syndrome or chronic tic disorder. Interventions Eight sessions of Comprehensive Behavioral Intervention for Tics or 8 sessions of supportive treatment delivered over 10 weeks. Subjects showing a positive response were given 3 monthly booster sessions. Main Outcome Measures Total Tic score of the Yale Global Tic Severity Scale and the Improvement scale of the Clinical Global Impression rated by a clinician blind to treatment assignment. Results Behavior therapy was associated with a significantly greater decrease on the Yale Global Tic Severity Scale (24.0 ± 6.47 to 17.8 ± 7.32) from baseline to endpoint compared to the control treatment (21.8 ± 6.59 to 19.3 ± 7.40) (P < .001; effect size = 0.57). Twenty-four of 63 subjects (38.1%) in CBIT were rated as Much Improved or Very Much Improved on the Clinical Global Impression-Improvement scale compared to 6.8% (4 of 63) in the control group (P < .0001). Attrition was 13.9% with no difference across groups. Subjects in behavior therapy available for assessment at 6 months posttreatment showed continued benefit. Conclusions Comprehensive behavior therapy is a safe and effective intervention for adults with Tourette syndrome. PMID:22868933

Effects of whole body vibration training on postural control in older individuals: a 1 year randomized controlled trial.

PubMed

Bogaerts, An; Verschueren, Sabine; Delecluse, Christophe; Claessens, Albrecht L; Boonen, Steven

2007-07-01

This randomized controlled trial investigated the effects of a 12 month whole body vibration training program on postural control in healthy older adults. Two hundred and twenty people were randomly assigned to a whole body vibration group (n=94), a fitness group (n=60) or a control group (n=66). The whole body vibration and fitness groups trained three times a week for 1 year. The vibration group performed exercises on a vibration platform and the fitness group performed cardiovascular, strength, balance and stretching exercises. Balance was measured using dynamic computerized posturography at baseline and after 6 and 12 months. Whole body vibration training was associated with reduced falls frequency on a moving platform when vision was disturbed and improvements in the response to toes down rotations at the ankle induced by the moving platform. The fitness group showed reduced falls frequency on the moving surface when vision was disturbed. Thus, whole body vibration training may improve some aspects of postural control in community dwelling older individuals.

The Efficacy of Adapted MBCT on Core Symptoms and Executive Functioning in Adults With ADHD: A Preliminary Randomized Controlled Trial.

PubMed

Hepark, Sevket; Janssen, Lotte; de Vries, Alicia; Schoenberg, Poppy L A; Donders, Rogier; Kan, Cornelis C; Speckens, Anne E M

2015-11-20

The aim of this study was to examine the effectiveness of mindfulness as a treatment for adults diagnosed with ADHD. A 12-week-adapted mindfulness-based cognitive therapy (MBCT) program is compared with a waiting list (WL) group. Adults with ADHD were randomly allocated to MBCT (n = 55) or waitlist (n = 48). Outcome measures included investigator-rated ADHD symptoms (primary), self-reported ADHD symptoms, executive functioning, depressive and anxiety symptoms, patient functioning, and mindfulness skills. MBCT resulted in a significant reduction of ADHD symptoms, both investigator-rated and self-reported, based on per-protocol and intention-to-treat analyses. Significant improvements in executive functioning and mindfulness skills were found. Additional analyses suggested that the efficacy of MBCT in reducing ADHD symptoms and improving executive functioning is partially mediated by an increase in the mindfulness skill "Act With Awareness." No improvements were observed for depressive and anxiety symptoms, and patient functioning. This study provides preliminary support for the effectiveness of MBCT for adults with ADHD. © The Author(s) 2015.

Marketing public health through older adult volunteering: Experience Corps as a social marketing intervention.

PubMed

Tan, Erwin J; Tanner, Elizabeth K; Seeman, Teresa E; Xue, Qian-Li; Rebok, George W; Frick, Kevin D; Carlson, Michelle C; Wang, Tao; Piferi, Rachel L; McGill, Sylvia; Whitfield, Keith E; Fried, Linda P

2010-04-01

We present a social marketing conceptual framework for Experience Corps Baltimore City (EC) in which the desired health outcome is not the promoted product or behavior. We also demonstrate the feasibility of a social marketing-based recruitment campaign for the first year of the Baltimore Experience Corps Trial (BECT), a randomized, controlled trial of the health benefits of EC participation for older adults. We recruited older adults from the Baltimore, MD, area. Participants randomized to the intervention were placed in public schools in volunteer roles designed to increase healthy behaviors. We examined the effectiveness of a recruitment message that appealed to generativity (i.e., to make a difference for the next generation), rather than potential health benefits. Among the 155 participants recruited in the first year of the BECT, the average age was 69 years; 87% were women and 85% were African American. Participants reported primarily generative motives as their reason for interest in the BECT. Public health interventions embedded in civic engagement have the potential to engage older adults who might not respond to a direct appeal to improve their health.

Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela R; Inscore, Stephen; Forkner, Emma; Vazquez, Marilu; Fallot, Andre; Ellis, Robert; Peters, Jay I

2008-12-01

The goal of disease management (DM) is to improve health outcomes and reduce cost through decreasing health care utilization. Although some studies have shown that DM improves asthma outcomes, these interventions have not been examined in a large randomized controlled trial. To compare the effectiveness of 2 previously successful DM programs with that of traditional care. Nine hundred two individuals with asthma (429 adults; 473 children) were randomly assigned to telephonic DM, augmented DM (ADM; DM plus in-home visits by a respiratory therapist), or traditional care. Data were collected at enrollment and at 6 and 12 months. Primary outcomes were time to first asthma-related event, quality of life (QOL), and rates of asthma-related health care utilization. Secondary outcomes included rate of controller medication initiation, number of oral corticosteroid bursts, asthma symptom scores, and number of school days missed. There were no significant differences between groups in time to first asthma-related event or health care utilization. Adult participants in the ADM group had greater improvement in QOL (P = .04) and a decrease in asthma symptoms (P = .001) compared with other groups. Of children not receiving controller medications at enrollment (13%), those in the intervention groups were more likely to have controller medications initiated than the control group (P = .01). Otherwise, there were no differences in outcomes. Overall, participation in asthma DM did not result in significant differences in utilization or clinical outcomes. The only significant impact was a higher rate of controllermedication initiation in children and improvement in asthma symptoms and QOL in adults who received ADM.

Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial.

PubMed

Papas, A S; Vollmer, W M; Gullion, C M; Bader, J; Laws, R; Fellows, J; Hollis, J F; Maupomé, G; Singh, M L; Snyder, J; Blanchard, P

2012-02-01

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).

Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics

USDA-ARS?s Scientific Manuscript database

Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate...

Effect of guided relaxation and imagery on falls self-efficacy: a randomized controlled trial.

