Science.gov

Sample records for 12-week intervention period

  1. Effects of a 12-week intervention period with football and running for habitually active men with mild hypertension.

    PubMed

    Knoepfli-Lenzin, C; Sennhauser, C; Toigo, M; Boutellier, U; Bangsbo, J; Krustrup, P; Junge, A; Dvorak, J

    2010-04-01

    The present study examined the effect of football (F, n=15) training on the health profile of habitually active 25-45-year-old men with mild hypertension and compared it with running (R, n=15) training and no additional activity (controls, C, n=17). The participants in F and R completed a 1-h training session 2.4 times/week for 12 weeks. Systolic and diastolic blood pressure decreased in all groups but the decrease in diastolic blood pressure in F (-9 +/- 5 (+/- SD) mmHg) was higher than that in C (-4 +/- 6 mmHg). F was as effective as R in decreasing body mass (-1.6 +/- 1.8 vs-1.5 +/- 2.1 kg) and total fat mass (-2.0 +/- 1.5 vs -1.6 +/- 1.5 kg) and in increasing supine heart rate variability, whereas no changes were detected for C. Maximal stroke volume improved in F (+13.1%) as well as in R (+10.1%) compared with C (-4.9%). Total cholesterol decreased in F (5.8 +/- 1.2 to 5.5 +/- 0.9 mmol/L) but was not altered in R and C. We conclude that football training, consisting of high-intensity intermittent exercise, results in positive effects on blood pressure, body composition, stroke volume and supine heart rate variability, and elicits at least the same cardiovascular health benefits as continuous running exercise in habitually active men with mild hypertension.

  2. The feasibility and benefits of a 12-week yoga intervention for pediatric cancer out-patients.

    PubMed

    Wurz, Amanda; Chamorro-Vina, Carolina; Guilcher, Gregory M T; Schulte, Fiona; Culos-Reed, S Nicole

    2014-10-01

    Increasing rates of survival present a new set of psychosocial and physical challenges for children undergoing treatment for cancer. Physical activity (PA) has been shown to be a safe and effective strategy to mitigate the significant burden of cancer and its treatments, with yoga increasingly gaining recognition as a gentle alternative. The purpose of this study was to determine the feasibility and benefits of a 12-week community-based yoga intervention on health-related quality of life (HRQL), select physical fitness outcomes and PA levels (PAL). Eight pediatric cancer out-patients (4 male; 4 female; Mage  = 11.88, SD = 4.26) participated in the 12-week intervention consisting of supervised yoga sessions 2 times/week. Participants (patients and parent proxies) completed measures assessing HRQL, physical fitness and PAL at baseline and post-intervention. Rates of recruitment, retention, attendance and adverse events indicated the program was feasible. Wilcoxon Signed Rank tests indicated significant improvements for patient (P = 0.02) and parent reported HRQL (P = 0.03), functional mobility (P = 0.01), hamstring flexibility (left, P = 0.01 and right P = 0.02), and total PAL (P = 0.02) pre to post intervention. This 12-week community-based yoga intervention was feasible and provides preliminary evidence for the benefits of yoga on HRQL, physical fitness and PAL in pediatric cancer out-patients. In a population where sedentary behavior and the associated co-morbidities are a growing concern, these results promote the continued exploration of yoga programming. © 2014 Wiley Periodicals, Inc.

  3. Fidelity to a 12-week structured medication adherence intervention in patients with HIV.

    PubMed

    Erlen, Judith A; Sereika, Susan M

    2006-01-01

    Researchers have been conducting efficacy and effectiveness studies on interventions that address medication-taking behavior in patients with HIV infection. However, they also must examine the fidelity to the research protocol for the delivery of the intervention. The aims of this study were to determine the level of fidelity to each of the specified end points (number of intervention sessions, session duration, number of telephone calls per session, the length of time between sessions, sessions with multiple interventions, and attrition from the intervention protocol) in the delivery of the 12-week, nurse-delivered, structured telephone intervention designed to improve medication adherence and to determine the factors (race, gender, and socioeconomic status) related to participation in the intervention. This descriptive correlational study was a substudy of a larger randomized clinical trial (N = 200) testing the effectiveness of a 12-week nurse-delivered intervention designed to improve medication adherence to antiretroviral medications in persons with HIV infection. The Intervention Tracking Form was used to collect data on all intervention delivery end points during the delivery of the structured intervention. A sociodemographic questionnaire was used to collect the sociodemographic characteristics of the sample. Two thirds of the sample (n = 66) were male, and slightly more than half were White. The average age was 39.68 (SD = 7.98) years. The average number of intervention sessions delivered was 8.1 (SD = 4.07). Participants were more likely to receive the first five intervention sessions (n = 77, 77.8%), and 21 (21.2%) dropped out of treatment before it was completed. Nearly one quarter (n = 24, 24.2%) of the sample had doubled-up interventions. Intervention sessions lasted, on average, 11.3 min. Typically, more than one telephone call was needed before the participant was reached (M = 2.2). The mean number of days between sessions was 11.5 days. Women were

  4. [Cost Effectiveness of Treatments of Psoriasis with a PASI 75 and one Period of 12 Weeks].

    PubMed

    Alfageme Roldán, Fernando; Bermejo Hernando, Almudena; Calvo González, José Luís; Marqués Sánchez, Pilar

    2016-04-13

    The objective was to evaluate the efficiency (relation between the cost and the results in health) of the treatments in psoriasis, seeking a higher quality of economic evaluations, consistency and transparency in these studies. We developed a model of economic evaluation in psoriasis collecting all the many direct and indirect costs of each treatment. The effectiveness indicator used was Psoriasis Area Severity Index [PASI 75] which is generally acceptable in studies of psoriasis. The effectiveness indicator was a PASI 75.Subsequently we calculated the Incremental Cost-Effectiveness Ratio (ICER) for the period of 12 weeks and PASI 75, ordering treatments by level of effectiveness at the expense of treatment costs. The most cost effective treatment was methotrexate (ICER -7.5) followed by acitretin (ICER 29.5). The least cost has proved effective PUVA (ICER 4,651), followed by UVB narrow band (2,886.1). when taking into account both direct and indirect costs together with efficiency, methotrexate is the most cost effective treatment.

  5. It's Time to Start Changing the Game: A 12-Week Workplace Team Sport Intervention Study.

    PubMed

    Brinkley, Andrew; McDermott, Hilary; Grenfell-Essam, Rachel; Munir, Fehmidah

    2017-08-23

    A 12-week multi-team sport programme was provided to employees of a large services organisation and conducted in workplaces. This programme was used to investigate the short-term effect of regular sports team participation on individual employee and organisational health. A large services organisation participated in this study. Two regional worksites of office workers were assigned as the team sport (intervention) (n = 28 participants) or control (n = 20 participants) groups. The team sport sessions were underpinned by psychological behaviour change theory and consisted of weekly 1-h team sport sessions for 12 weeks. Measures of aerobic fitness, physical activity behaviour, group cohesion, interaction and communication, psychological wellbeing, health, anthropometrics and workplace experiences were recorded pre- and post-intervention. Data were analysed using a series of mixed ANOVAs. After 12 weeks significant improvements were observed in VO2 max (+ 4.5 ± 5.8 ml/min kg, P < .002, η (2)p = .182), interpersonal communication within teams (+ 3%, P < .042, η (2)p = .087) and mean weekly physical activity duration (+ 154.74', P < .002, η (2)p = .071) in the intervention group. A significant (P < .012, η (2)p = .130) effect on body composition was observed in the intervention group. Participation in team sport may be an effective method to improve the aerobic fitness and physical activity behaviour of employees, and promote interpersonal communication between colleagues. Individual health outcomes and social interactions have the capacity to influence the health of the organisation. The extent of which these findings are replicable across a scope of organisations should be examined objectively over the long term.

  6. A 12-week Interdisciplinary Intervention Program for Children who are Obese

    PubMed Central

    Taylor, Laura; Williamson, Megan; Robinson, Chris

    2011-01-01

    Childhood obesity is a growing problem, for which multi-disciplinary interventions are needed. Purpose: This interdisciplinary intervention program was designed to improve the health of children who were obese. Methods: Twenty-five children, mean age 8.1 (1.5) years; body mass index (BMI)> 98th percentile, and their parents completed the 12-week (3 days/wk) intervention consisting of aerobic and resistance exercise appropriate to age and developmental levels. Baseline and posttest measures of blood values, fitness, and cardiovascular risk factors were performed. Data were analyzed using paired t-tests with significance accepted at P ≤ .05. Results: Significant differences between means (SD) for pre- and post-measurements were, respectively: BMI 30.31 (4.56), 27.80 (4.54), body-fat percent 43.7 (11.5), 40.7 (10.9), waist circumference 82.1 (7.1), 80.4(6.1) cm, calf circumference 34.2 (3.1), 35.2 (3.1) cm; step-test heart rate 137 (20), 126 (12) bpm, push-ups 1.0 (1.8), 5.6 (3.8), sit-ups 23.6 (12.7), 33.2 (13.8), sit-and-reach 35.1 (7.4), 41.2 (5.8) cm; systolic BP 102 (10), 108 (9) mmHg, glucose 4.9(0.3), 4.8 (0.4) mmol/L, total cholesterol 4.6 (1.0), 4.2 (0.8) mmol/L, ALT 41 (9), 35 (8) U/L, bilirubin 6.3 (2.4), 5.6 (2.1) μmol/L, and BUN 4.9 (1.1), 4.3 (0.9) mmol/L. Conclusions: This interdisciplinary intervention program positively affected the fitness and health status of children who were obese by involving the children and parents. PMID:22163176

  7. A 12-week Interdisciplinary Intervention Program for Children who are Obese.

    PubMed

    Farris, James W; Taylor, Laura; Williamson, Megan; Robinson, Chris

    2011-12-01

    Childhood obesity is a growing problem, for which multi-disciplinary interventions are needed. This interdisciplinary intervention program was designed to improve the health of children who were obese. Twenty-five children, mean age 8.1 (1.5) years; body mass index (BMI)> 98(th) percentile, and their parents completed the 12-week (3 days/wk) intervention consisting of aerobic and resistance exercise appropriate to age and developmental levels. Baseline and posttest measures of blood values, fitness, and cardiovascular risk factors were performed. Data were analyzed using paired t-tests with significance accepted at P ≤ .05. Significant differences between means (SD) for pre- and post-measurements were, respectively: BMI 30.31 (4.56), 27.80 (4.54), body-fat percent 43.7 (11.5), 40.7 (10.9), waist circumference 82.1 (7.1), 80.4(6.1) cm, calf circumference 34.2 (3.1), 35.2 (3.1) cm; step-test heart rate 137 (20), 126 (12) bpm, push-ups 1.0 (1.8), 5.6 (3.8), sit-ups 23.6 (12.7), 33.2 (13.8), sit-and-reach 35.1 (7.4), 41.2 (5.8) cm; systolic BP 102 (10), 108 (9) mmHg, glucose 4.9(0.3), 4.8 (0.4) mmol/L, total cholesterol 4.6 (1.0), 4.2 (0.8) mmol/L, ALT 41 (9), 35 (8) U/L, bilirubin 6.3 (2.4), 5.6 (2.1) μmol/L, and BUN 4.9 (1.1), 4.3 (0.9) mmol/L. This interdisciplinary intervention program positively affected the fitness and health status of children who were obese by involving the children and parents.

  8. Exercise and quality of life in patients with cystic fibrosis: A 12-week intervention study.

    PubMed

    Schmidt, Anne Mette; Jacobsen, Ulla; Bregnballe, Vibeke; Olesen, Hanne Vebert; Ingemann-Hansen, Thorsten; Thastum, Mikael; Oluf Schiøtz, Peter

    2011-11-01

    It was hypothesised that increased exercise capacity is related to improved quality of life (QoL) in patients with cystic fibrosis (CF). A 12-week individually tailored unsupervised aerobic exercise programme was offered to 42 patients with CF. At the start and at the end of the exercise programme, data on QoL, current exercise habits and preferences, anthropometric data, exercise test, and lung function test were collected. Adherence was observed by a heart rate (HR) monitor. A total of 24 patients accepted to be enrolled in the exercise programme and 14 completed the programme. Another 14 patients declined to be enrolled in the exercise programme but completed the Cystic Fibrosis Questionnaire for Adolescents and Adults (CFQ-R 14+). Four patients did not want to participate at all. The 14 patients completing the exercise programme had a significantly increased VO(2max), but they showed no significant change in total QoL score. However, the scores in the domain of treatment burden and emotional functioning increased significantly. There was no significant difference in QoL and lung function between patients participating in the exercise programme (n = 24) and non-participants (n = 14). A 12-week individually tailored unsupervised aerobic exercise programme where HR monitors were used significantly affected VO(2max). Improvement in QoL could not be demonstrated in this study.

  9. Higher Physical Fatigue Predicts Adherence to a 12-Week Exercise Intervention in Women With Elevated Blood Pressure

    PubMed Central

    Sadja, Julie; Tomfohr, Lianne; Jiménez, Jessica A.; Edwards, Kate M.; Rock, Cheryl L.; Calfas, Karen; Mills, Paul J.

    2012-01-01

    Objective To investigate predictors of exercise adherence to a 12-week exercise intervention for sedentary women and men with elevated blood pressure (BP). Methods Fifty-one otherwise healthy and unmedicated adults (27 women and 24 men) with elevated BP (≥120/80 mmHg but <179/109 mmHg) participated in a 12-week exercise intervention involving cardiovascular and strength training. Participants kept weekly exercise logs detailing minutes spent exercising each week. The following were assessed before and after the intervention: cardiorespiratory fitness (in mL/kg/min), body mass index (BMI), level of habitual physical activity, physical fatigue, self-efficacy for exercise habits, and social support. Results Regression analysis revealed that mean exercise minutes/week were predicted by higher age (p < .05), higher cardiorespiratory fitness (p < .05), and a gender by physical fatigue interaction (p < .01; R2 = 0.34, F < 3.248, p < .01). Women who reported higher physical fatigue prior to the intervention spent more time exercising during the 12-week intervention than those with lower levels of physical fatigue. This relationship persisted after controlling for age, BMI, cardiorespiratory fitness, level of habitual physical activity prior to the intervention, self-efficacy for exercise habits, and social support (p < .01). The gender by physical fatigue interaction explained 13.9% of the variance in mean minutes exercised/week above and beyond the effects of covariates. Conclusion Both gender and fatigue should be considered when developing exercise interventions, such that more initial physical fatigue in women is associated with a tendency to devote greater amounts of time to exercising. PMID:21988095

  10. Changes in physical activity levels following 12-week family intervention in Hispanic girls: Bounce study

    USDA-ARS?s Scientific Manuscript database

    Pediatric obesity is a major health problem among Hispanic girls. Physical activity guidelines recommend that children engage in at least 60 min of moderate to vigorous activity daily. To examine the changes in physical activity level pre- and post-intervention. Hispanic girls in control (CG; N=26, ...

  11. Effects of a 12-week aerobic exercise intervention on eating behaviour, food cravings, and 7-day energy intake and energy expenditure in inactive men.

    PubMed

    Rocha, Joel; Paxman, Jenny; Dalton, Caroline; Winter, Edward; Broom, David R

    2016-11-01

    This study examined effects of 12 weeks of moderate-intensity aerobic exercise on eating behaviour, food cravings, and weekly energy intake and expenditure in inactive men. Eleven healthy men (mean ± SD: age, 26 ± 5 years; body mass index, 24.6 ± 3.8 kg·m(-2); maximum oxygen uptake, 43.1 ± 7.4 mL·kg(-1)·min(-1)) completed the 12-week supervised exercise programme. Body composition, health markers (e.g., blood pressure), eating behaviour, food cravings, and weekly energy intake and expenditure were assessed before and after the exercise intervention. There were no intervention effects on weekly free-living energy intake (p = 0.326, d = -0.12) and expenditure (p = 0.799, d = 0.04) or uncontrolled eating and emotional eating scores (p > 0.05). However, there was a trend with a medium effect size (p = 0.058, d = 0.68) for cognitive restraint to be greater after the exercise intervention. Total food cravings (p = 0.009, d = -1.19) and specific cravings of high-fat foods (p = 0.023, d = -0.90), fast-food fats (p = 0.009, d = -0.71), and carbohydrates/starches (p = 0.009, d = -0.56) decreased from baseline to 12 weeks. Moreover, there was a trend with a large effect size for cravings of sweets (p = 0.052, d = -0.86) to be lower after the exercise intervention. In summary, 12 weeks of moderate-intensity aerobic exercise reduced food cravings and increased cognitive restraint, but these changes were not accompanied by changes in other eating behaviours or weekly energy intake and expenditure. The results indicate the importance of exercising for health improvements even when reductions in body mass are modest.

  12. A 12-week lifestyle intervention for middle-aged, overweight men who are supporters of local sporting clubs.

    PubMed

    Sealey, Rebecca Maree; Twomey, Julie; Pringle, Fiona Alyce; Cheffins, Tracy; Gupta, Smita

    2013-09-01

    To evaluate the effectiveness of a 12-week lifestyle program for changes in healthy lifestyle knowledge, health perceptions and body composition of middle-aged, overweight men. A participatory, action-based experimental design was employed with a convenience sample (n = 24) of middle-aged men who were supporters of either a local rugby league or rugby union club. Participants attended an introductory session and baseline testing in week one, participated in once-weekly group circuit exercise and lifestyle education sessions for 10 weeks and attended post-testing and project evaluation in week 12. Fourteen participants completed the project. Healthy lifestyle knowledge did not improve significantly. As a combined group there were significant improvements in both physical and mental components of the SF12 questionnaire and in waist girth. The rugby league cohort achieved significant improvement in the SF12 physical component, weight, BMI and waist girth. The rugby union cohort achieved significant improvement in the SF12 mental component and waist girth. Participants reported a variety of health improvement and lifestyle changes following the project and reported appreciation at the involvement of the sporting club. The men's lifestyle program resulted in significant improvement in body composition, resulting in a reduction in obesity-related disease risk in some participants.

  13. Arabic 12 Weeks Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    Volumes 1 and 2 (Lesson Units 1-55) of this beginning course in Arabic follow the Defense Language Institute format for intensive 12-week language courses, designed for native-speaker instructors using audiolingual methodology in the classroom. The third (and final) volume in this series constitutes a reference guide to pronunciation and grammar…

  14. Swahili 12 Weeks Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-weeks course in basic Swahili comprises 55 lesson units in five volumes. The general course format consists of (1) perception drills for comprehension, oral production, and association using "situational picture" illustrations; (2) dialogs in English and Swahili, with cartoon guides; (3) sequenced pattern and recombination drills, and (4)…

  15. Swahili 12 Weeks Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-weeks course in basic Swahili comprises 55 lesson units in five volumes. The general course format consists of (1) perception drills for comprehension, oral production, and association using "situational picture" illustrations; (2) dialogs in English and Swahili, with cartoon guides; (3) sequenced pattern and recombination drills, and (4)…

  16. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years) were assigned to either the yoga intervention group (n = 87) or the waitlist control group (n = 86). 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR) and maximal oxygen uptake (VO2max)), muscular strength and endurance (curl-up and push-up tests), and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS) test). Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P < 0.01), curl-up (P < 0.05) and push-up (P < 0.001) tests, and the MBS left and right leg tests (both P < 0.001) in both genders. Significant change was also found for resting HR between groups in women (P < 0.05) but not in men. Further analysis comparing participants between younger and older subgroups yielded similar findings, except that the older participants in the yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89%) and attendance (94%) were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. PMID:26167196

  17. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial.

    PubMed

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years) were assigned to either the yoga intervention group (n = 87) or the waitlist control group (n = 86). 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR) and maximal oxygen uptake (VO2max)), muscular strength and endurance (curl-up and push-up tests), and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS) test). Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P < 0.01), curl-up (P < 0.05) and push-up (P < 0.001) tests, and the MBS left and right leg tests (both P < 0.001) in both genders. Significant change was also found for resting HR between groups in women (P < 0.05) but not in men. Further analysis comparing participants between younger and older subgroups yielded similar findings, except that the older participants in the yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89%) and attendance (94%) were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults.

  18. Effects of a 12-week lifestyle intervention on health outcome and serum adipokines in middle-aged Korean men with borderline high blood pressure.

    PubMed

    Kim, Eun Jin; Cho, Sang Woon; Kang, Ji Yeon; Choi, Tae In; Park, Yoo Kyoung

    2012-10-01

    High blood pressure, in relation to blood levels of adipokines such as adiponectin and leptin, is highly associated with an unhealthy lifestyle including sedentary behaviors, poor dietary habits such as excess sodium intake, and heavy drinking. Strategies to reduce blood pressure may benefit the levels of adipokines. Thus, we aimed to investigate the effects of lifestyle intervention on blood pressure and serum adipokines in middle-aged Korean men with borderline high blood pressure (systolic blood pressure [SBP] ≥ 130 mm Hg or diastolic blood pressure [DBP] ≥ 85 mm Hg). Fifty-two men (aged 42.5 ± 8.5 years) with normal weight (body mass index [BMI] < 25 kg/m(2)) and high BP (NH group) and 40 men (age 42.0 ± 8.4 years) who were obese (BMI ≥ 25 kg/m(2)) with high BP (OH group) underwent 5 sessions of one-on-one intensive counseling including instruction on a nutritionally balanced diet, a low-sodium diet, how to understand calorie requirements, and strategies to implement regular exercise for blood pressure regulation over 12 weeks. In order to increase the awareness of sodium education, a salt sensory test using an unseasoned soup was performed. Anthropometrics, blood pressure measurements, 24-hour recalls were performed, and blood levels of lipids, fasting plasma glucose, C-reactive protein (CRP), leptin, and adiponectin were analyzed at week 0 and at week 12. Sodium consumption was roughly estimated using the Dish-based Frequency Questionnaire-15. Weight, BMI, body fat (kg and %), waist circumference, hip circumference, and blood pressure were significantly decreased after 12 weeks (p < 0.05) in all subjects. Similarly, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and CRP were decreased (p < 0.05), but LDL-C/HDL-C was significantly decreased (p < 0.01) only in the obese subjects. At baseline, blood levels of leptin were significantly higher in the obese subjects than in the normal weight

  19. Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.

    PubMed

    Yeung, Alan; Kiat, Hosen; Denniss, A Robert; Cheema, Birinder S; Bensoussan, Alan; Machliss, Bianca; Colagiuri, Ben; Chang, Dennis

    2014-10-24

    Negative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours. This is a parallel arm, multi-centre, randomised controlled trial that will assess the outcomes of post- phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group. Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week. Group based sessions will be led by an experienced yoga instructor. This will involve teaching beginner students a hatha yoga sequence that incorporates asana (poses and postures), pranayama (breathing control) and meditation. The primary outcomes of this study are negative affective states of anxiety, depression and stress assessed using the Depression Anxiety Stress Scale. Secondary outcomes include measures of quality of life, and cardiovascular and cognitive function. The cardiovascular outcomes will include blood pressure, heart rate, heart rate variability, pulse wave velocity, carotid intima media thickness measurements, lipid/glucose profiles and C-reactive protein assays. Assessments will be conducted prior to (week 0), mid-way through (week 6) and following the intervention period (week 12) as well as at a four week follow-up (week 16). This study will determine the effect of yoga practice on negative affective states

  20. Cost-effectiveness of biologic treatments for psoriasis based on subjective and objective efficacy measures assessed over a 12-week treatment period.

    PubMed

    Nelson, Andrew A; Pearce, Daniel J; Fleischer, Alan B; Balkrishnan, Rajesh; Feldman, Steven R

    2008-01-01

    The cost-effectiveness of biologic agents is not well delineated. To determine the cost-effectiveness of biologic agents in cost per patient achieving a minimally important difference in Dermatology Life Quality Index (DLQI MID) and cost per patient achieving a 75% improvement in Psoriasis Area Severity Index (PASI-75), assessed over a 12-week period. Efficacies of the agents were determined through a literature review; treatment paradigms and associated costs were determined. The cost-effectiveness of the agents was determined and sensitivity analysis performed. Etanercept at a dose of 25 mg administered subcutaneously (SQ) once weekly was the most cost-effective agent in cost per patient achieving DLQI minimally important difference; infliximab at a dose of 3 mg/kg administered intravenously (IV) for 3 infusions, adalimumab at a dose of 40 mg SQ every other week, and etanercept at a dose of 25 mg SQ twice weekly were the next most cost-effective agents in cost per patient achieving the DLQI minimally important difference. Intravenous infliximab at a dose of 3 mg/kg was the most cost-effective agent in terms of cost per patient achieving PASI-75 improvement; intravenous infliximab at a dose of 5 mg/kg and adalimumab at a dose of 40 mg SQ every other week were the next most cost-effective agents in cost per patient achieving PASI-75 improvement. This study had a limited time horizon of 12 weeks; generalizing the results to longer treatment periods may not be accurate and is not advisable. Additionally, when sensitivity analyses were performed, multiple agents had overlapping cost-effectiveness ratios at relatively low levels of variance; thus it may not be accurate to differentiate the cost-effectiveness of these agents. Different biologic agents for psoriasis appear to have different cost-effectiveness values; within the limitations of the available data, infliximab and adalimumab appear to be the most cost-effective agents.

  1. Effect of a 12-week integrative oncology intervention on gastro-intestinal concerns in patients with gynecological and breast cancer undergoing chemotherapy.

    PubMed

    Shalom-Sharabi, Ilanit; Keinan-Boker, Lital; Samuels, Noah; Lavie, Ofer; Lev, Efraim; Ben-Arye, Eran

    2017-09-01

    Research on the long-term effects of complementary and integrative medicine (CIM) is limited. In this study, we explore the impact of a CIM intervention on gastro-intestinal (GI)-related concerns in patients with breast/gynecological cancer undergoing chemotherapy. Patients reporting chemotherapy-related GI concerns were referred by their cancer care providers to a CIM consultation and treatments and assessed at baseline and at 12 weeks. The following tools were used: Edmonton Symptom Assessment Scale (ESAS), Measure Yourself Concerns and Wellbeing (MYCAW) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The intervention group was subdivided according to adherence to the integrative care program (AIC), defined as attending ≥4 CIM treatments with ≤30 days between each session. Controls chose not to undergo the CIM consultation or treatments. Of 289 patients reporting GI-related concerns, 42 were treated with CIM and optimally assessed (intervention arm; AIC = 33), as were 32 of controls. ESAS scores for appetite and nausea improved more significantly in the intervention group, more so in the AIC subgroup (appetite, p = 0.025; nausea, p = 0.033). MYCAW scores for GI-related concerns also improved in the intervention group, again more so in the adherent subgroup. EORTC scores improved more significantly with respect to global health (p = 0.021) and cognitive functioning (p = 0.031) in the intervention group, when compared to controls. The integration of a 12-week CIM intervention in conventional supportive cancer care may reduce nausea and improve appetite in patients with breast/gynecological cancer undergoing chemotherapy.

  2. Fructose intervention for 12 weeks does not impair glycemic control or incretin hormone responses during oral glucose or mixed meal tests in obese men.

    PubMed

    Matikainen, N; Söderlund, S; Björnson, E; Bogl, L H; Pietiläinen, K H; Hakkarainen, A; Lundbom, N; Eliasson, B; Räsänen, S M; Rivellese, A; Patti, L; Prinster, A; Riccardi, G; Després, J-P; Alméras, N; Holst, J J; Deacon, C F; Borén, J; Taskinen, M-R

    2017-06-01

    Incretin hormones glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic polypeptide (GIP) are affected early on in the pathogenesis of metabolic syndrome and type 2 diabetes. Epidemiologic studies consistently link high fructose consumption to insulin resistance but whether fructose consumption impairs the incretin response remains unknown. As many as 66 obese (BMI 26-40 kg/m(2)) male subjects consumed fructose-sweetened beverages containing 75 g fructose/day for 12 weeks while continuing their usual lifestyle. Glucose, insulin, GLP-1 and GIP were measured during oral glucose tolerance test (OGTT) and triglycerides (TG), GLP-1, GIP and PYY during a mixed meal test before and after fructose intervention. Fructose intervention did not worsen glucose and insulin responses during OGTT, and GLP-1 and GIP responses during OGTT and fat-rich meal were unchanged. Postprandial TG response increased significantly, p = 0.004, and we observed small but significant increases in weight and liver fat content, but not in visceral or subcutaneous fat depots. However, even the subgroups who gained weight or liver fat during fructose intervention did not worsen their glucose, insulin, GLP-1 or PYY responses. A minor increase in GIP response during OGTT occurred in subjects who gained liver fat (p = 0.049). In obese males with features of metabolic syndrome, 12 weeks fructose intervention 75 g/day did not change glucose, insulin, GLP-1 or GIP responses during OGTT or GLP-1, GIP or PYY responses during a mixed meal. Therefore, fructose intake, even accompanied with mild weight gain, increases in liver fat and worsening of postprandial TG profile, does not impair glucose tolerance or gut incretin response to oral glucose or mixed meal challenge. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University

  3. A 12-week multidomain intervention versus active control to reduce risk of Alzheimer's disease: study protocol for a randomized controlled trial.

    PubMed

    Anstey, Kaarin J; Bahar-Fuchs, Alex; Herath, Pushpani; Rebok, George W; Cherbuin, Nicolas

    2013-02-27

    Disappointing results from clinical trials of disease-modifying interventions for Alzheimer's dementia (AD), along with reliable identification of modifiable risk factors in mid life from epidemiological studies, have contributed to calls to invest in risk-reduction interventions. It is also well known that AD-related pathological processes begin more than a decade before the development of clinical signs. These observations suggest that lifestyle interventions might be most effective when targeting non-symptomatic adults at risk of AD. To date, however, the few dementia risk-reduction programs available have targeted individual risk factors and/or were restricted to clinical settings. The current study describes the development of an evidence-based, theoretically-driven multidomain intervention to reduce AD risk in adults at risk. The design of Body Brain Life (BBL) is a randomized controlled trial (RCT) to evaluate a 12-week online AD risk-reduction intervention. Eligible participants with several modifiable risk factors on the Australian National University (ANU) AD Risk Index (ANU-ADRI) are randomly allocated to an online only group, an online and face-to-face group, or an active control group. We aim to recruit 180 participants, to undergo a comprehensive cognitive and physical assessment at baseline, post-intervention, and 6-month follow-up assessment. The intervention comprises seven online modules (dementia literacy, risk factor education, engagement in physical, social, and cognitive lifestyles, nutrition, and health monitoring) designed using contemporary models of health behavior change. The BBL program is a novel online intervention to reduce the risk of AD in middle-aged adults at risk. The trial is currently under way. It is hypothesized that participants in the intervention arms will make lifestyle changes in several domains, and that this will lead to a reduction in their AD risk profile. We also expect to show that health behavior change is

  4. Assessing the Utility of Low-Cost Particulate Matter Sensors over a 12-Week Period in the Cuyama Valley of California

    PubMed Central

    Roberts, Paul T.

    2017-01-01

    The use of low-cost air quality sensors has proliferated among non-profits and citizen scientists, due to their portability, affordability, and ease of use. Researchers are examining the sensors for their potential use in a wide range of applications, including the examination of the spatial and temporal variability of particulate matter (PM). However, few studies have quantified the performance (e.g., accuracy, precision, and reliability) of the sensors under real-world conditions. This study examined the performance of two models of PM sensors, the AirBeam and the Alphasense Optical Particle Counter (OPC-N2), over a 12-week period in the Cuyama Valley of California, where PM concentrations are impacted by wind-blown dust events and regional transport. The sensor measurements were compared with observations from two well-characterized instruments: the GRIMM 11-R optical particle counter, and the Met One beta attenuation monitor (BAM). Both sensor models demonstrated a high degree of collocated precision (R2 = 0.8–0.99), and a moderate degree of correlation against the reference instruments (R2 = 0.6–0.76). Sensor measurements were influenced by the meteorological environment and the aerosol size distribution. Quantifying the performance of sensors in real-world conditions is a requisite step to ensuring that sensors will be used in ways commensurate with their data quality. PMID:28783065

  5. Assessing the Utility of Low-Cost Particulate Matter Sensors over a 12-Week Period in the Cuyama Valley of California.

    PubMed

    Mukherjee, Anondo; Stanton, Levi G; Graham, Ashley R; Roberts, Paul T

    2017-08-05

    The use of low-cost air quality sensors has proliferated among non-profits and citizen scientists, due to their portability, affordability, and ease of use. Researchers are examining the sensors for their potential use in a wide range of applications, including the examination of the spatial and temporal variability of particulate matter (PM). However, few studies have quantified the performance (e.g., accuracy, precision, and reliability) of the sensors under real-world conditions. This study examined the performance of two models of PM sensors, the AirBeam and the Alphasense Optical Particle Counter (OPC-N2), over a 12-week period in the Cuyama Valley of California, where PM concentrations are impacted by wind-blown dust events and regional transport. The sensor measurements were compared with observations from two well-characterized instruments: the GRIMM 11-R optical particle counter, and the Met One beta attenuation monitor (BAM). Both sensor models demonstrated a high degree of collocated precision (R² = 0.8-0.99), and a moderate degree of correlation against the reference instruments (R² = 0.6-0.76). Sensor measurements were influenced by the meteorological environment and the aerosol size distribution. Quantifying the performance of sensors in real-world conditions is a requisite step to ensuring that sensors will be used in ways commensurate with their data quality.

  6. A 12-week intervention with protein-enriched foods and drinks improved protein intake but not physical performance of older patients during the first 6 months after hospital release: a randomised controlled trial.