PubMed

Kim, Bang Hyun; Newton, Roberta A; Sachs, Michael L; Glutting, Joseph J; Glanz, Karen

2012-06-01

To examine the effects of guided relaxation and imagery (GRI) on improvement in falls self-efficacy in older adults who report having a fear of falling. Randomized, controlled trial with allocation to GRI or guided relaxation with music of choice. General community. Ninety-one men and women aged 60 to 92. Participants were randomized to listen to a GRI audio compact disk (intervention group) or a guided relaxation audio compact disk and music of choice (control group) twice a week for 6 weeks for 10 minutes per session. Primary outcome measure was the Short Falls Efficacy Scale-International (FES-I). Secondary outcome measures were the Leisure Time Exercise Questionnaire (LTEQ) and the Timed Up and Go (TUG) mobility test. GRI participants reported greater improvements on the Short FES-I (P = .002) and LTEQ (P = .001) scores and shorter time on the TUG (P = .002) than the guided relaxation and music-of-choice group. GRI was more effective at increasing falls self-efficacy and self-reported leisure time exercise and reducing times on a simple mobility test than was guided relaxation with music of choice. GRI is an effective, simple, low-cost tool for older adults to improve falls self-efficacy and leisure time exercise behaviors. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

PubMed Central

LOCHER, JULIE L.; BALES, CONNIE W.; ELLIS, AMY C.; LAWRENCE, JEANNINE C.; NEWTON, LAURA; RITCHIE, CHRISTINE S.; ROTH, DAVID L.; BUYS, DAVID L.; VICKERS, KRISTIN S.

2012-01-01

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article. PMID:22098180

Mindfulness-Oriented Recovery Enhancement for Internet Gaming Disorder in U.S. Adults: A Stage 1 Randomized Controlled Trial

PubMed Central

Li, Wen; Garland, Eric L.; McGovern, Patricia; O'Brien, Jennifer E.; Tronnier, Christine; Howard, Matthew O.

2017-01-01

Empirical studies have identified increasing rates of Internet Gaming Disorder (IGD) and associated adverse consequences. However, very few evidence-based interventions have been evaluated for IGD or problematic video gaming behaviors. This study evaluated Mindfulness-Oriented Recovery Enhancement (MORE) as a treatment for IGD. Thirty adults (M age = 25.0, SD = 5.4) with IGD or problematic video gaming behaviors were randomized to 8 weeks of group-based MORE or 8 weeks of a support group (SG) control condition. Outcome measures were administered at pre-and posttreatment, and 3-month following treatment completion using self-report instruments. Linear mixed models were used for outcome analyses. MORE participants had significantly greater reductions in the number of DSM-5 IGD criteria they met, craving for video gaming, and maladaptive cognitions associated with gaming than SG participants, and therapeutic benefits were maintained at 3-month follow-up. MORE is a promising treatment approach for IGD. PMID:28437120

Predictors of retention among African American and Hispanic older adult research participants in the Well Elderly 2 randomized controlled trial.

PubMed

Carlson, Mike; Jackson, Jeanne; Mandel, Deborah; Blanchard, Jeanine; Holguin, Jess; Lai, Mei-Ying; Marterella, Abbey; Vigen, Cheryl; Gleason, Sarah; Lam, Claudia; Azen, Stan; Clark, Florence

2014-04-01

The purpose of this study was to document predictors of long-term retention among minority participants in the Well Elderly 2 Study, a randomized controlled trial of a lifestyle intervention for community-dwelling older adults. The primary sample included 149 African American and 92 Hispanic men and women aged 60 to 95 years, recruited at senior activity centers and senior residences. Chi-square and logistic regression procedures were undertaken to examine study-based, psychosocial and health-related predictors of retention at 18 months following study entry. For both African Americans and Hispanics, intervention adherence was the strongest predictor. Retention was also related to high active coping and average (vs. high or low) levels of activity participation among African Americans and high social network strength among Hispanics. The results suggest that improved knowledge of the predictors of retention among minority elders can spawn new retention strategies that can be applied at individual, subgroup, and sample-wide levels.

Do Brief Alcohol Interventions Reduce Tobacco Use among Adolescents and Young Adults? A Systematic Review and Meta-Analysis

PubMed Central

Hennessy, Emily A.; Tanner-Smith, Emily E.; Steinka-Fry, Katarzyna T.

2015-01-01

This meta-analysis synthesizes studies of brief interventions (BIs) that targeted alcohol consumption and reported both alcohol and tobacco outcomes. It examines whether BIs reduce alcohol and tobacco use for adolescents and young adults among interventions that (1) directly targeted tobacco and alcohol use, or (2) did not target tobacco use but measured it as a secondary outcome. Multiple databases and grey literature sources were searched (1980–2012) resulting in the identification of 18 randomized or controlled quasi-experimental studies (5949 participants). Analyses were conducted using random effects inverse-variance weighted three-level models. BIs were associated with a significant reduction in alcohol consumption relative to control groups (ḡ = 0.11, 95% CI [0.04, 0.17]) but not with a significant decrease in tobacco use (ḡ = 0.07, 95% CI [−0.01, 0.16]). Directly addressing tobacco was not a significant moderator affecting tobacco use outcomes. Post-hoc exploratory analysis revealed potential questions to address with future research. PMID:26130030

Improvements in Cardiovascular Risk Factors in Young Adults in a Randomized Trial of Approaches to Weight Gain Prevention

PubMed Central

Wing, Rena R.; Tate, Deborah F.; Garcia, Katelyn R.; Bahnson, Judy; Lewis, Cora E.; Espeland, Mark A.

2017-01-01

Objective Weight gain occurs commonly in young adults and increases cardiovascular (CVD) risk. We previously reported that two self-regulation interventions reduced weight gain relative to control. Here we examine whether these interventions also benefit CVD risk factors. Methods SNAP (Study of Novel Approaches to Weight Gain Prevention) was a randomized trial in 2 academic settings (N=599; 18–35 years; body mass index 21–30 kg/m2) comparing two interventions (Self-Regulation with Small Changes; Self-Regulation with Large Changes) and Control. Small Changes taught participants to make daily small changes (approximately 100 calorie) in intake and activity. Large Changes taught participants to initially lose 5–10 pounds to buffer anticipated weight gains. CVD risk factors were assessed at baseline and 2 years in 471 participants. Results Although Large Changes was associated with more beneficial changes in glucose, insulin, and HOMA-IR than Control, these differences were not significant after adjusting for multiple comparisons or 2-year weight change. Comparison of participants grouped by percent weight change baseline to 2 years showed significant differences for several CVD risk factors, with no interaction with treatment condition. Conclusions Magnitude of weight change, rather than specific weight gain prevention interventions, was related to changes in CVD risk factors in young adults. PMID:28782918

Effects of supplementation with the fat-soluble vitamins E and D on fasting flow-mediated vasodilation in adults: a meta-analysis of randomized controlled trials.