    PubMed

    Beelen, Janne; de Roos, Nicole M; de Groot, Lisette C P G M

    2017-06-01

    During and after hospitalisation, older adults are recommended to consume 1·2-1·5 g of protein/kg body weight per d (g/kg per d) to improve recovery. This randomised controlled trial studied the effectiveness of a 12-week intervention with protein-enriched foods and drinks by following-up seventy-five older patients (mean age: 76·8 (sd 6·9) years) during their first 6 months after hospital discharge. Primary outcomes were protein intake and physical performance (measured with Short Physical Performance Battery (SPPB)). Secondary outcomes for physical recovery were gait speed, chair-rise time, leg-extension strength, hand-grip strength, body weight, nutritional status (Mini Nutritional Assessment), independence in activities of daily living (ADL) and physical activity. The intervention group consumed more protein during the 12-week intervention period compared with the control group (P<0·01): 112 (sd 34) g/d (1·5 (sd 0·6) g/kg per d) v. 78 (sd 18) g/d (1·0 (sd 0·4) g/kg per d). SPPB total score, gait speed, chair-rise time, body weight and nutritional status improved at week 12 compared with baseline (time effect P<0·05), but were not different between groups. Leg-extension strength, hand-grip strength and independence in ADL did not change. In conclusion, protein-enriched products enabled older adults to increase their protein intake to levels that are higher than their required intake. In these older adults with already adequate protein intakes and limited physical activity, protein enrichment did not enhance physical recovery in the first 6 months after hospital discharge.

  7. Effects of a 12-week alpine skiing intervention on endothelial progenitor cells, peripheral arterial tone and endothelial biomarkers in the elderly.

    PubMed

    Niederseer, David; Steidle-Kloc, Eva; Mayr, Matthias; Müller, Edith E; Cadamuro, Janne; Patsch, Wolfgang; Dela, Flemming; Müller, Erich; Niebauer, Josef

    2016-07-01

    Endothelial dysfunction occurs early during atherogenesis and it can be normalized by exercise training. Unfortunately, patients' compliance with exercise prescription remains low, often because the given choices do not appeal to them. In Alpine regions, skiing is a popular mode of exercise, and therefore we set out to assess whether it can induce antiatherogenic effects. We randomized 42 subjects into a group of 12weeks of guided skiing (intervention group, IG, n=22; 12 males/10 females; age: 66.6±2.1years) or a control group (CG, n=20; 10 males/10 females; age: 67.3±4.4years). Early (CD3-CD34+CD45+) and late endothelial progenitor cells (EPCs; CD45dimCD34+KDR+ peripheral blood mononuclear cells, PBMCs), peripheral arterial tonometry and endothelial biomarkers were assessed at the beginning and end of the study. In the IG, participants completed 28.5±2.6 skiing days at an average heart rate of 72.7±8.5% of their maximum heart rate. Changes in early (IG: +0.001±0.001% PBMC; CG: -0.001±0.001% PBMC; IG vs. CG: p<0.001) but not late EPCs differed significantly. Changes in peripheral arterial tone differed significantly between IG (Reactive Hyperemia Index: +0.18±0.76) and CG (-0.39±0.85; p=0.045), as did homocysteine (IG: -1.3±1.3μmol/l; CG: -0.4±1.4μmol/l; p=0.037) while other endothelial biomarkers remained essentially unchanged. This study shows that skiing induces several beneficial effects on markers of atherogenesis including EPCs, peripheral arterial tone and homocysteine. Our findings suggest that recreational alpine skiing may serve as a further mode of preventive exercise training, which might result in improved compliance with current recommendations. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. Portuguese Special Course: 12 Weeks.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-week course in beginning Portuguese comprises four volumes of student text (Lessons 1-55) and a fifth volume of Portuguese-English/English-Portuguese vocabulary. Lesson materials consist of basic dialogs with English translation, recombination dialogs, readings and comprehension questions, oral exercises, and in later units, additional…

  9. Whole grain compared with refined wheat decreases the percentage of body fat following a 12-week, energy-restricted dietary intervention in postmenopausal women.

    PubMed

    Kristensen, Mette; Toubro, Søren; Jensen, Morten Georg; Ross, Alastair B; Riboldi, Giancarlo; Petronio, Michela; Bügel, Susanne; Tetens, Inge; Astrup, Arne

    2012-04-01

    Observational studies show inverse associations between intake of whole grain and adiposity and cardiovascular risk; however, only a few dietary intervention trials have investigated the effect of whole-grain consumption on health outcomes. We studied the effect of replacing refined wheat (RW) with whole-grain wheat (WW) for 12 wk on body weight and composition after a 2-wk run-in period of consumption of RW-containing food intake. In this open-label randomized trial, 79 overweight or obese postmenopausal women were randomized to an energy-restricted diet (deficit of ~1250 kJ/d) with RW or WW foods providing 2 MJ/d. Body weight and composition, blood pressure, and concentration of circulating risk markers were measured at wk 0, 6, and 12. Fecal output and energy excretion were assessed during run-in and wk 12. Plasma alkylresorcinol analysis indicated good compliance with the intervention diets. Body weight decreased significantly from baseline in both the RW (-2.7 ± 1.9 kg) and WW (-3.6 ± 3.2 kg) groups, but the decreases did not differ between the groups (P = 0.11). The reduction in body fat percentage was greater in the WW group (-3.0%) than in the RW group (-2.1%) (P = 0.04). Serum total and LDL cholesterol increased by ~5% (P < 0.01) in the RW group but did not change in the WW group; hence, the changes differed between the groups (P = 0.02). In conclusion, consumption of whole-grain products resulted in a greater reduction in the percentage fat mass, whereas body weight changes did not differ between the RW and WW groups. Serum total and LDL cholesterol, two important risk factors of cardiovascular disease, increased with RW but not WW consumption, which may suggest a cardioprotective role for whole grain.

  10. Dairy Food Consumption and Meal-Induced Cortisol Response Interacted to Influence Weight Loss in Overweight Women Undergoing a 12-Week, Meal-Controlled, Weight Loss Intervention1234

    PubMed Central

    Witbracht, Megan G.; Van Loan, Marta; Adams, Sean H.; Keim, Nancy L.; Laugero, Kevin D.

    2013-01-01

    Dairy food enhances weight loss in animal models, possibly by modifying the metabolic effects of cortisol. This study determined in overweight women (ages 20.0–45.9 y; n = 51) whether including dairy food in an energy-restricted diet affects cortisol concentrations and whether differences in provoked cortisol explain the magnitude of weight loss. Women received either an adequate amount of dairy food (AD), the equivalent of ≥711 mL/d milk, or a low amount of dairy food (LD), the equivalent to ≤238 mL/d milk, in a 12-wk, energy-restricted dietary intervention. Participants were tested in a 12-h laboratory visit, which included 2 standard meals and a dinner buffet that was consumed ad libitum. Salivary cortisol was measured from waking to bedtime. Energy restriction increased (P ≤ 0.04) the minimum and decreased (P ≤ 0.02) the diurnal amplitude in the salivary cortisol concentration from baseline to postintervention. Energy restriction enhanced the dinner meal–stimulated salivary cortisol response (DMR) (P ≤ 0.02) but only in the LD group. Compared with the LD treatment, the AD treatment induced (P ≤ 0.04) greater reductions in body weight and fat, but only in women characterized as having a baseline DMR (responders) (n = 26); weight and fat lost in the AD and LD groups were similar in nonresponders (n = 25). Overall, energy restriction dampened diurnal salivary cortisol fluctuations [symptomatic of hypothalamic-pituitary-adrenal (HPA) axis dysfunction] and enhanced dinner meal–stimulated salivary cortisol concentrations. The AD treatment prevented the latter. Furthermore, certain phenotypic markers of HPA axis function may help to expose the weight-reducing effects of consuming dairy food. PMID:23190756

  11. Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes.

    PubMed

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Pieters, Indra C; Cahen, Djuna L; Diamant, Michaela; van Raalte, Daniël H

    2015-11-19

    Incretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis. Conversely, these agents may reduce blood pressure, glomerular hyperfiltration, albuminuria and hepatic steatosis. While large-sized cardiovascular safety trials can potentially identify the clinical significance of some of these pleiotropic actions, small-sized mechanistic studies are important to understand the (patho)physiological rationale of these findings. The current protocol describes a mechanistic study to assess cardiovascular, renal and gastrointestinal effects, and mechanisms of incretin-based therapies in type 2 diabetes. 60 patients with type 2 diabetes will undergo acute and prolonged randomised, double-blind, intervention studies. The acute intervention will consist of intravenous administration of the GLP-1 receptor agonist exenatide or placebo. For the prolonged intervention, patients will be randomised to 12-week treatment with the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebos. For each examined organ system, a primary end point is defined. Primary cardiovascular end point is change in resting heart rate variability assessed by beat-to-beat heart rate monitor and spectral analyses software. Primary renal end point is change in glomerular filtration rate assessed by the classic inulin clearance methodology. Primary gastrointestinal end points are change in pancreatic exocrine function assessed by MRI-techniques (acute intervention) and faecal elastase-1 levels (12-week intervention). Secondary end points include

  12. Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes

    PubMed Central

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Pieters, Indra C; Cahen, Djuna L; Diamant, Michaela; van Raalte, Daniël H

    2015-01-01

    Introduction Incretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis. Conversely, these agents may reduce blood pressure, glomerular hyperfiltration, albuminuria and hepatic steatosis. While large-sized cardiovascular safety trials can potentially identify the clinical significance of some of these pleiotropic actions, small-sized mechanistic studies are important to understand the (patho)physiological rationale of these findings. The current protocol describes a mechanistic study to assess cardiovascular, renal and gastrointestinal effects, and mechanisms of incretin-based therapies in type 2 diabetes. Methods and analyses 60 patients with type 2 diabetes will undergo acute and prolonged randomised, double-blind, intervention studies. The acute intervention will consist of intravenous administration of the GLP-1 receptor agonist exenatide or placebo. For the prolonged intervention, patients will be randomised to 12-week treatment with the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebos. For each examined organ system, a primary end point is defined. Primary cardiovascular end point is change in resting heart rate variability assessed by beat-to-beat heart rate monitor and spectral analyses software. Primary renal end point is change in glomerular filtration rate assessed by the classic inulin clearance methodology. Primary gastrointestinal end points are change in pancreatic exocrine function assessed by MRI-techniques (acute intervention) and faecal elastase-1 levels (12-week intervention

  13. Exploring factors related to changes in body composition, insulin sensitivity and aerobic capacity in response to a 12-week exercise intervention in overweight and obese women with and without polycystic ovary syndrome

    PubMed Central

    Harrison, Cheryce L.; Hutchison, Samantha; de Courten, Barbora; Stepto, Nigel K.

    2017-01-01

    Objective To determine factors associated with differential changes in body fat, insulin resistance and aerobic capacity following a 12-week exercise intervention in overweight and obese women with and without polycystic ovary syndrome (PCOS). Methods 16 overweight and obese women (9 PCOS; 7 without PCOS) completed a supervised progressive 12-week exercise program. Primary outcomes included changes in indicators of insulin sensitivity (including glucose infusion rate relative to fat-free mass [GIR/FFM]), body composition, and aerobic capacity (VO2 peak; 12 participants only). Comparisons were made between women with and without PCOS, and between participants who lost ≥5% (classified as exercise responders) and <5% (non-responders) in body fat (assessed by dual-energy X-ray absorptiometry). Results Training decreased body fat percentage by (mean; 95% CI) -2.3%; -5.3, 0.7% in women with PCOS and by -6.4%; -10.9, -1.9% in women without PCOS (P = 0.08). Ten women (7 PCOS; 3 without PCOS) did not reduce body fat by ≥5%. All participants improved VO2 peak (mean change 27%; 16–39%) but four (2 PCOS; 2 without PCOS) demonstrated decreases in GIR/FFM (mean change for whole cohort: 37%; 3–71%). Android-gynoid fat ratio (0.58; 0.51, 0.66 vs 0.46; 0.40, 0.51; P<0.01) was significantly higher and GIR/FFM (6.69; 3.49, 9.90 vs 11.44; 9.15, 13.72 mg/kg/min; P = 0.01) was significantly lower in non-responders compared with responders at baseline, but non-responders had significant post-training decreases in android-gynoid ratio (-0.02; -0.04, -0.01; P = 0.03), and increases in VO2 peak (7.24; 2.28, 12.21 mL/kg/min; P = 0.01) and GIR/FFM (1.44; 0.27, 2.61 mg/kg/min; P = 0.02). In women with PCOS, pre-training VO2 peak was significantly negatively correlated with change in total body fat (r = -0.75; P = 0.02), and pre-training fasting glucose negatively correlated with changes in VO2 peak (r = -0.76; P = 0.04), but positively correlated with changes in GIR (r = 0.67; P = 0

  14. 12 weeks' aerobic and resistance training without dietary intervention did not influence oxidative stress but aerobic training decreased atherogenic index in middle-aged men with impaired glucose regulation.

    PubMed

    Venojärvi, Mika; Korkmaz, Ayhan; Wasenius, Niko; Manderoos, Sirpa; Heinonen, Olli J; Lindholm, Harri; Aunola, Sirkka; Eriksson, Johan G; Atalay, Mustafa

    2013-11-01

    Our aim was to determine whether 12 weeks' aerobic Nordic walking (NW) or resistance exercise training (RT) without diet-induced weight loss could decrease oxidative stress and atherogenic index of plasma (AIP), prevalence of metabolic syndrome (MetS) and MetS score in middle-aged men with impaired glucose regulation (IGR) (n=144. 54.5 ± 6.5 years). In addition, we compared effects of intervention between overweight and obese subgroups. Prevalence of MetS and AIP index decreased only in NW group and MetS score in both NW and RT groups but not in control group. The changes in AIP index correlated inversely with changes in plasma antioxidant capacity. The change in AIP index remained a significant independent predictor of the changes in MetS score after the model was adjusted for age, BMI and volume of exercise (MET h/week) in NW group. There were no changes in the other measured markers of oxidative stress and related cytokines (e.g. osteopontin and osteoprotegerin) in any of the groups. Nordic walking decreased prevalence of MetS and MetS score. Improved lipid profile remained a predictor of decreased MetS score only in NW group and it seems that Nordic walking has more beneficial effects on cardiovascular disease risks than RT training. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Effects of 12 Weeks Resistance Training on Serum Irisin in Older Male Adults.

    PubMed

    Zhao, Jiexiu; Su, Zhongjun; Qu, Chaoyi; Dong, Yanan

    2017-01-01

    Background: To assess the effects of resistance training on circulating irisin concentration in older male adults, and to investigate the association between resistance training induced alteration of irisin and body fat. Methods: Seventeen older adults (mean age is 62.1 years old) were randomized into old control group (male, n = 7), and old training group (male, n = 10). The control group has no any exercise intervention. The resistance training group underwent leg muscle strength and core strength training program two times/wk, 55 min/class for 12 weeks. Before and after the intervention, we evaluated serum irisin level and body composition. Results: Serum irisin level was significantly increased in the resistance training group after the 12 weeks intervention period (P < 0.01), but not in the control group. In the resistance training group, the reduction in whole-body fat percent was negatively correlated with the increase in serum irisin level (r = -0.705, P < 0.05). Conclusion: After the 12 weeks intervention, circulating irisin levels were significantly elevated in the older adults. In summary, serum irisin may be involved in the regulation of body fat in older male adults.

  16. Effects of 12 Weeks Resistance Training on Serum Irisin in Older Male Adults

    PubMed Central

    Zhao, Jiexiu; Su, Zhongjun; Qu, Chaoyi; Dong, Yanan

    2017-01-01

    Background: To assess the effects of resistance training on circulating irisin concentration in older male adults, and to investigate the association between resistance training induced alteration of irisin and body fat. Methods: Seventeen older adults (mean age is 62.1 years old) were randomized into old control group (male, n = 7), and old training group (male, n = 10). The control group has no any exercise intervention. The resistance training group underwent leg muscle strength and core strength training program two times/wk, 55 min/class for 12 weeks. Before and after the intervention, we evaluated serum irisin level and body composition. Results: Serum irisin level was significantly increased in the resistance training group after the 12 weeks intervention period (P < 0.01), but not in the control group. In the resistance training group, the reduction in whole-body fat percent was negatively correlated with the increase in serum irisin level (r = −0.705, P < 0.05). Conclusion: After the 12 weeks intervention, circulating irisin levels were significantly elevated in the older adults. In summary, serum irisin may be involved in the regulation of body fat in older male adults. PMID:28382004

  17. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

    PubMed

    Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

    2017-02-01

    Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  18. Variability of skin autofluorescence measurement over 6 and 12 weeks and the influence of benfotiamine treatment.

    PubMed

    Stirban, Alin; Pop, Alexandra; Fischer, Annelie; Heckermann, Sascha; Tschoepe, Diethelm

    2013-09-01

    Measurements of skin autofluorescence (SAF) allow for a simple and noninvasive quantification of tissue advanced glycation end-products (AGEs), a marker linked to the risk of diabetes complications. The aim of this study was to test the repeatability of SAF over 6 and 12 weeks and to test whether benfotiamine, a thiamine prodrug suggested to reduce AGEs formation under hyperglycemic conditions, is able to attenuate SAF when administered over 6 weeks. In a double-blind, placebo-controlled, randomized, crossover study, 22 patients with type 2 diabetes mellitus (T2DM) received 900 mg/day benfotiamine or placebo for 6 weeks (washout period of 6 weeks between). At the beginning and at the end of each treatment period, SAF was assessed in the fasting state, as well as 2, 4, and 6 h following a mixed test meal. The respective intra-individual and inter-individual variability of fasting SAF was 6.9% and 24.5% within 6 weeks and 10.9% and 23.1% within 12 weeks. The respective variability calculated for triplicate comparisons was 9.9% and 27.7%. A short-term therapy with benfotiamine did not influence SAF significantly, nor did we find a significant postprandial SAF increase. In patients with T2DM, repeated, timely spaced SAF measurements have an intra-subject variability of below 11%. Using these data, sample sizes were calculated for interventional studies aiming at reducing SAF. Benfotiamine treatment for 6 weeks did not significantly influence SAF; for this, a longer-term therapy is probably needed.

  19. Tea tree oil gel for mild to moderate acne; a 12 week uncontrolled, open-label phase II pilot study.

    PubMed

    Malhi, Harsimran Kaur; Tu, Jenny; Riley, Thomas V; Kumarasinghe, Sujith Prasad; Hammer, Katherine A

    2017-08-01

    The efficacy, tolerability and acceptability of a tea tree oil gel (200 mg/g) and face wash (7 mg/g) were evaluated for the treatment of mild to moderate facial acne. In this open-label, uncontrolled phase II pilot study, participants applied tea tree oil products to the face twice daily for 12 weeks and were assessed after 4, 8 and 12 weeks. Efficacy was determined from total numbers of facial acne lesions and the investigator global assessment (IGA) score. Tolerability was evaluated by the frequency of adverse events and the mean tolerability score determined at each visit. Product acceptability was assessed via a questionnaire at the end of the study period. Altogether 18 participants were enrolled, of whom 14 completed the study. Mean total lesion counts were 23.7 at baseline, 17.2 at 4, 15.1 at 8 and 10.7 at 12 weeks. Total lesion counts differed significantly over time by repeated measures anova (P < 0.0001). The mean IGA score was 2.4 at baseline, 2.2 at 4, 2.0 at 8 and 1.9 at 12 weeks, which also differed significantly over time (P = 0.0094). No serious adverse events occurred and minor local tolerability events were limited to peeling, dryness and scaling, all of which resolved without intervention. This study shows that the use of the tea tree oil products significantly improved mild to moderate acne and that the products were well tolerated. © 2016 The Australasian College of Dermatologists.

  20. The added value of a brief self-efficacy coaching on the effectiveness of a 12-week physical activity program.

    PubMed

    Seghers, Jan; Van Hoecke, Ann-Sophie; Schotte, Astrid; Opdenacker, Joke; Boen, Filip

    2014-01-01

    Self-efficacy has been found to be an important precondition for behavioral change in sedentary people. The current study examined the effectiveness and added value of including a 15-minute self-efficacy coaching at the start of a 12-week lifestyle physical activity (PA) program. Participants were randomly assigned to a standard-intervention group (without additional self-efficacy coaching, N = 116) or extra-intervention group (with additional self-efficacy coaching, N = 111). Body mass index (BMI), cardiovascular fitness, self-reported PA, and self-efficacy beliefs were assessed at baseline and immediately after the intervention period. Perceived adherence to the PA program was assessed postintervention. At posttest, a significant increase in cardiovascular fitness and decrease in BMI were found in both groups. Significant intervention effects emerged on PA behavior, self-efficacy, and program adherence, in favor of the extra-intervention group. Self-efficacy mediated the intervention effect on program adherence whereas no evidence was found for its role as mediator of PA change. Adding a 15-minute self-efficacy coaching at the start of a lifestyle PA program is a promising strategy to enhance the intervention effects on PA behavior, self-efficacy beliefs, and program adherence. However, the role of self-efficacy as mediator of the intervention effect on in PA was not fully supported.

  1. Effects of a 12-week strength training program on experimented fencers' movement time.

    PubMed

    Redondo, Juan C; Alonso, Cruz J; Sedano, Silvia; de Benito, Ana M

    2014-12-01

    The purpose of this study was to determine the effects of a 12-week strength training program on movement time (MT) on fencers of national level. Twelve male fencers were randomly divided into 2 groups: the control group (CG: N = 6; age, 22.3 ± 8.1 years) and the treatment group (TG: N = 6; age, 24.8 ± 7.2 years). The CG fencers followed the standard physical conditioning program, which was partially modified for the TG. The TG participated in a 12-week strength training program divided into 2 parts: maximal strength training, including weightlifting exercises (2 days a week for 6 weeks) and explosive strength training, with combined weights and plyometric exercises (2 days a week for 6 weeks). Body mass, body fat, muscle mass, jumping ability, maximal strength, reaction time, and MT were measured on 4 separate occasions. The TG demonstrated significant increases (p ≤ 0.05) in maximal strength and jumping ability after 6 weeks of training and in MT after 12 weeks. These improvements remained unaltered during the 4-week detraining period. It may be concluded that a 12-week strength training program can improve maximal and explosive strength, and these increases can be transferred to MT performance. However, fencers need time to transfer the gains.

  2. A 12-week randomized double-blind parallel pilot trial of Sinetrol XPur on body weight, abdominal fat, waist circumference, and muscle metabolism in overweight men.

    PubMed

    Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Rouanet, Jean Max

    2015-01-01

    Overweight and obesity are associated to increased risk of developing non-communicable diseases that might dramatically affect life expectancy according World Health Organization. Overweight, obesity, and decline in physical activity are correlated to a significant propensity to lose skeletal muscle mass as a result of prolonged inflammation and oxidative stress whereas cohort surveys and clinical investigations have demonstrated health benefits of Citrus-based polyphenols to reverse such regression. Overweight men were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a Citrus-based polyphenol extract, Sinetrol® XPur. Body composition, anthropometric, and blood parameters were assessed before and at the end of the intervention period. After 12 weeks, while the silhouette slimmed down, metabolic parameters were significantly improved and skeletal muscle catabolism held back. These data suggest that over a 12-week period, the efficacy of the supplement improve both overweight process and correlated skeletal muscle mass metabolism.

  3. Kinematic Measurement of 12-week Head Control Correlates with 12-month Neurodevelopment in Preterm Infants

    PubMed Central

    Bentzley, Jessica P; Coker-Bolt, Patty; Moreau, Noelle; Hope, Kathryn; Ramakrishnan, Viswanathan; Brown, Truman; Mulvihill, Denise; Jenkins, Dorothea

    2015-01-01

    Background Although new interventions treating neonatal brain injury show great promise, our current ability to predict clinical functional outcomes is poor. Quantitative biomarkers of long-term neurodevelopmental outcome are critically needed to gauge treatment efficacy. Kinematic measures derived from commonly used developmental tasks may serve as early objective markers of future motor outcomes. Aim To develop reliable kinematic markers of head control at 12 weeks corrected gestational age (CGA) from two motor tasks: head lifting in prone and pull-to-sit Study design and subjects Prospective observational study of 22 preterm infants born between 24 and 34 weeks of gestation Outcome measures Bayley Scales of Infant Development III (Bayley) motor scores Results Intrarater and interrater reliability of prone head lift angles and pull-to-sit head angles were excellent. Prone head lift angles at 12 weeks CGA correlated with white matter NAA/Cho, concurrent Test of Infant Motor Performance (TIMP) scores, and 12-month Bayley motor scores. Head angles during pull-to-sit at 12-weeks CGA correlated with TIMP scores. Conclusions Poor ability to lift the head in prone and an inability to align the head with the trunk during the pull-to-sit task were associated with poorer future motor outcome scores. Kinematic measurements of head control in early infancy may serve as reliable objective quantitative markers of future motor impairment and neurodevelopmental outcome. PMID:25621433

  4. Change in perceived psychosocial status following a 12-week Tai Chi exercise programme.

    PubMed

    Taylor-Piliae, Ruth E; Haskell, William L; Waters, Catherine M; Froelicher, Erika Sivarajan

    2006-05-01

    This paper reports a study to examine change in psychosocial status following a 12-week Tai Chi exercise intervention among ethnic Chinese people with cardiovascular disease risk factors living in the United States of America. Regular participation in physical activity is associated with protection against cardioavascular disease, and improvements in physical and psychological health. Increasing amounts of scientific evidence suggests that mind-body exercise, such as Tai Chi, are related to improvements in mental health, emotional well-being, and stress reduction. No prior study has examined the effect of a Tai Chi exercise intervention on psychosocial status among people with cardiovascular disease risk factors. This was a quasi-experimental study. Participants attended a 60-minute Tai Chi exercise class three times per week for 12 weeks. Data were collected at baseline, 6 and 12 weeks following the intervention. Psychosocial status was assessed using Chinese versions of Cohen's Perceived Stress Scale, Profile of Mood States, Multidimensional Scale of Perceived Social Support, and Tai Chi exercise self-efficacy. A total of 39 participants, on average 66-year-old (+/-8.3), married (85%), Cantonese-speaking (97%), immigrants participated. The majority were women (69%), with < or =12 years education (87%). Statistically significant improvements in all measures of psychosocial status were found (P < or = 0.05) following the intervention. Improvement in mood state (eta2 = 0.12), and reduction in perceived stress (eta2 = 0.13) were found. In addition, Tai Chi exercise statistically significantly increased self-efficacy to overcome barriers to Tai Chi (eta2 = 0.19), confidence to perform Tai Chi (eta2 = 0.27), and perceived social support (eta2 = 0.12). Tai Chi was a culturally appropriate mind-body exercise for these older adults, with statistically significant psychosocial benefits observed over 12-weeks. Further research examining Tai Chi exercise using a randomized

  5. Influence of 12-week Nordic Walking training on biomarkers of endothelial function in healthy postmenopausal women.

    PubMed

    Pospieszna, Barbara; Karolkiewicz, Joanna; Tarnas, Jacek; Lewandowski, Jacek; Laurentowska, Maria; Pilaczyńska-Szcześniak, Łucja

    2017-09-01

    The aim of this study was to evaluate the effects of a 12-week Nordic Walking (NW) intervention on nitric oxide synthase activity (eNOS), levels of antibodies against oxidatively modified low-density lipoproteins (oLAb), plasma antioxidant capacity (TAC), thiobarbituric acid reactive substance (TBARS) concentration, carbohydrate and lipid metabolism, and atherosclerosis risk factors (AIP) in postmenopausal women. A sample of 39 women, divided into two comparable groups: training (N.=20) and control (N.=19), took part in the study. Participants in the training group performed a 12-week supervised NW training: 60-minute sessions of exercise, repeated three times per week. The biochemical and anthropometric data were obtained before and after the intervention. During the first and the last training sessions, the individual walking distance in trained group was measured. After the intervention, significant differences in covered distance, body mass, BMI, fat mass, insulin level (P<0.01), systolic blood pressure and TBARS concentration (P<0.05) were found in trained women. Applied training was able to improve functional capacity and body composition in healthy postmenopausal women. It appears to be no direct link between a significant decrease in the level of systolic blood pressure, the level of eNOS activity, TAC, oLAb and plasma TBARS concentration in trained women. It seems probable that NW training would be more effective for postmenopausal women with more severely impaired endothelial function.

  6. Double-blind, double-dummy, multinational, multicenter, parallel-group design clinical trial of clinical non-inferiority of formoterol 12 microg/unit dose in a b.i.d. regimen administered via an HFA-propellant-pMDI or a dry powder inhaler in a 12-week treatment period of moderate to severe stable persistent asthma in adult patients.

    PubMed

    Dusser, D; Vicaut, E; Lefrançois, G

    2005-01-01

    Pressurized metered-dose inhalers (pMDIs) have traditionally used CFCs as propellants. However, the worldwide phase-out of CFCs has necessitated the development of new pMDIs that use alternative propellants. One such replacement is the hydrofluoroalkane HFA-134a. This study sought to establish the clinical non-inferiority of a new HFA-134a-containing pMDI to a conventional dry powder inhaler (DPI) in the administration of formoterol to adult patients with moderate-to-severe, stable persistent asthma. The secondary aim was to collect safety data in a multiple-dose long-term study. During this multicenter, double-blind, parallel study, 500 patients were randomized to receive 12 microg of formoterol twice daily for 12 weeks via either an HFA pMDI or a DPI. If necessary, the dose could be increased to 24 microg twice daily. At baseline, all patients (aged 18-70 years) had an FEV1 40-80% of predicted and a documented positive response to the reversibility test. After 12 weeks' therapy, the adjusted mean morning PEFR was 343.69 l/min in the formoterol HFA pMDI group and 344.56 l/min in the formoterol DPI group. Because the lower limit of the 95% CI for the between-group difference (-11.64 l/min) was well within the non-inferiority margin (-20 l/min), the HFA device was deemed clinically non-inferior to the DPI device. This finding was confirmed when evening PEFR and FEV1 were assessed. Both formulations of formoterol were well tolerated during prolonged multiple dosing. This study provides evidence that the new HFA-formulated formoterol pMDI has a similar efficacy and safety profile to the conventional formoterol DPI in the treatment of patients with moderate-to-severe asthma.

  7. Left Ventricular Adaptation to 12 Weeks of Indoor Cycling at the Gym in Untrained Females.

    PubMed

    Hedman, Kristofer; Bjarnegård, Niclas; Länne, Toste

    2017-09-01

    Cross-sectional studies provide evidence of larger cardiac dimensions and mass in endurance trained than in untrained females. Much less is known regarding adaptations in cardiac function following training in untrained subjects. We aimed to study left ventricular (LV) adaptation to indoor cycling in previously untrained females, in regard of LV dimensions, mass and function. 42 sedentary females were divided into 2 equally sized groups, either training indoor cycling at regular classes at a local gym for 12 weeks, in average 2.6 times per week, or maintaining their sedentary lifestyle. Echocardiography at rest and a maximal exercise test were performed before and after the intervention. Exercise capacity increased in average 16% in the exercise group (p<0.001), together with decreased heart rate at rest (p<0.05) and at 120 watts steady-state (p<0.001). There were no difference in systolic or diastolic function following the intervention and minimal increases in LV internal diameter in diastole (+1 mm, p<0.01). LV mass was unchanged with training (137±25 vs. 137±28 g, p=0.911). Our findings indicate that attending indoor cycling classes at a gym 2-to-3 times per week for 12 weeks is enough to improve exercise capacity, while a higher volume of training is required to elicit cardiac adaptations. © Georg Thieme Verlag KG Stuttgart · New York.

  8. 12 weeks of simulated barefoot running changes foot-strike patterns in female runners.

    PubMed

    McCarthy, C; Fleming, N; Donne, B; Blanksby, B

    2014-05-01

    To investigate the effect of a transition program of simulated barefoot running (SBR) on running kinematics and foot-strike patterns, female recreational athletes (n=9, age 29 ± 3 yrs) without SBR experience gradually increased running distance in Vibram FiveFingers SBR footwear over 12 weeks. Matched controls (n=10, age 30 ± 4 yrs) continued running in standard footwear. A 3-D motion analysis of treadmill running at 12 km/h(-1) was performed by both groups, barefoot and shod, pre- and post-intervention. Post-intervention data indicated a more-forefoot strike pattern in the SBR group compared to controls; both running barefoot (P>0.05), and shod (P<0.001). When assessed barefoot, there were significant kinematic differences across time in the SBR group for ankle flexion angle at toe-off (P<0.01). When assessed shod, significant kinematic changes occurred across time, for ankle flexion angles at foot-strike (P<0.001) and toe-off (P<0.01), and for range of motion (ROM) in the absorptive phase of stance (P<0.01). A knee effect was recorded in the SBR group for flexion ROM in the absorptive phase of stance (P<0.05). No significant changes occurred in controls. Therefore, a 12-week transition program in SBR could assist athletes seeking a more-forefoot strike pattern and "barefoot" kinematics, regardless of preferred footwear.

  9. A Comparison of 12 Weeks of Pilates and Aquatic Training on the Dynamic Balance of Women with Mulitple Sclerosis

    PubMed Central

    Marandi, Sayyed Mohammad; Nejad, Vahid Shayegan; Shanazari, Zohreh; Zolaktaf, Vahid

    2013-01-01

    Background: Multiple Sclerosis (MS) is a disabling chronic disease of the nervous system in which the myelin system of the central nervous system is deteriorated. The objective of this study is to understand the effect of Pilates exercises and aquatic training for a 12 week period on the dynamic balance of MS patients. Methods: The research method is semi-experimental. As a result, among the female patients visiting the MS clinic of Kashani hospital in Esfahan, 57 patients with disease intensity levels between 0 and 4.5 were taken as samples. The average length of the disease was 8 ± 2 years, 20;40 years old, and they were randomly divided into three groups of Pilates exercise group, aquatic training group, and the control group. The exercise schedule for the experiment groups consisted of 12 weeks, three sessions per week, and 1 hour for each session. The dynamic balance of the patients, before and after the exercises was measured by Six Spot Step Test. Results: The adjusted mean differences of Timed Up and Go Test (TUGT) scores of the experimental groups are significantly different (P<0.05). Therefore, it can be said that Pilates exercise interventions and aquatic training can significantly increase the dynamic balance of the examinees in the post-experiment stage. Conclusions: Performing the Pilate exercises and aquatic training increases dynamic balance of the MS patients. Considering the role of dynamic balance on physical fitness and enabling the person in doing is daily chores and routines, and its direct effect on the quality of life, it leads the specialists in applying these exercises as a supplementary treatment along with the medicinal treatments for MS patients. PMID:23717760

  10. A randomized, double-blind, parallel-group, phase III study of shortening the dosing interval of subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis and an inadequate response to subcutaneous tocilizumab every other week: Results of the 12-week double-blind period.

    PubMed

    Ogata, Atsushi; Tanaka, Yoshiya; Ishii, Tomonori; Kaneko, Motohide; Miwa, Hiroko; Ohsawa, Shino

    2017-06-16

    To determine the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) monotherapy every week (qw) versus every other week (q2w) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC q2w. Adult patients in Japan with inadequate response to TCZ-SC q2w were randomized to either TCZ-SC 162 mg qw monotherapy or TCZ-SC 162 mg q2w monotherapy for 12 weeks (double-blind). The primary endpoint was the change from baseline in adjusted Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) at week 12. Efficacy, safety and pharmacokinetics were assessed. TCZ-SC qw was superior to TCZ-SC q2w for adjusted mean change in DAS28-ESR from baseline to week 12. The difference in the change in DAS28-ESR between TCZ-SC qw and q2w was -1.21 (95%CI: -2.13, -0.30, p = .0108). A higher proportion of patients receiving TCZ-SC qw achieved DAS28-ESR remission/low disease activity than TCZ-SC q2w. Adverse events were 71.4% and 66.7% for TCZ-SC qw and q2w, respectively; infection was the most common event with one fatal case with TCZ-SC qw. In patients with inadequate response to TCZ-SC q2w, shortening the dosing interval to qw improved efficacy with acceptable tolerability. Occurrence of infection for both TCZ q2w and qw is important and needs careful attention.

  11. Rating of perceived exertion after 12 weeks of high-intensity, intermittent sprinting.

    PubMed

    Heydari, Mehrdad; Boutcher, Stephen H

    2013-02-01

    The effect of a 12-week high-intensity intermittent exercise (HIIE) intervention on the rating of perceived exertion (RPE) response of young males was examined. Participants (N = 38; M BMI = 28.7 kg x m(-2), SD = 3.1; M age = 24.9 yr., SD = 4.3) were randomly assigned to either an exercise or control group. The exercise group received HIIE three times per week, 20 min. per session, for 12 weeks. RPE was assessed before and after HIIE training and during pre- and post-maximal oxygen uptake (VO2 max) testing. After HIIE training, RPE was significantly higher in Weeks 11-12 compared to Weeks 1-2. In contrast, heart rate was similar throughout training. Comparing post- to pre-VO2 max test, RPE was significantly lower in the exercise group, whereas for controls, RPE was similar. Aerobic power improved 15% for the exercise group, with no significant change for controls. HIIE resulted in significant increases in RPE, whereas RPE during the VO2 max test was significantly decreased.

  12. The efficacy of 12 weeks supervised exercise in obesity management.

    PubMed

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) .

  13. Myogenic response of human skeletal muscle to 12 weeks of resistance training at light loading intensity.

    PubMed

    Mackey, A L; Holm, L; Reitelseder, S; Pedersen, T G; Doessing, S; Kadi, F; Kjaer, M

    2011-12-01

    There is strong evidence for enhanced numbers of satellite cells with heavy resistance training. The satellite cell response to very light muscle loading is, however, unknown. We, therefore, designed a 12-week training protocol where volunteers trained one leg with a high load (H) and the other leg with a light load (L). Twelve young healthy men [mean age 25 ± 3 standard deviation (SD) years] volunteered for the study. Muscle biopsies were collected from the m. vastus lateralis of both legs before and after the training period and satellite cells were visualized by CD56 immunohistochemistry. A significant main effect of time was observed (P<0.001) for the number of CD56+ cells per fiber (L: from 0.11 ± 0.02 to 0.13 ± 0.03; H: from 0.12 ± 0.03 to 0.15 ± 0.05, mean ± SD). The finding that 12 weeks of training skeletal muscle even with very light loads can induce an increase in the number of satellite cells reveals a new aspect of myogenic precursor cell activation and suggests that satellite cells may play a role in skeletal muscle adaptation over a broad physiological range. © 2010 John Wiley & Sons A/S.

  14. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    PubMed Central

    Thorup, Anne Cathrine; Lambert, Max Norman; Kahr, Henriette Strøm; Bjerre, Mette; Jeppesen, Per Bendix

    2015-01-01

    Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p < 0.01) at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p < 0.01). CTx decreased in the RC group with −9.94 (±4.93)%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed. PMID:26265926

  15. Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial).

    PubMed

    Greenwood, Sharlene A; Koufaki, Pelagia; Mercer, Thomas H; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C

    2015-10-01

    Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Single-blind, randomized, controlled, parallel trial. 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n=20), resistance training (n=20), or usual care (n=20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Pulse wave velocity, peak oxygen uptake (Vo2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of -2.2±0.4 (95% CI, -3.1 to -1.3) m/s (P<0.001) and between resistance training and usual care of -2.6±0.4 (95% CI, -3.4 to -1.7) m/s (P<0.001) at 12 weeks. Secondary analyses indicated significant improvements in Vo2peak in the aerobic training group and in Vo2peak, sit-to-stand 60, and isometric muscle force in the resistance training group compared with usual care at 12 weeks. There were no reported adverse events, cardiovascular events, or hospitalizations as a result of the intervention. Pilot study, small sample size, no measure of endothelial function. Both aerobic training and resistance

  16. Effects of 12 Weeks High-Intensity & Reduced-Volume Training in Elite Athletes

    PubMed Central

    Kilen, Anders; Larsson, Tanja Hultengren; Jørgensen, Majke; Johansen, Lars; Jørgensen, Susanne; Nordsborg, Nikolai B.

    2014-01-01

    It was investigated if high-intensity interval training (HIT) at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON) or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT comprised ∼5 h vs. 1 h and total distance was ∼17 km vs. 35 km per week for HIT and CON, respectively. HIT was performed as 6-10×10-30 s maximal effort interspersed by 2–4 minutes of rest. Performance of 100 m all-out freestyle and 200 m freestyle was similar before and after the intervention in both HIT (60.4±4.0 vs. 60.3±4.0 s; n = 13 and 133.2±6.4 vs. 132.6±7.7 s; n = 14) and CON (60.2±3.7 vs. 60.6±3.8 s; n = 15 and 133.5±7.0 vs. 133.3±7.6 s; n = 15). Maximal oxygen uptake during swimming was similar before and after the intervention in both the HIT (4.0±0.9 vs. 3.8±1.0 l O2×min−1; n = 14) and CON (3.8±0.7 vs. 3.8±0.7 l O2×min−1; n = 11) group. Oxygen uptake determined at fixed submaximal speed was not significantly affected in either group by the intervention. Body fat % tended to increase (P = 0.09) in the HIT group (15.4±1.6% vs. 16.3±1.6%; P = 0.09; n = 16) and increased (P<0.05) in the CON group (13.9±1.5% vs. 14.9±1.5%; n = 17). A distance reduction of 50% and a more than doubled HIT amount for 12 weeks did neither improve nor compromise performance or physiological capacity in elite swimmers. PMID:24736598

  17. Do soccer and Zumba exercise improve fitness and indicators of health among female hospital employees? A 12-week RCT.

    PubMed

    Barene, S; Krustrup, P; Jackman, S R; Brekke, O L; Holtermann, A

    2014-12-01

    This randomized controlled study investigated the effectiveness of soccer and Zumba on fitness and health indicators in female participants recruited from a workplace. One hundred seven hospital employees were cluster-randomized to either a soccer group (SG), Zumba group (ZG), or control group (CG). Intervention effects for the two training groups were compared with CG. The training was conducted outside working hours as 2-3 1-h sessions per week for 12 weeks. Peak oxygen uptake (VO2peak ), fat percentage, fat mass, bone mineral content, and plasma osteocalcin were measured before and after the intervention period. Based on intention-to-treat-analyses, SG significantly improved the VO2peak relative to body mass (5%; P = 0.02) and decreased heart rate during 100-W cycle exercise (-7 bpm; P = 0.01), total body fat percentage (-1.1%; P = 0.002), and total body fat mass (-1.0 kg; P = 0.001) compared with CG. ZG significantly improved the VO2peak relative to body mass (5%; P = 0.03) and decreased total fat mass (-0.6 kg; P < 0.05) compared with CG. Plasma osteocalcin increased in SG (21%; P < 0.001) and ZG (10%; P = 0.01) compared with CG. The present study indicates that workplace initiated short-term soccer training as well as Zumba outside working hours may result in fitness and modest health benefits among female hospital employees.

  18. Long-term effects of a 12-week exercise training program on clinical outcomes in idiopathic pulmonary fibrosis.

    PubMed

    Vainshelboim, Baruch; Oliveira, Jose; Fox, Benjamin Daniel; Soreck, Yafit; Fruchter, Oren; Kramer, Mordechai Reuven

    2015-06-01

    Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, lung disease, with few therapeutic options. Data are limited with respect to the long-term effect of exercise training (ET) in IPF. This study sought to evaluate the long-term effects of a 12-week ET program on clinical outcomes in IPF patients. Thirty-four IPF patients were randomly allocated to ET or control groups. ET group participated in a 12-week supervised exercise program, while the control group continued with regular medical treatment alone. Exercise capacity, 30 s-chair-stand test for leg strength, dyspnea, and Saint George's Respiratory Questionnaire (SGRQ) for quality of life (QOL) were assessed at baseline and re-evaluated at 11 months from baseline. In addition, at 30-month time point from baseline, the impact of the 12-week intervention was analyzed with respect to survival and cardio-respiratory-related hospitalizations. Thirty-two patients completed the 12-week intervention and 28 patients (14 in each group) were re-evaluated. At 11-month follow-up, no significant differences between the groups and time effect were demonstrated for most outcomes. ET group showed preserved values at the baseline level while the control group showed a trend of deterioration. Only the 30 s-chair-stand test (mean difference 3 stands, p = 0.01) and SGRQ (mean difference -6 units, p = 0.037) were significantly different between the groups. At 30 months, the survival analysis showed three deaths, eight hospitalizations occurred in the control group versus one death, one lung transplantation and seven hospitalizations in the ET group, with no significant differences between groups. At 11-month follow-up, the 12-week ET program showed clinical outcomes were preserved at baseline levels with some maintenance of improvements in leg strength and QOL in the ET group. The control group showed a trend of deterioration in the outcomes. At 30 months, the 12-week ET program did not show benefits in prognosis although

  19. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients.

    PubMed

    Sarıfakıoğlu, Banu; Güzelant, Aliye Yıldırım; Güzel, Eda Celik; Güzel, Savaş; Kızıler, Ali Rıza

    2014-10-01

    The aims of this study were to investigate the effect of exercise therapy on the oxidative stress in fibromyalgia patients and relationship between oxidative stress and fibromyalgia symptoms. Thirty women diagnosed with fibromyalgia according to the American College of Rheumatology preliminary criteria, and 23 healthy women whose age- and weight-matched women were enrolled the study. Pain intensity with visual analog scale (VAS), the number of tender points, the fibromyalgia impact questionnaire (FIQ), the Beck depression inventory (BDI) were evaluated. The oxidative stress parameters thiobarbituric acid reactive substances, protein carbonyls, and nitric oxide, and antioxidant parameters thiols and catalase were investigated in patients and control group. After, combined aerobic and strengthen exercise regimen was given to fibromyalgia group. Exercise therapy consisted of a warming period of 10 min, aerobic exercises period of 20 min, muscle strengthening exercises for 20 min, and 10 min cooling down period. Therapy was lasting 1 h three times per week over a 12-week period. All parameters were reevaluated after the treatment in the patient group. The oxidative stress parameters levels were significantly higher, and antioxidant parameters were significantly lower in patients with fibromyalgia than in the controls. VAS, FIQ, and BDI scores decreased significantly with exercise therapy. The exercise improved all parameters of oxidative stress and antioxidant parameters. Also, all clinical parameters were improved with exercise. We should focus on oxidative stress in the treatment for fibromyalgia with the main objective of reducing oxidative load.

  20. The Columbia-Bronx VA amalgamative clerkship: an effective, 12-week, integrated, longitudinal clinical experience.

    PubMed

    Diuguid-Gerber, Jillian; Porter, Samuel; Quiah, Samuel C; Nickerson, Katherine; Jones, Deborah; Audi, Zeena; Richards, Boyd F

    2017-01-01

    Many medical schools have adopted the longitudinal integrated clerkship (LIC) model in response to calls for increased continuity in clinical learning environments. However, because of implementation challenges, such programs are not feasible at some institutions or are limited to a small number of students. In January 2014, Columbia University College of Physicians and Surgeons (P&S) recognized the need to explore different LIC formats and began offering four, 12-week amalgamative clerkships (AC). Students within this curricular track experienced primary care, internal medicine 'away', orthopedic surgery, urology, and an elective in an integrated format. P&S developed the AC in partnership with the James J. Peters VA Medical Center in Bronx, NY (BVA). All patient care and educational conferences took place at the BVA during the 12-week experience. The learning objectives of the AC were aligned to the learning objectives of a 52-week20 LIC also offered at Columbia. An evaluation process was developed to determine studentlearning experiences and preliminary outcomes, including how well the LIC-related objectivescould be achieved in a shorter period of time. In 2015, P&S collected AC evaluation data through three student feedback sessions. Students reported that the AC provided opportunity for patient continuity, patient-centered care approaches, meaningful roles for students, career development opportunities, and health systems awareness. Early outcomes indicate that the BVA AC provides a degree of longitudinality that can influence student perceptions of patient care, career development, and health systems, consistent with the larger LIC. The team continues to gather additional data on students' experiences and investigate additional sites that have potential to serve as future AC learning environments.

  1. The Columbia-Bronx VA amalgamative clerkship: an effective, 12-week, integrated, longitudinal clinical experience

    PubMed Central

    Diuguid-Gerber, Jillian; Porter, Samuel; Quiah, Samuel C.; Nickerson, Katherine; Jones, Deborah; Audi, Zeena; Richards, Boyd F.

    2017-01-01

    ABSTRACT Background: Many medical schools have adopted the longitudinal integrated clerkship (LIC) model in response to calls for increased continuity in clinical learning environments. However, because of implementation challenges, such programs are not feasible at some institutions or are limited to a small number of students. Objective: In January 2014, Columbia University College of Physicians and Surgeons (P&S) recognized the need to explore different LIC formats and began offering four, 12-week amalgamative clerkships (AC). Students within this curricular track experienced primary care, internal medicine ‘away’, orthopedic surgery, urology, and an elective in an integrated format. Design: P&S developed the AC in partnership with the James J. Peters VA Medical Center in Bronx, NY (BVA). All patient care and educational conferences took place at the BVA during the 12-week experience. The learning objectives of the AC were aligned to the learning objectives of a 52-week LIC also offered at Columbia. An evaluation process was developed to determine student learning experiences and preliminary outcomes, including how well the LIC-related objectives could be achieved in a shorter period of time. Results: In 2015, P&S collected AC evaluation data through three student feedback sessions. Students reported that the AC provided opportunity for patient continuity, patient-centered care approaches, meaningful roles for students, career development opportunities, and health systems awareness. Conclusions: Early outcomes indicate that the BVA AC provides a degree of longitudinality that can influence student perceptions of patient care, career development, and health systems, consistent with the larger LIC. The team continues to gather additional data on students’ experiences and investigate additional sites that have potential to serve as future AC learning environments. PMID:28317473

  2. Effect of a 12-week aerobic training program on perceptual and affective responses in obese women

    PubMed Central

    Freitas, Luís Alberto Garcia; Ferreira, Sandro dos Santos; Freitas, Rosemari Queiroz; Henrique de Souza, Carlos; Garcia, Erick Doner Santos de Abreu; Gregorio da Silva, Sergio

    2015-01-01

    [Purpose] The aim of this study was to observe the effect of self-selected intensity or imposed intensity during aerobic training on perceptual and affective responses in obese women. [Subjects] The study included 26 obese women aged 30–60 years. [Methods] The subjects were randomly divided into two groups, with 13 subjects in each group: self-selected intensity and imposed intensity (10% above ventilatory threshold) groups. All subjects completed an intervention program that lasted 12 weeks, with three exercise sessions a week. The rating of perceived exertion and affective responses (Feeling Scale and Felt Arousal Scale) were monitored in the first, sixth, and twelfth weeks. [Results] Significant differences were observed between groups in heart rate and rating of perceived exertion. The affective responses during exercise were more negative in the imposed intensity group. [Conclusion] Use of a self-selected exercise intensity can promote smaller negative affective responses during exercise and provide a sufficient stimulus for improvement in cardiorespiratory fitness. PMID:26311958

  3. LA Sprouts: A 12-week gardening, nutrition, and cooking randomized control trial improves determinants of dietary behaviors

    PubMed Central

    Davis, Jaimie N; Martinez, Lauren C.; Spruijt-Metz, Donna; Gatto, Nicole M.

    2015-01-01

    Objective To evaluate the effect of an exploratory 12-week nutrition, cooking and gardening RCT (“LA Sprouts”) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden/eat/cook FV; motivation to garden/eat/cook FV; attitudes towards FV; nutrition and gardening knowledge; and home gardening habits. Design and Participants Four elementary schools with 304 predominately Hispanic/Latino 3rd–5th grade students were randomized to either the LA Sprouts (n=167 students) or Control group (n=137 students). LA Sprouts participants received 12 weeks of weekly 90-minute culturally tailored gardening, nutrition, and cooking classes after school. Questionnaire data examining dietary determinants were obtained at baseline and post-intervention. Results After the 12-week program, LA Sprouts participants compared with controls improved scores for identification of vegetables (+11% vs. +5%; P=.001), nutrition and gardening knowledge (+14.5% vs. −5.0%; P =.003), and were more likely to garden at home (+7.5% vs. −4.4%; P=.003). Conclusions The LA Sprouts program positively impacted a number of determinants of dietary behaviors, which suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. PMID:26453367

  4. Effect of 12 weeks of Tai Chi training on soleus Hoffmann reflex and control of static posture in older adults.

    PubMed

    Chen, Yung-Sheng; Zhou, Shi; Cartwright, Colleen

    2011-06-01

    To investigate the effect of 12 weeks of Tai Chi training on soleus (SOL) Hoffmann reflex (H-reflex) modulation and postural control in standing under 4 sensory conditions in older adults. Experimental research design with pre- and posttraining tests in a training group and a control group. University biomechanics laboratory. Community-dwelling older adults (N=34) were assigned to a training (n=20; mean ± SD age, 72.9±4.4y) and a control (n=14; mean ± SD age, 72.9±6.5y) group. Tai Chi participants attended a 1-hour session of Yang style Tai Chi, 3 sessions a week, for 12 weeks, while control participants maintained their regular daily activities during the same period. SOL H-reflex (maximal amplitudes of H-reflex [H(max)] and M-wave [M(max)] waves) and mean displacement of the center of pressure (COP) in the anterior-posterior (COP(A-P)) and medial-lateral (COP(M-L)) directions were measured during bipedal standing, with the feet placed on a forceplate and the heels 6cm apart, under 4 sensory conditions: stable surface with eyes open, stable surface with eyes closed, unstable surface with eyes open, and unstable surface with eyes closed. SOL H(max)/M(max) ratio in the Tai Chi group was upregulated significantly in all 4 sensory tasks after the 12-week Tai Chi training (P<.05). No significant change in COP measurements (mean displacement of COP(A-P) and COP(M-L)) was found in either the Tai Chi or control group after the 12-week period. An increase in SOL H(max)/M(max) ratio during static postural tasks is observed after 12 weeks of Tai Chi training in older adults under all 4 sensory conditions. However, training-induced changes in H-reflex were not accompanied by improvement of performance in the static postural control tasks. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  5. Mechanisms used to increase peak propulsive force following 12-weeks of gait training in individuals poststroke

    PubMed Central

    Hsiao, HaoYuan; Knarr, Brian A.; Pohlig, Ryan T.; Higginson, Jill S.; Binder-Macleod, Stuart A.

    2016-01-01

    Current rehabilitation efforts for individuals poststroke focus on increasing walking speed because it is a predictor of community ambulation and participation. Greater propulsive force is required to increase walking speed. Previous studies have identified that trailing limb angle (TLA) and ankle moment are key factors to increases in propulsive force during gait. However, no studies have determined the relative contribution of these two factors to increase propulsive force following intervention. The purpose of this study was to quantify the relative contribution of ankle moment and TLA to increases in propulsive force following 12-weeks of gait training for individuals poststroke. Forty-five participants were assigned to 1 of 3 training groups: training at self-selected speeds (SS), at fastest comfortable speeds (Fast), and Fast with functional electrical stimulation (FastFES). For participants who gained paretic propulsive force following training, a biomechanical-based model previously developed for individuals poststroke was used to calculate the relative contributions of ankle moment and TLA. A two-way, mixed-model design, analysis of covariance adjusted for baseline walking speed was performed to analyze changes in TLA and ankle moment across groups. The model showed that TLA was the major contributor to increases in propulsive force following training. Although the paretic TLA increased from pre-training to post-training, no differences were observed between groups. In contrast, increases in paretic ankle moment were observed only in the FastFES group. Our findings suggested that specific targeting may be needed to increase ankle moment. PMID:26776931

  6. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program.

    PubMed

    O'Neil, Patrick M; Theim, Kelly R; Boeka, Abbe; Johnson, Gail; Miller-Kovach, Karen

    2012-12-01

    Greater use of key self-regulatory behaviors (e.g., self-monitoring of food intake and weight) is associated with greater weight loss within behavioral weight loss treatments, although this association is less established within widely-available commercial weight loss programs. Further, high hedonic hunger (i.e., susceptibility to environmental food cues) may present a barrier to successful behavior change and weight loss, although this has not yet been examined. Adult men and women (N=111, body mass index M±SD=31.5±2.7kg/m(2)) were assessed before and after participating in a 12-week commercial weight loss program. From pre- to post-treatment, reported usage of weight control behaviors improved and hedonic hunger decreased, and these changes were inversely associated. A decrease in hedonic hunger was associated with better weight loss. An improvement in reported weight control behaviors (e.g., self-regulatory behaviors) was associated with better weight loss, and this association was even stronger among individuals with high baseline hedonic hunger. Findings highlight the importance of specific self-regulatory behaviors within weight loss treatment, including a commercial weight loss program developed for widespread community implementation. Assessment of weight control behavioral skills usage and hedonic hunger may be useful to further identify mediators of weight loss within commercial weight loss programs. Future interventions might specifically target high hedonic hunger and prospectively examine changes in hedonic hunger during other types of weight loss treatment to inform its potential impact on sustained behavior change and weight control.

  7. Self-presentation in exercise: changes over a 12-week cardiovascular programme for overweight and obese sedentary females.

    PubMed

    Pearson, Erin S; Hall, Craig R; Gammage, Kimberley L

    2013-01-01

    Self-presentational concerns, shown to influence exercise-related cognitions and behaviours, are evaluated frequently in the absence of exercise or following a single bout of physical activity. The purpose of the present study was to examine longitudinally, the extent to which participating in a structured 12-week cardiovascular exercise intervention elicited changes in self-presentational efficacy expectancy (SPEE) and social physique anxiety (SPA). Participants were 80 sedentary women with overweight or obesity (mean body mass index 29.02 kg/m(2), SD=4.71) between the ages of 19 and 45 wanting to begin an exercise programme (mean age 33.4 years, SD=7.6). The Self-Presentational Efficacy Scale (SPES) and the Social Physique Anxiety Scale (SPAS) were completed by each participant prior to commencing the study, and at the 6- and 12-week time points. For those who completed the programme, repeated measures ANOVAs indicated significant increases in SPEE between baseline and week 6 (P<0.001, η(2)=0.37), and week 6 to 12 (P<0.05, η(2)=0.10), while SPA decreased significantly between baseline and week 6 (P<0.01, η(2)=0.16). Bivariate correlation analyses revealed that length of participation in the study was positively related to SPEE and negatively related to SPA. Implications of focusing on these variables within a physical activity intervention are discussed with respect to exercise behaviour, programme development and adherence.

  8. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women

    PubMed Central

    2011-01-01

    Background Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC) have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. Methods/Design The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA), haemoglobin A1C (HbA1C), triglycerides and C-reactive protein (CRP). Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. Discussion The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP) is designed to provide a rigorous

  9. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women.

    PubMed

    Canuto, Karla J; McDermott, Robyn A; Cargo, Margaret; Esterman, Adrian J

    2011-08-19

    Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC) have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA), haemoglobin A1C (HbA1C), triglycerides and C-reactive protein (CRP). Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP) is designed to provide a rigorous physiological and client

  10. A randomised placebo controlled 12 week trial of budesonide and prednisolone in rheumatoid arthritis

    PubMed Central

    Kirwan, J; Hallgren, R; Mielants, H; Wollheim, F; Bjorck, E; Persson, T; Book, C; Bowman, S; Byron, M; Cox, N; Field, M; Kanerud, L; Leirisalo-Repo, M; Malaise, M; Mohammad, A; Palmer, R; Petersson, I; Ringertz, B; Sheldon, P; Simonsson, M; Snowden, N; Van den Bosch, F

    2004-01-01

    Objectives: To compare budesonide, a locally acting glucocorticoid with minimal systemic exposure, with conventional glucocorticoid treatment and placebo in rheumatoid arthritis. Methods: A double blind, randomised, controlled trial over 12 weeks in 143 patients with active rheumatoid arthritis, comparing budesonide 3 mg daily, budesonide 9 mg daily, prednisolone 7.5 mg daily, and placebo. Particular attention was paid to the pattern of clinical response and to changes in the four week period following discontinuation of treatment. Results: There were improvements in tender joint count and swollen joint count on budesonide 9 mg compared with placebo (28% for tender and 34% for swollen joint counts, p<0.05). Prednisolone 7.5 mg gave similar results, while budesonide 3 mg was less effective. ACR20 response criteria were met by 25% of patients on placebo, 22% on budesonide 3 mg, 42% on budesonide 9 mg, and 56% on prednisolone 7.5 mg. A rapid and significant reduction in symptoms and signs in response to budesonide 9 mg and prednisolone 7.5 mg was evident by two weeks and maximal at eight weeks. There was no evidence that budesonide provided a different pattern of symptom control from prednisolone, or that symptoms became worse than placebo treatment levels after discontinuation of glucocorticoid treatment. Adverse effects attributable to glucocorticoids were equally common in all groups. Conclusions: The symptomatic benefits of budesonide 9 mg and prednisolone 7.5 mg are achieved within a short time of initiating treatment, are maintained for three months, and are not associated with any rebound in symptoms after stopping treatment. PMID:15140776

  11. Prospective randomized clinical trial of hydrophilic tapered implant placement at maxillary posterior area: 6 weeks and 12 weeks loading.

    PubMed

    Kim, Seong-Beom; Yun, Pil-Young; Kim, Sang-Yun; Yi, Yang-Jin; Kim, Ji-Yun; Kim, Young-Kyun

    2016-10-01

    Early loading of implant can be determined by excellent primary stability and characteristic of implant surface. The implant system with recently improved surface can have load application 4-6 weeks after installing in maxilla and mandible. This study evaluated the effect of healing period to the stability of hydrophilic tapered-type implant at maxillary posterior area. This study included 30 patients treated by hydrophilic tapered-type implants (total 41 implants at maxilla) and classified by two groups depending on healing period. Group 1 (11 patients, 15 implants) was a control group and the healing period was 12 weeks, and Group 2 (19 patients, 26 implants) was test group and the healing period was 6 weeks. Immediately after implant placement, at the first impression taking, implant stability was measured using Osstell Mentor. The patients also took periapical radiographs after restoration delivery, 12 months after restoration and final followup period. The marginal bone loss around the implants was measured using the periapical radiographs. All implants were survived and success rate was 97.56%. The marginal bone loss was less than 1mm after 1 year postoperatively except the one implant. The stabilities of the implants were not correlated with age, healing period until loading, insertion torque (IT), the diameter of fixture and the location of implant. Only the quality of bone in group 2 (6 week) was correlated with the stability of implant. Healing period of 6 weeks can make the similar clinical prognosis of implants to that of healing period of 12 weeks if bone quality is carefully considered in case of early loading.

  12. Prospective randomized clinical trial of hydrophilic tapered implant placement at maxillary posterior area: 6 weeks and 12 weeks loading

    PubMed Central

    2016-01-01

    PURPOSE Early loading of implant can be determined by excellent primary stability and characteristic of implant surface. The implant system with recently improved surface can have load application 4-6 weeks after installing in maxilla and mandible. This study evaluated the effect of healing period to the stability of hydrophilic tapered-type implant at maxillary posterior area. MATERIALS AND METHODS This study included 30 patients treated by hydrophilic tapered-type implants (total 41 implants at maxilla) and classified by two groups depending on healing period. Group 1 (11 patients, 15 implants) was a control group and the healing period was 12 weeks, and Group 2 (19 patients, 26 implants) was test group and the healing period was 6 weeks. Immediately after implant placement, at the first impression taking, implant stability was measured using Osstell Mentor. The patients also took periapical radiographs after restoration delivery, 12 months after restoration and final followup period. The marginal bone loss around the implants was measured using the periapical radiographs. RESULTS All implants were survived and success rate was 97.56%. The marginal bone loss was less than 1mm after 1 year postoperatively except the one implant. The stabilities of the implants were not correlated with age, healing period until loading, insertion torque (IT), the diameter of fixture and the location of implant. Only the quality of bone in group 2 (6 week) was correlated with the stability of implant. CONCLUSION Healing period of 6 weeks can make the similar clinical prognosis of implants to that of healing period of 12 weeks if bone quality is carefully considered in case of early loading. PMID:27826390

  13. Does 12-Week Latin Dance Training Affect the Self-Confidence of the University Students?

    ERIC Educational Resources Information Center

    Meric, Odemis; Ilhan, Adilogullari

    2016-01-01

    In this research, it is aimed to investigate the effect of 12-week Latin dance training on the self-confidence of university students. This research was conducted with a total of 60 students, including 30 students as control and 30 students as the working group. A 33-item self-confidence scale developed by Akin (2007) was applied to both control…

  14. The Effects of a 12-Week Walking Program on Community-Dwelling Older Adults

    ERIC Educational Resources Information Center

    Cheng, Shun-Ping; Tsai, Tzu-I; Lii, Yun-Kung; Yu, Shu; Chou, Chen-Liang; Chen, I-Ju

    2009-01-01

    Walking is a popular and easily accessible form of physical activity. However, walking instruction for older adults is based on the evidence gathered from younger populations. This study evaluated walking conditions, strength, balance, and subjective health status after a 12-week walking-training program in community-dwelling adults greater than…

  15. The Effects of a 12-Week Walking Program on Community-Dwelling Older Adults

    ERIC Educational Resources Information Center

    Cheng, Shun-Ping; Tsai, Tzu-I; Lii, Yun-Kung; Yu, Shu; Chou, Chen-Liang; Chen, I-Ju

    2009-01-01

    Walking is a popular and easily accessible form of physical activity. However, walking instruction for older adults is based on the evidence gathered from younger populations. This study evaluated walking conditions, strength, balance, and subjective health status after a 12-week walking-training program in community-dwelling adults greater than…

  16. Mother-Infant Interaction and Cognitive Development in the 12-Week-Old Infant.

    ERIC Educational Resources Information Center

    Gallas, Howard B.; Lewis, Michael

    This study explored the relationship between the mother-infant interaction and the concurrent perceptual-cognitive and intellectual status of the infant. One hundred and eight-nine 12-week-old infants were given a battery of perceptual-cognitive tasks, including the Mental Developmental Index (MDI) of the Bayley Scales, the Corman-Escalona Scales…

  17. Achondrogenesis type 2 diagnosed by transvaginal ultrasound at 12 weeks' gestation.

    PubMed

    Soothill, P W; Vuthiwong, C; Rees, H

    1993-06-01

    Ultrasound examination at 12 weeks' gestation revealed severe generalised subcutaneous oedema in a pregnancy at risk for achondrogenesis type II. Transvaginal scanning confirmed the oedema and suggested abnormal limb development. The prenatal diagnosis was confirmed by X-ray examination after transvaginal termination.

  18. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    ERIC Educational Resources Information Center

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  19. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    ERIC Educational Resources Information Center

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  20. LA Sprouts: A 12-Week Gardening, Nutrition, and Cooking Randomized Control Trial Improves Determinants of Dietary Behaviors.

    PubMed

    Davis, Jaimie N; Martinez, Lauren C; Spruijt-Metz, Donna; Gatto, Nicole M

    2016-01-01

    To evaluate the effect of an exploratory 12-week nutrition, cooking, and gardening trial (LA Sprouts) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden, eat, and cook FV; motivation to garden, eat, and cook FV; attitudes toward FV; nutrition and gardening knowledge; and home gardening habits. Randomized controlled trial. Four elementary schools. Three hundred four predominately Hispanic/Latino third- through fifth-grade students were randomized to either the LA Sprouts group (n = 167 students) or control group (n = 137 students). Twelve-week after-school nutrition, cooking, and gardening intervention. Determinants of dietary behavior as measured by questionnaire at baseline and postintervention. Analyses of covariance. After the 12-week program, compared with controls, LA Sprouts participants improved scores for identification of vegetables (+11% vs +5%; P = .001) and nutrition and gardening knowledge (+14.5% vs -5.0%; P = .003), and were more likely to garden at home (+7.5% vs -4.4%; P = .003). The LA Sprouts program positively affected a number of determinants of dietary behaviors that suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  1. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study.