PubMed

Joris, Peter J; Mensink, Ronald P

2015-03-10

The effects of fat-soluble vitamin supplementation on cardiovascular disease (CVD) risk are not clear. Therefore, we performed a meta-analysis to quantify effects of fat-soluble vitamin supplements on fasting flow-mediated vasodilation (FMD) of the brachial artery, a validated marker to assess CVD risk. Randomized placebo-controlled trials (RCTs) were identified by a systematic search till July 2014. Seven RCTs studying the effects of vitamin E supplements (range: 300 to 1800 IU per day) and nine RCTs examining the effects of vitamin D supplements, that involved, respectively, 303 and 658 adults, were included. No studies with carotenoid or vitamin K supplements were found. Vitamin E supplementation increased FMD vs. control by 2.42% (95% CI: 0.46% to 4.37%; p = 0.015). No effects of vitamin D supplementation were found (0.15%; 95% CI: -0.21% to 0.51%; p = 0.41). These effects did not depend on subject characteristics, treatment characteristics or technical aspects of the FMD measurement. However, no dose-response relationship was evident for vitamin E, statistical significance depended on one study, while the levels of supplement were far above recommended intakes. The current meta-analysis, therefore, does not provide unambiguous evidence to support the use of fat-soluble vitamin supplements to improve fasting FMD in adults.

Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

PubMed Central

Degli Stefani, Mario; Biasutti, Michele

2016-01-01

Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

Working memory training in healthy young adults: Support for the null from a randomized comparison to active and passive control groups

PubMed Central

Lawlor-Savage, Linette; Goghari, Vina M.

2017-01-01

Training of working memory as a method of increasing working memory capacity and fluid intelligence has received much attention in recent years. This burgeoning field remains highly controversial with empirically-backed disagreements at all levels of evidence, including individual studies, systematic reviews, and even meta-analyses. The current study investigated the effect of a randomized six week online working memory intervention on untrained cognitive abilities in a community-recruited sample of healthy young adults, in relation to both a processing speed training active control condition, as well as a no-contact control condition. Results of traditional null hypothesis significance testing, as well as Bayesian factor analyses, revealed support for the null hypothesis across all cognitive tests administered before and after training. Importantly, all three groups were similar at pre-training for a variety of individual variables purported to moderate transfer of training to fluid intelligence, including personality traits, motivation to train, and expectations of cognitive improvement from training. Because these results are consistent with experimental trials of equal or greater methodological rigor, we suggest that future research re-focus on: 1) other promising interventions known to increase memory performance in healthy young adults, and; 2) examining sub-populations or alternative populations in which working memory training may be efficacious. PMID:28558000

Effects of Supplementation with the Fat-Soluble Vitamins E and D on Fasting Flow-Mediated Vasodilation in Adults: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Joris, Peter J.; Mensink, Ronald P.

2015-01-01

The effects of fat-soluble vitamin supplementation on cardiovascular disease (CVD) risk are not clear. Therefore, we performed a meta-analysis to quantify effects of fat-soluble vitamin supplements on fasting flow-mediated vasodilation (FMD) of the brachial artery, a validated marker to assess CVD risk. Randomized placebo-controlled trials (RCTs) were identified by a systematic search till July 2014. Seven RCTs studying the effects of vitamin E supplements (range: 300 to 1800 IU per day) and nine RCTs examining the effects of vitamin D supplements, that involved, respectively, 303 and 658 adults, were included. No studies with carotenoid or vitamin K supplements were found. Vitamin E supplementation increased FMD vs. control by 2.42% (95% CI: 0.46% to 4.37%; p = 0.015). No effects of vitamin D supplementation were found (0.15%; 95% CI: −0.21% to 0.51%; p = 0.41). These effects did not depend on subject characteristics, treatment characteristics or technical aspects of the FMD measurement. However, no dose-response relationship was evident for vitamin E, statistical significance depended on one study, while the levels of supplement were far above recommended intakes. The current meta-analysis, therefore, does not provide unambiguous evidence to support the use of fat-soluble vitamin supplements to improve fasting FMD in adults. PMID:25763531

Preventing musculoskeletal injuries among recreational adult volleyball players: design of a randomised prospective controlled trial.

PubMed

Gouttebarge, Vincent; Zwerver, Johannes; Verhagen, Evert

2017-08-02

Both acute and overuse injuries are common among recreational volleyball players, especially finger/wrist, ankle, shoulder and knee injuries. Consequently, an intervention ('VolleyVeilig') was developed to prevent or reduce the occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational volleyball players. This article describes the design of a study evaluating the effectiveness of the developed intervention on the one-season occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational adult volleyball players. A randomized prospective controlled trial with a follow-up period of one volleyball season will be conducted. Participants will be healthy recreational adult volleyball players (18 years of age or older) practicing volleyball (training and/or match) at least twice a week. The intervention ('VolleyVeilig') consists of a warm-up program based on more than 50 distinct exercises (with different variations and levels). The effect of the intervention programme on the occurrence of injuries will be compared to volleyball as usual. Outcome measures will be incidence of acute injury (expressed as number of injuries per 1000 h of play) and prevalence of overuse injuries (expressed as percentage). This study will be one of the first randomized prospective controlled trials evaluating the effectiveness of an intervention on the occurrence of both acute and overuse injuries among recreational adult volleyball players. Outcome of this study could possibly lead to the nationwide implementation of the intervention in all volleyball clubs in The Netherlands, ultimately resulting in less injuries. Dutch Trial Registration NTR6202 , registered February 1st 2017. Version 3, February 2017.

Positive Association of Vitamin E Supplementation with Hemoglobin Levels in Mildly Anemic Healthy Pakistani Adults.

PubMed

Jilani, Tanveer; Azam, Iqbal; Moiz, Bushra; Mehboobali, Naseema; Perwaiz Iqbal, Mohammad

2015-01-01

Hemoglobin levels slightly below the lower limit of normal are common in adults in the general population in developing countries. A few human studies have suggested the use of antioxidant vitamins in the correction of mild anemia. The objective of the present study was to investigate the association of vitamin E supplementation in mildly anemic healthy adults with post-supplemental blood hemoglobin levels in the general population of Karachi, Pakistan. In a single-blinded and placebo-controlled randomized trial, 124 mildly anemic subjects from the General Practitioners' Clinics and personnel of the Aga Khan University were randomized into intervention (n = 82) and control (n = 42) group. In the intervention group, each subject was given vitamin E (400 mg) everyday for a period of three months, while control group subjects received a placebo. Eighty six subjects completed the trial. Fasting venous blood was collected at baseline and after three months of supplementation. Hemoglobin levels and serum/plasma concentrations of vitamin E, vitamin B12, folate, ferritin, serum transferrin receptor (sTfR), glucose, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, creatinine, total-antioxidant-status and erythropoietin were measured and analyzed using repeated measures ANOVA and multiple linear regression. The adjusted regression coefficients (β) and standard error [SE(β)] of the significant predictors of post-supplemental hemoglobin levels were serum concentration of vitamin E (0.983[0.095]), gender (- 0.656[0.244]), sTfR (- 0.06[0.02]) and baseline hemoglobin levels (0.768[0.077]). The study showed a positive association between vitamin E supplementation and enhanced hemoglobin levels in mildly anemic adults.

Social problem-solving plus psychoeducation for adults with personality disorder: pragmatic randomised controlled trial.

PubMed

Huband, Nick; McMurran, Mary; Evans, Chris; Duggan, Conor

2007-04-01

Social problem-solving therapy may be relevant in the treatment of personality disorder, although assessments of its effectiveness are uncommon. To determine the effectiveness of a problem-solving intervention for adults with personality disorder in the community under conditions resembling routine clinical practice. Participants were randomly allocated to brief psychoeducation plus 16 problem-solving group sessions (n=87) or to waiting-list control (n=89). Primary outcome was comparison of scores on the Social Problem Solving Inventory and the Social Functioning Questionnaire between intervention and control arms at the conclusion of treatment, on average at 24 weeks after randomisation. In intention-to-treat analysis, those allocated to intervention showed significantly better problem-solving skills (P<0.001), higher overall social functioning (P=0.031) and lower anger expression (P=0.039) compared with controls. No significant differences were found on use of services during the intervention period. Problem-solving plus psychoeducation has potential as a preliminary intervention for adults with personality disorder.

The Moderating Role of Executive Functioning in Older Adults' Responses to a Reminder of Mortality

PubMed Central

Maxfield, Molly; Pyszczynski, Tom; Greenberg, Jeff; Pepin, Renee; Davis, Hasker P.

2011-01-01

In previous research, older adults responded to mortality salience (MS) with increased tolerance, whereas younger persons responded with increased punitiveness. One possible explanation for this is that many older adults adapt to challenges of later life, such as the prospect of mortality, by becoming more flexible. Recent studies suggest that positively-oriented adaptation is more likely for older adults with high levels of executive functioning. We thus hypothesized that the better an older adult's executive functioning, the more likely MS would result in increased tolerance. Older and younger adults were randomly assigned to MS or control conditions, and then evaluated moral transgressors. As in previous research, younger adults were more punitive following reminders of mortality; executive functioning did not affect their responses. Among older adults, high functioning individuals responded to MS with increased tolerance rather than intolerance, whereas those low in functioning became more punitive. PMID:21728445

A Pecan-Rich Diet Improves Cardiometabolic Risk Factors in Overweight and Obese Adults: A Randomized Controlled Trial.

PubMed

McKay, Diane L; Eliasziw, Misha; Chen, C Y Oliver; Blumberg, Jeffrey B

2018-03-11

Evidence from observational and intervention studies has shown a high intake of tree nuts is associated with a reduced risk of cardiovascular disease (CVD), mortality from type 2 diabetes (T2DM), and all-cause mortality. However, there is limited data regarding their effects on indicators of cardiometabolic risk other than hypercholesterolemia, and little is known about the demonstrable health benefits of pecans ( Carya illinoensis (Wangenh.) K.Koch). We conducted a randomized, controlled feeding trial to compare the effects of a pecan-rich diet with an isocaloric control diet similar in total fat and fiber content, but absent nuts, on biomarkers related to CVD and T2DM risk in healthy middle-aged and older adults who are overweight or obese with central adiposity. After 4 weeks on a pecan-rich diet, changes in serum insulin, insulin resistance (HOMA-IR) and beta cell function (HOMA-β) were significantly greater than after the control diet ( p < 0.05). Pecan consumption also lowered the risk of cardiometabolic disease as indicated by a composite score reflecting changes in clinically relevant markers. Thus, compared to the control diet, the pecan intervention had a concurrent and clinically significant effect on several relevant markers of cardiometabolic risk.

A Pecan-Rich Diet Improves Cardiometabolic Risk Factors in Overweight and Obese Adults: A Randomized Controlled Trial

PubMed Central

McKay, Diane L.; Eliasziw, Misha; Chen, C. Y. Oliver

2018-01-01

Evidence from observational and intervention studies has shown a high intake of tree nuts is associated with a reduced risk of cardiovascular disease (CVD), mortality from type 2 diabetes (T2DM), and all-cause mortality. However, there is limited data regarding their effects on indicators of cardiometabolic risk other than hypercholesterolemia, and little is known about the demonstrable health benefits of pecans (Carya illinoensis (Wangenh.) K.Koch). We conducted a randomized, controlled feeding trial to compare the effects of a pecan-rich diet with an isocaloric control diet similar in total fat and fiber content, but absent nuts, on biomarkers related to CVD and T2DM risk in healthy middle-aged and older adults who are overweight or obese with central adiposity. After 4 weeks on a pecan-rich diet, changes in serum insulin, insulin resistance (HOMA-IR) and beta cell function (HOMA-β) were significantly greater than after the control diet (p < 0.05). Pecan consumption also lowered the risk of cardiometabolic disease as indicated by a composite score reflecting changes in clinically relevant markers. Thus, compared to the control diet, the pecan intervention had a concurrent and clinically significant effect on several relevant markers of cardiometabolic risk. PMID:29534487

Socioeconomic status and weight control practices in British adults

PubMed Central

Wardle, J; Griffith, J

2001-01-01

STUDY OBJECTIVE—Attitudes and practices concerning weight control in British adults were examined to test the hypothesis that variation in concern about weight and deliberate weight control might partly explain the socioeconomic status (SES) gradient in obesity. Higher SES groups were hypothesised to show more weight concern and higher levels of dieting.
SETTING—Data were collected as part of the monthly Omnibus Survey of the Office of National Statistics in March 1999.
PARTICIPANTS—A stratified, probability sample of 2690 households was selected by random sampling of addresses in Britain. One randomly selected person in each household was interviewed at their home.
MAIN RESULTS—As predicted, higher SES men and women had higher levels of perceived overweight, monitored their weight more closely, and were more likely to be trying to lose weight. Higher SES groups also reported more restrictive dietary practices and more vigorous physical activity.
CONCLUSIONS—The results are consistent with the idea that part of the protection against weight gain in higher SES groups could be a higher frequency of weight monitoring, a lower threshold for defining themselves as overweight, and a greater likelihood of deliberate efforts at weight control.


Keywords: socioeconomic status; weight control; obesity PMID:11160173

History of foster care among homeless adults with mental illness in Vancouver, British Columbia: a precursor to trajectories of risk.

PubMed

Patterson, Michelle L; Moniruzzaman, Akm; Somers, Julian M

2015-02-26

It is well documented that a disproportionate number of homeless adults have childhood histories of foster care placement(s). This study examines the relationship between foster care placement as a predictor of adult substance use disorders (including frequency, severity and type), mental illness, vocational functioning, service use and duration of homelessness among a sample of homeless adults with mental illness. We hypothesize that a history of foster care predicts earlier, more severe and more frequent substance use, multiple mental disorder diagnoses, discontinuous work history, and longer durations of homelessness. This study was conducted using baseline data from two randomized controlled trials in Vancouver, British Columbia for participants who responded to a series of questions pertaining to out-of-home care at 12 months follow-up (n = 442). Primary outcomes included current mental disorders; substance use including type, frequency and severity; physical health; duration of homelessness; vocational functioning; and service use. In multivariable regression models, a history of foster care placement independently predicted incomplete high school, duration of homelessness, discontinuous work history, less severe types of mental illness, multiple mental disorders, early initiation of drug and/or alcohol use, and daily drug use. This is the first Canadian study to investigate the relationship between a history of foster care and current substance use among homeless adults with mental illness, controlling for several other potential confounding factors. It is important to screen homeless youth who exit foster care for substance use, and to provide integrated treatment for concurrent disorders to homeless youth and adults who have both psychiatric and substance use problems. Both trials are registered with the International Standard Randomized Control Trial Number Register and were assigned ISRCTN57595077 (Vancouver At Home Study: Housing First plus assertive community treatment versus congregate housing plus supports versus treatment as usual) and ISRCTN66721740 (Vancouver At Home Study: Housing First plus intensive case management versus treatment as usual) on September 9, 2012.