    PubMed

    Merolli, Mark; Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-08-07

    Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients

  2. The effects of 12 weeks of step aerobics training on functional fitness of elderly women.

    PubMed

    Hallage, Tatiane; Krause, Maressa P; Haile, Luke; Miculis, Cristiane P; Nagle, Elizabeth F; Reis, Rodrigo S; Da Silva, Sergio G

    2010-08-01

    The purpose of this study was to determine the effects of 12 weeks of step aerobics (SA) training on the functional fitness of apparently healthy older women. Thirteen previously sedentary elderly women (mean age 63.14 years) participated in this study. Subjects performed 3 training sessions per week for 30-60 minutes per session. All measurements were assessed at baseline, after 12 weeks of training (posttest), and after 1 month of detraining. Assessments included the evaluation of body mass index (BMI), waist circumference (WC), strength of the upper (arm-curl [AC] test) and lower body (30-second chair-stand test [CS]), dynamic balance and agility (8 foot up and go [8 ft]), flexibility (chair sit-and-reach [CSR]), and cardiorespiratory fitness (6-minute walk test [6MW]). Step aerobics significantly improved all functional fitness components except for BMI. The 12 weeks of SA promoted a large effect size in the following measurements: WC (d = 1.6); CSR (d = 1.51); CS (d = 1.49); AC (d = 1.41); 8 ft (d = 1.32); and 6MW (d = 1.06) (p < 0.05). These results indicate that 12 weeks of SA had a positive effect on the functional fitness components of these older women. Furthermore, these findings were confirmed by the reverse effect observed after 1 month of detraining, except for upper body strength (AC test). In conclusion, 12 weeks of SA training can promote improvements in the functional fitness of apparently healthy older women. Therefore, SA can be considered an effective exercise modality to prevent the loss of functional fitness and its associated consequences.

  3. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

    PubMed

    Kowdley, Kris V; Gordon, Stuart C; Reddy, K Rajender; Rossaro, Lorenzo; Bernstein, David E; Lawitz, Eric; Shiffman, Mitchell L; Schiff, Eugene; Ghalib, Reem; Ryan, Michael; Rustgi, Vinod; Chojkier, Mario; Herring, Robert; Di Bisceglie, Adrian M; Pockros, Paul J; Subramanian, G Mani; An, Di; Svarovskaia, Evguenia; Hyland, Robert H; Pang, Phillip S; Symonds, William T; McHutchison, John G; Muir, Andrew J; Pound, David; Fried, Michael W

    2014-05-15

    High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen. In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir-sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, -4 to 6) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower (95% CI, -6 to 4); these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events. Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks. (Funded

  4. Antenatal ultrasound and postnatal autopsy findings in terminations after 12 weeks' gestation due to fetal abnormality: population-based study in Western Norway, 1988-2002.

    PubMed

    Parkar, A P; Olsen, Ø E; Maartmann-Moe, H; Daltveit, A K; Gjelland, K; Rosendahl, K

    2009-09-01

    Ultrasound screening has been part of antenatal care for several decades, and warrants high expertise to meet the criteria for a worthwhile screening program. In particular, the rate of false positives should be low. To examine time trends of pregnancy terminations for fetal abnormality after 12 weeks' gestation, and to assess the agreement between antenatal ultrasound and post-termination autopsy findings for the main pathologies leading to termination. During the period 1988 to 2002, 198 pregnancies were terminated for fetal abnormality after 12 weeks' gestation. We reviewed the case notes for those 151 who were autopsied (male/female/undetermined ;= ;91/56/4). Annual rates of live births and stillbirths were retrieved from the Medical Birth Registry of Norway. Antenatal ultrasound provided a correct diagnosis of the major abnormality in 149/151 cases (99%), based on post-termination autopsy findings. The annual rate of terminations after 12 weeks' gestation varied between 0.6 and 3.4 (mean 1.8) per 1000 live births, with a trend toward higher rates over the study period (P=0.001, chi-square test for linear-by-linear association). The specificity of antenatal ultrasound for major abnormalities was high, as compared to postnatal autopsy findings. The mean annual rates of termination after 12 weeks' gestation tended to increase over the 14-year study period.

  5. 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.

  6. The effect of 12-week Pilates exercises on wellness in the elderly

    PubMed Central

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  7. The effect of 12-week Pilates exercises on wellness in the elderly.

    PubMed

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly.

  8. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women

    PubMed Central

    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-01-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korean dance. [Results] Two-factor analysis of variance revealed significant group × time interactions for body mass, diastolic blood pressure, appendicular muscle mass. For high-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and the ratio of oxidized low-/high-density lipoprotein cholesterol, two-factor analysis of variance revealed significant interactions (group × time), indicating responses differed significantly between the control and exercise groups after 12 weeks. [Conclusion] A 12-week low- to moderate-intensity exercise program appears to be beneficial for obese elderly women by improving risk factors for cardiovascular disease. PMID:26157235

  9. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  10. A 12-week placebo-controlled study of rupatadine 10 mg once daily compared with cetirizine 10 mg once daily, in the treatment of persistent allergic rhinitis.

    PubMed

    Fantin, S; Maspero, J; Bisbal, C; Agache, I; Donado, E; Borja, J; Mola, O; Izquierdo, I

    2008-07-01

    With the current increasing incidence of allergies worldwide, new treatments showing efficacy and long term safety are needed for chronic conditions such as persistent allergic rhinitis (PER). New generation H1-antihistamines have demonstrated anti-allergic properties, which could possibly enhance their effectiveness in long-term periods of treatment. To investigate the efficacy of rupatadine, in controlling symptoms of PER over a 12-week period. A randomized, double blind, parallel-group, placebo-controlled study was carried out in patients aged older than 12 years with PER. Main inclusion criteria were: instantaneous total symptom score (i6TSS) >or=45, nasal obstruction score or=2 as moderate during the first visit. The primary efficacy endpoint was the 12-week average change from baseline of the patients' i6TSS. In all, 736 patients were selected. Of them, 543 (73.8%) were randomized in three different groups: placebo (n = 185), cetirizine (n = 175) and rupatadine (n = 183). Rupatadine (P = 0.008) but not cetirizine (P = 0.07) statistically reduced the baseline i6TSS vs placebo (47.8%, 44.7% and 38.8%, respectively), after 12 weeks. Onset of action was observed at the first 24 h for both treatments (rupatadine vs placebo, P = 0.013; cetirizine vs placebo, P = 0.015). Furthermore, instantaneous total nasal symptoms score (iTNSS) (including nasal blockage) mean change from baseline showed a significant reduction with rupatadine 10 mg in comparison with placebo, along all treatment duration of 12 weeks. Study treatments were well tolerated. Rupatadine significantly relieves symptoms of PER, providing a rapid onset of action and maintains its effects over a long period of 12-weeks.

  11. Gut microbiota composition in relation to the metabolic response to 12-week combined polyphenol supplementation in overweight men and women.

    PubMed

    Most, J; Penders, J; Lucchesi, M; Goossens, G H; Blaak, E E

    2017-09-01

    The intestinal microbiota may have a profound impact on host metabolism. As evidence suggests that polyphenols affect substrate utilization, the present study aimed to investigate the effects of polyphenol supplementation on intestinal microbiota composition in humans. Furthermore, we examined whether (changes in) gut microbiota composition may determine the metabolic response to polyphenol supplementation. In this randomized, double-blind, placebo (PLA)-controlled trial, 37 overweight and obese men and women (18 males/19 females, 37.8±1.6 years, body mass index: 29.6±0.5 kg/m(2)) received either epigallocatechin-3-gallate and resveratrol (EGCG+RES, 282 and 80 mg/day, respectively) or PLA for 12 weeks. Before and after intervention, feces samples were collected to determine microbiota composition. Fat oxidation was assessed by indirect calorimetry during a high-fat mixed meal test (2.6 MJ, 61 energy% fat) and skeletal muscle mitochondrial oxidative capacity by means of ex vivo respirometry on isolated skeletal muscle fibers. Body composition was measured by dual-energy X-ray absorptiometry. Fecal abundance of Bacteroidetes was higher in men as compared with women, whereas other assessed bacterial taxa were comparable. EGCG+RES supplementation significantly decreased Bacteroidetes and tended to reduce Faecalibacterium prausnitzii in men (P=0.05 and P=0.10, respectively) but not in women (P=0.15 and P=0.77, respectively). Strikingly, baseline Bacteroidetes abundance was predictive for the EGCG+RES-induced increase in fat oxidation in men but not in women. Other bacterial genera and species were not affected by EGCG+RES supplementation. We demonstrated that 12-week EGCG+RES supplementation affected the gut microbiota composition in men but not in women. Baseline microbiota composition determined the increase in fat oxidation after EGCG+RES supplementation in men.

  12. Growth and change in blood haemoglobin concentration among underweight Malawian infants receiving fortified spreads for 12 weeks: a preliminary trial.

    PubMed

    Kuusipalo, Heli; Maleta, Kenneth; Briend, André; Manary, Mark; Ashorn, Per

    2006-10-01

    Fortified spreads (FSs) have proven effective in the rehabilitation of severely malnourished children. We examined acceptability, growth and change in blood haemoglobin (Hb) concentration among moderately underweight ambulatory infants given FS. This was a randomised, controlled, parallel-group, investigator-blind clinical trial in rural Malawi. Six- to 17-month-old underweight infants (weight for age < -2), whose weight was greater than 5.5 kg and weight-for-height z score greater than -3 received for 12 weeks at home 1 of 8 food supplementation schemes: nothing, 5, 25, 50, or 75 g/day milk-based FS or 25, 50, or 75 g/day soy-based FS. Outcome measures included change in weight, length and blood Hb concentration. A total of 126 infants started and 125 completed the intervention. All infants accepted the spread well, and no intolerance was recorded. Average weight and length gains were higher among infants receiving daily 25 to 75 g FS than among those receiving only 0 to 5 g FS. Mean Hb concentration remained unchanged among unsupplemented controls but increased by 10 to 17 g/L among infants receiving any FS. All average gains were largest among infants receiving 50 g of FS daily: mean difference (95% confidence interval) in the 12-week gain between infants in 50 g milk-based FS group and the unsupplemented group was 290 g (range, -130 to 700 g), 0.9 cm (range, -0.3 to 2.2 cm), and 17 g/L (range, 0 to 34 g/L) for weight, length and blood Hb concentration, respectively. In soy- vs milk-based FS groups, average outcomes were comparable. Supplementation with 25 to 75 g/day of highly fortified spread is feasible and may promote growth and alleviate anaemia among moderately malnourished infants. Further trials should test this hypothesis.

  13. A Novel Functional Electrical Stimulation Treatment for Recovery of Hand Function in Hemiplegia: 12-Week Pilot Study

    PubMed Central

    Knutson, Jayme S.; Hisel, Terri Z.; Harley, Mary Y.; Chae, John

    2011-01-01

    Background Loss of finger extension is common after stroke and can severely limit hand function. Contralaterally controlled functional electrical stimulation (CCFES) is a new treatment aimed at restoring volitional finger and thumb extension. A previous pilot study showed reductions in hand impairment after 6 weeks of CCFES, but the effect did not persist after end of treatment. Objective This study aimed to evaluate the feasibility of achieving greater and more persistent gains with CCFES by increasing the treatment period to 12 weeks. Methods CCFES uses neuromuscular electrical stimulation to open the paretic hand in direct proportion to the degree of volitional opening of the unimpaired contralateral hand, which is detected by an instrumented glove. Three subjects with chronic hemiplegia participated in a 12-week CCFES treatment, which consisted of daily CCFES-assisted active repetitive hand-opening exercises and twice weekly functional task practice with CCFES. Results Maximum voluntary finger extension increased by 101° and 68° for subjects 1 and 2, respectively, but subject 3 had no improvement in finger extension. Box and Block score increased by 6, 15, and 7 blocks, and upper extremity Fugl-Meyer score increased by 11, 15, and 7 points for subjects 1, 2, and 3, respectively. The finger extension gains declined at the 1-month and 3-month follow-up for subjects 1 and 2, but the gains in Box and Block and Fugl-Meyer scores persisted at follow-up. Conclusions Greater reductions in hand impairment were achieved by extending the treatment period. The effect and its longevity may be related to baseline impairment level. PMID:18812432

  14. Effects of 12-weeks resistance training on sprint and jump performance in competitive adolescent rugby union players.

    PubMed

    Harries, Simon K; Lubans, David R; Buxton, Anthony; MacDougall, Thomas H J; Callister, Robin

    2017-07-17

    Sprint performance is an important characteristic for success in many sports, including rugby union. Resistance training is used to increase muscular fitness (i.e. strength, endurance and power) and may also be effective for improving sprint and jump performances. The aims of this study were to examine the effects of resistance training using two different periodized programs (linear and daily undulating) on sprint and jump performance and explore relationships between performance measures. Sixteen male (16.9 ± 1.0 y) adolescent rugby union players participated in 12 weeks of resistance training. A further 10 male (15.5 ± 1.0 y) participants were recruited as a control group. Assessments of strength (box squat), 10 and 20 m sprint (electronically timed), and jump height (maximal unloaded (body mass only) and loaded (body mass + 10 kg) countermovement jumps) were conducted before and after 12 weeks training. Large to very large increases in 1RM box squat (linear: 33.9%; p < 0.001; ES = 1.64; daily undulating: 44.5%; p < 0.001; ES = 2.33) were observed after training. Small decreases were seen in 10 (linear: -1.6%; p = 0.171; ES = -0.84; daily undulating: -2.5%; p = 0.038; ES = -0.36) and 20 m (linear: -0.5%; p = 0.506; ES = -0.20; daily undulating: -1.7%; p = 0.047; ES = -0.27) sprint times. Small-to-moderate associations between changes in lower body strength and improvements in 10 and 20 m sprint times were found. Resistance training increases lower body strength in adolescent rugby union players and increases in lower body strength may transfer to improved sprinting performance with improvements following daily undulating periodized resistance training slightly superior.

  15. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment).

    PubMed

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Steady state was reached within 1-2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3-9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia.

  16. Chronic flexibility improvement after 12 week of stretching program utilizing the ACSM recommendations: hamstring flexibility.

    PubMed

    Sainz de Baranda, P; Ayala, F

    2010-06-01

    The ACSM flexibility training recommendations emphasize proper stretching of muscles supporting the major joints, but there is a little evidence to support this recommendation in terms of effectiveness, and which stretching parameters (technique and single stretch duration) are more adequate. A randomized controlled clinical trial design was use to investigate whether the ACSM flexibility training recommendation parameters improve hip flexion range of motion. A total of 173 subjects, 122 men (21.3+/-2.5 years; 176.33+/-8.35 cm; 74.42+/-10.80 kg) and 51 women (20.7+/-1.6 years; 163.43+/-6.57 cm; 60.12+/-7.88 kg), classified as recreationally active young adult university students were randomly assigned to 1 of 7 groups: 1 control group (no stretching) or 1 of 6 stretching groups. All stretching groups performed 12 weeks of flexibility training with a consistent stretch daily dose (180 s) and frequency (3 days per week) parameters and different stretch technique (passive or active) and single stretch duration (15, 30, or 45 s). Hip flexion passive range of motion (PROM) was determined through the bilateral straight-leg raise test before, during (at 4 and 8 weeks), and after the program (12 weeks). All stretching groups performed hip flexion PROM after flexibility training. A significant improvement was identified in mean PROM for each stretching group, but no significant differences were found between stretch technique and single stretch duration (p>0.05). The control group's mean PROM decreased (Delta PROM: -0.08 degrees, 95% confidence interval [CI]=-2.3 to 5.3), whereas all stretching groups increased PROM (Delta PROM: 15.14 degrees, 95% CI=10.19 to 23.56) in hip flexion after 12 weeks of stretching (p<0.05). The present study suggests that the current ACSM flexibility training recommendations are effective for improving hip flexion ROM in recreationally active young adults.

  17. The effects of 12 weeks Pilates-inspired exercise training on functional performance in older women: A randomized clinical trial.

    PubMed

    Vieira, Natália Donzeli; Testa, Daniela; Ruas, Paula Cristine; Salvini, Tânia de Fátima; Catai, Aparecida Maria; Melo, Ruth Caldeira

    2017-04-01

    Recent scientific evidence supports the benefits of Pilates exercises on postural balance and muscle strength of older persons. However, their effects on other aspects of physical fitness, which are also important for independent living in older age, are still unknown. To investigate the effects of a 12-week Pilates-inspired exercise program on the functional performance of community-dwelling older women. Forty community-dwelling older women were randomly enrolled in a Pilates-inspired exercise training (2 times/week, 60 min/session) (PG, n = 21, 66.0 ± 1.4yrs) or kept in the control group (CG; n = 19, 63.3 ± 0.9yrs). The Pilates exercises were conducted in small groups and performed on mats (using accessories such as exercise rubber bands, swiss and exercise balls). The functional performance on one-leg stance (OLS), timed up and go (TUG), five-times-sit-to-stand (STS) and 6-min walk (6 MW) tests was evaluated before and after the 12-week Pilates training or control follow-up period. After 12 weeks, time effects were observed for STS (p = 0.03) and 6 MW tests (p < 0.01). Only among PG subjects did the time spent to rise from a chair and return to a seated position decrease significantly (2.0 s faster, p = 0.02) and the distance walked in 6 min increase (∼30 m, p < 0.01). OLS and TUG performance remained unaltered in both groups. Pilates-inspired exercises improved dynamic balance, lower-extremity strength and aerobic resistance in community-dwelling older women. Therefore, it may be a potentially effective exercise regimen to maintain physical fitness in old age. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Effect on 12-week Intensive Dietary and Exercise Program on Weight Reduction and Maintenance in Obese Women with Weight Cycling History

    PubMed Central

    2017-01-01

    This study examined the effect of 12-week intensive dietary and exercise intervention program on body composition and stress-related hormones in obese women and to examine the residual effect after the intervention. The participants of this study were 30 obese women who had a body mass index of over 25 kg/m2 and over 30% in body fat. They were classified into 2 groups depending on the history of weight cycling (WC); the WC group (≥ ±5% of the original body weight) and the non-weight cycling (NWC) group. Both groups were subject to a nutritional intervention program every 2 weeks with a mandatory exercise intervention for 12 weeks. Thereafter, the nutrition/exercise interventions were ceased for 12 weeks, after which the participants' levels of the hormones relating to energy metabolism and stress, meal intakes, dietary habits, level of knowledge on sodium intake, frequency of sodium intake, and quality of life (QOL) were checked. The changes of body weight were 71.3 ± 5.5 kg (week 0) vs. 65.0 ± 6.6 kg (week 12) vs. 65.6 ± 7.1 kg (week 24) in WC group and 71.6 ± 8.6 kg (week 0) vs. 68.8 ± 9.7 kg (week 12) vs. 70.3 ± 9.4 kg (week 24) in the NWC group. The levels of hormones, meal intakes, and QOL scores were better in the WC group, as adherence to the nutritional intervention was higher. We suggest that that adherence to dietary habits heavily influences weight loss and maintenance in individuals who frequently attempt to lose weight and consequently go through a vicious cycle of weight recycling. PMID:28770181

  19. A Clinician Referral and 12-Week Exercise Training Program for Men With Prostate Cancer: Outcomes to 12 Months of the ENGAGE Cluster Randomized Controlled Trial.

    PubMed

    Gaskin, Cadeyrn J; Craike, Melinda; Mohebbi, Mohammadreza; Courneya, Kerry S; Livingston, Patricia M

    2017-05-01

    The ENGAGE (efficacy of a referral and physical activity program for survivors of prostate cancer) study established that a clinician referral and 12-week exercise training program increased vigorous physical activity at 12 weeks among men with prostate cancer. Here, we report the 6- and 12-month outcomes. In this multicenter cluster randomized controlled trial, we compared a clinician referral and exercise training program to usual care. Discounted gym membership was offered to men in the intervention condition on completion of the 12-week exercise program. Self-reported physical activity at 6 and 12 months was the primary outcome. Quality of life, anxiety, and depressive symptoms were secondary outcomes. A total of 147 men meeting eligibility criteria agreed to participate (54 intervention, 93 control). A positive interaction effect for vigorous physical activity was observed at 6 months, but not 12 months. No significant effects for the secondary outcomes were found. A clinician referral and community-based supervised and unsupervised exercise training program, along with discounted gym membership, had a positive short-term effect on vigorous physical activity levels, but did not improve quality of life, in men with prostate cancer.

  20. Celecoxib versus diclofenac for the treatment of ankylosing spondylitis: 12-week randomized study in Norwegian patients.

    PubMed

    Walker, Chris; Essex, Margaret N; Li, Chunming; Park, Peter W

    2016-06-01

    To compare the efficacy and safety of two different doses of celecoxib and diclofenac in the treatment of Norwegian patients with ankylosing spondylitis. In this 12-week, double-blind, non-inferiority trial patients were randomized to 200 mg once daily (qd) celecoxib, 400 mg qd celecoxib, or 50 mg three times daily (tid) diclofenac. The primary objective compared patients' assessments of Global Pain Intensity, measured on a visual analogue scale. A total of 330 patients were randomized (200 mg celecoxib, n = 107; 400 mg celecoxib, n = 108; diclofenac, n = 115). Least squares mean changes in Global Pain Intensity at 12 weeks were -25.8 mm, -30.6 mm and -28.2 mm, respectively. Both celecoxib treatment groups were non-inferior to diclofenac. More patients in the 400 mg celecoxib group met the Assessments in Ankylosing Spondylitis 20 responder criteria at Week 12 (60.2%) than in the celecoxib 200 mg (51.4%) and the diclofenac 50 mg (57.4%) groups. Adverse events were mild-to-moderate in severity, with dyspepsia and diarrhoea the most commonly reported. Celecoxib and diclofenac both provided pain reduction, in addition to improvements in disease activity and functional capacity, in patients with ankylosing spondylitis. © The Author(s) 2016.

  1. Celecoxib versus diclofenac for the treatment of ankylosing spondylitis: 12-week randomized study in Norwegian patients*

    PubMed Central

    Essex, Margaret N; Li, Chunming; Park, Peter W

    2016-01-01

    Objective To compare the efficacy and safety of two different doses of celecoxib and diclofenac in the treatment of Norwegian patients with ankylosing spondylitis. Methods In this 12-week, double-blind, non-inferiority trial patients were randomized to 200 mg once daily (qd) celecoxib, 400 mg qd celecoxib, or 50 mg three times daily (tid) diclofenac. The primary objective compared patients’ assessments of Global Pain Intensity, measured on a visual analogue scale. Results A total of 330 patients were randomized (200 mg celecoxib, n = 107; 400 mg celecoxib, n = 108; diclofenac, n = 115). Least squares mean changes in Global Pain Intensity at 12 weeks were −25.8 mm, −30.6 mm and −28.2 mm, respectively. Both celecoxib treatment groups were non-inferior to diclofenac. More patients in the 400 mg celecoxib group met the Assessments in Ankylosing Spondylitis 20 responder criteria at Week 12 (60.2%) than in the celecoxib 200 mg (51.4%) and the diclofenac 50 mg (57.4%) groups. Adverse events were mild-to-moderate in severity, with dyspepsia and diarrhoea the most commonly reported. Conclusions Celecoxib and diclofenac both provided pain reduction, in addition to improvements in disease activity and functional capacity, in patients with ankylosing spondylitis. PMID:26980340

  2. Introduction of misoprostol for the treatment of incomplete abortion beyond 12 weeks of pregnancy in Benin.

    PubMed

    Adisso, Sosthène; Hounkpatin, Benjamin I B; Komongui, Gounnou D; Sambieni, Olivier; Perrin, René X

    2014-07-01

    Improving the care of women who have undergone a spontaneous or induced abortion is an important step in reducing abortion-related morbidity and mortality. Both the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization recommend the use of manual vacuum aspiration (MVA) and misoprostol rather than sharp curettage to treat incomplete abortion. MVA was introduced into the public healthcare service in Benin in 2006 and since 2008 misoprostol has been available in 3 large maternity hospitals. The present study opted to use an oral dose of 800 μg and not to limit to pregnancies of up to 12 weeks, but to include women with second trimester abortions. After 5 years, results show that around three-quarters of the women treated with misoprostol at 13-18 weeks of pregnancy required MVA to complete uterine evacuation and approximately one-quarter had severe bleeding, confirming that the indication of misoprostol for incomplete abortion should be limited to pregnancies of up to 12 weeks. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  3. Critical Learning Periods and Programs of Early Intervention.

    ERIC Educational Resources Information Center

    Magill, Richard A.

    In an effort to clarify understanding of the concept of critical learning periods, this paper discusses problems that people concerned with the motor development of children have had determining relationships between critical periods and learning, and a "readiness model" is offered as a solution that could enhance understanding of critical…

  4. Effect of a 12-week yoga therapy program on mental health status in elderly women inmates of a hospice

    PubMed Central

    Ramanathan, Meena; Bhavanani, Ananda Balayogi; Trakroo, Madanmohan

    2017-01-01

    Aim and Objectives: This study was undertaken to evaluate the effectiveness of yoga on the mental health status of elderly women inmates residing in a hospice in Puducherry. Materials and Methods: Forty elderly women were randomly divided into yoga and wait-listed control group. A yoga therapy program of 60 min was given twice a week for 12 weeks. This protocol was specially designed for senior citizens, keeping in mind their health status and physical limitations that included simple warm-up and breath-body movement coordination practices (jathis and kriyas), static stretching postures (asanas), breathing techniques (pranayamas), and relaxation. Hamilton anxiety scale for measuring anxiety, Hamilton rating scale for depression, and Rosenberg self-esteem scale to measure self-esteem were administered to both groups before and after the 12-week study period. Data were assessed for normality, and appropriate parametric and nonparametric statistical methods were applied for intra- and inter-group comparisons. Results: Overall, intra- and inter-group comparison of prepost data showed statistically significant (P < 0.001) differences for all three parameters. There was an overall improvement in the scores indicating decreased levels of depression and anxiety coupled with an increase in the level of self-esteem after the yoga therapy program. Discussion: The influence of yoga in the reduction of depression and anxiety scores and improvement in self-esteem scores in elderly women subjects is evident from this study. As reported in earlier studies, this may be attributed to changes in central neurotransmitters such as gamma-aminobutyric-acid coupled with increased parasympathetic tone and decreased sympatho-adrenal activity. Conclusion: It is recommended that yoga should be a part of health-care facilities for elderly as it can enhance the quality of life by improving their overall mental health status. It could provide a healthy and positive alternative from depressing

  5. Changes of Heart Rate Variability during Methylphenidate Treatment in Attention-Deficit Hyperactivity Disorder Children: A 12-Week Prospective Study.

    PubMed

    Kim, Hayeon Jennifer; Yang, Jaewon; Lee, Moon Soo

    2015-09-01

    The aim of this study was to clarify the relationship between the autonomic nervous system and attention deficit hyperactivity disorder (ADHD) rating scales and to evaluate the usefulness of heart rate variability (HRV) as a psychophysiological biomarker for ADHD. Subjects were recruited from outpatients in the Department of Child and Adolescent Psychiatry at the Korea University Medical Center from August 2007 to December 2010. Subjects received methylphenidate. Time- and frequency-domain analyses of HRV, the Korean ADHD rating scale (K-ARS), and computerized ADHD diagnostic system were evaluated before treatment. After a 12-week period of medication administration, we repeated the HRV measurements and K-ARS rating. Eighty-six subjects were initially enrolled and 37 participants completed the 12-week treatment and HRV measurements subsequent to the treatment. Significant correlations were found between the K-ARS inattention score and some HRV parameters. All of the HRV parameters, except the standard deviations of the normal-to-normal interval, very low frequency, and low frequency to high frequency, showed a significant positive correlation between baseline and endpoint measures in completers. High frequency (HF) and the square root of the mean squared differences of successive normal-to-normal intervals (RMSSD), which are related to parasympathetic vagal tone, showed significant decreases from baseline to endpoint. The HRV test was shown to be reproducible. The decrease in HF and RMSSD suggests that parasympathetic dominance in ADHD can be altered by methylphenidate treatment. It also shows the possibility that HRV parameters can be used as psychophysiological markers in the treatment of ADHD.

  6. MORTALITY INCREASES WHEN RADICAL CYSTECTOMY IS DELAYED MORE THAN 12 WEEKS: RESULTS FROM A SEER-MEDICARE ANALYSIS

    PubMed Central

    Gore, John L.; Lai, Julie; Setodji, Claude M.; Litwin, Mark S.; Saigal, Christopher S.

    2009-01-01

    Background: Single-institution series have documented the adverse impact of a 12-week delay between resection of muscle-invasive bladder cancer and radical cystectomy. These data are derived from tertiary centers, in which referral populations may confound outcomes. We sought to examine the survival impact of a delay in radical cystectomy using nationally representative data. Methods: From the linked SEER-Medicare dataset, we identified subjects with stage 2 transitional cell carcinoma (TCC) of the bladder who underwent radical cystectomy between 1992 and 2001. We examined delays of 8, 12, and 24 weeks and incorporated these delay cutoffs into multivariate Cox proportional hazards survival models. Covariates included age, race/ethnicity, marital status, Charlson comorbidity index, and cancer grade. Results: We identified 441 subjects with stage 2 TCC who underwent cystectomy during the study period. Compared with immediate surgery (i.e., within 4–8 weeks of transurethral resection), longer time to cystectomy increased the risk of both disease-specific and overall mortality (HR 2.0, p<0.01 and HR 1.6, p<0.01, respectively, for those delayed 12-24 weeks; HR 2.0, p<0.01 for disease-specific and overall death among those delayed beyond 24 weeks 1 year following diagnosis). Covariates associated with overall mortality included older age (HR 1.04, p<0.01) and comorbidity (HR 2.0 for Charlson ≥ 3 vs Charlson 0-1, p<0.01). Conclusions: Delay in definitive surgical treatment beyond 12 weeks conferred an increased risk of disease-specific and all-cause mortality among subjects with stage 2 bladder cancer. PMID:19142878

  7. Alkylresorcinols in adipose tissue biopsies as biomarkers of whole-grain intake: an exploratory study of responsiveness to advised intake over 12 weeks.

    PubMed

    Wu, H; Kolehmainen, M; Mykkänen, H; Poutanen, K; Uusitupa, M; Schwab, U; Wolk, A; Landberg, R

    2015-11-01

    Alkylresorcinols (ARs) have been suggested as biomarkers of whole-grain wheat and rye intake. Plasma AR concentrations have a short half-life; hence, long-term biomarkers are needed. This study evaluated the responsiveness of ARs in adipose tissue biopsies as biomarkers after a whole-grain intake intervention. Samples and data of 27 participants from a 12-week randomized parallel-group dietary intervention were available. The participants were replacing their habitual diet with a whole-grain-enriched diet (WGDG) or a refined grain diet (RDG) during the intervention. Blood samples and adipose tissue biopsies were collected at baseline and after 12 weeks, and AR concentrations in the plasma and adipose tissues from the participants were compared against estimated whole-grain intake. AR concentrations in the adipose tissue and plasma did not change after 12 weeks in the WGDG group, as no significant increase in whole-grain intake was observed, but was significantly lower than baseline in the RDG group (P<0.05), owing to decreased whole-grain intake in this group. Plasma and adipose tissue AR concentrations were significantly higher in the WGDG group than in the RDG group (P<0.05), and were highly correlated with average whole-grain intake estimated by food records (Spearman's r=0.60-0.72 (P<0.05, n=16) for total and individual AR homolog concentrations in the plasma; r=0.60--0.84, (P<0.05, n=16) for total and individual AR homolog concentrations in the adipose tissue). In this small pilot study, AR concentrations in adipose tissue responded to reduced intake of whole grain over 12 weeks. Although not significantly different from plasma AR, adipose tissue AR concentrations were highly correlated with whole-grain intake after a 12-week intervention. These results show that adipose tissue AR concentrations have promise as biomarkers of whole-grain wheat and rye intake. Larger studies are needed to evaluate whether they are better long-term biomarkers than AR in the

  8. Health markers in obese adolescents improved by a 12-week recreational soccer program: a randomised controlled trial.

    PubMed

    Vasconcellos, Fabrício; Seabra, Andre; Cunha, Felipe; Montenegro, Rafael; Penha, Jociene; Bouskela, Eliete; Nogueira Neto, José Firmino; Collett-Solberg, Paulo; Farinatti, Paulo

    2016-01-01

    The effects of a recreational soccer program (RSP) upon body composition, heart rate variability (HRV), biochemical markers, cardio-respiratory fitness, and endothelial function in obese adolescents were investigated. A randomised controlled clinical trial was conducted with 30 adolescents aged 12-17 years and body mass index (BMI) >2 standard deviations of WHO reference values, which were assigned to RSP (n = 10, 2 girls) and obese control (n = 10, 4 girls) groups. The 12-week RSP included 60-min sessions performed 3 times/week. BMI, waist circumference, blood pressure, blood glucose, lipid profile, insulin, C-reactive protein, HRV, and maximal oxygen consumption (VO2peak) were evaluated following standardised procedures. Body composition was determined by dual-energy X-ray absorptiometry and endothelial function by venous occlusion plethysmography. After intervention, RSP exhibited significant reductions in BMI (-0.7 ± 0.2 kg · m(-2)), waist circumference (-8.2 ± 1.4 cm), %body fat (-2.2 ± 0.4%), systolic blood pressure (-5.0 ± 2.3 mmHg), total cholesterol (-16.2 ± 5.8 mg · dL(-1)), triglycerides (-20.5 ± 12.9 mg · dL(-1)), C-reactive protein (-0.06 ± 0.01 mg · dL(-1)), insulin resistance (HOMA-IR, -1.4 ± 0.6), and sympathetic activity (LF, -13.9 ± 6.6 un) vs. controls (P < 0.05). Significant increase was observed in parasympathetic activity (HF, 13.9 ± 6.6 un), VO2peak (7.9 ± 2.8 ml · kg(-1) · min(-1)), and high-density lipoprotein cholesterol (11.0 ± 6.3 mg · dL(-1)) (P < 0.05). Vascular conductance (19.5 ± 8.1 ml · min(-1) · 100 ml, P = 0.005) increased and vascular resistance (-5.9 ± 2.4 ml · min(-1) · 100 ml, P = 0.041) decreased in RSP, but not in controls. A 12-week recreational soccer intervention was effective to improve biochemical, cardiovascular, and fitness health markers in obese adolescents.