Effectiveness of Individual Placement and Support Supported Employment for Young Adults

PubMed Central

Bond, Gary R.; Drake, Robert E.; Campbell, Kikuko

2015-01-01

Objective The Individual Placement and Support (IPS) model of supported employment was first developed in community mental health centers for adults with severe mental illness. While IPS is an established evidence-based practice in this broad population, evidence on its effectiveness focused specifically on young adults has been limited. The current study aimed to address this gap. Methods To investigate the effects of IPS on young adults, the authors conducted a secondary analysis on a pooled sample of 109 unemployed young adults (under age 30) from four randomized controlled trials employing a common research protocol that included a standardized measurement battery and rigorous fidelity monitoring. Researchers assessed these participants over 18 months on nine competitive employment outcome measures. Results On all measures the IPS group had significantly better employment outcomes. Overall, 40 (82%) of IPS participants obtained employment during follow-up compared to 25 (42%) of control participants, Χ2 =17.9, p < .001. IPS participants averaged 25.0 weeks of employment, compared to 7.0 weeks for control participants, t = 4.50, p < .001. Conclusions The current analysis supports a small number of previous studies in showing that IPS is highly effective in helping young adults to attain competitive employment. When young adults acquire competitive jobs and initiate a path toward normal adult roles, they may avoid the cycle of disability and psychiatric patient roles that are demeaning and demoralizing. PMID:25138195

Cognitive-behavioral therapy for ADHD in medication-treated adults with continued symptoms.

PubMed

Safren, Steven A; Otto, Michael W; Sprich, Susan; Winett, Carol L; Wilens, Timothy E; Biederman, Joseph

2005-07-01

The purpose of the present study was to examine the potential efficacy, patient acceptability, and feasibility of a novel, cognitive-behavioral therapy (CBT) for adults with attention-deficit hyperactivity disorder (ADHD) who have been stabilized on medications but still show clinically significant symptoms. Thirty-one adults with ADHD and stable psychopharmacology for ADHD were randomized to CBT plus continued psychopharmacology or continued psychopharmacology alone. Assessments included ADHD severity and associated anxiety and depression rated by an independent evaluator (IE) and by self-report. At the outcome assessment, those who were randomized to CBT had lower IE-rated ADHD symptoms (p < .01) and global severity (p < .002), as well as self-reported ADHD symptoms (p < .0001) than those randomized to continued psychopharmacology alone. Those in the CBT group also had lower IE-rated and self-report anxiety (p's < .04), lower IE-rated depression (p < .01), and a trend to have lower self-reported depression (p = .06). CBT continued to show superiority over continued psychopharmacology alone when statistically controlling levels of depression in analyses of core ADHD symptoms. There were significantly more treatment responders among patients who received CBT (56%) compared to those who did not (13%) (p < .02). These data support the hypothesis that CBT for adults with ADHD with residual symptoms is a feasible, acceptable, and potentially efficacious next-step treatment approach, worthy of further testing.

Sleep Quality and Body Composition Variations in Obese Male Adults after 14 Weeks of Yoga Intervention: A Randomized Controlled Trial

PubMed Central

Rshikesan, PB; Subramanya, Pailoor; Singh, Deepeshwar

2017-01-01

Background: Obesity is a big challenge all over the world. It is associated with many noncommunicable diseases. Yoga known to be add-on treatment may be effective for obesity control. Aim: To assess the effect of integrated approach of yoga therapy (IAYT) for body composition and quality of sleep in adult obese male. Subjects and Methods: A randomized controlled trial was conducted for 14 weeks on obese male of urban setting. Eighty individuals were randomly divided into two groups, i.e., yoga group (n = 40; age; 40.03 ± 8.74 years, body mass index [BMI] 28.7 ± 2.35 kg/m2) and control group (age; 42.20 ± 12.06 years, BMI 27.70 ± 2.05 kg/m2). The IAYT was imparted to yoga group for 1½ hour for 5 days in a week for 14 weeks. The control group continued their regular activities. The body composition by InBody R20 and sleep quality by Pittsburgh Sleep Quality Index (PSQI) were assessed. Statistical analysis was done for within and between groups using SPSS version 21. The correlation analysis was done on the difference in pre-post values. Results: The results showed that weight (P = 0.004), BMI (P = 0.008), bone mass (P = 0.017), obesity degree (P = 0.005), and mineral mass (P = 0.046) were improved in yoga group and no change in control group (P > 0.05). The global score of PSQI improved (P = 0.017) in yoga group alone. Conclusion: The results indicate the beneficial effects of IAYT on body composition and sleep quality in obese males. The yoga practice may reduce obesity with the improvement in quality of life. PMID:29422743

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

PubMed

Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

2016-06-01

To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

Transscleral Selective Laser Trabeculoplasty Without a Gonioscopy Lens.

PubMed

Geffen, Noa; Ofir, Shay; Belkin, Avner; Segev, Fani; Barkana, Yaniv; Kaplan Messas, Audrey; Assia, Ehud I; Belkin, Michael

2017-03-01

The purpose of the study was to investigate results of selective laser trabeculoplasty (SLT) performed directly on the sclera without a gonioscopy lens. Interventional case series, prospective, randomized, masked, controlled clinical trial. Setting: Meir Medical Center, Kfar-Saba, Israel. Adults with uncontrolled primary open angle or pseudoexfoliation glaucoma randomized into 2 groups. The controls underwent conventional SLT with 100 spots delivered using a gonioscopy lens for 360 degrees of the trabecular meshwork. The study group underwent irradiation using the same parameters with the laser applications administered on the perilimbal sclera. Study visits: 1 hour, 1, 7, 30, 60, 180, and 365 days postprocedure. Intraocular pressure (IOP) and side effects. Thirty adults were randomized into 2 groups. The mean (±SD) pretreatment IOP was 20.21±3.19 mm Hg for the study group (n=14) and 21.14±2.98 mm Hg for the controls (n=14; P =0.43), dropping to 15.50±3.77 and 15.00±4.08 mm Hg (P =0.74) after 6 months and to 16.00±3.31 and 14.00±2.45 mm Hg (P =0.22) after 12 months. The average IOP reduction after 6 and 12 months was 23.4% and 20.83% for the study group and 27.1% and 33.77% for the controls (P=0.528). Success (a decrease of ≥15% at 6 months with no additional medications, laser, or glaucoma surgery) was achieved in 12 (85.7%) study patients and 9 (69.2%) controls (P=0.385). Complications were mild and transient (n=30), although significantly higher in the controls (n=15; P <0.0001). SLT applied directly to the perilimbal sclera may be as efficacious as the conventional procedure for 1 year.

Green tea (Camellia sinensis) for patients with knee osteoarthritis: A randomized open-label active-controlled clinical trial.