  9. An Exercise Prescription Intervention Program with Periodic Ergometric Grading

    NASA Technical Reports Server (NTRS)

    Owen, C. A.; Beard, E. F.

    1970-01-01

    A long term exercise prescription type of physical conditioning program has been available to executive personnel of the NASA Manned Spacecraft Center for the past two years. Periodic ergometric testing with a heart rate controlled, automatically programmed, bicycle ergometer is used to follow the individual's progress and appropriately alter his exercise prescription from time to time. Such a program appears feasible, and acceptance is excellent, dropout rates small and periodic testing participation good. Subjects training diligently can maintain satisfactory levels of conditioning.

  10. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection.

    PubMed

    Abergel, Armand; Metivier, Sophie; Samuel, Didier; Jiang, Deyuan; Kersey, Kathryn; Pang, Phillip S; Svarovskaia, Evguenia; Knox, Steven J; Loustaud-Ratti, Veronique; Asselah, Tarik

    2016-10-01

    Genotype 4 hepatitis C virus (HCV) was considered difficult to treat in the era of pegylated interferon-alpha (Peg-IFN-α) and ribavirin regimens. We evaluated the efficacy and safety of therapy with the nonstructural (NS) 5A inhibitor, ledipasvir, combined with the NS5B polymerase inhibitor, sofosbuvir, in patients with HCV genotype 4. In this phase 2, open-label study, 44 patients (22 treatment naïve and 22 treatment experienced) received a fixed-dose combination tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir orally once-daily for 12 weeks. The primary endpoint was the percentage of patients with HCV RNA <15 IU/mL 12 weeks after stopping therapy (SVR12). Among study participants, HCV genotype 4 subtypes were well represented (4a, n = 25; 4d, n = 10; other subtypes, n = 9). Ten patients (23%) had compensated cirrhosis. Of the 22 treatment-experienced patients, 21 (95%) had a non-CC IL-28B genotype. All 44 patients completed the full 12 weeks of dosing. The SVR12 rate was 93% (41 of 44; 95% confidence interval, 81-99). SVR12 rates were similar between treatment-naïve (95%; 21 of 22) and treatment-experienced (91%; 20 of 22) patients. All 3 patients who did not achieve SVR12 had virological relapse within 4 weeks of the end of treatment; all 3 had baseline HCV RNA ≥800,000 IU/mL, a non-CC IL-28B genotype, and pretreatment NS5A resistance-associated variants. None of the patients who relapsed had cirrhosis. The most common adverse events were asthenia, headache, and fatigue. No patients experienced a serious adverse event. The all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV 4 subtypes in both treatment-naïve and -experienced patients, including those with compensated cirrhosis. (EudraCT number: 2013-003978-27; Clinicaltrials.gov NCT02081079) (Hepatology 2016;64:1049-1056). © 2016 by the American Association for the Study of Liver Diseases.

  11. [Uterine rupture in a patient with bicornuate uterus at 12 weeks of amenorrhea: about a case].

    PubMed

    Itchimouh, Sanaa; Khabtou, Karima; Mahdaoui, Sakher; Boufettal, Houssine; Samouh, Naima

    2016-01-01

    The incidence of uterine malformations affecting reproduction is difficult to assess. Their identification requires a specific assessment (hysterosalpingography, hysteroscopy, laparoscopy). Spontaneous fertility can be affected depending on the type of uterine abnormality. All these abnormalities can affect the evolution of pregnancy causing early and late miscarriage, ectopic pregnancy, threat of premature labour, premature labour, vascular pathologies during pregnancy and inadequate intra-uterine growth. Bicornuate uterus is the most common uterine malformation and represents about half of all uterine anomalies The occurrence of this type of pregnancy is associated with an increased risk of maternal mortality, but early diagnosis and proper monitoring can lead pregnancies to term on malformed uterus. Ultrasound screening should allow for a systematic identification of such cases in order to take the necessary preventive measures. We report a case of uterine rupture in a patient with unicervical bicornuate uterus at 12 weeks of amenorrhea.

  12. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD.

    PubMed

    Buhl, R; Dunn, L J; Disdier, C; Lassen, C; Amos, C; Henley, M; Kramer, B

    2011-10-01

    Two, once daily (q.d.) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the β(2)-agonist indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability. Patients with moderate-to-severe COPD were randomised to treatment with indacaterol 150 μg q.d. (n=797) or tiotropium 18 μg q.d. (n=801) for 12 weeks. After 12 weeks, the two treatments had similar overall effects on "trough" (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.01 versus 1.43; p<0.001) and St George's Respiratory Questionnaire (SGRQ) total score (least squares means 37.1 versus 39.2; p<0.001; raw mean change from baseline -5.1 versus -3.0), and were significantly more likely to achieve clinically relevant improvements in these end-points (indacaterol versus tiotropium odds ratios of 1.49 for TDI and 1.43 for SGRQ, both p<0.001). Adverse events were recorded for 39.7% and 37.2% of patients in the indacaterol and tiotropium treatment groups, respectively. The most frequent adverse events were COPD worsening, cough and nasopharyngitis. Both bronchodilators demonstrated spirometric efficacy. The two treatments were well tolerated with similar adverse event profiles. Compared with tiotropium, indacaterol provided significantly greater improvements in clinical outcomes.

  13. Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases.

    PubMed

    Novák, Zoltán; Yáñez, Anahí; Kiss, Ildikó; Kuna, Piotr; Tortajada-Girbés, Miguel; Valiente, Román

    2016-08-01

    Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). The primary hypothesis of non-inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria. © 2016 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.

  14. Improvements in metabolic and neuromuscular fitness after 12-week bodypump® training.

    PubMed

    Greco, Camila C; Oliveira, Anderson S; Pereira, Marcelo P; Figueira, Tiago R; Ruas, Vinícius D; Gonçalves, Mauro; Denadai, Benedito S

    2011-12-01

    Greco, CC, Oliveira, AS, Pereira, MP, Figueira, TR, Ruas, VD, Gonçalves, M, and Denadai, BS. Improvements in metabolic and neuromuscular fitness after 12-week Bodypump® training. J Strength Cond Res 25(12): 3422-3431, 2011-The purpose of this study was to evaluate the effects of a 12-week group fitness training program (Bodypump®) on anthropometry, muscle strength, and aerobic fitness. Nineteen women (21.4 ± 2.0 years old) were randomly assigned to a training group (n = 9) and to a control group (n = 10). We show that this training program improved the 1 repetition maximum squats by 33.1% (p < 0.001) and the maximal isometric voluntary contraction (MVC) by 13.6% (p < 0.05). Additionally, decreases in knee extensor electromyographic activity during the MVC (30%, p < 0.01) and during the squats (15%, p < 0.05) and lunges of a simulated Bodypump® session were observed after the training. Concomitantly, blood lactate and heart rate after squats of a simulated Bodypump® session were decreased by 33 and 7% (p < 0.05), respectively. Body mass, body fat, and the running velocity at the onset of blood lactate accumulation did not change significantly in response to this training program. We conclude that Bodypump® training improves muscular strength and decreases metabolic stress during lower limb exercises. However, no significant improvements in running aerobic fitness nor in body mass and body fat were observed. Practitioners of Bodypump® training may benefit from the increased muscular strength and the decreased muscular fatigability during exercise tasks whose motor patterns are related to those involved in this training program. However, these functional gains do not seem to be transferable into running aerobic fitness.

  15. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    PubMed Central

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  16. Do 12-week yoga program influence respiratory function of elderly women?

    PubMed

    Bezerra, Lídia Aguiar; de Melo, Helton Fabrício; Garay, Ana Paula; Reis, Victor Machado; Aidar, Felipe José; Bodas, Ana Rita; Garrido, Nuno Domingos; de Oliveira, Ricardo Jacó

    2014-09-29

    Aging produces several respiratory limitations and reduces tolerance to physical efforts, sometimes leading to pulmonary diseases in the elderly. The literature draws attention to the possible benefits of Yoga practice among the elderly, presenting evidence for significant improvements in quality of life. It was hypothesized that yoga practice can improve respiratory function in the elderly. The effects of a yoga program on pulmonary volumes and respiratory muscle strength were verified in 36 elderly women divided into a yoga group [YG] (63.1 ± 13.3 years of age) and a control group (61.0 ± 6.9 years of age). Maximal inspiratory and expiratory pressure (MIP and MEP) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were measured by a ventilometer. The program comprised 65 min sessions, 3 times/week during 12 weeks. The heart rate and respiratory rate decreased significantly in the YG (76-39 ± 8-03 vs. 74-61±10.26 bpm and 18.61 ± 3.15 vs. 16.72 ± 3.12 resp/min, respectively). In the YG, VT and VE increased significantly (0.55 ± 0.22 vs. 0.64 ± 0.2 ml and 9.19 ± 2.39 vs. 10.05 ± 2.11 ml, respectively), as well as VC (1.48 ± 0.45 vs. 2.03 ± 0.72 ml). Improvements were also found in MIP and MEP in the YG (62.17 ± 14.77 vs. 73.06 ± 20.16 cmH2O and 80.56 ± 23.94 vs. 86.39 ± 20.16 cmH2O, respectively). It was concluded that a 12-week yoga program significantly improves pulmonary function of aged women.

  17. Do 12-Week Yoga Program Influence Respiratory Function of Elderly Women?

    PubMed Central

    Bezerra, Lídia Aguiar; de Melo, Helton Fabrício; Garay, Ana Paula; Reis, Victor Machado; Aidar, Felipe José; Bodas, Ana Rita; Garrido, Nuno Domingos; de Oliveira, Ricardo Jacó

    2014-01-01

    Aging produces several respiratory limitations and reduces tolerance to physical efforts, sometimes leading to pulmonary diseases in the elderly. The literature draws attention to the possible benefits of Yoga practice among the elderly, presenting evidence for significant improvements in quality of life. It was hypothesized that yoga practice can improve respiratory function in the elderly. The effects of a yoga program on pulmonary volumes and respiratory muscle strength were verified in 36 elderly women divided into a yoga group [YG] (63.1 ± 13.3 years of age) and a control group (61.0 ± 6.9 years of age). Maximal inspiratory and expiratory pressure (MIP and MEP) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were measured by a ventilometer. The program comprised 65 min sessions, 3 times/week during 12 weeks. The heart rate and respiratory rate decreased significantly in the YG (76-39 ± 8-03 vs. 74-61±10.26 bpm and 18.61 ± 3.15 vs. 16.72 ± 3.12 resp/min, respectively). In the YG, VT and VE increased significantly (0.55 ± 0.22 vs. 0.64 ± 0.2 ml and 9.19 ± 2.39 vs. 10.05 ± 2.11 ml, respectively), as well as VC (1.48 ± 0.45 vs. 2.03 ± 0.72 ml). Improvements were also found in MIP and MEP in the YG (62.17 ± 14.77 vs. 73.06 ± 20.16 cmH2O and 80.56 ± 23.94 vs. 86.39 ± 20.16 cmH2O, respectively). It was concluded that a 12-week yoga program significantly improves pulmonary function of aged women. PMID:25713658

  18. Variable effects of 12 weeks of omega-3 supplementation on resting skeletal muscle metabolism.

    PubMed

    Gerling, Christopher J; Whitfield, Jamie; Mukai, Kazutaka; Spriet, Lawrence L

    2014-09-01

    Omega-3 supplementation has been purported to improve the function of several organs in the body, including reports of increased resting metabolic rate (RMR) and reliance on fat oxidation. However, the potential for omega-3s to modulate human skeletal muscle metabolism has received little attention. This study examined the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation on whole-body RMR and the content of proteins involved in fat metabolism in human skeletal muscle. Recreationally active males supplemented with 3.0 g/day of EPA and DHA (n = 21) or olive oil (n = 9) for 12 weeks. Resting muscle biopsies were sampled in a subset of 10 subjects before (pre) and after (post) omega-3 supplementation. RMR significantly increased (5.3%, p = 0.040) following omega-3 supplementation (Pre, 1.33 ±0.05; Post, 1.40 ±0.04 kcal/min) with variable individual responses. When normalizing for body mass, this effect was lost (5.2%, p = 0.058). Omega-3s did not affect whole-body fat oxidation, and olive oil did not alter any parameter assessed. Omega-3 supplementation did not affect whole muscle, sarcolemmal, or mitochondrial FAT/CD36, FABPpm, FATP1 or FATP4 contents or mitochondrial electron chain and PDH proteins, but did increase the long form of UCP3 by 11%. In conclusion, supplementation with a high dose of omega-3s for 12 weeks increased RMR in a small and variable manner in a group of healthy young men. Omega-3 supplementation also had no effect on several proteins involved in skeletal muscle fat metabolism and did not cause mitochondrial biogenesis.

  19. Promoting healthful diets and exercise: efficacy of a 12-week after-school program in urban African Americans.

    PubMed

    Engels, Hermann-J; Gretebeck, Randall J; Gretebeck, Kimberlee A; Jiménez, Linda

    2005-03-01

    This study examined the effectiveness of a unique extracurricular after-school initiative designed to promote healthy diets and exercise in urban African Americans. The Students and Parents Actively Involved in Being Fit after-school program was offered for 12 weeks to students and their parents/guardians at an urban middle school. Specific aims of the intervention were to increase participants' vegetable and fruit intake by using established 5 A Day for Better Health educational resource materials/activities and to affect their health-related fitness through dance, games, and fitness activities. Fifty-six children and 25 parents/guardians completed a standard battery of evaluations before and after the program. Pre-post pairwise t test revealed that both children and their parents/guardians showed an increase in fruit consumption and a reduction in diastolic blood pressure (P <.05). Moreover, children showed improvements in systolic blood pressure and fruit juice, salad, and nonfried potato consumption while parents/guardians showed a decrease in body fat, body mass index, and endurance walk/run time (P <.05). Overall, findings indicate that children tended to gain more diet-related benefits while parents/guardians tended to derive more fitness-related benefits. After-school programs like the Students and Parents Actively Involved in Being Fit initiative can potentially contribute to improved health levels in urban African Americans.

  20. Daughters and mothers exercising together (DAMET): a 12-week pilot project designed to improve physical self-perception and increase recreational physical activity.

    PubMed

    Ransdell, L B; Dratt, J; Kennedy, C; O'Neill, S; DeVoe, D

    2001-01-01

    This paper presents the results of a 12-week single-sex, family-based physical activity intervention grounded in Social Cognitive Theory. Mother/daughter pairs and triads (n = 20) attended physical activity and classroom sessions twice weekly. Physiological data (VO2peak, height, and weight), psychological data (physical self-perception profile subscale scores), information about physical activity participation (PAP, d x wk(-1)) and qualitative impressions (QI) of the program were collected pre- and post-intervention. PAP and QI were also collected 6-months after completing the intervention. Although no significant increases in physical activity were reported, significant improvements in perceived sport competence, physical condition, and strength and muscularity were reported over time. The social cognitive theory, as used to plan this physical activity intervention, offered a promising theoretical perspective for facilitating improved physical self-perception in adolescent girls and their mothers.

  1. The Evolution of Walking-Related Outcomes Over the First 12 Weeks of Rehabilitation for Incomplete Traumatic Spinal Cord Injury: The Multicenter Randomized Spinal Cord Injury Locomotor Trial

    PubMed Central

    Dobkin, B.; Barbeau, H.; Deforge, D.; Ditunno, J.; Elashoff, R.; Apple, D.; Basso, M.; Behrman, A.; Fugate, L.; Harkema, S.; Saulino, M.; Scott, M.

    2014-01-01

    Background The Spinal Cord Injury Locomotor Trial (SCILT) compared 12 weeks of step training with body weight support on a treadmill (BWSTT) that included overground practice to a defined but more conventional overground mobility intervention (CONT) in patients with incomplete traumatic SCI within 8 weeks of onset. No previous studies have reported walking-related outcomes during rehabilitation. Methods This single-blinded, randomized trial entered 107 American Spinal Injury Association (ASIA) C and D patients and 38 ASIA B patients with lesions between C5 and L3 who were unable to walk on admission for rehabilitation. The Functional Independence Measure (FIM-L) for walking, 15-m walking speed, and lower extremity motor score (LEMS) were collected every 2 weeks. Results No significant differences were found at entry and during the treatment phase (12-week mean FIM-L = 5, velocity = 0.8 m/s, LEMS = 35, distance walked in 6 min = 250 m). Combining the 2 arms, a FIM-L ≥ 4 was achieved in < 10% of ASIA B patients, 92% of ASIA C patients, and all of ASIA D patients. Walking speed of ≥ 0.6 m/s correlated with a LEMS near 40 or higher. Conclusions Few ASIA B and most ASIA C and D patients achieved functional walking ability by the end of 12 weeks of BWSTT and CONT, consistent with the primary outcome data at 6 months. Walking-related measures assessed at 2-week intervals reveal that time after SCI is an important variable for entering patients into a trial with mobility outcomes. By about 6 weeks after entry, most patients who will recover have improved their FIM-L to >3 and are improving in walking speed. Future trials may reduce the number needed to treat by entering patients with FIM-L < 4 at > 8 weeks after onset if still graded ASIA B and at > 12 weeks if still ASIA C. PMID:17172551

  2. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    PubMed Central

    Leite, Marceli Rocha; Ramos, Ercy Mara Cipulo; Kalva-Filho, Carlos Augusto; Freire, Ana Paula Coelho Figueira; de Alencar Silva, Bruna Spolador; Nicolino, Juliana; de Toledo-Arruda, Alessandra Choqueta; Papoti, Marcelo; Vanderlei, Luiz Carlos Marques; Ramos, Dionei

    2015-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization), require further investigation. Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD. Methods Sixteen patients with COPD were divided into an aerobic (continuous and interval) training group (AT) (n=10) and a control group (CG) (n=6). An incremental test (initial speed of 2.0 km·h−1, constant slope of 3%, and increments of 0.5 km·h−1 every 2 minutes) was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak) (50 minutes of continuous effort), followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort), and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery). Intensities were adjusted through an incremental test performed at the end of each period. Results The AT presented an increase in the high frequency index (ms2) (P=0.04), peak oxygen uptake (VO2peak) (P=0.01), vVO2peak (P=0.04), and anaerobic threshold (P=0.02). No significant changes were observed in the CG (P>0.21) group. Neither of the groups presented changes in mucociliary clearance after 12 weeks (AT: P=0.94 and CG: P=0.69). Conclusion Twelve weeks of aerobic training (continuous and interval sessions) positively influenced the autonomic modulation and aerobic parameters in patients with COPD. However, mucociliary clearance was not affected by aerobic training. PMID:26648712

  3. A 12-week subchronic intramuscular toxicity study of risperidone-loaded microspheres in rats.

    PubMed

    Zhang, J; Ye, L; Wang, W; Du, G; Yu, X; Zhu, X; Dong, Q; Cen, X; Guan, X; Fu, F; Tian, J

    2015-02-01

    Long-acting injectable formulations of antipsychotics have been an important treatment option to increase the compliance of the patient with schizophrenia by monitoring drug administration and identifying medication noncompliance and to improve the long-term management of schizophrenia. Risperidone, a serotoninergic 5-HT2 and dopaminergic D2 receptor antagonist, was developed to be a long-acting sustained-release formulation for the treatment of schizophrenia. In this study, 12-week subchronic toxicity study of risperidone-loaded microspheres (RMs) in rats by intramuscular injection with an 8-week recovery phase was carried out to investigate the potential subchronic toxicity of a novel long-acting sustained-release formulation. The results indicated that the dosage of 10-90 mg/kg of RM for 2 weeks did not cause treatment-related mortality. The main drug-related findings were contributed to the dopamine D2 receptor and α1-adrenoceptor antagonism of risperidone such as elevation of serum and pituitary prolactin levels and ptosis and changes in reproductive system (uterus, ovary, vagina, mammary gland, testis, seminal vesicle, epididymis, and prostate). In addition, foreign body granuloma in muscle at injection sites caused by poly-lactide-co-glycolide was observed. At the end of the recovery phase, these changes mostly returned to normal. The results indicated that RM had a good safety profile in rats. © The Author(s) 2015.

  4. Exercise Training in Treatment and Rehabilitation of Hip Osteoarthritis: A 12-Week Pilot Trial

    PubMed Central

    Patil, Radhika; Karinkanta, Saija; Tokola, Kari; Kannus, Pekka

    2017-01-01

    Introduction. Osteoarthritis (OA) of the hip is one of the major causes of pain and disability in the older population. Although exercise is an effective treatment for knee OA, there is lack of evidence regarding hip OA. The aim of this trial was to test the safety and feasibility of a specifically designed exercise program in relieving hip pain and improving function in hip OA participants and to evaluate various methods to measure changes in their physical functioning. Materials and Methods. 13 women aged ≥ 65 years with hip OA were recruited in this 12-week pilot study. Results. Pain declined significantly over 30% from baseline, and joint function and health-related quality of life improved slightly. Objective assessment of physical functioning showed statistically significant improvement in the maximal isometric leg extensor strength by 20% and in the hip extension range of motion by 30%. Conclusions. The exercise program was found to be safe and feasible. The present evidence indicates that the exercise program is effective in the short term. However, adequate powered RCTs are needed to determine effects of long-term exercise therapy on pain and progression of hip OA. PMID:28116214

  5. Better understanding of homologous recombination through a 12-week laboratory course for undergraduates majoring in biotechnology.

    PubMed

    Li, Ming; Shen, Xiaodong; Zhao, Yan; Hu, Xiaomei; Hu, Fuquan; Rao, Xiancai

    2017-07-08

    Homologous recombination, a central concept in biology, is defined as the exchange of DNA strands between two similar or identical nucleotide sequences. Unfortunately, undergraduate students majoring in biotechnology often experience difficulties in understanding the molecular basis of homologous recombination. In this study, we developed and implemented a 12-week laboratory course for biotechnology undergraduates in which gene targeting in Streptococcus suis was used to facilitate their understanding of the basic concept and process of homologous recombination. Students worked in teams of two to select a gene of interest to create a knockout mutant using methods that relied on homologous recombination. By integrating abstract knowledge and practice in the process of scientific research, students gained hands-on experience in molecular biology techniques while learning about the principle and process of homologous recombination. The learning outcomes and survey-based assessment demonstrated that students substantially enhanced their understanding of how homologous recombination could be used to study gene function. Overall, the course was very effective for helping biotechnology undergraduates learn the theory and application of homologous recombination, while also yielding positive effects in developing confidence and scientific skills for future work in research. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(4):329-335, 2017. © 2017 The International Union of Biochemistry and Molecular Biology.

  6. A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis.

    PubMed

    Grotz, V Lee; Pi-Sunyer, Xavier; Porte, Daniel; Roberts, Ashley; Richard Trout, J

    2017-08-01

    The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control. Copyright © 2017 Heartland Food Products Group. Published by Elsevier Inc. All rights reserved.

  7. Effects of a 12-week physical activities programme on sleep in female university students.

    PubMed

    Hurdiel, Rémy; Watier, Timothée; Honn, Kimberly; Pezé, Thierry; Zunquin, Gautier; Theunynck, Denis

    2017-01-01

    Lack of sleep is known to negatively affect adolescent's health and the links between regular physical activity and sleep are unclear.This pilot study investigated whether the regular practice of physical activities among sedentary female students would improve their sleep. Nineteen female students, identified as sedentary and having poor subjective sleep quality were assigned in two groups to a 12-week university physical activities programme in accordance with the recommendations of World Health Organisation (N = 10) or to a control condition (N = 9). Sleep was assessed with actigraphy before and after the study and with the Pittsburg Sleep Quality 15 Index (PSQI) at the beginning, middle, and end of the study. The intensity of physical activities was controlled by heart rate monitor. The analysis showed that sleep quality in the physical activities group improved, with the mean ± SD PSQI score decreasing from 9.1 ± 1.7 to 4.8 ± 2.0. Despite some limitations, these pilot data indicate that a physical activities programme is feasible to implement in students, and that participation in such a programme improves sleep in 18- 24 -year-old female adolescents. Further potential benefits remain to be investigated in follow-up research.

  8. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study

    PubMed Central

    2010-01-01

    Background Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. Methods A flexible dose of trazodone (50-300 mg/day), was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement Scale (PGI). Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. Results Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI), and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2%) patients. Conclusions In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. Trial registration This trial has been registered with ClinicalTrials.gov number NCT-00791739. PMID:20831796

  9. Olanzapine augmentation in treatment-resistant panic disorder: a 12-week, fixed-dose, open-label trial.

    PubMed

    Sepede, Gianna; De Berardis, Domenico; Gambi, Francesco; Campanella, Daniela; La Rovere, Raffaella; D'Amico, Michele; Cicconetti, Alessandra; Penna, Laura; Peca, Silvana; Carano, Alessandro; Mancini, Enrico; Salerno, Rosa Maria; Ferro, Filippo Maria

    2006-02-01

    The purpose of our study was to evaluate the efficacy and tolerability of low-dose olanzapine augmentation in selective serotonin reuptake inhibitor (SSRI)-resistant panic disorder (PD) with or without agoraphobia. In this 12-week, open-label study, 31 adult outpatients with treatment-resistant PD who had previously failed to respond to SSRI treatment were treated with fixed dose of olanzapine (5 mg/d) in addition to SSRI. Efficacy was assessed using the Panic Attack and Anticipatory Anxiety Scale (PAAAS), the Agoraphobic Cognitions Questionnaire (ACQ), the Hamilton Rating Scale for Anxiety (HAM-A), the Hamilton Rating Scale for Depression (HAM-D), the Global Assessment of Functioning Scale (GAF), and the Clinical Global Impression of Improvement (CGI-I). Twenty-six patients completed the trial period with a dropout rate of 16.1%. At week 12, 21 patients were responders (81.8%), and an overall improvement on all rating scales was observed in all patients both with or without agoraphobia. Fifteen patients (57.7%) achieved remission. Olanzapine was well tolerated and the most frequent adverse effects were mild-to-moderate weight gain and drowsiness. No extrapyramidal symptoms were reported. Olanzapine appears to be effective as augmentation strategy in the treatment of SSRI-resistant PD, but study limitations must be considered and placebo-controlled studies are needed.

  10. Variability of Insulin Requirements Over 12 Weeks of Closed-Loop Insulin Delivery in Adults With Type 1 Diabetes.

    PubMed

    Ruan, Yue; Thabit, Hood; Leelarathna, Lalantha; Hartnell, Sara; Willinska, Malgorzata E; Dellweg, Sibylle; Benesch, Carsten; Mader, Julia K; Holzer, Manuel; Kojzar, Harald; Evans, Mark L; Pieber, Thomas R; Arnolds, Sabine; Hovorka, Roman

    2016-05-01

    To quantify variability of insulin requirements during closed-loop insulin delivery. We retrospectively analyzed overnight, daytime, and total daily insulin amounts delivered during a multicenter closed-loop trial involving 32 adults with type 1 diabetes. Participants applied hybrid day-and-night closed-loop insulin delivery under free-living home conditions over 12 weeks. The coefficient of variation was adopted to measure variability of insulin requirements in individual subjects. Data were analyzed from 1,918 nights, 1,883 daytime periods and 1,564 total days characterized by closed-loop use over 85% of time. Variability of overnight insulin requirements (mean [SD] coefficient of variation 31% [4]) was nearly twice as high as variability of total daily requirements (17% [3], P < 0.001) and was also higher than variability of daytime insulin requirements (22% [4], P < 0.001). Overnight insulin requirements were significantly more variable than daytime and total daily amounts. This may explain why some people with type 1 diabetes report frustrating variability in morning glycemia. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  11. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers

    PubMed Central

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran

    2016-01-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m2) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit. PMID:27152300

  12. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers.

    PubMed

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran; Kye, Seung Hee; Park, Yoo Kyoung

    2016-04-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m(2)) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit.

  13. Aloe sterol supplementation improves skin elasticity in Japanese men with sunlight-exposed skin: a 12-week double-blind, randomized controlled trial

    PubMed Central

    Tanaka, Miyuki; Yamamoto, Yuki; Misawa, Eriko; Nabeshima, Kazumi; Saito, Marie; Yamauchi, Koji; Abe, Fumiaki; Furukawa, Fukumi

    2016-01-01

    Background/objective Recently, it was confirmed that the daily oral intake of plant sterols of Aloe vera gel (Aloe sterol) significantly increases the skin barrier function, moisture, and elasticity in photoprotected skin. This study aimed to investigate whether Aloe sterol intake affected skin conditions following sunlight exposure in Japanese men. Methods We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin conditions in 48 apparently healthy men (age range: 30–59 years; average: 45 years). The subjects were instructed to expose the measurement position of the arms to the sunlight outdoors every day for 12 weeks. The skin parameters were measured at 0 (baseline), 4, 8, and 12 weeks. Results Depending on the time for the revelation of the sunlight, the b* value and melanin index increased and the skin moisture decreased. After taking an Aloe sterol tablet daily for 12 weeks, the skin elasticity index (R2, R5, and R7) levels were significantly higher than the baseline value. There were no differences between the groups in these skin elasticity values. In the subgroup analysis of subjects aged <46 years, the change in the R5 and R7 was significantly higher in the Aloe group than in the placebo group at 8 weeks (P=0.0412 and P=0.0410, respectively). There was a difference in the quantity of sun exposure between each subject, and an additional clinical study that standardizes the amount of ultraviolet rays is warranted. No Aloe sterol intake-dependent harmful phenomenon was observed during the intake period. Conclusion Aloe sterol ingestion increased skin elasticity in the photodamaged skin of men aged <46 years. PMID:27877061

  14. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies.

    PubMed

    Buse, John B; DeFronzo, Ralph A; Rosenstock, Julio; Kim, Terri; Burns, Colleen; Skare, Sharon; Baron, Alain; Fineman, Mark

    2016-02-01

    Delayed-release metformin (Met DR) is formulated to deliver the drug to the lower bowel to leverage the gut-based mechanisms of metformin action with lower plasma exposure. Met DR was assessed in two studies. Study 1 compared the bioavailability of single daily doses of Met DR to currently available immediate-release metformin (Met IR) and extended-release metformin (Met XR) in otherwise healthy volunteers. Study 2 assessed glycemic control in subjects with type 2 diabetes (T2DM) over 12 weeks. Study 1 was a phase 1, randomized, four-period crossover study in 20 subjects. Study 2 was a 12-week, phase 2, multicenter, placebo-controlled, dose-ranging study in 240 subjects with T2DM randomized to receive Met DR 600, 800, or 1,000 mg administered once daily; blinded placebo; or unblinded Met XR 1,000 or 2,000 mg (reference). The bioavailability of 1,000 mg Met DR b.i.d. was ∼50% that of Met IR and Met XR (study 1). In study 2, 600, 800, and 1,000 mg Met DR q.d. produced statistically significant, clinically relevant, and sustained reductions in fasting plasma glucose (FPG) levels over 12 weeks compared with placebo, with an ∼40% increase in potency compared with Met XR. The placebo-subtracted changes from baseline in HbA1c level at 12 weeks were consistent with changes in FPG levels. All treatments were generally well tolerated, and adverse events were consistent with Glucophage/Glucophage XR prescribing information. Dissociation of the glycemic effect from plasma exposure with gut-restricted Met DR provides strong evidence for a predominantly lower bowel-mediated mechanism of metformin action. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  15. A SYSTEMATIC REVIEW OF INTERVENTIONS TARGETING PATERNAL MENTAL HEALTH IN THE PERINATAL PERIOD.

    PubMed

    Rominov, Holly; Pilkington, Pamela D; Giallo, Rebecca; Whelan, Thomas A

    2016-05-01

    Interventions targeting parents' mental health in the perinatal period are critical due to potential consequences of perinatal mental illness for the parent, the infant, and their family. To date, most programs have targeted mothers. This systematic review explores the current status and evidence for intervention programs aiming to prevent or treat paternal mental illness in the perinatal period. Electronic databases were systematically searched to identify peer-reviewed studies that described an intervention targeting fathers' mental health in the perinatal period. Mental health outcomes included depression, anxiety, and stress as well as more general measures of psychological functioning. Eleven studies were identified. Three of five psychosocial interventions and three massage-technique interventions reported significant effects. None of the couple-based interventions reported significant effects. A number of methodological limitations were identified, including inadequate reporting of study designs, and issues with the timing of interventions. The variability in outcomes measures across the studies made it difficult to evaluate the overall effectiveness of the interventions. Father-focused interventions aimed at preventing perinatal mood problems will be improved if future studies utilize more rigorous research strategies.

  16. Paroxetine-induced hyponatremia in older adults: a 12-week prospective study.

    PubMed

    Fabian, Tanya J; Amico, Janet A; Kroboth, Patricia D; Mulsant, Benoit H; Corey, Sharon E; Begley, Amy E; Bensasi, Salem G; Weber, Elizabeth; Dew, Mary Amanda; Reynolds, Charles F; Pollock, Bruce G

    2004-02-09

    Older depressed patients are at high risk for development of hyponatremia after initiation of the selective serotonin reuptake inhibitor paroxetine, despite clinical monitoring and preventive management. The purposes of this study were to determine the incidence and etiology of paroxetine-induced hyponatremia in older patients and to identify patient characteristics that may account for variability in susceptibility to this adverse event. This prospective, longitudinal study was conducted in a university-based ambulatory psychiatric research clinic from August 1999 through September 2001. Patients included 75 men and women aged 63 through 90 years (mean +/- SD age, 75.3 +/- 6.0 years) who received a diagnosis of a current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, major depressive episode and were prescribed paroxetine. We monitored plasma sodium levels before initiating paroxetine therapy and after 1, 2, 4, 6, and 12 weeks of treatment. In a subset of individuals, we measured levels of antidiuretic hormone, glucose, serum urea nitrogen, and creatinine. Hyponatremia was defined as a plasma sodium level of less than 135 mEq/L after initiation of paroxetine therapy. Hyponatremia developed in 9 (12%) of the 75 patients after initiation of paroxetine treatment. Mean +/- SD time to development of hyponatremia was 9.3 +/- 4.7 days (median, 9 days; range, 1-14 days; n = 8). In the multivariate regression, lower body mass index and lower baseline plasma sodium level (<138 mEq/L) were significant risk factors for the development of hyponatremia in these patients. Hyponatremia is an under recognized and potentially serious complication of paroxetine treatment in older patients. Our results provide a foundation for understanding the etiology and risk factors associated with paroxetine-induced hyponatremia.

  17. Effects of 12 weeks of dynamic strength training with local vibration.

    PubMed

    Drummond, Marcos D M; Couto, Bruno P; Augusto, Izabela G; Rodrigues, Sara A; Szmuchrowski, Leszek A

    2014-01-01

    The purpose of this study was to investigate the chronic effects of dynamic strength training (ST) with local vibration on the maximum strength of elbow flexor muscles. Twenty healthy male untrained volunteers were divided randomly into the following two groups: the conventional training group (CTG) or the vibration training group (VTG). Both groups performed ST for 12 weeks, three times a week. The ST protocol included four sets of 8-10 repetition maximums (RMs) of unilateral elbow flexion exercise. The VTG performed this training protocol with local vibration at a frequency of 30 Hz and amplitude of 6 mm. The mean values of the one repetition maximum (1RM) tests for both groups increased significantly from the pretest week to the fourth week and from the fourth week to the eighth week (CTG: mean 19.02, s = 7.88%, p = 0.01; mean 10.50, s = 6.86%, p = 0.019, respectively; VTG: mean 16.02, s = 8.30%, p = 0.017; mean 12.55, s = 8.76%, p = 0.019, respectively). The increases in the maximal voluntary contraction (MVC) tests were also statistically significant from the pretest week to the fourth week and from the fourth week to the eighth week (CTG: mean 12.32, s = 8.33%, p = 0.004; mean 9.95, s = 5.32%, p = 0.006, respectively; VTG: mean 10.16, s = 11.71%, p = 0.003; mean 10.36, s = 2.96%, p = 0.01, respectively). There was no significant difference between the 1RM and MVC test results in the eighth and twelfth weeks in either group. No significant differences were observed between the groups (p < 0.05). In conclusion, the application of local vibration does not change the chronic effects of dynamic ST in untrained individuals.

  18. Agomelatine in the treatment of fibromyalgia: a 12-week, open-label, uncontrolled preliminary study.

    PubMed

    Bruno, Antonio; Micò, Umberto; Lorusso, Simona; Cogliandro, Nadia; Pandolfo, Gianluca; Caminiti, Maurizio; Zoccali, Rocco A; Muscatello, Maria R A

    2013-08-01

    Pharmacological therapy for fibromyalgia syndrome (FMS) is actually unsatisfactory; analgetic and nonsteroidal anti-inflammatory drugs are not very effective. On the other hand, it is opportune to underline that antidepressant drugs produce positive response on pain in patients with FMS. Furthermore, many studies showed that using variable doses of melatonin (3-6 mg/d) in subjects affected from FMS had significantly been effective on pain, sleep, daytime fatigue, and depression. This study was aimed to evaluate the efficacy of agomelatine on depression, anxiety, cognition, and pain in a sample of drug-free FMS patients. Agomelatine was administered at the single daily dose of 25 mg/d to 15 fibromyalgia "drug-free" female subjects during 12 weeks. Outcome measures included the Hamilton Rating Scale for Depression, the Hamilton Rating Scale for Anxiety, the Zung Self-Rating Depression Scale, the Zung Self-Rating Anxiety Scale, the Visual Analog Scale of Pain, the Quality of Life Index, the Wisconsin Card Sorting Test, the Verbal Fluency Task-Controlled Oral Word Association Test, and the Stroop Color-Word Test. Treatment with agomelatine significantly improved depression, anxiety, and pain in patients with FMS. Regarding executive/cognitive symptoms, treatment with agomelatine did not have a significant impact on the explored neuropsychological domains, although there was a trend toward the improvement of performances. The findings showed that agomelatine was effective and well tolerated in patients with FMS. Further research is needed to fully evaluate the role of agomelatine as a potential pharmacological strategy for the treatment of FMS.

  19. Magnesium Replacement Does Not Improve Insulin Resistance in Patients With Metabolic Syndrome: A 12-Week Randomized Double-Blind Study

    PubMed Central

    Lima de Souza e Silva, Maria de Lourdes; Cruz, Thomaz; Rodrigues, Luiz Erlon; Ladeia, Ana Marice; Bomfim, Olivia; Olivieri, Lucas; Melo, Juliana; Correia, Raquel; Porto, Mirna; Cedro, Alexandre

    2014-01-01

    Background To evaluate the effect of magnesium (Mg) replacement on insulin resistance and cardiovascular risk factors in women with metabolic syndrome (MS) without diabetes. Methods This 12-week clinical randomized double-blind study compared the effects of 400 mg/day of Mg with those of a placebo (n = 72) on fasting glucose, insulin, HOMA-IR, lipid profile and CRP. Mg was measured in serum (SMg) and in mononuclear cells (MMg). Results Hypomagnesemia (SMg < 1.7 mg/dL) was seen in 23.2% of patients and intracellular depletion in 36.1% of patients. The MMg means were lower in patients with obesity (0.94 ± 0.54 μg/mg vs. 1.19 ± 0.6 μg/mg, P = 0.04), and insulin resistance (0.84 ± 0.33 μg/mg vs. 1.14 ± 0.69 µg/mg, P < 0.05). Mg replacement did not alter SMg (1.82 ± 0.14 mg/dL vs. 1.81 ± 0.16 mg/dL, P = 0.877) and tended to increment MMg (0.90 ± 0.40 μg/mg vs. 1.21 ± 0.73 μg/mg, P = 0.089). HOMA-IR did not alter in interventions nor in placebo group (3.2 ± 2.0 to 2.8 ± 1.9, P = 0.368; 3.6 ± 1.9 to 3.2 ± 1.8, respectively), neither did other metabolic parameters. Conclusion Serum and intracellular Mg depletion is common in patients with MS; however, Mg replacement in recommended dosage did not increase significantly Mg levels, neither reduced insulin resistance or metabolic control. PMID:25247020

  20. Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis.

    PubMed

    Spolidoro Paschoal, Natalia de Oliva; Natour, Jamil; Machado, Flavia S; de Oliveira, Hilda Alcântara Veiga; Furtado, Rita Nely Vilar

    2015-10-01

    To evaluate the effectiveness and tolerance of intraarticular injection (IAI) of triamcinolone hexacetonide (TH) for the treatment of osteoarthritis (OA) of hand interphalangeal (IP) joints. Sixty patients who underwent IAI at the most symptomatic IP joint were randomly assigned to receive TH/lidocaine (LD; n = 30) with TH 20 mg/ml and LD 2%, or just LD (n = 30). The injected joint was immobilized with a splint for 48 h in both groups. Patients were assessed at baseline and at 1, 4, 8, and 12 weeks by a blinded observer. The following variables were assessed: pain at rest [visual analog scale (VAS)r], pain at movement (VASm), swelling (physician VASs), goniometry, grip and pinch strength, hand function, treatment improvement, daily requirement of paracetamol, and local adverse effects. The proposed treatment (IAI with TH/LD) was successful if statistical improvement (p < 0.05) was achieved in at least 2 of 3 VAS. Repeated-measures ANOVA test was used to analyze intervention response. Fifty-eight patients (96.67%) were women, and the mean age was 60.7 years (± 8.2). The TH/LD group showed greater improvement than the LD group for VASm (p = 0.014) and physician VASs (p = 0.022) from the first week until the end of the study. In other variables, there was no statistical difference between groups. No significant adverse effects were observed. The IAI with TH/LD has been shown to be more effective than the IAI with LD for pain on movement and joint swelling in patients with OA of the IP joints. Regarding pain at rest, there was no difference between groups. ClinicalTrials.gov (NCT02102620).

  1. Role of 12-week resistance training in preserving the heart against ischemia-reperfusion-induced injury.

    PubMed

    Soufi, Farhad Ghadiri; Saber, Mohaddeseh Mahmoudi; Ghiassie, Rafigheh; Alipour, Mohsen

    2011-01-01

    Discovering an effective approach to provide cardioprotection against coronary artery disease has long been sought. We studied the cardioprotective effect of resistance training against ischemia-reperfusion-induced injury. Twenty male rats were divided into trained and sedentary groups (n = 10 in each). The rats were exercised in squat-training apparatus (12 repetitions/set, four sets/day and five days/week for 12 weeks). After the last training session, transient regional ischemia of left anterior descending coronary artery (40 min) was followed by 80 min of reperfusion. Coronary flow, left ventricular developed pressure, diastolic pressure and infarct size were measured. After 35 min of ischemia, coronary flow and developed pressure were higher in trained than untrained groups (10.37 ± 0.96 vs 7.54 ± 0.89 mL/min × g, p < 0.01 for coronary flow and 67.74 ± 3.31 vs 52.39 ± 4.28 mm Hg, p < 0.01 for developed pressure) and this difference persisted until 50 min of reperfusion (10.59 ± 0.88 vs 7.71 ± 0.73 mL/ /min × g, p < 0.01 for coronary flow and 58.12 ± 4.07 vs 39.56 ± 3.79 mm Hg, p < 0.01 for developed pressure). Diastolic pressure was significantly lower from 35 min of ischemia (11.51 ± 5.37 vs 24.53 ± 5.44 mm Hg, p < 0.05) through 35 min of reperfusion in trained rather than sedentary rats (30.62 ± 3.19 vs 43 ± 7.11 mm Hg, p < 0.01). Resistance exercise training reduced the infarct size statistically in trained rats as compared with sedentary animals (39.32 ± 4.09 vs 29.36 ± 4.17 percentage of zone at risk, p < 0.05). These results show that chronic resistance exercise provides cardioprotection against myocardial injuries.

  2. Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE).

    PubMed

    Motaweih, Ahmed K; Usova, Elena; Hussain, Wajid; Dello, Ziad; Schmidt, Birgit; Petri, Thomas

    2015-05-09

    Observational studies can provide important information on the efficacy and safety of antihypertensive agents in the real-life clinical setting. AdADOSE was a large observational study to assess the effectiveness of nifedipine GITS in combination with other antihypertensive agent(s). The study was also the first to examine the role of combination therapy with nifedipine GITS in the Middle East, Pakistan and Russia, regions that are associated with particularly high cardiovascular risk. AdADOSE was a 12-week, international, multicenter, prospective, observational study. Patients with hypertension (ie, blood pressure [BP] >140/90 mm Hg, or >130/80 mm Hg in patients at high or very high cardiovascular risk) received once-daily nifedipine GITS (30, 60 or 90 mg) in combination with another antihypertensive or as add-on to existing therapy. The primary study endpoint was the proportion of patients who achieved the target BP of <140/90 mm Hg (or <130/80 mm Hg for those at high or very high cardiovascular risk). Study outcomes are reported by descriptive statistics. The study enrolled 4497 patients (n = 4477, safety population; n = 3430, efficacy population). Baseline mean systolic/diastolic BP (SBP/DBP) was 166.4/99.7 mm Hg; 85.2 % of patients had received prior antihypertensive treatment, and 90.6 % had ≥ 1 concomitant diseases. Following combination treatment with nifedipine GITS, target BP was achieved by 64.8% of patients without concomitant diseases, and by 56.5%, 32.3% and 22.6% with 1, 2-3 and >3 concomitant diseases, respectively. The proportion of patients achieving target BP was 51.5% in previously untreated and 33.7% in previously treated patients. Nifedipine GITS combination treatment provided mean SBP/DBP changes of -36.1/-18.8 mm Hg in all patients, -40.2/-21.5 mm Hg in previously untreated patients, and -35.6/-18.4 mm Hg in previously treated patients, with similar BP reductions irrespective of the number of concomitant diseases. Drug-related adverse

  3. Decreasing cardiovascular risk factors in obese individuals using a combination of PGX® meal replacements and PGX® granules in a 12-week clinical weight modification program.

    PubMed

    Reichert, Ronald G; Lyon, Michael R; Kacinik, Veronica; Gahler, Roland J; Manjoo, Priya; Purnama, Monica; Wood, Simon

    2013-05-07

    In this open, clinically based, weight modification program, we determined in six sedentary obese adults (five women; one male; age range 30-62 years) that the combination of a modified calorie diet plus PGX® meal replacement and PGX® supplementation resulted in a significant reduction in several cardiovascular risk factors over a 12-week time period. This included a significant improvement in lipids (-0.98 mmol/l LDL-C), reduction in average weight (-9.2 kg), mean reduction in fat (-4.1%) and an increase in fat-free mass (2.8%).

  4. Characterizing periodic messaging interventions across health behaviors and media: systematic review.

    PubMed

    De Leon, Elaine; Fuentes, Laura W; Cohen, Joanna E

    2014-03-25

    Periodic prompts serve as tools for health behavior interventions to encourage and maintain behavior changes. Past literature reviews have examined periodic messages targeting specific behaviors (smoking, physical activity, diet, etc) or media (telephone, email, face-to-face, newsletter, etc) and have found them to be effective in impacting health behavior in the short term. Our goal was to review the literature related to periodic messaging and prompts in order to explore typical characteristics, assess the role of prompt timing, identify common theoretical models used, and identify characteristics associated with the effectiveness of periodic prompts. Electronic searches of PubMed, PsycINFO, CINAHL, and Web of Science were conducted in October 2012 and May 2013. Database search terms included variant terms for periods, prompts, interventions, media, and health behaviors. Forty-two of the 55 included research articles found that prompts resulted in significant positive behavioral outcomes for participants. Prompts were delivered via text messages, email, mailed communications, and in a few instances via phone. Generally, the provision of feedback and specific strategies to accomplish behavior change appears to be important for the success of periodic prompts. Rationale for prompt timing was rarely provided, although some studies did organize message content around days of the week or times perceived to be high risk for particular behaviors. Smoking cessation interventions tended to be organized around quit date. Among studies using theoretical models to inform their interventions, the transtheoretical model was most common. Periodic messaging interventions yield positive results for short-term health behavior changes. Interventions including feedback and prompts that included strategies were more likely to report significantly positive outcomes. Work remains to better understand elements that make periodic prompts successful and whether they are effective in

  5. Characterizing Periodic Messaging Interventions Across Health Behaviors and Media: Systematic Review

    PubMed Central

    Fuentes, Laura W; Cohen, Joanna E

    2014-01-01

    Background Periodic prompts serve as tools for health behavior interventions to encourage and maintain behavior changes. Past literature reviews have examined periodic messages targeting specific behaviors (smoking, physical activity, diet, etc) or media (telephone, email, face-to-face, newsletter, etc) and have found them to be effective in impacting health behavior in the short term. Objective Our goal was to review the literature related to periodic messaging and prompts in order to explore typical characteristics, assess the role of prompt timing, identify common theoretical models used, and identify characteristics associated with the effectiveness of periodic prompts. Methods Electronic searches of PubMed, PsycINFO, CINAHL, and Web of Science were conducted in October 2012 and May 2013. Database search terms included variant terms for periods, prompts, interventions, media, and health behaviors. Results Forty-two of the 55 included research articles found that prompts resulted in significant positive behavioral outcomes for participants. Prompts were delivered via text messages, email, mailed communications, and in a few instances via phone. Generally, the provision of feedback and specific strategies to accomplish behavior change appears to be important for the success of periodic prompts. Rationale for prompt timing was rarely provided, although some studies did organize message content around days of the week or times perceived to be high risk for particular behaviors. Smoking cessation interventions tended to be organized around quit date. Among studies using theoretical models to inform their interventions, the transtheoretical model was most common. Conclusions Periodic messaging interventions yield positive results for short-term health behavior changes. Interventions including feedback and prompts that included strategies were more likely to report significantly positive outcomes. Work remains to better understand elements that make periodic prompts

  6. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    PubMed

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease.

  7. A 12-week low-carbohydrate, high-fat diet improves metabolic health outcomes over a control diet in a randomised controlled trial with overweight defence force personnel.

    PubMed

    Zinn, Caryn; McPhee, Julia; Harris, Nigel; Williden, Micalla; Prendergast, Kate; Schofield, Grant

    2017-07-12

    Overweight, obesity, and poor health is becoming a global concern for defence force personnel. Conventional nutrition guidelines are being questioned for their efficacy in achieving optimal body composition and long-term health. This study compared the effects of a 12-week low-carbohydrate, high-fat diet with a conventional, high-carbohydrate, low-fat diet on weight reduction and metabolic health outcomes in at-risk New Zealand Defence Force personnel. In this randomised controlled trial, 41 overweight personnel were assigned to intervention and control groups. Weight, waist circumference, fasting lipids, and glycaemic control were assessed at baseline and at 12 weeks. Within-group change scores were analysed using the t statistic and interpreted using a p < 0.05 level of statistical significance. Between-group mean differences and confidence intervals were analysed using effect sizes and magnitude-based inferences. Twenty-six participants completed the trial (14 intervention, 12 control). Both groups showed statistically significant weight and waist circumference reductions; the intervention group significantly reduced triglycerides and serum glucose and significantly increased high-density lipoprotein cholesterol (HDLc). Relative to control, the intervention group showed small, possibly to likely beneficial effects for weight, triglycerides, glucose, insulin, and homeostasis model assessment of insulin resistance; moderate, likely beneficial effects for HDL cholesterol, triglyceride:HDLc ratio and HbA1c; and a small, likely harmful effect for low-density lipoprotein cholesterol. This dietary approach shows promise for short-term weight loss and improved metabolic health outcomes conditions compared with mainstream recommendations. It should be offered to defence force personnel at least as a viable alternative means to manage their weight and health.

  8. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    ERIC Educational Resources Information Center

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  9. Cognitive Performance in the 12-Week-Old Infant: The Effects of Birth Order, Birth Spacing, Sex, and Social Class.

    ERIC Educational Resources Information Center

    Lewis, Michael; Gallas, Howard

    This study examines the effects of sex, socioeconomic status, birth order and birth spacing on the cognitive performance of 12-week-old infants. A brief review of research on neonatal cognitive ability is followed by a description of the study itself. The subjects, 189 three-month-old Caucasian infants (61 first borns, 58 second borns, and 49…

  10. Light and maternal influence in the entrainment of activity circadian rhythm in infants 4-12 weeks of age.

    PubMed

    Thomas, Karen A; Burr, Robert L; Spieker, Susan

    2016-07-01

    The influence of light and maternal activity on early infant activity rhythm were studied in 43 healthy, maternal-infant pairs. Aims included description of infant and maternal circadian rhythm of environmental light, assessing relations among of activity and light circadian rhythm parameters, and exploring the influence of light on infant activity independent of maternal activity. Three-day light and activity records were obtained using actigraphy monitors at infant ages 4, 8, and 12 weeks. Circadian rhythm timing, amplitude, 24-hour fit, rhythm center, and regularity were determined using cosinor and nonparametric circadian rhythm analyses (NPCRA). All maternal and infant circadian parameters for light were highly correlated. When maternal activity was controlled, the partial correlations between infant activity and light rhythm timing, amplitude, 24-hour fit, and rhythm center demonstrated significant relation (r = .338 to .662) at infant age 12 weeks, suggesting entrainment. In contrast, when maternal light was controlled there was significant relation between maternal and infant activity rhythm (r = 0.470, 0.500, and 0.638 at 4, 8 and 12 weeks, respectively) suggesting the influence of maternal-infant interaction independent of photo entrainment of cycle timing over the first 12 weeks of life. Both light and maternal activity may offer avenues for shaping infant activity rhythm during early infancy.

  11. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    ERIC Educational Resources Information Center

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  12. Effect of a 12-Week Summer Break on School Day Physical Activity and Health-Related Fitness in Low-Income Children from CSPAP Schools.

    PubMed

    Fu, You; Brusseau, Timothy A; Hannon, James C; Burns, Ryan D

    2017-01-01

    Background. The purpose of this study was to examine the effect of a 12-week summer break on school day physical activity and health-related fitness (HRF) in children from schools receiving a Comprehensive School Physical Activity Program (CSPAP). Methods. Participants were school-aged children (N = 1,232; 624 girls and 608 boys; mean age = 9.5 ± 1.8 years) recruited from three low-income schools receiving a CSPAP. Physical activity and HRF levels were collected during the end of spring semester 2015 and again during the beginning of fall semester 2015. Physical activity was assessed using the Yamax DigiWalker CW600 pedometer. HRF measures consisted of body mass index (BMI) and the Progressive Aerobic Cardiovascular Endurance Run (PACER). Results. Results from a doubly MANCOVA analysis indicated that pedometer step counts decreased from 4,929 steps in the spring to 4,445 steps in the fall (mean difference = 484 steps; P < 0.001; Cohen's d = 0.30) and PACER laps decreased from 31.2 laps in the spring to 25.8 laps in the fall (mean difference = 5.4 laps; P < 0.001; Cohen's d = 0.33). Conclusions. Children from schools receiving a CSPAP intervention had lower levels of school day physical activity and cardiorespiratory endurance following a 12-week summer break.

  13. Effects of 12-week concurrent high-intensity interval strength and endurance training programme on physical performance in healthy older people.

    PubMed

    García-Pinillos, Felipe; Laredo-Aguilera, José A; Muñoz-Jiménez, Marcos; Latorre-Román, Pedro A

    2017-03-13

    This study aimed to analyse the effect of 12-week low-volume HIIT-based concurrent training programme on body composition, upper- and lower-body muscle strength, mobility and balance in older adults, as well as to compare it with a low- moderate-intensity continuous training. 90 active older adults were randomly assigned to experimental (EG, n=47), and control (CG, n=43) groups. Body composition and physical functioning were assessed before (pre-test) and after (post-test) a 12-week intervention. A 2-way repeated measures ANOVA was used to test for an interaction between training programme and groups. The time x group interaction revealed no significant between-group differences at pre-test (p≥0.05). The group x time interaction showed significant improvements for the EG in body composition parameters (p<0.05) and physical functioning (muscle strength: p<0.001; mobility: p<0.001; and balance: p<0.05); while the CG remained unchanged (p≥0.05). This HIIT-based concurrent training programme led to greater improvements in body composition, muscle strength, mobility and balance in healthy older people than a regular low- moderate-intensity continuous training, despite the reduction in overall training volume.

  14. Effect of a 12-Week Summer Break on School Day Physical Activity and Health-Related Fitness in Low-Income Children from CSPAP Schools

    PubMed Central

    2017-01-01

    Background. The purpose of this study was to examine the effect of a 12-week summer break on school day physical activity and health-related fitness (HRF) in children from schools receiving a Comprehensive School Physical Activity Program (CSPAP). Methods. Participants were school-aged children (N = 1,232; 624 girls and 608 boys; mean age = 9.5 ± 1.8 years) recruited from three low-income schools receiving a CSPAP. Physical activity and HRF levels were collected during the end of spring semester 2015 and again during the beginning of fall semester 2015. Physical activity was assessed using the Yamax DigiWalker CW600 pedometer. HRF measures consisted of body mass index (BMI) and the Progressive Aerobic Cardiovascular Endurance Run (PACER). Results. Results from a doubly MANCOVA analysis indicated that pedometer step counts decreased from 4,929 steps in the spring to 4,445 steps in the fall (mean difference = 484 steps; P < 0.001; Cohen's d = 0.30) and PACER laps decreased from 31.2 laps in the spring to 25.8 laps in the fall (mean difference = 5.4 laps; P < 0.001; Cohen's d = 0.33). Conclusions. Children from schools receiving a CSPAP intervention had lower levels of school day physical activity and cardiorespiratory endurance following a 12-week summer break. PMID:28377791

  15. The effects of 12-week psyllium fibre supplementation or healthy diet on blood pressure and arterial stiffness in overweight and obese individuals.

    PubMed

    Pal, Sebely; Khossousi, Alireza; Binns, Colin; Dhaliwal, Satvinder; Radavelli-Bagatini, Simone

    2012-03-01

    Endothelial dysfunction and increased arterial stiffness occur early in the pathogenesis of the metabolic syndrome and they are both powerful independent predictors of cardiovascular risk. A high-fibre diet has been correlated with lower BMI and a lower incidence of hyperlipidaemia, CVD, hypertension and diabetes. The present randomised, parallel-design study compared the effects of fibre intake from a healthy diet v. fibre supplement diets on blood pressure (BP) and vascular function over 12 weeks. Overweight and obese adults were randomised to one of three groups: control (with placebo), fibre supplement (FIB) or healthy eating group with placebo (HLT). Systolic blood pressure (SBP) was lower in the FIB group compared with the control group at week 6, but not at week 12. However, SBP was lower in the HLT group compared with control group at week 12. At week 6, the FIB group presented lower diastolic blood pressure and augmentation index compared with the control group, but this result did not persist to the end of the study. The present study did not show any improvements in BP or vascular function in overweight and obese individuals with psyllium fibre supplementation over 12 weeks of intervention. However, a healthy diet provided the greatest improvements in BP in overweight and obese subjects. Further research with hypertensive individuals is necessary to elucidate whether increased fibre consumption in the form of psyllium supplementation may provide a safe and acceptable means to reduce BP, vascular function and the risk of developing CVD.

  16. Lack of effects of fish oil supplementation for 12 weeks on resting metabolic rate and substrate oxidation in healthy young men: A randomized controlled trial.

    PubMed

    Jannas-Vela, Sebastian; Roke, Kaitlin; Boville, Stephanie; Mutch, David M; Spriet, Lawrence L

    2017-01-01

    Fish oil (FO) has been shown to have beneficial effects in the body via incorporation into the membranes of many tissues. It has been proposed that omega-3 fatty acids in FO may increase whole body resting metabolic rate (RMR) and fatty acid (FA) oxidation in human subjects, but the results to date are equivocal. The purpose of this study was to investigate the effects of a 12 week FO supplementation period on RMR and substrate oxidation, in comparison to an olive oil (OO) control group, in young healthy males (n = 26; 22.8 ± 2.6 yr). Subjects were matched for age, RMR, physical activity, VO2max and body mass, and were randomly separated into a group supplemented with either OO (3 g/d) or FO containing 2 g/d eicosapentaenoic acid (EPA) and 1 g/d docosahexaenoic acid (DHA). Participants visited the lab for RMR and substrate oxidation measurements after an overnight fast (10-12 hr) at weeks 0, 6 and 12. Fasted blood samples were taken at baseline and after 12 weeks of supplementation. There were significant increases in the EPA (413%) and DHA (59%) levels in red blood cells after FO supplementation, with no change of these fatty acids in the OO group. RMR and substrate oxidation did not change after supplementation with OO or FO after 6 and 12 weeks. Since there was no effect of supplementation on metabolic measures, we pooled the two treatment groups to determine whether there was a seasonal effect on RMR and substrate oxidation. During the winter season, there was an increase in FA oxidation (36%) with a concomitant decrease (34%) in carbohydrate (CHO) oxidation (p < 0.01), with no change in RMR. These measures were unaffected during the summer season. In conclusion, FO supplementation had no effect on RMR and substrate oxidation in healthy young males. Resting FA oxidation was increased and CHO oxidation reduced over a 12 week period in the winter, with no change in RMR.

  17. Lack of effects of fish oil supplementation for 12 weeks on resting metabolic rate and substrate oxidation in healthy young men: A randomized controlled trial

    PubMed Central

    Jannas-Vela, Sebastian; Roke, Kaitlin; Boville, Stephanie; Mutch, David M.; Spriet, Lawrence L.

    2017-01-01

    Fish oil (FO) has been shown to have beneficial effects in the body via incorporation into the membranes of many tissues. It has been proposed that omega-3 fatty acids in FO may increase whole body resting metabolic rate (RMR) and fatty acid (FA) oxidation in human subjects, but the results to date are equivocal. The purpose of this study was to investigate the effects of a 12 week FO supplementation period on RMR and substrate oxidation, in comparison to an olive oil (OO) control group, in young healthy males (n = 26; 22.8 ± 2.6 yr). Subjects were matched for age, RMR, physical activity, VO2max and body mass, and were randomly separated into a group supplemented with either OO (3 g/d) or FO containing 2 g/d eicosapentaenoic acid (EPA) and 1 g/d docosahexaenoic acid (DHA). Participants visited the lab for RMR and substrate oxidation measurements after an overnight fast (10–12 hr) at weeks 0, 6 and 12. Fasted blood samples were taken at baseline and after 12 weeks of supplementation. There were significant increases in the EPA (413%) and DHA (59%) levels in red blood cells after FO supplementation, with no change of these fatty acids in the OO group. RMR and substrate oxidation did not change after supplementation with OO or FO after 6 and 12 weeks. Since there was no effect of supplementation on metabolic measures, we pooled the two treatment groups to determine whether there was a seasonal effect on RMR and substrate oxidation. During the winter season, there was an increase in FA oxidation (36%) with a concomitant decrease (34%) in carbohydrate (CHO) oxidation (p < 0.01), with no change in RMR. These measures were unaffected during the summer season. In conclusion, FO supplementation had no effect on RMR and substrate oxidation in healthy young males. Resting FA oxidation was increased and CHO oxidation reduced over a 12 week period in the winter, with no change in RMR. Trial Registration: ClinicalTrials.gov NCT02092649 PMID:28212390

  18. Effect of 12 weeks of yoga training on the somatization, psychological symptoms, and stress-related biomarkers of healthy women

    PubMed Central

    2014-01-01

    Background Previous studies have shown that the practice of yoga reduces perceived stress and negative feelings and that it improves psychological symptoms. Our previous study also suggested that long-term yoga training improves stress-related psychological symptoms such as anxiety and anger. However, little is known about the beneficial effects of yoga practice on somatization, the most common stress-related physical symptoms, and stress-related biomarkers. We performed a prospective, single arm study to examine the beneficial effects of 12 weeks of yoga training on somatization, psychological symptoms, and stress-related biomarkers. Methods We recruited healthy women who had no experience with yoga. The data of 24 participants who were followed during 12 weeks of yoga training were analyzed. Somatization and psychological symptoms were assessed before and after 12 weeks of yoga training using the Profile of Mood State (POMS) and the Symptom Checklist-90-Revised (SCL-90-R) questionnaires. Urinary 8-hydroxydeoxyguanosine (8-OHdG), biopyrrin, and cortisol levels were measured as stress-related biomarkers. The Wilcoxon signed-rank test was used to compare the stress-related biomarkers and the scores of questionnaires before and after 12 weeks of yoga training. Results After 12 weeks of yoga training, all negative subscale scores (tension-anxiety, depression, anger-hostility, fatigue, and confusion) from the POMS and somatization, anxiety, depression, and hostility from the SCL-90-R were significantly decreased compared with those before starting yoga training. Contrary to our expectation, the urinary 8-OHdG concentration after 12 weeks of yoga training showed a significant increase compared with that before starting yoga training. No significant changes were observed in the levels of urinary biopyrrin and cortisol after the 12 weeks of yoga training. Conclusions Yoga training has the potential to reduce the somatization score and the scores related to mental health

  19. Cloacal and surface temperatures of tom turkeys exposed to different rearing temperature regimes during the first 12 weeks of growth.

    PubMed

    Mayes, S L; Strawford, M L; Noble, S D; Classen, H L; Crowe, T G

    2015-06-01

    Years of genetic selection have caused an increase in growth rate and market body mass in agricultural poultry species compared to earlier genetic strains, potentially altering their physiological requirements. The objective of this study was to expose Hybrid Converter tom turkeys on a weekly basis to the recommended rearing temperature regime (TCON: control) or 4°C below the recommended standard (TTRT: treatment) to determine their thermal responses. Once per week for 12 weeks, 12 turkeys were individually exposed to either TCON or TTRT for a 2-h period. Surface temperatures of the breast (TBREAST), wing (TWING), drumstick (TDRUM), head (THEAD), and shank (TSHANK) were measured at 20-min intervals using an infrared camera, while a thermal data logger measured the skin surface temperature under the wing (TLOGGER) at 30-s intervals. The cloacal temperature (TCORE) was measured using a medical thermometer at the start and end of the exposure period. Regardless of exposure temperature, the TBREAST (TCON: P<0.001 and TTRT: P<0.001), TWING (TCON: P<0.001 and TTRT: P<0.001), and TDRUM (TCON: P<0.001 and TTRT: P<0.001) decreased from weeks 4 to 6 and remained constant from weeks 1 to 3 and 8 to 12. THEAD was elevated in week 2 (TCON: P<0.001) or week 3 (TTRT: P<0.001), TSHANK increased slightly during week 3 for both TCON (P<0.001) and TTRT (P<0.001), and TLOGGER (TCON: P<0.001 and TTRT: P=0.001) and TCORE (TCON: P<0.001 and TTRT: P<0.001) were lower during the first week. Thereafter, THEAD, TSHANK, TLOGGER, and TCORE remained constant. Exposure to TTRT resulted in lower TBREAST, TWING, and TDRUM compared to TCON. Generally, THEAD, TSHANK, TLOGGER, and TCORE were not affected by the different exposure temperatures. The data demonstrated that the degree of thermal response expressed is dependent on the location of measurement, age, and exposure temperature.