PubMed

Hashempur, Mohammad Hashem; Sadrneshin, Sara; Mosavat, Seyed Hamdollah; Ashraf, Alireza

2018-02-01

Green tea is known as a dietary supplement and a novel functional food worldwide. Since there are increasing preclinical evidence about efficacy of green tea for treating osteoarthritis, this study has aimed at assessing its efficacy and safety for patients with knee osteoarthritis. This is a randomized open-label active-controlled clinical trial. As many as fifty adults with osteoarthritis of knee were randomly allocated to receive the green tea extract (in dosage form of tablet) plus diclofenac tablet as "intervention group"; or: diclofenac tablet alone as "control group" for a period of four weeks. Patients were assessed at the beginning of intervention, and then 4 weeks later, in terms of pain score via visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire's total score in addition to its 3 sub-scores. Furthermore, they were asked about any adverse effects during intervention period. Mean differences of VAS pain, total WOMAC, and WOMAC physical function scores in green tea group showed a significant reduction, compared with the control group (P = 0.038, P = 0.006, and P = 0.004, respectively). However, No significant differences between the two groups were observed, regarding mean differences of WOMAC pain and stiffness scores of the enrolled patients (P = 0.163, and P = 0.150, respectively). Additionally, only 1 patient reported gastric upset [in control group]. It seems that green tea extract might well be considered as an adjunctive treatment both for control of pain and for the betterment of knee joint physical function in adults with osteoarthritis. However, further studies of longer duration and larger sample size are needed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Space Fortress game training and executive control in older adults: A pilot intervention

PubMed Central

Stern, Yaakov; Blumen, Helena M.; Rich, Leigh W.; Richards, Alexis; Herzberg, Gray; Gopher, Daniel

2012-01-01

We investigated the feasibility of using the Space Fortress (SF) game, a complex video game originally developed to study complex skill acquisition in young adults, to improve executive control processes in cognitively healthy older adults. The study protocol consisted of 36 one-hour game play sessions over 3 months with cognitive evaluations before and after, and a follow-up evaluation at 6 months. Sixty participants were randomized to one of three conditions: Emphasis Change (EC) – elders were instructed to concentrate on playing the entire game but place particular emphasis on a specific aspect of game play in each particular game; Active Control (AC) – game play with standard instructions; Passive Control (PC) – evaluation sessions without game play. Primary outcome measures were obtained from five tasks, presumably tapping executive control processes. A total of 54 older adults completed the study protocol. One measure of executive control, WAIS-III letter–number sequencing, showed improvement in performance from pre- to post-evaluations in the EC condition, but not in the other two conditions. These initial findings are modest but encouraging. Future SF interventions need to carefully consider increasing the duration and or the intensity of the intervention by providing at-home game training, reducing the motor demands of the game, and selecting appropriate outcome measures. PMID:21988726

A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

ERIC Educational Resources Information Center

Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

2011-01-01

Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

PubMed Central

Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

2015-01-01

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states. PMID:25569274

Effect of Nutrients, Dietary Supplements and Vitamins on Cognition: a Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Forbes, Scott C.; Holroyd-Leduc, Jayna M.; Poulin, Marc J.; Hogan, David B.

2015-01-01

Background Observational studies have suggested that various nutrients, dietary supplements, and vitamins may delay the onset of age-associated cognitive decline and dementia. We systematically reviewed recent randomized controlled trials investigating the effect of nutritional interventions on cognitive performance in older non-demented adults. Methods We searched MEDLINE, CINAHL, Embase, and the Cochrane Library for articles published between 2003 and 2013. We included randomized trials of ≥ 3 months’ duration that examined the cognitive effects of a nutritional intervention in non-demented adults > 40 years of age. Meta-analyses were done when sufficient trials were available. Results Twenty-four trials met inclusion criteria (six omega-3 fatty acids, seven B vitamins, three vitamin E, eight other interventions). In the meta-analyses, omega-3 fatty acids showed no significant effect on Mini-Mental State Examination (MMSE) scores (four trials, mean difference 0.06, 95% CI −0.08 – 0.19) or digit span forward (three trials, mean difference −0.02, 95% CI −0.30 – 0.25), while B vitamins showed no significant effect on MMSE scores (three trials, mean difference 0.02, 95% CI −0.22 – 0.25). None of the vitamin E studies reported significant effects on cognitive outcomes. Among the other nutritional interventions, statistically significant differences between the intervention and control groups on at least one cognitive domain were found in single studies of green tea extract, Concord grape juice, chromium picolinate, beta-carotene, two different combinations of multiple vitamins, and a dietary approach developed for the control of hypertension. Conclusions Omega-3 fatty acids, B vitamins, and vitamin E supplementation did not affect cognition in non-demented middle-aged and older adults. Other nutritional interventions require further evaluation before their use can be advocated for the prevention of age-associated cognitive decline and dementia. PMID:26740832

Comparison between ultrasound guided technique and digital palpation technique for radial artery cannulation in adult patients: An updated meta-analysis of randomized controlled trials.

PubMed

Bhattacharjee, Sulagna; Maitra, Souvik; Baidya, Dalim K

2018-06-01

Possible advantages and risks associated with ultrasound guided radial artery cannulation in-comparison to digital palpation guided method in adult patients are not fully known. We have compared ultrasound guided radial artery cannulation with digital palpation technique in this meta-analysis. Meta-analysis of randomized controlled trials. Trials conducted in operating room, emergency department, cardiac catheterization laboratory. PubMed and Cochrane Central Register of Controlled Trials (CENTRAL) were searched (from 1946 to 20th November 2017) to identify prospective randomized controlled trials in adult patients. Two-dimensional ultrasound guided radial artery catheterization versus digital palpation guided radial artery cannulation. Overall cannulation success rate, first attempt success rate, time to cannulation and mean number of attempts to successful cannulation. Odds ratio (OR) and standardized mean difference (SMD) or mean difference (MD) with 95% confidence interval (CI) were calculated for categorical and continuous variables respectively. Data of 1895 patients from 10 studies have been included in this meta- analysis. Overall cannulation success rate was similar between ultrasound guided technique and digital palpation [OR (95% CI) 2.01 (1.00, 4.06); p = 0.05]. Ultrasound guided radial artery cannulation is associated with higher first attempt success rate of radial artery cannulation in comparison to digital palpation [OR (95% CI) 2.76 (186, 4.10); p < 0.001]. No difference was seen in time to cannulate [SMD (95% CI) -0.31 (-0.65, 0.04); p = 0.30] and mean number of attempt [MD (95% CI) -0.65 (-1.32, 0.02); p = 0.06] between USG guided technique with palpation technique. Radial artery cannulation by ultrasound guidance may increase the first attempt success rate but not the overall cannulation success when compared to digital palpation technique. However, results of this meta-analysis should be interpreted with caution due presence of heterogeneity. Copyright © 2018 Elsevier Inc. All rights reserved.

Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial.