  20. Safety of dietary conjugated linoleic acid (CLA) in a 12-weeks trial in healthy overweight Japanese male volunteers.

    PubMed

    Iwata, Toshio; Kamegai, Takeshi; Yamauchi-Sato, Yoshie; Ogawa, Akiko; Kasai, Michio; Aoyama, Toshiaki; Kondo, Kazuo

    2007-01-01

    A study was conducted to investigate the short-term safety of dietary conjugated linoleic acid (CLA) in overweight Japanese male volunteers. The study design was a randomized, double-blind placebo-controlled trial including 60 healthy overweight volunteers (body mass index (BMI), 25 approximately 35 kg/m(2)). The subjects were randomly assigned to three groups: 5.4 g CLA-triacylglycerol (3.4 g as CLA), 10.8 g CLA-triacylglycerol (6.8 g as CLA) and placebo (10.8 g safflower oil) daily for 12 weeks. The CLA-triaclyglycerol contained 9c,11t- and 10t,12c-isomers at an equal proportion. The safety was evaluated by analyses of blood parameters and by clinical examinations at the baseline, and at 6 and 12 weeks, including vital signs and adverse effects. All subjects completed the study. The occurrence of adverse events tended to be higher in the CLA groups than in the placebo group, but all of the adverse events were mild to moderate, within normal ranges, and temporary. Serum aspartate aminotransferase (AST) activity did not differ significantly between the groups at 12 weeks, but in the high CLA group it was slightly increased from the baseline. Serum alanine aminotransferase (ALT) activity was higher in the high CLA group than in the placebo group after 12 weeks and was higher than at the baseline in both CLA groups. However, statistical analysis of the population of apparently healthy volunteers who had normal blood parameters at the baseline revealed that AST and ALT levels did not differ significantly among the 3 groups at 12 weeks. Moreover, no clinically significant changes in vital signs were observed in any of the groups. These results indicate that CLA at a dose of 3.4 g/day is a safe dietary level in healthy Japanese populations in terms of the parameters examined.

  1. Effects of chair yoga therapy on physical fitness in patients with psychiatric disorders: A 12-week single-blind randomized controlled trial.

    PubMed

    Ikai, Saeko; Uchida, Hiroyuki; Mizuno, Yuya; Tani, Hideaki; Nagaoka, Maki; Tsunoda, Kenichi; Mimura, Masaru; Suzuki, Takefumi

    2017-07-19

    Since falls may lead to fractures and have serious, potentially fatal outcomes, prevention of falls is an urgent public health issue. We examined the effects of chair yoga therapy on physical fitness among psychiatric patients in order to reduce the risk of falls, which has not been previously reported in the literature. In this 12-week single-blind randomized controlled trial with a 6-week follow-up, inpatients with mixed psychiatric diagnoses were randomly assigned to either chair yoga therapy in addition to ongoing treatment, or treatment-as-usual. Chair yoga therapy was conducted as twice-weekly 20-min sessions over 12 weeks. Assessments included anteflexion in sitting, degree of muscle strength, and Modified Falls Efficacy Scale (MFES) as well as QOL, psychopathology and functioning. Fifty-six inpatients participated in this study (36 men; mean ± SD age, 55.3 ± 13.7 years; schizophrenia 87.5%). In the chair yoga group, significant improvements were observed in flexibility, hand-grip, lower limb muscle endurance, and MFES at week 12 (mean ± SD: 55.1 ± 16.6 to 67.2 ± 14.0 cm, 23.6 ± 10.6 to 26.8 ± 9.7 kg, 4.9 ± 4.0 to 7.0 ± 3.9 kg, and 114.9 ± 29.2 to 134.1 ± 11.6, respectively). Additionally, these improvements were observable six weeks after the intervention was over. The QOL-VAS improved in the intervention group while no differences were noted in psychopathology and functioning between the groups. The intervention appeared to be highly tolerable without any notable adverse effects. The results indicated sustainable effects of 20-min, 12-week, 24-session chair yoga therapy on physical fitness. Chair yoga therapy may contribute to reduce the risk of falls and their unwanted consequences in psychiatric patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Influence of anxiety symptoms on improvement of neurocognitive functions in patients with major depressive disorder: A 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    PubMed

    Yoo, Ikki; Woo, Jong-Min; Lee, Seung-Hwan; Fava, Maurizio; Mischoulon, David; Papakostas, George I; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Jeon, Hong Jin

    2015-10-01

    Previous research has reported evidence that patients with major depressive disorder (MDD) show anxiety symptoms and neurocognitive impairments. However, the influence of anxiety on neurocognitive function in MDD patients during antidepressant treatment is unclear. MDD patients (n=164) completed a 12-week, multicenter, randomized trial assigned in a 1:1 ratio to either tianeptine or escitalopram. Changes of anxiety symptoms were assessed by the Hamilton Anxiety Rating Scale (HAM-A), and the Hamilton Depression Rating Scale (HAM-D), self-rated subjective cognitive impairment on memory and concentration, the Mini-Mental Status Examination (MMSE), Continuous Performance Test (CPT), Verbal Learning Test (VLT), and Raven's Progressive Matrices (RPM) were assessed every 4 weeks. During 12 weeks of treatment, decrease in the HAM-A score was significantly associated with improvement of subjective cognitive impairments on memory (p<0.001) and concentration (p<0.001), and objective measures on delayed memory (p=0.006) and reasoning ability (p=0.002), after adjusting for covariates such as baseline HAM-A scores, time, sex, age, education years and assigned medication using the Mixed effects and Generalized Estimated Equation model analysis. However, the other cognitive outcome variables, immediate memory, commission error, and MMSE, which showed significant improvement through 12-week study period, showed no significant association with improvement of anxiety. Improvement of anxiety symptoms was significantly associated with improvement in subjective and objective neurocognitive functions such as delayed memory and reasoning ability in elderly MDD patients during antidepressant treatment, but not significantly associated with improvement of immediate memory and commission error. ClinicalTrials.gov identifier NCT01309776. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. GLYCATED ALBUMIN AT 4 WEEKS CORRELATES WITH A1C LEVELS AT 12 WEEKS AND REFLECTS SHORT-TERM GLUCOSE FLUCTUATIONS

    PubMed Central

    Desouza, Cyrus V.; Rosenstock, Julio; Zhou, Rong; Holcomb, Richard G.; Fonseca, Vivian A.

    2016-01-01

    Objective Evaluate the performance of glycated albumin (GA) monitoring by comparing it to other measures of glycemic control during intensification of antidiabetic therapy. Methods This 12-week, prospective, multicenter study compared the diagnostic clinical performance of GA to glycated hemoglobin A1C (A1C), fructosamine corrected for albumin (FRA), fasting plasma glucose (FPG), and mean blood glucose (MBG) estimated from self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) in 30 patients with suboptimally controlled type 1 or 2 diabetes. Results Mean A1C decreased from 9.5% to 8.1%. Mean SMBG correlated closely with CGM (Pearson r = 0.783 for daily estimates and r = 0.746 for weekly estimates, P<.0001). Both GA and FRA levels significantly correlated with changes from baseline in A1C and mean weekly SMBG (P<.001).The lowest observed median GA occurred at 4 weeks, followed by a small increase and then a slight reduction, mirroring changes in overall mean SMBG values. The median A1C fell throughout the treatment period, failing to reflect short-term changes in SMBG. A ≥1% reduction in GA at 4 weeks was significantly associated with a ≥0.5% change in A1C at 12 weeks (odds ratio [OR] = 19.0, 95% confidence interval [CI]: 1.4, 944, P = .018). Conclusion In patients receiving glucose-lowering therapy, changes in GA at 4 weeks were concordant with changes in A1C at 12 weeks, and both GA and FRA more accurately reflected short-term blood glucose fluctuations than A1C. PMID:26214108

  4. Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial.

    PubMed

    Heo, Jung-Yoon; Jeon, Hong Jin; Fava, Maurizio; Mischoulon, David; Baer, Lee; Clain, Alisabet; Doorley, James; Pisoni, Angela; Papakostas, George I

    2015-03-01

    Anxious depression, defined as major depressive disorder (MDD) accompanied by high levels of anxiety, seems to be difficult to treat with traditional antidepressant monotherapy. The purpose of this study was to assess the efficacy of ziprasidone monotherapy in patients with anxious depression versus non-anxious depression. One hundred and twenty outpatients were enrolled in a 12-week study that was divided into two 6-week periods according to the sequential parallel comparison design. Patients were randomized in a 2:3:3 multi-ratio to receive ziprasidone for 12 weeks, placebo for 6 weeks, followed by ziprasidone for 6 weeks, or placebo for 12 weeks. Efficacy was measured according to the 17-item Hamilton Depression Rating Scale (HRDS-17), Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-SR). Anxious depression was defined as a score of ≥7 on the HDRS-17 anxiety/somatization subscale. In phase I and II, ziprasidone monotherapy led to no significant changes compared with placebo on the HDRS-17 and QIDS-SR scores in patients with both anxious and non-anxious depression. In the pooled analysis, ziprasidone monotherapy also produced no significance on the HDRS-17 (Z = 0.25, P = 0.80) and QIDS-SR (Z = 0.43, P = 0.67) in patients with anxious depression. In conclusion, treatment with ziprasidone monotherapy may produce no significant improvement compared with placebo in patients with in anxious depression. ClinicalTrials.gov identifier: NCT00555997. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis.

    PubMed

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kameda, Hiroyuki; Tamura, Masahiro; Mihara, Hanako; Kaku, Kohei

    2016-09-01

    Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest. The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected. Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P < 0.0001). This interim analysis characterized the safety profile of tofogliflozin in Japanese elderly patients with type 2 diabetes mellitus during the early post-marketing period. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  6. Modeling Day-to-Day Variability of Glucose-Insulin Regulation Over 12-Week Home Use of Closed-Loop Insulin Delivery.

    PubMed

    Yue Ruan; Wilinska, Malgorzata E; Thabit, Hood; Hovorka, Roman

    2017-06-01

    Parameters of physiological models of glucose-insulin regulation in type 1 diabetes have previously been estimated using data collected over short periods of time and lack the quantification of day-to-day variability. We developed a new hierarchical model to relate subcutaneous insulin delivery and carbohydrate intake to continuous glucose monitoring over 12 weeks while describing day-to-day variability. Sensor glucose data sampled every 10-min, insulin aspart delivery and meal intake were analyzed from eight adults with type 1 diabetes (male/female 5/3, age 39.9 ± 9.5 years, BMI 25.4 ± 4.4kg/m(2), HbA1c 8.4 ± 0.6% ) who underwent a 12-week home study of closed-loop insulin delivery. A compartment model comprised of five linear differential equations; model parameters were estimated using the Markov chain Monte Carlo approach within a hierarchical Bayesian model framework. Physiologically, plausible a posteriori distributions of model parameters including insulin sensitivity, time-to-peak insulin action, time-to-peak gut absorption, and carbohydrate bioavailability, and good model fit were observed. Day-to-day variability of model parameters was estimated in the range of 38-79% for insulin sensitivity and 27-48% for time-to-peak of insulin action. In conclusion, a linear Bayesian hierarchical approach is feasible to describe a 12-week glucose-insulin relationship using conventional clinical data. The model may facilitate in silico testing to aid the development of closed-loop insulin delivery systems.

  7. The immediate post-operative period following lung transplantation: mapping of nursing interventions

    PubMed Central

    Duarte, Rayssa Thompson; Linch, Graciele Fernanda da Costa; Caregnato, Rita Catalina Aquino

    2014-01-01

    OBJECTIVES: to investigate the principle nursing interventions/actions, prescribed in the immediate post-operative period for patients who receive lung transplantation, recorded in the medical records, and to map these using the Nursing Interventions Classification (NIC) taxonomy. METHOD: retrospective documental research using 183 medical records of patients who received lung transplantation (2007/2012). The data of the patients' profile were grouped in accordance with the variables investigated, and submitted to descriptive analysis. The nursing interventions prescribed were analyzed using the method of cross-mapping with the related interventions in the NIC. Medical records which did not contain nursing prescriptions were excluded. RESULTS: the majority of the patients were male, with medical diagnoses of pulmonary fibrosis, and underwent lung transplantation from a deceased donor. A total of 26 most frequently-cited interventions/actions were found. The majority (91.6%) were in the complex and basic physiological domains of the NIC. It was not possible to map two actions prescribed by the nurses. CONCLUSIONS: it was identified that the main prescriptions contained general care for the postoperative period of major surgery, rather than prescriptions individualized to the patient in the postoperative period following lung transplantation. Care measures related to pain were underestimated in the prescriptions. The mapping with the taxonomy can contribute to the elaboration of the care plan and to the use of computerized systems in this complex mode of therapy. PMID:25493673

  8. The immediate post-operative period following lung transplantation: mapping of nursing interventions.

    PubMed

    Duarte, Rayssa Thompson; Linch, Graciele Fernanda da Costa; Caregnato, Rita Catalina Aquino

    2014-10-01

    To investigate the principle nursing interventions/actions, prescribed in the immediate post-operative period for patients who receive lung transplantation, recorded in the medical records, and to map these using the Nursing Interventions Classification (NIC) taxonomy. Retrospective documental research using 183 medical records of patients who received lung transplantation (2007/2012). The data of the patients' profile were grouped in accordance with the variables investigated, and submitted to descriptive analysis. The nursing interventions prescribed were analyzed using the method of cross-mapping with the related interventions in the NIC. Medical records which did not contain nursing prescriptions were excluded. The majority of the patients were male, with medical diagnoses of pulmonary fibrosis, and underwent lung transplantation from a deceased donor. A total of 26 most frequently-cited interventions/actions were found. The majority (91.6%) were in the complex and basic physiological domains of the NIC. It was not possible to map two actions prescribed by the nurses. It was identified that the main prescriptions contained general care for the postoperative period of major surgery, rather than prescriptions individualized to the patient in the postoperative period following lung transplantation. Care measures related to pain were underestimated in the prescriptions. The mapping with the taxonomy can contribute to the elaboration of the care plan and to the use of computerized systems in this complex mode of therapy.

  9. The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women.

    PubMed

    Nadi, Maryam; Marandi, Seyyed Mohammad; Esfarjani, Fahimeh; Saleki, Mohammad; Mohammadi, Mahboobeh

    2017-01-01

    Peripheral neuropathy is a common complaint of diabetes. This study aimed to determine the effects of 12 weeks combined training with Vitamin D supplement on improvement of sensory-motor neuropathy in women with diabetic neuropathy. This clinical trial study conducted on 90 patients were selected and randomly divided into two groups. Finally, 81 adult females with diabetes type II (20-55 years old) were interred in this study. The control group had no training, but received Vitamin D. The experimental group received Vitamin D and 12 weeks training program (3 days a week, 60 min/session) including aerobic exercises, strength, and flexibility. Aerobic exercise intensity was set at 60-70% maximum heart rate and resistance training intensity was determined by 10 R.M. Michigan neuropathy questionnaire, reflex hammer and tuning fork 128 Hz used to screening tense of neuropathy (Michigan Neuropathy Screening Instrument) that were used for pretest and posttest. Following 3 months combined training and supplementation with Vitamin D, had observed a significant reduction in numbness (P = 0.001), pain (0.002), tingling (P = 0.001), and weakness (P = 0.002) in the lower limb and also increases in sense of touch intervention (P = 0.005), detects the position of the fingers (P = 0.001) and vibration perception (P = 0.001) in tissues. Knee reflexes (P = 0.77) and ankles reflexes (P = 0.47) did not significantly change after interventions. It seems that taking part in combined training and supplementation with Vitamin D can improve the symptoms of sensory-motor neuropathy.

  10. A 12-week sports-based exercise programme for inactive Indigenous Australian men improved clinical risk factors associated with type 2 diabetes mellitus.

    PubMed

    Mendham, Amy E; Duffield, Rob; Marino, Frank; Coutts, Aaron J

    2015-07-01

    This study assessed the effect of a 12-week sports-based exercise intervention on glucose regulation, anthropometry and inflammatory markers associated with the prevalence of type 2 diabetes mellitus (T2DM) in Indigenous Australian men. Twenty-six inactive Indigenous Australian men (48.6±6.6 years) were randomized into exercise (n=16) or control (n=10)conditions. Training included ∼2-3 days/week for 12 weeks of sports and gym exercises in a group environment, whilst control participants maintained normal activity and dietary patterns. Pre- and post-intervention testing included: anthropometry, peak aerobic capacity, fasting blood chemistry of inflammatory cytokines, adiponectin, leptin, cholesterol, glucose, insulin and C-peptide. An oral glucose tolerance test measured glucose, insulin and C-peptide 30, 60, 90 and 120min post 75g glucose ingestion. The exercise condition decreased insulin area under the curve (25±22%), increased estimated insulin sensitivity (35±62%) and decreased insulin resistance (9±35%; p<0.05), compared with control (p>0.05). The exercise condition decreased in body mass index, waist circumference and waist to hip ratio (p<0.05), compared to control (p>0.05). Leptin decreased in the exercise group, with no changes for adiponectin (p>0.05) or inflammatory markers (p>0.05) in either condition. Aerobic fitness variables showed significant increases in peak oxygen consumption for the exercise condition compared to no change in control (p>0.05). Findings indicate positive clinical outcomes in metabolic, anthropometric and aerobic fitness variables. This study provides evidence for sport and group-based activities leading to improved clinical risk factors associated with T2DM development in clinically obese Indigenous Australian men. Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  11. Management of osteoarthritis (OA) with the pharma-standard supplement FlexiQule (Boswellia): a 12-week registry.

    PubMed

    Belcaro, G; Dugall, M; Luzzi, R; Ledda, A; Pellegrini, L; Hu, S; Ippolito, E

    2015-10-22

    This registry study assessed the pharma-standard supplement FlexiQule (Boswellia extract in capsules) in the management of symptoms associated to osteoarthritis (OA) also managed with the 'standard management' (SM) in comparison with a group of patients managed only with SM. The 12- week registry included patients with symptomatic knee arthrosis. They were able to walk on a treadmill for a walking test and to complete the WOMAC questionnaire.

  12. The Effects of a 12-Week Faculty and Staff Exercise Program on Health-Related Variables in a University Setting

    PubMed Central

    REBOLD, MICHAEL J.; KOBAK, MALLORY S.; PEROUTKY, KYLENE; GLICKMAN, ELLEN L.

    2015-01-01

    The obesity epidemic has grown in the past decade due to physical inactivity (i.e., having a sedentary job) and an increase in caloric intake. This problem combined with the reluctance of many faculty and staff members exercising in the same environment as student’s presents a unique challenge in an academic setting. The purpose of this study was to examine the effectiveness of a 12-week exercise program focused toward the faculty and staff in improving several health-related variables such as curl-ups, push-ups, sit-and-reach, and balance. Fifty-seven faculty and staff participated in the current study. Participants engaged in a variety of exercise classes taught by certified instructors three days a week for 12-weeks. Paired samples t-tests illustrated a significant (p < 0.001) decrease in body mass and significant (p ≤ 0.001) improvements in curl-ups, push-ups, sit-and-reach, and balance. This data demonstrates that a 12-week faculty and staff exercise program has the potential to improve performance in several health-related variables such as curl-ups, push-ups, sit-and-reach, and balance. The ability of this program to improve health-related variables and possibly delay or prevent the development of overweight and/or obesity, sarcopenia, and other chronic diseases is encouraging. PMID:27182412

  13. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students.

    PubMed

    Kim, Seungsuk; Han, Gunsoo

    2016-08-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants' exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects' body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students.

  14. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients

    PubMed Central

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-01-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  15. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    PubMed

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy.

  16. The Effects of a 12-Week Faculty and Staff Exercise Program on Health-Related Variables in a University Setting.

    PubMed

    Rebold, Michael J; Kobak, Mallory S; Peroutky, Kylene; Glickman, Ellen L

    The obesity epidemic has grown in the past decade due to physical inactivity (i.e., having a sedentary job) and an increase in caloric intake. This problem combined with the reluctance of many faculty and staff members exercising in the same environment as student's presents a unique challenge in an academic setting. The purpose of this study was to examine the effectiveness of a 12-week exercise program focused toward the faculty and staff in improving several health-related variables such as curl-ups, push-ups, sit-and-reach, and balance. Fifty-seven faculty and staff participated in the current study. Participants engaged in a variety of exercise classes taught by certified instructors three days a week for 12-weeks. Paired samples t-tests illustrated a significant (p < 0.001) decrease in body mass and significant (p ≤ 0.001) improvements in curl-ups, push-ups, sit-and-reach, and balance. This data demonstrates that a 12-week faculty and staff exercise program has the potential to improve performance in several health-related variables such as curl-ups, push-ups, sit-and-reach, and balance. The ability of this program to improve health-related variables and possibly delay or prevent the development of overweight and/or obesity, sarcopenia, and other chronic diseases is encouraging.

  17. The effect of coaching intervention on elite fast bowling technique over a two year period.

    PubMed

    Ranson, Craig; King, Mark; Burnett, Angus; Worthington, Peter; Shine, Kevin

    2009-11-01

    Fast bowling in cricket is an activity that is well recognised as having high injury prevalence and there has been debate regarding the most effective fast bowling technique. The aim of this study was to determine whether two-year coaching interventions conducted in a group of elite young fast bowlers resulted in fast bowling technique alteration. Selected kinematics of the bowling action of 14 elite young fast bowlers were measured using an 18 camera Vicon Motion Analysis system before and after two-year coaching interventions that addressed specific elements of fast bowling technique. Mann-Whitney tests were used to determine whether any changes in kinematic variables occurred pre- and post-intervention between those who had the coaching interventions and those who didn't. The coaching interventions, when applied, resulted in a more side-on shoulder alignment at back foot contact (BFC) (p = 0.002) and decreased shoulder counter-rotation (p = 0.001) however, there was no difference in the degree of change in back and front knee flexion angles or lower trunk side-flexion. This study has clearly shown that specific aspects of fast bowling technique are changeable over a two-year period in elite level fast bowlers and this may be attributed to coaching intervention.

  18. Subchronic (12-week) inhalation toxicity study of methanol-fueled engine exhaust in rats

    SciTech Connect

    Maejima, Kazuhito; Suzuki, Tadao ); Numata, Hiroaki ); Maekawa, Akihiko ); Nagase, Sumi ); Ishinishi, Noburu )

    1994-01-01

    To evaluate the inhalation toxicity to rats of exhaust at low concentration for longer periods, Fischer 344 rats were exposed to 3 concentrations of exhaust generated by an M85 methanol-fueled engine (methanol with 15% gasoline) without catalyst for 8 h/d, 6 d/wk for 4, 8, or 12 wk. Concentration- and time-dependent increase carboxyhemoglobin in the erythrocytes and decrease in cytochrome P-450 in the lungs were observed in all treated groups. Furthermore, significant increases in plasma formaldehyde were observed in the group exposed to the highest concentration of exhaust (carbon monoxide, 89.8 ppm; formaldehyde, 2.3 ppm; methanol, 8.1 ppm; nitrogen oxides, 22.9 ppm; nitrogen dioxide, 1.1 ppm) for 8 or 12 wk. No change of plasma folic acid was observed in any group, and no methanol or formic acid was detected in the plasma in any animals. Histopathologically, exposure-related changes were found only in the nasal cavity of the high-concentration group. Slight hyperplasia/squamous metaplasias of the respiratory epithelium lining the nasoturbinate and maxilloturbinate were observed after 4 wk of exposure, and the incidences and degrees of these lesions increased slightly with the exposure time. No changes were found in the olfactory epithelium of the nasal cavity. As judged by optical microscopy, the exhaust concentration with no effect on the nasal cavity under the experimental conditions was concluded to be the medium concentration level containing 0.55 ppm formaldehyde. In the present study, however, concentration- and time-dependent increase of carboxyhemoglobin in the erythrocytes and decrease of the lung P-450 level were observed. Therefore, further study on more long-term inhalation of lower concentrations of exhaust might be needed. 31 refs., 2 figs., 3 tabs.

  19. Effect of 12-week isokinetic training on muscle strength in adult with healed thermal burn.

    PubMed

    Ebid, Anwar A; Omar, Mohammed T A; Abd El Baky, Amal M

    2012-02-01

    Severe burns result in marked and prolonged skeletal muscle catabolism and weakness, which persist despite 'standard" rehabilitation programmes of occupational and physical therapy. Therefore, the objectives of this study were of twofold: to quantify the long-term effects of burns on leg muscle strength and to assess whether adults with thermal burn would benefit from the isokinetic training programme. Burned adult patients, with 35-55% total body surface area (TBSA) burned, were assessed at 6 months after burn in respect to leg muscle strength at 150° s(-1), using isokinetic dynamometry. Non-burned adults were assessed similarly, and served as controls. The burned adults participated in the resistance training programme 3 times weekly. The isokinetic exercise programme was begun with 60% of the average peak torque. Intensity of isokinetic exercise was increased from one set to five sets during the first through fifth sessions and remained at six sets for the remaining 6th to 24th sessions. Finally, a dose of 10 sets was applied for the 25th to the 36th sessions. Each set consisted of five repetitions of concentric contraction in angular velocities of 150° s(-1) for knee extensors, and flexors. All exercise sessions were preceded by a 5-min warm-up period on the treadmill. Subjects with burns more than 35% of TBSA produced significantly less torque, work, and power in the quadriceps and hamstring than control subjects (20.5%, 15.2%, p<0.05). Three months after isokinetic programme, muscle strength further increased by 17.9%±10.1% compared to the baseline measurement for burned patients but continued to be below the concurrent age-matched, non-burned adult. We found that adults with severe burns, relative to non-burned adults, had significantly lower peak torque as well as total work performance using the extensors and flexors muscles of the thigh. Participation in isokinetic training resulted in a greater improvement in extensor and flexor muscle strength in

  20. Effects of low carbohydrate diets on weight and glycemic control among type 2 diabetes individuals: a systemic review of RCT greater than 12 weeks.

    PubMed

    Castañeda-González, L M; Bacardí Gascón, M; Jiménez Cruz, A

    2011-01-01

    Low carbohydrate diets (LCD) have shown beneficial effects on short-term weight reduction programs for obese individuals without diabetes, but the long-term evidence of efficacy on individuals with type 2 diabetes is not conclusive. To evaluate, the effectiveness of 12 or more weeks of LCD compared to Low Fat Diet (LFD), Usual Care Diet (UCD) or Low Glycemic Index Diet (LGID) on weight reduction and AIC on type 2 diabetes individuals. A systematic review was conducted on randomized trials registered in PubMed, Cochrane and EBSCOhost from January 1st 2000 to January 1st 2010 including those with an intervention program with LCD in type 2 diabetes subjects and a follow-up ≥ 12 weeks. Available data on study design; carbohydrate composition of diet; duration of diet; and the outcomes of weight, lipid levels (total, low density lipoprotein and high-density lipoprotein cholesterol, and triglycerides), hemoglobin A1C percent and/or fasting glucose were extracted. Five studies showed greater weight reduction with LCD, of which four demonstrated no significant difference. The longest trial intervention studies did not show a difference in weight change. Only two studies showed greater reduction of A1C with LCD, including the longest intervention trial with a low carbohydrate Mediterranean diet. This review shows that there are no consistent differences in weight and A1C changes over the long-term treatment with LCD and LFD, UCD or LGID.

  1. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

    PubMed

    Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-04-25

    The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: -2.1, SD 3.3 kg, enhanced: -3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: -2.0, SD 3.5 cm, enhanced: -3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: -0.01, SD 0.02, enhanced: -0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional

  2. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    PubMed

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

  3. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    PubMed Central

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

  4. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed Central

    Park, Sang Hyuk; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  5. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed

    Park, Sang Hyuk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β 2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%-8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6-12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6-12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6-12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks.

  6. Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study

    PubMed Central

    2014-01-01

    Background StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults. Methods Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention. Results Resistance training increased 1-RM strength (p < 0.008), vertical jump height (p < 0.03), and isokinetic strength (p < 0.05) in both SS and placebo groups. No significant group-by-time interactions were observed (all p-values >0.10). Conclusions These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone. PMID:24910543

  7. Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study.

    PubMed

    Furlong, Jonathan; Rynders, Corey A; Sutherlin, Mark; Patrie, James; Katch, Frank I; Hertel, Jay; Weltman, Arthur

    2014-01-01

    StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults. Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention. Resistance training increased 1-RM strength (p < 0.008), vertical jump height (p < 0.03), and isokinetic strength (p < 0.05) in both SS and placebo groups. No significant group-by-time interactions were observed (all p-values >0.10). These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone.

  8. A primary care-based randomized controlled trial of 12-week whole-body vibration for balance improvement in type 2 diabetes mellitus.

    PubMed

    Del Pozo-Cruz, Jesús; Alfonso-Rosa, Rosa M; Ugia, José Luis; McVeigh, Joseph G; Pozo-Cruz, Borja Del; Sañudo, Borja

    2013-11-01

    To determine whether a 12-week whole-body vibration (WBV) training program improved balance in participants with type 2 diabetes mellitus (T2DM). Randomized controlled trial. Primary health care setting. Participants with T2DM (N=50). Participants were randomly allocated to either a WBV group (n=25), which performed a 12-week WBV-based exercise program on an oscillating platform (12-16Hz-4mm; 3 sessions/wk), or a usual-care control group (n=25). Clinical and sociodemographic variables were recorded at baseline. Static balance and dynamic balance were also assessed at baseline by measuring postural sway (measurement of center of pressure [COP] excursions in the anteroposterior and mediolateral directions) using a Wii Balance Board and the Timed Up and Go test. Significant between-group differences in COP excursions with participants' eyes closed were found with their feet apart and feet together. In addition, participants in the WBV group exhibited significantly lower COP excursions with their eyes closed after the intervention, while participants in the control group experienced a nonsignificant deterioration in COP excursions (ie, greater excursion) with their eyes open (mediolateral axis). There was no significant difference in the Timed Up and Go test values postintervention. WBV provides a safe and well-tolerated approach to improve balance in participants with T2DM. These findings may have important implications for falls prevention in those with T2DM in the primary health care setting. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  9. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

    PubMed

    Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

    2013-08-01

    The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p < 0.05) and anterior-posterior plane with eyes closed (p < 0.01). Significant improvements were observed in Romberg quotient about surface (p < 0.05) and speed (p < 0.01) but not about distance (p > 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

  10. Smoking cessation intervention for pregnant women: a call for extension to the postpartum period.

    PubMed

    Coleman-Cowger, Victoria H

    2012-07-01

    The association between smoking during pregnancy and adverse maternal/neonatal health outcomes is widely acknowledged, and recent health care reform has filled a much-needed gap by extending prenatal smoking cessation intervention coverage to all pregnant women on Medicaid. While more extensive coverage will improve quit rates during pregnancy, there continues to be a need to address high relapse rates in the postpartum period for both the insured and the uninsured. Smoking during the postpartum period exposes infants directly and indirectly to negative health effects, and has additional costs to mothers and society. Approximately 80% of women who quit smoking during pregnancy relapse in the first year postpartum, highlighting a need for effective continuing care that supports them through the challenging postpartum period when stress is high and motivations to stay quit may change. Existing relapse prevention interventions, typically delivered during pregnancy, have been found to be of little benefit during the postpartum period, suggesting the need for a more formal continuing care approach. Phone-based protocols are promising because they address the need for flexible access, and are known to be effective at increasing quit rates and sustained cessation.

  11. Turkish 12 Week Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This audiolingual beginner's course has been prepared for the Defense Language Institute intensive program in modern spoken Turkish. The course, consisting of six volumes of basic text in 55 units begins with an introductory section which presents the linguistic background, phonology, and distinguishing features of Turkish. The lesson format…

  12. Turkish 12 Week Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This audiolingual beginner's course has been prepared for the Defense Language Institute intensive program in modern spoken Turkish. The course, consisting of six volumes of basic text in 55 units begins with an introductory section which presents the linguistic background, phonology, and distinguishing features of Turkish. The lesson format…

  13. A randomized 12-week clinical comparison of an oscillating-rotating toothbrush to a new sonic brush in the reduction of gingivitis and plaque.

    PubMed

    Klukowska, M; Grender, J M; Conde, E; Ccahuana-Vasquez, Renzo Alberto; Goyal, C R

    2014-01-01

    To evaluate the efficacy of a marketed oscillating-rotating (O-R) power toothbrush (Oral-B Triumph with SmartGuide and FlossAction brush head, D34/EB25) to a new sonic toothbrush (Sonicare FlexCare Platinum) in the reduction of gingivitis and plaque over a 12-week test period. This was a single center, randomized, open label, examiner-blind, two-treatment, parallel group study. Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group. Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at Baseline, Week 6, and Week 12. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI), and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA) with Baseline as the covariate. In total, 130 subjects (65 per group) were randomized to treatment and 127 subjects completed the study. Both brushes produced statistically significant (p < 0.001) reductions in gingivitis and plaque measures relative to Baseline. At Week 12, the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures (p = 0.007). Additionally, the O-R brush presented significantly fewer bleeding sites (p < 0.007) and significantly greater reductions in whole mouth plaque measures (p < or = 0.035) at Weeks 6 and 12 versus the sonic brush. The benefit for the O-R brush versus the sonic brush at Week 12 was 11.7% for gingivitis, 19.8% for number of bleeding sites, and 12.2% for whole mouth plaque. There were no adverse events reported or observed for either brush. The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks 6 and 12, as well as significantly greater gingivitis reductions over the

  14. Effectiveness of a 12-week school-based educational preventive program on weight and fasting blood glucose in "at-risk" adolescents of type 2 diabetes mellitus: Randomised controlled trial.