PubMed

Patel, Mitesh S; Asch, David A; Rosin, Roy; Small, Dylan S; Bellamy, Scarlett L; Heuer, Jack; Sproat, Susan; Hyson, Chris; Haff, Nancy; Lee, Samantha M; Wesby, Lisa; Hoffer, Karen; Shuttleworth, David; Taylor, Devon H; Hilbert, Victoria; Zhu, Jingsan; Yang, Lin; Wang, Xingmei; Volpp, Kevin G

2016-03-15

Financial incentive designs to increase physical activity have not been well-examined. To test the effectiveness of 3 methods to frame financial incentives to increase physical activity among overweight and obese adults. Randomized, controlled trial. (ClinicalTrials.gov: NCT 02030119). University of Pennsylvania. 281 adult employees (body mass index ≥27 kg/m2). 13-week intervention. Participants had a goal of 7000 steps per day and were randomly assigned to a control group with daily feedback or 1 of 3 financial incentive programs with daily feedback: a gain incentive ($1.40 given each day the goal was achieved), lottery incentive (daily eligibility [expected value approximately $1.40] if goal was achieved), or loss incentive ($42 allocated monthly upfront and $1.40 removed each day the goal was not achieved). Participants were followed for another 13 weeks with daily performance feedback but no incentives. Primary outcome was the mean proportion of participant-days that the 7000-step goal was achieved during the intervention. Secondary outcomes included the mean proportion of participant-days achieving the goal during follow-up and the mean daily steps during intervention and follow-up. The mean proportion of participant-days achieving the goal was 0.30 (95% CI, 0.22 to 0.37) in the control group, 0.35 (CI, 0.28 to 0.42) in the gain-incentive group, 0.36 (CI, 0.29 to 0.43) in the lottery-incentive group, and 0.45 (CI, 0.38 to 0.52) in the loss-incentive group. In adjusted analyses, only the loss-incentive group had a significantly greater mean proportion of participant-days achieving the goal than control (adjusted difference, 0.16 [CI, 0.06 to 0.26]; P = 0.001), but the adjusted difference in mean daily steps was not significant (861 [CI, 24 to 1746]; P = 0.056). During follow-up, daily steps decreased for all incentive groups and were not different from control. Single employer. Financial incentives framed as a loss were most effective for achieving physical activity goals. National Institute on Aging.

A randomized controlled evaluation of the tobacco status project, a Facebook intervention for young adults.

PubMed

Ramo, Danielle E; Thrul, Johannes; Delucchi, Kevin L; Hall, Sharon; Ling, Pamela M; Belohlavek, Alina; Prochaska, Judith J

2018-05-24

To test the efficacy of the Tobacco Status Project (TSP) Facebook smoking cessation intervention for young adults relative to referral to an on-line program on biochemically verified 7-day abstinence from smoking. Two-group parallel randomized controlled trial, comparing TSP (n = 251) to on-line control (n = 249) with follow-up to 12 months. On-line, throughout the United States. Young adult cigarette smokers (mean age 21 years; 73% white, 55% female, 87% daily smokers). TSP provided private Facebook groups tailored to stage of change to quit smoking, daily contacts, weekly live counseling sessions, and for those ready to quit, six cognitive behavioral therapy counseling sessions. Some TSP groups were assigned randomly to receive a monetary incentive for engagement. Control provided referral to the National Cancer Institute Smokefree.gov website. PRIMARY OUTCOME: Biochemically verified 7-day abstinence over 12 months. Post-treatment (3-month) abstinence; reported abstinence, quit attempt, reduction in smoking, readiness to quit smoking over 12 months. Verified 7-day abstinence was not significantly different for intervention compared with control over 1 year: month 3 (8.3 versus 3.2%), 6 (6.2 versus 6.0%), and 12 (5.9 versus 10.0%); odds ratio (OR) = 1.07; 95% confidence interval (CI) = 0.23, 4.97; retention = 71%. There was an effect at 3 months (OR = 2.52; CI = 1.56, 4.04; P < 0.0001). There were no 12-month treatment effects for reported abstinence (P = 0.746), reduction in smoking by 50% or more (P = 0.533), likelihood of having made a quit attempt (P = 0.387) or stage of change over time (0.968). Participants in TSP engaged more and rated the intervention more favorably than those in the control condition. Compared with referral to a smoking cessation website, a novel USA-focused Facebook smoking cessation intervention did not improve abstinence from smoking over 1 year, but increased abstinence at the end of treatment and was engaging to participants. © 2018 Society for the Study of Addiction.

Following the Physical Activity Guidelines for Adults With Spinal Cord Injury for 16 Weeks Does Not Improve Vascular Health: A Randomized Controlled Trial.

PubMed

Totosy de Zepetnek, Julia O; Pelletier, Chelsea A; Hicks, Audrey L; MacDonald, Maureen J

2015-09-01

To evaluate the effects of following the physical activity guidelines (PAG) for adults with spinal cord injury (SCI) for 16 weeks. Randomized controlled trial. Community exercise program. Individuals with SCI (N=23; neurological level of injury, C3-T11; American Spinal Injury Association Impairment Scale A-C; time postinjury, 12.0±9.9 y; age, 41.4±11.6 y). Participants were randomly assigned to PAG training (n=12) or active control (n=11) groups. PAG training involved ≥20 minutes of moderate-vigorous aerobic exercise (rating of perceived exertion 3-6 on 10-point scale) and 3×10 repetitions of upper-body strengthening exercises (50%-70% 1 repetition maximum) 2 times per week. The control group maintained existing physical activity levels with no guidance on training intensity. Outcome measures were obtained pre- and postintervention. Vascular health indicators included arterial stiffness via carotid distensibility and pulse wave velocity, and endothelial function via flow-mediated-dilation. Fasted blood samples were analyzed for markers of cardiovascular disease (CVD) risk. Body composition was assessed via anthropometrics and with dual-energy x-ray absorptiometry. Twenty-one individuals completed the intervention (PAG=12, control=9). Group-by-time interactions were observed for whole-body mass (P=.03), whole-body fat (P=.04), visceral adipose tissue (P=.04), and carotid artery distensibility (P=.05), suggesting maintained body composition and carotid stiffness in the PAG group concurrent with declines in the control group. No changes were found in any other outcome measure. While 16 weeks of adherence to the PAG in adults with SCI is insufficient to improve many markers of CVD risk, it may prevent declines in others. The PAG should continue to be promoted as a means to increase physical fitness and maintain body composition in individuals with SCI, but changes may be needed to achieve other health outcomes. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Heat and moisture exchangers (HMEs) and heated humidifiers (HHs) in adult critically ill patients: a systematic review, meta-analysis and meta-regression of randomized controlled trials.

PubMed

Vargas, Maria; Chiumello, Davide; Sutherasan, Yuda; Ball, Lorenzo; Esquinas, Antonio M; Pelosi, Paolo; Servillo, Giuseppe

2017-05-29

The aims of this systematic review and meta-analysis of randomized controlled trials are to evaluate the effects of active heated humidifiers (HHs) and moisture exchangers (HMEs) in preventing artificial airway occlusion and pneumonia, and on mortality in adult critically ill patients. In addition, we planned to perform a meta-regression analysis to evaluate the relationship between the incidence of artificial airway occlusion, pneumonia and mortality and clinical features of adult critically ill patients. Computerized databases were searched for randomized controlled trials (RCTs) comparing HHs and HMEs and reporting artificial airway occlusion, pneumonia and mortality as predefined outcomes. Relative risk (RR), 95% confidence interval for each outcome and I 2 were estimated for each outcome. Furthermore, weighted random-effect meta-regression analysis was performed to test the relationship between the effect size on each considered outcome and covariates. Eighteen RCTs and 2442 adult critically ill patients were included in the analysis. The incidence of artificial airway occlusion (RR = 1.853; 95% CI 0.792-4.338), pneumonia (RR = 932; 95% CI 0.730-1.190) and mortality (RR = 1.023; 95% CI 0.878-1.192) were not different in patients treated with HMEs and HHs. However, in the subgroup analyses the incidence of airway occlusion was higher in HMEs compared with HHs with non-heated wire (RR = 3.776; 95% CI 1.560-9.143). According to the meta-regression, the effect size in the treatment group on artificial airway occlusion was influenced by the percentage of patients with pneumonia (β = -0.058; p = 0.027; favors HMEs in studies with high prevalence of pneumonia), and a trend was observed for an effect of the duration of mechanical ventilation (MV) (β = -0.108; p = 0.054; favors HMEs in studies with longer MV time). In this meta-analysis we found no superiority of HMEs and HHs, in terms of artificial airway occlusion, pneumonia and mortality. A trend favoring HMEs was observed in studies including a high percentage of patients with pneumonia diagnosis at admission and those with prolonged MV. However, the choice of humidifiers should be made according to the clinical context, trying to avoid possible complications and reaching the appropriate performance at lower costs.

A Web-Based Psychoeducational Intervention Program for Depression and Anxiety in an Adult Community in Selangor, Malaysia: Protocol of a Randomized Controlled Trial.

PubMed

Kader Maideen, Siti Fatimah; Mohd-Sidik, Sherina; Rampal, Lekhraj; Mukhtar, Firdaus; Ibrahim, Normala; Phang, Cheng-Kar; Tan, Kit-Aun; Ahmad, Rozali

2016-06-21

Mental disorders are a major public health problem and are debilitating in many nations throughout the world. Many individuals either do not or are not able to access treatment. The Internet can be a medium to convey to the community accessible evidenced-based interventions to reduce these burdens. The objective of this study is to investigate the effectiveness of 4 weeks of a Web-based psychoeducational intervention program for depressive and anxiety symptoms in the community of Selangor, Malaysia. A two-arm randomized controlled trial of a single-blind study will be conducted to meet the objective of this study. We aim to recruit 84 participants each for the intervention and control groups. The recruitment will be from participants who participated in the first phase of this research. The primary outcomes of this study are depressive and anxiety scores, which will be assessed using the Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7, respectively. The secondary outcome includes mental health literacy of the participants, which will be assessed using the self-developed and adapted Mental Health Literacy Questionnaire. The psychoeducational intervention program consists of four sessions, which will be accessed each week. The depressive and anxiety symptoms will be compared between participants who participated in the psychoeducational program compared with the control group. Depressive and anxiety scores and mental health literacy will be assessed at week 1 and at follow-ups at week 5 and week 12, respectively. The psychoeducational intervention program consists of four sessions, which will be accessed at each week. The depressive and anxiety symptoms will be compared between the intervention and control groups using a series of mixed ANOVAs. Depressive and anxiety scores and mental health literacy will be assessed at week 1 and at two follow-ups at week 5 and week 12, respectively. To our knowledge, this study will be the first randomized controlled trial of a Web-based psychoeducational intervention program for depression and anxiety in an adult community in Malaysia. The results from this study will determine the effectiveness of a psychoeducational intervention program in the management of depression and anxiety among adults in the community. If proven to be effective, the intervention can serve as a new modality to manage and reduce the burden of these disorders in the community. International Standard Randomized Controlled Trial Number (ISRCTN): 39656144; http://www.isrctn.com/ISRCTN39656144 (Archived by WebCite at http://www.webcitation.org/6hSVhV71K).

High-fluoride toothpaste: a multicenter randomized controlled trial in adults

PubMed Central

Srinivasan, Murali; Schimmel, Martin; Riesen, Martine; Ilgner, Alexander; Wicht, Michael J; Warncke, Michael; Ellwood, Roger P; Nitschke, Ina; Müller, Frauke; Noack, Michael J

2014-01-01

Objective The aim of this single – blind, multicenter, parallel, randomized controlled trial was to evaluate the effectiveness of the application of a high-fluoride toothpaste on root caries in adults. Methods Adult patients (n = 130, ♂ = 74, ♀ = 56; mean age ± SD: 56.9 ± 12.9) from three participating centers, diagnosed with root caries, were randomly allocated into two groups: Test (n = 64, ♂ = 37, ♀ = 27; lesions = 144; mean age: 59.0 ± 12.1; intervention: high-fluoride toothpaste with 5000 ppm F), and Control (n = 66, ♂ = 37, ♀ = 29; lesions = 160; mean age: 54.8 ± 13.5; intervention: regular-fluoride toothpaste with 1350 ppm F) groups. Clinical examinations and surface hardness scoring of the carious lesions were performed for each subject at specified time intervals (T0 – at baseline before intervention, T1 – at 3 months and T2 – at 6 months after intervention). Mean surface hardness scores (HS) were calculated for each patient. Statistical analyses comprised of two-way analysis of variance and post hoc comparisons using the Bonferroni–Dunn correction. Results At T0, there was no statistical difference between the two groups with regard to gender (P = 0.0682, unpaired t-test), or age (P = 0.9786, chi-squared test), and for the overall HS (Test group: HS = 3.4 ± 0.61; Control group: HS = 3.4 ± 0.66; P = 0.8757, unpaired t-test). The anova revealed significantly better HS for the test group than for the control groups (T1: Test group: HS = 2.9 ± 0.67; Control group: HS = 3.1 ± 0.75; T2: Test group: HS = 2.4 ± 0.81; Control group: HS = 2.8 ± 0.79; P < 0.0001). However, the interaction term time-point*group was not significant. Conclusions The application of a high-fluoride containing dentifrice (5000 ppm F) in adults, twice daily, significantly improves the surface hardness of otherwise untreated root caries lesions when compared with the use of regular fluoride containing (1350 ppm F) toothpastes. PMID:24354454

A randomized controlled trial of a commercially available weight loss program

USDA-ARS?s Scientific Manuscript database

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians refer obese adults for intensive, multi-component behavioral counseling, yet most obese Americans choose a self-help approach to lose weight. The current study examined weight loss between a community-based, intensive behavi...

Dialectical Behavior Therapy for Adolescents: Theory, Treatment Adaptations, and Empirical Outcomes

ERIC Educational Resources Information Center

MacPherson, Heather A.; Cheavens, Jennifer S.; Fristad, Mary A.

2013-01-01

Dialectical behavior therapy (DBT) was originally developed for chronically suicidal adults with borderline personality disorder (BPD) and emotion dysregulation. Randomized controlled trials (RCTs) indicate DBT is associated with improvements in problem behaviors, including suicide ideation and behavior, non-suicidal self-injury (NSSI), attrition,…