    PubMed

    Bani Salameh, Ayman; Al-Sheyab, Nihaya; El-Hneiti, Mamdouh; Shaheen, Abeer; Williams, Leonie M; Gallagher, Robyn

    2017-02-28

    To assess the effectiveness of a 12-week school-based educational preventive program for type 2 diabetes by change in weight and fasting blood glucose level in Jordanian adolescents. Sixteen percent of Jordanian adults have obesity-related type 2 diabetes and 5.6% of obese adolescents examined, however one-third unexamined. Rates in Arabic countries will double in 20 years, but this can be prevented and reversed by controlling obesity. A single-blinded randomised controlled trial was conducted in 2 unisex high schools in Irbid, Jordan, in 2012. Intervention and control participants, aged 12 to 18 years, were visibly overweight/obese. They were randomly allocated to the intervention (n = 205) or control (n = 196) groups. At-risk students were assessed before and after the 12-week intervention, for change in weight and fasting blood glucose level following preventive instruction and parent-supported changes. Mean age of participants was 15.3 years with equal percentages of both males (49.4%) and females. Post intervention, the intervention group, demonstrated statistically significant reductions: mean difference of 3.3 kg in weight (P < .000) and 1.36 mg/dL (0.075 mmol/L) in fasting blood glucose (P < .000). School-based early prevention intervention effectively reduced weight and fasting blood glucose in Jordanian at-risk adolescents.

  15. Effects of a 12-week program of Tai Chi exercise on the kidney disease quality of life and physical functioning of patients with end-stage renal disease on hemodialysis.

    PubMed

    Chang, Jo-Han; Koo, Malcolm; Wu, Sheng-Wen; Chen, Chiu-Yuan

    2017-02-01

    Previous studies have shown that exercise training in patients with end-stage renal disease could improve their physical functioning and quality of life. Nevertheless, few studies have evaluated the effects of Tai Chi exercise in patients on hemodialysis. To investigate the effects of a Tai Chi exercise intervention on the quality of life and physical functioning in end-stage renal disease patients on hemodialysis. A pre-post experimental design. Patients, aged 20 years or older, on hemodialysis recruited from the hemodialysis unit at a medical center in central Taiwan were assigned, based on their own preference, to either a control group (n=25) or an intervention group (n=21). A weekly one-hour short-form Yang style Tai Chi session for a total of 12 weeks. Physical functioning and Kidney Disease Quality of Life (KDQOL) at the baseline and at the end of the intervention. The least square means of repetition of sit-to-stand cycles in one minute (STS-60), 6-min walk test, and gait speed test were significantly improved in the intervention group. In addition, the least square means of the five different dimensions of the KDQOL were all significantly higher in the intervention group, except the SF-12 physical health score. Improvements in the kidney disease quality of life and physical functioning were observed in Taiwanese patients on hemodialysis with a 12-week Tai Chi exercise intervention. Copyright © 2016. Published by Elsevier Ltd.

  16. Body composition in full-term healthy infants measured with air displacement plethysmography at 1 and 12 weeks of age.

    PubMed

    Eriksson, Britt; Löf, Marie; Forsum, Elisabet

    2010-04-01

    To use Pea Pod, a device based on air displacement plethysmography, to study body composition of healthy, full-term infants born to well-nourished women with a western life-style. Body composition was assessed in 53 girls and 55 boys at 1 week (before 10 days of age) and at 12 weeks (between 77 and 91 days of age). At 1 week girls contained 13.4 +/- 3.7% body fat and boys 12.5 +/- 4.0%. At 12 weeks, these figures were 26.3 +/- 4.2% (girls) and 26.4 +/- 5.1% (boys). Body fat (%) did not differ significantly between the genders. Body fat (%) at the two measurements was not correlated. At 1 week, the weight (r = 0.20, p = 0.044) and BMI (r = 0.26, p = 0.007) of the infants, but not their body fat (g, %) or fat free mass (g), correlated with BMI before pregnancy in their mothers. Pea Pod has potential for use in studies investigating the effect of external (i.e. nutritional status) and internal (i.e. age, gender, gestational age at birth) factors on infant body composition. This may be of value when studying relationships between the nutritional situation during early life and adult health.

  17. Effects of 12-week core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescents with idiopathic scoliosis

    PubMed Central

    Ko, Kwang-Jun; Kang, Seol-Jung

    2017-01-01

    To identify the effects of core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescent patients with idiopathic scoliosis. Subjects in the present study consisted of primary school students who were confirmed to have scoliosis on radiologic examination performed during their visit to the National Fitness Center in Seoul, Korea. Depending on whether they participated in a 12-week core stabilization exercise program, subjects were divided into the exercise (n=14, age 12.71±0.72 years) or control (n=15, age 12.80±0.86 years) group. The exercise group participated in three sessions of core stabilization exercise per week for 12 weeks. The Cobb angle, flexibility, and lumbar muscle strength tests were performed before and after core stabilization exercise. Repeated-measure two-way analysis of variance was performed to compare the treatment effects between the exercise and control groups. There was no significant difference in thoracic Cobb angle between the groups. The exercise group had a significant decrease in the lumbar Cobb angle after exercise compared to before exercise (P<0.001). The exercise group also had a significant increase in lumbar flexor and extensor muscles strength after exercise compared to before exercise (P<0.01 and P<0.001, respectively). Core stabilization exercise can be an effective therapeutic exercise to decrease the Cobb angle and improve lumbar muscle strength in adolescents with idiopathic scoliosis. PMID:28503541

  18. Effects of 12-week core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescents with idiopathic scoliosis.

    PubMed

    Ko, Kwang-Jun; Kang, Seol-Jung

    2017-04-01

    To identify the effects of core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescent patients with idiopathic scoliosis. Subjects in the present study consisted of primary school students who were confirmed to have scoliosis on radiologic examination performed during their visit to the National Fitness Center in Seoul, Korea. Depending on whether they participated in a 12-week core stabilization exercise program, subjects were divided into the exercise (n=14, age 12.71±0.72 years) or control (n=15, age 12.80±0.86 years) group. The exercise group participated in three sessions of core stabilization exercise per week for 12 weeks. The Cobb angle, flexibility, and lumbar muscle strength tests were performed before and after core stabilization exercise. Repeated-measure two-way analysis of variance was performed to compare the treatment effects between the exercise and control groups. There was no significant difference in thoracic Cobb angle between the groups. The exercise group had a significant decrease in the lumbar Cobb angle after exercise compared to before exercise (P<0.001). The exercise group also had a significant increase in lumbar flexor and extensor muscles strength after exercise compared to before exercise (P<0.01 and P<0.001, respectively). Core stabilization exercise can be an effective therapeutic exercise to decrease the Cobb angle and improve lumbar muscle strength in adolescents with idiopathic scoliosis.

  19. Behavioral Sleep Medicine Interventions for Restless Legs Syndrome and Periodic Limb Movement Disorder

    PubMed Central

    Pigeon, Wilfred R.; Yurcheshen, Michael

    2009-01-01

    SYNOPSIS Restless Legs Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD) are sleep disorders that are commonly seen in clinical practice. The standard treatment recommendations for these disorders are pharmacologic; most recently both conditions are most typically managed with pramipexole or ropinerole, which are FDA approved for the treatment of RLS. A mix of behavioral suggestions is included in treatment algorithms for providers as well as in patient education materials. While these suggestions have considerable merit, they are typically not delivered as an intervention, but instead provided as a series of helpful tips. There is emerging evidence for providing such suggestions as a more active and comprehensive intervention as part of a cognitive-behavioral package as well as for exercise therapy and cognitive behavioral therapy for insomnia to be delivered as active treatments for RLS and/or PLMD. PMID:20161553

  20. Herbal medicine Davaie Loban in mild to moderate Alzheimer's disease: A 12-week randomized double-blind placebo-controlled clinical trial.

    PubMed

    Tajadini, Haleh; Saifadini, Rostam; Choopani, Rasool; Mehrabani, Mitra; Kamalinejad, Mohammad; Haghdoost, Ali Akbar

    2015-12-01

    In traditional texts on herbal medicines, various medicinal plants have been noted to have beneficial effects on dementia and Alzheimer's disease. According to the traditional books Herbal medicine Davaie Loban (DL) has beneficial effects in Alzheimer's disease. The study aim was to determine the clinical efficacy of DL in patients with mild-to-moderate Alzheimer's disease. Double blind randomized clinical trial. Shahid Beheshti University of Medical Sciences. This included patients older than 50 years with mild to moderate Alzheimer's disease according to ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale; ADAS≥12) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB; CDR≤2). Twenty-four patients completed the study in DL group and 20 in placebo group. ADAS-cog and CDR-SOB were filled out for patients to define the improvement in memory over the study period. At 4 weeks and 12 weeks there was significant difference in mean (SEM) ADAS-cog scores between DL and placebo groups and it was lower in DL group (p<0.001). At baseline, no significant difference was seen regarding mean (SEM) scores of CDR-SOB between DL and placebo groups (p=0.096). However, at 4 and 12 weeks there was significant difference in mean (SE) CDR-SOB scores between DL and placebo groups and it was lower in DL group (p<0.001). Our findings suggest that DL may be effective in improvement of memory in patients with mild-to-moderate Alzheimer's disease. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. A 12-week supplementation with quercetin does not affect natural killer cell activity, granulocyte oxidative burst activity or granulocyte phagocytosis in female human subjects.

    PubMed

    Heinz, Serena A; Henson, Dru A; Nieman, David C; Austin, Melanie D; Jin, Fuxia

    2010-09-01

    Quercetin, a flavonoid found in fruits and vegetables, is a strong antioxidant with anti-inflammatory, antimicrobial and immune-modulating properties. The purpose of the present study was to investigate the effects of long-term quercetin supplementation on innate immune function and inflammation in human subjects. Female subjects (n 120; aged 30-79 years) were recruited from the community and randomised to one of three groups, with supplements administered using double-blinded procedures: 500 mg quercetin/d (n 38), 1000 mg quercetin/d (n 40) or placebo (n 42). Subjects ingested two soft chew supplements twice daily during the 12-week study period. Fasting blood samples were obtained pre- and post-study and were analysed for plasma quercetin, IL-6, TNF-alpha and leucocyte subset cell counts. Natural killer cell activity (NKCA) and lymphocyte subsets were assessed in a subset of seventy-four subjects. Granulocyte oxidative burst activity (GOBA) and phagocytosis were assessed in sixty-four subjects. Eighteen subjects had overlapping data. Quercetin supplementation at two doses compared with placebo increased plasma quercetin (interaction effect; P < 0.001) but had no significant influence on blood leucocyte subsets, plasma IL-6 or TNF-alpha concentration, NKCA, GOBA or phagocytosis. NKCA was inversely correlated with BMI (r - 0.25; P = 0.035) and body fat percentage (r - 0.38; P = 0.001), and positively correlated with self-reported physical fitness level (r 0.24; P = 0.032). In summary, results from the present double-blinded, placebo-controlled, randomised trial indicated that quercetin supplementation at 500 and 1000 mg/d for 12 weeks significantly increased plasma quercetin levels but had no influence on measures of innate immune function or inflammation in community-dwelling adult females.

  2. The Ontogeny of Face Recognition: Eye Contact and Sweet Taste Induce Face Preference in 9- and 12-Week-Old Human Infants.

    ERIC Educational Resources Information Center

    Blass, Elliott M.; Camp, Carole A.

    2001-01-01

    Calm or crying 9- and 12-week-olds sat facing a researcher who gazed into their eyes or at their forehead and delivered either a sucrose solution or pacifier or delivered nothing. Found that combining sweet taste and eye contact was necessary and sufficient for calm 9- and 12-week-olds to form a preference for the researcher, but not for crying…

  3. Comparative effects of 12 weeks of equipment based and mat Pilates in patients with Chronic Low Back Pain on pain, function and transversus abdominis activation. A randomized controlled trial.

    PubMed

    Cruz-Díaz, David; Bergamin, M; Gobbo, S; Martínez-Amat, Antonio; Hita-Contreras, Fidel

    2017-08-01

    Pilates method has been recommended for patients with chronic low back pain (CLBP) and the activation of transversus abdominis has been deemed to play an important role in the improvement of these patients. Nevertheless, the evidence of the activation of TrA in Pilates practitioners remains unclear. To assess the effectiveness of 12 weeks of Pilates practice in disability, pain, kinesiophobia and transversus abdominis activation in patients with chronic nonspecific Low Back Pain. A randomized controlled trial was carried out. A single-blind randomized controlled trial with repeated measures at 6 and 12 weeks was carried out. A total of ninety eight patients with low back pain were included and randomly allocated to a Pilates Mat group (PMG) equipment based with apparatus Pilates (PAG) or control group (CG). Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) Tampa Scale of Kinesiophobia (TSK), and transversus abdominis (TrA) activation assessed by real time ultrasound measurement (US) were assessed as outcome measures. Improvement were observed in both intervention groups in all the included variables at 6 and 12 weeks (p<0.001). Faster enhancement was observed in the equipment based Pilates group (p=0.007). Equipment based and mat Pilates modalities are both effective in the improvement of TaA activation in patients with CLBP with associate improvement on pain, function and kinesiophobia. Significant differences were observed after 12 weeks of intervention in PMG and PAG with faster improvement in PAG suggesting that, feedback provided by equipment could help in the interiorization of Pilates principles. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Effect of an integrated community-based package for maternal and newborn care on feeding patterns during the first 12 weeks of life: a cluster-randomized trial in a South African township.

    PubMed

    Ijumba, Petrida; Doherty, Tanya; Jackson, Debra; Tomlinson, Mark; Sanders, David; Swanevelder, Sonja; Persson, Lars-Åke

    2015-10-01

    To analyse the effect of community-based counselling on feeding patterns during the first 12 weeks after birth, and to study whether the effect differs by maternal HIV status, educational level or household wealth. Cluster-randomized trial with fifteen clusters in each arm to evaluate an integrated package providing two pregnancy and five postnatal home visits delivered by community health workers. Infant feeding data were collected using 24 h recall of nineteen food and fluid items. A township near Durban, South Africa. Pregnant women (1894 intervention and 2243 control) aged 17 years or more. Twelve weeks after birth, 1629 (intervention) and 1865 (control) mother-infant pairs were available for analysis. Socio-economic conditions differed slightly across intervention groups, which were considered in the analyses. There was no effect on early initiation of breast-feeding. At 12 weeks of age the intervention doubled exclusive breast-feeding (OR=2·29; 95 % CI 1·80, 2·92), increased exclusive formula-feeding (OR=1·70; 95 % CI 1·28, 2·27), increased predominant breast-feeding (OR=1·71; 95 % CI 1·34, 2·19), decreased mixed formula-feeding (OR=0·68; 95 % CI 0·55, 0·83) and decreased mixed breast-feeding (OR=0·54; 95 % CI 0·44, 0·67). The effect on exclusive breast-feeding at 12 weeks was stronger among HIV-negative mothers than HIV-positive mothers (P=0·01), while the effect on mixed formula-feeding was significant only among HIV-positive mothers (P=0·03). The effect on exclusive feeding was not different by household wealth or maternal education levels. A perinatal intervention package delivered by community health workers was effective in increasing exclusive breast-feeding, exclusive formula-feeding and decreasing mixed feeding.

  5. Effect of an integrated community-based package for maternal and newborn care on feeding patterns during the first 12 weeks of life: a cluster-randomized trial in a South African township

    PubMed Central

    Ijumba, Petrida; Doherty, Tanya; Jackson, Debra; Tomlinson, Mark; Sanders, David; Swanevelder, Sonja; Persson, Lars-Åke

    2015-01-01

    Objective To analyse the effect of community-based counselling on feeding patterns during the first 12 weeks after birth, and to study whether the effect differs by maternal HIV status, educational level or household wealth. Design Cluster-randomized trial with fifteen clusters in each arm to evaluate an integrated package providing two pregnancy and five postnatal home visits delivered by community health workers. Infant feeding data were collected using 24 h recall of nineteen food and fluid items. Setting A township near Durban, South Africa. Subjects Pregnant women (1894 intervention and 2243 control) aged 17 yearsor more. Results Twelve weeks after birth, 1629 (intervention) and 1865 (control) mother–infant pairs were available for analysis. Socio-economic conditions differed slightly across intervention groups, which were considered in the analyses. There was no effect on early initiation of breast-feeding. At 12 weeks of age the intervention doubled exclusive breast-feeding (OR=2·29; 95 % CI 1·80, 2·92), increased exclusive formula-feeding (OR=1·70; 95 % CI 1·28, 2·27), increased predominant breast-feeding (OR=1·71; 95 % CI 1·34, 2·19), decreased mixed formula-feeding (OR=0·68; 95 % CI 0·55, 0·83) and decreased mixed breast-feeding (OR=0·54; 95 % CI 0·44, 0·67). The effect on exclusive breast-feeding at 12 weeks was stronger among HIV-negative mothers than HIV-positive mothers (P=0·01), while the effect on mixed formula feeding was significant only among HIV-positive mothers (P=0·03). The effect on exclusive feeding was not different by household wealth or maternal education levels. Conclusions A perinatal intervention package delivered by community health workers was effective in increasing exclusive breast-feeding, exclusive formula feeding and decreasing mixed feeding. PMID:25660465

  6. The first 12 weeks following discharge from hospital: the experience of Gujarati South Asian survivors of acute myocardial infarction and their families.

    PubMed

    Webster, Rosemary A; Thompson, David R; Davidson, Patricia M

    2003-10-01

    The period following discharge from hospital after an acute myocardial infarction (MI) is associated with vulnerability and psychosocial and physical morbidity for many survivors and their families. It is reported that people experience interpersonal, family and financial problems, self-care obstacles, work and physical difficulties. Culture and ethnicity undeniably influence the illness experience and the process of recovery and adjustment. This study investigated the perceptions of Gujarati survivors of acute MI and their families in Leicester, United Kingdom in the first 12 weeks following discharge in order to develop a profile of their health seeking beliefs and needs. Thirty-one interviews with 19 Gujarati MI survivors and their families (representing approximately 31 hours of dialogue) were analysed using grounded theory. Qualitative data revealed a period of vulnerability not only for survivors but also their families as they processed recent events and faced the future. Data analysis revealed nine interrelated themes describing the post-discharge experience for Gujarati survivors and their families. Data revealed that normal life was often markedly changed by the MI experience. Reflection, contemplation and resignation characterize this period of vulnerability. Overwhelmingly, data analysis revealed that the Gujarati culture, beliefs and customs influenced the recovery experience.

  7. Regulating Critical Period Plasticity: Insight from the Visual System to Fear Circuitry for Therapeutic Interventions

    PubMed Central

    Nabel, Elisa M.; Morishita, Hirofumi

    2013-01-01

    Early temporary windows of heightened brain plasticity called critical periods developmentally sculpt neural circuits and contribute to adult behavior. Regulatory mechanisms of visual cortex development – the preeminent model of experience-dependent critical period plasticity-actively limit adult plasticity and have proved fruitful therapeutic targets to reopen plasticity and rewire faulty visual system connections later in life. Interestingly, these molecular mechanisms have been implicated in the regulation of plasticity in other functions beyond vision. Applying mechanistic understandings of critical period plasticity in the visual cortex to fear circuitry may provide a conceptual framework for developing novel therapeutic tools to mitigate aberrant fear responses in post traumatic stress disorder. In this review, we turn to the model of experience-dependent visual plasticity to provide novel insights for the mechanisms regulating plasticity in the fear system. Fear circuitry, particularly fear memory erasure, also undergoes age-related changes in experience-dependent plasticity. We consider the contributions of molecular brakes that halt visual critical period plasticity to circuitry underlying fear memory erasure. A major molecular brake in the visual cortex, perineuronal net formation, recently has been identified in the development of fear systems that are resilient to fear memory erasure. The roles of other molecular brakes, myelin-related Nogo receptor signaling and Lynx family proteins – endogenous inhibitors for nicotinic acetylcholine receptor, are explored in the context of fear memory plasticity. Such fear plasticity regulators, including epigenetic effects, provide promising targets for therapeutic interventions. PMID:24273519

  8. Regulating critical period plasticity: insight from the visual system to fear circuitry for therapeutic interventions.

    PubMed

    Nabel, Elisa M; Morishita, Hirofumi

    2013-01-01

    Early temporary windows of heightened brain plasticity called critical periods developmentally sculpt neural circuits and contribute to adult behavior. Regulatory mechanisms of visual cortex development - the preeminent model of experience-dependent critical period plasticity-actively limit adult plasticity and have proved fruitful therapeutic targets to reopen plasticity and rewire faulty visual system connections later in life. Interestingly, these molecular mechanisms have been implicated in the regulation of plasticity in other functions beyond vision. Applying mechanistic understandings of critical period plasticity in the visual cortex to fear circuitry may provide a conceptual framework for developing novel therapeutic tools to mitigate aberrant fear responses in post traumatic stress disorder. In this review, we turn to the model of experience-dependent visual plasticity to provide novel insights for the mechanisms regulating plasticity in the fear system. Fear circuitry, particularly fear memory erasure, also undergoes age-related changes in experience-dependent plasticity. We consider the contributions of molecular brakes that halt visual critical period plasticity to circuitry underlying fear memory erasure. A major molecular brake in the visual cortex, perineuronal net formation, recently has been identified in the development of fear systems that are resilient to fear memory erasure. The roles of other molecular brakes, myelin-related Nogo receptor signaling and Lynx family proteins - endogenous inhibitors for nicotinic acetylcholine receptor, are explored in the context of fear memory plasticity. Such fear plasticity regulators, including epigenetic effects, provide promising targets for therapeutic interventions.

  9. Effects of barnidipine on blood pressure and left ventricular diastolic function in patients with hypertension and metabolic syndrome: A 12-week, open-label noncomparison study

    PubMed Central

    Angeli, Fabio; Repaci, Salvatore; Borgioni, Claudia; Sardone, Mariagrazia; Scotti, Aurelio; Verdecchia, Paolo

    2008-01-01

    Background: Barnidipine is one of a new generation of dihydropyridine calcium-channel blockers. Despite evidence of favorable effects on blood pressure (BP) and insulin sensitivity, this drug has rarely been tested in hypertensive patients with metabolic syndrome (MS). Objective: The aim of this study was to evaluate the effects of barnidipine on BP and left ventricular (LV) diastolic function in patients with hypertension and MS. Methods: Consecutive subjects aged 18 to 75 years with systolic BP (SBP) of 140 to 179 mm Hg and/or diastolic BP (DBP) of 90 to 109 mm Hg and MS (based on Adult Treatment Panel III criteria) were assessed for inclusion in the study. Lifestyle changes according to current guidelines were recommended and barnidipine monotherapy 10 mg daily was initiated. All patients entered a 2-week run-in period. After a 6-week treatment period, the daily dosage was doubled for the remainder of the study in patients whose BP remained uncontrolled (≥140/≥90 mm Hg). We assessed the glycolipidic profile and LV structure and function using standard Doppler and tissue Doppler imaging (TDI) echocardiography before and after 12 weeks of treatment. Ambulatory BP records and electrocardiographic and echocardiographic tracings were coded and shipped to a central laboratory for blinded analysis. Possible adverse events (AEs) were recorded at predetermined intervals throughout the follow-up period and at unplanned intervals whenever an AE became known to the investigators. Results: Thirty-four consecutive patients were assessed for inclusion. Thirty consecutive patients (20 men, 10 women; mean {SD| age, 55.9 {10.3| years; 5 current smokers) were included in the study. At study entry, mean office SBP was 146 mm Hg, DBP was 87 mm Hg, and heart rate was 72 beats/min. At the study end, mean office SBP/DBP was <140/90 mm Hg in 20 patients (66.7%). From baseline to study end, 24-hour ambulatory BP decreased significantly by 12 and 8 mm Hg for SBP and DBP, respectively

  10. Gene expression profiling of kidneys from Sprague-Dawley rats following 12-week inhalation exposure to silver nanoparticles.

    PubMed

    Dong, Mi Sook; Choi, Ji-Yoon; Sung, Jae Hyuck; Kim, Jin Sik; Song, Kyung Seuk; Ryu, Hyun Ryol; Lee, Ji Hyun; Bang, In Seok; An, Kangho; Park, Hyun Min; Song, Nam Woong; Yu, Il Je

    2013-07-01

    The specific properties of silver nanoparticles (AgNPs), such as antimicrobial activity and electrical conductivity, allow them to be used in many fields. However, their expanding application is also raising health, environmental and safety concerns. Previous in vivo AgNP toxicity studies have indicated a gender-different accumulation of silver in the kidneys, with 2-3 times more silver in female kidneys compared to male kidneys. However, no other studies have further addressed this gender difference. Accordingly, the current study investigated the gender-dependent effect of AgNPs on the kidney gene level based on toxicogenomic studies of kidneys obtained from rats exposed to AgNPs via inhalation for 12 weeks. When compared with the fresh air control, the silver nanoparticle-exposed kidneys included 104 genes with a more than 1.3-fold expression increase. For the male rat kidneys exposed to a low or high dose of silver nanoparticles, 96 genes exhibited expression changes, where six genes changed with both the low and high dose; four increased and two decreased. Meanwhile, for the female rat kidneys exposed to a low or high dose of silver nanoparticles, 66 genes exhibited expression changes, where 11 genes changed with both the low and high dose; nine increased and two decreased. Gender-dependent gene expression changes of more than 2-fold were linked to 163 genes, with 79 genes in the male kidneys and 84 genes in the female kidneys, plus gender-dependent gene expression changes of more than 5-fold were linked to 21 genes. However, no genes involved in apoptosis or the cell cycle were activated by the 12-week silver nanoparticle inhalation exposure. Overall, the male rat kidneys showed a higher expression of genes involved in xenobiotic metabolism, while the female rat kidneys showed a higher expression of genes involved in extracellular signaling.

  11. Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid-dependent population.

    PubMed

    McDermott, Katherine A; Griffin, Margaret L; Connery, Hilary S; Hilario, E Yvette; Fiellin, David A; Fitzmaurice, Garrett M; Weiss, Roger D

    2015-02-01

    Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence. We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population. Using data from a multisite, randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence (June 2006-July 2009), we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted (N = 360). Outcomes were determined from the Substance Use Report, a self-report measure of substance use, and confirmatory urinalysis. Predictive values were calculated to determine the importance of abstinence versus use at various time points within the first month of treatment (week 1, weeks 1-2, 1-3, or 1-4) in predicting successful versus unsuccessful treatment outcome (based on abstinence or near-abstinence from opioids) in the last 4 weeks of buprenorphine-naloxone treatment (weeks 9-12). Outcome was best predicted by medication response after 2 weeks of treatment. Two weeks of initial abstinence was moderately predictive of treatment success (positive predictive value = 71%), while opioid use in both of the first 2 weeks was strongly predictive of unsuccessful treatment outcome (negative predictive value [NPV] = 84%), especially when successful outcome was defined as total abstinence from opioids in weeks 9-12 (NPV = 94%). Evaluating prescription opioid-dependent patients after 2 weeks of buprenorphine-naloxone treatment may help determine the likelihood of successful outcome at

  12. Real-world effectiveness for 12 weeks of ledipasvir-sofosbuvir for genotype 1 hepatitis C: the Trio Health study.

    PubMed

    Tapper, E B; Bacon, B R; Curry, M P; Dieterich, D T; Flamm, S L; Guest, L E; Kowdley, K V; Lee, Y; Tsai, N C; Younossi, Z M; Afdhal, N H

    2017-01-01

    Early data regarding the "real-world" experience with novel therapies for hepatitis C (HCV) are encouraging. Data are still limited, however, regarding real-world rates of sustained virologic response (SVR) for ledipasvir-sofosbuvir (LDV-SOF), particularly for patients with prior treatment failure. We performed a retrospective cohort study of 1597 patients with chronic genotype 1 HCV who were treated using 12 weeks of the following regimens LDV-SOF±ribavirin (RBV) (n=1521 without RBV, n=76 with RBV). The primary outcome was SVR-determined at 12 weeks in an intention-to-treat design. Prescription according to Food and Drug Administration (FDA) approved labelling (adding RBV for patients with cirrhosis and treatment failure) was assessed in multivariate models. The study population was aged 60 years on average (range 19-89), 60% male, 50% Caucasian, 43% cared for at an academic centre and 30% cirrhotic. Overall, LDV-SOF resulted in a 94% SVR rate. Only 44 (2.9%) patients relapsed. LDV-SOF+RBV yielded SVR in 97% with 0 viral relapses. While cirrhosis and thrombocytopenia were associated with lower odds of SVR, in a multivariable regression model, only treatment at an academic centre and prescriptions contrary to FDA labelling were significantly associated with lower SVR-odds ratios, 0.56 95% CI (0.35-0.87) and 0.29 95% CI(0.12-0.68), respectively. The real-world experience with LDV-SOF mirrors the SVR rates observed in clinical trials. Efforts to promote prescription within FDA recommendations are warranted. © 2016 John Wiley & Sons Ltd.

  13. The impact of a 12-week resistance training program on strength, body composition, and self-concept of Hispanic adolescents.

    PubMed

    Velez, Amelia; Golem, Devon L; Arent, Shawn M

    2010-04-01

    Current evidence suggests that a resistance training program may be physically and psychologically beneficial for adolescents. The purpose of this study was to examine the effects of a structured resistance training program on strength, body composition, and self-concept in normal and overweight Hispanic adolescents. Male and female participants (n = 28; 16.1 +/- 0.2 y; 164.5 +/- 1.4 cm; 63.3 +/- 2.5 kg; 20.0 +/- 1.7% body fat [BF]) were recruited from a predominantly Hispanic high school. Prior to the 12-week program, strength, body composition, and self-concept were assessed. Subjects were randomly assigned to a control group (CON; n = 15) or to a resistance training group (RT; n = 13) that participated in supervised strength training 3 days/week. All measures were repeated at the end of the 12-week program. RT had significantly greater strength increases for bench press (p < 0.001), seated row (p = 0.002), shoulder press (p < 0.001), and squats (p = 0.002). RT had significant reductions in %BF (p = 0.001), whereas CON had slightly increased %BF. RT had an increase in condition/stamina competence (p = 0.008), attractive body adequacy (p = 0.017), and global self-worth (p = 0.013) from pretest to posttest, whereas no change was observed for CON. In conclusion, resistance training resulted in significant physiological and psychological improvements in Hispanic adolescents compared to typical school-based activities. These findings indicate that resistance training can be incorporated into the activities of Hispanic adolescents to promote improved health and fitness.

  14. Transrectal Doppler sonography of uterine blood flow during the first 12 weeks after parturition in healthy dairy cows.

    PubMed

    Krueger, Lars; Koerte, Juliane; Tsousis, Georgios; Herzog, Kathrin; Flachowsky, Gerhard; Bollwein, Heinrich

    2009-08-01

    The aim of this study was to determine if transrectal colour Doppler sonography of uterine arteries is a useful method to quantify uterine changes during the first 12 weeks after parturition in cows. Examinations were carried out on days 1, 7, 14, 28, 56 and 86 after parturition (day 0) in 42 Holstein-Friesian multiparous dairy cows (mean lactation number: 2.63+/-0.73). Findings obtained by transrectal manual palpation were quantified using scores for uterine size (SUS) graded from 1 to 6. The mean diameter of intrauterine fluid accumulation within the uterine body and the presence of a dominant follicle and/or a corpus luteum were examined using B-mode sonography. Blood flow was measured by determining blood flow volume (BFV) and pulsatility index (PI) of the uterine arteries. Clinical uterine involution was complete on day 28 as demonstrated by transrectal palpation and B-mode sonography. BFV declined (P<0.05) steeply between days 1 and 7 from 4312 ml/min to 1443 ml/min and moderately (P<0.05) to 230 ml/min on day 28. From this time on there were no significant changes (P>0.05) of BFV until the end of the study. The pulsatility index rose from 1.54 on day 1 reaching a peak value of 5.56 on day 28 and decreased (P<0.05) linearly to 3.13 on day 86. The results show that transrectal colour Doppler sonography is an additional tool for examining uterine changes during the first 12 weeks after parturition in cows. While uterine blood flow changes were only demonstrated during the first 4 weeks of the puerperium, the pulsatility index was also suitable to investigate alterations in uterine perfusion during the next 8 weeks after parturition.

  15. Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid dependent population

    PubMed Central

    McDermott, Katherine A.; Griffin, Margaret L.; Connery, Hilary S.; Hilario, E. Yvette; Fiellin, David A.; Fitzmaurice, Garrett M.; Weiss, Roger D.

    2015-01-01

    Objective Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence. We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population. Method Using data from a multi-site, randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence (June 2006–July 2009), we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted. Outcomes were determined from the Substance Use Report, a self-report measure of substance use, and confirmatory urinalysis. Predictive values were calculated to determine the importance of abstinence vs. use at various time points within the first month of treatment (week 1, weeks 1–2, 1–3, or 1–4) in predicting successful vs. unsuccessful treatment outcome (based on abstinence or near-abstinence from opioids) in the last 4 weeks of buprenorphine-naloxone treatment (weeks 9–12). Results Outcome was best predicted by medication response after two weeks of treatment. Two weeks of initial abstinence was moderately predictive of treatment success (positive predictive value = 71%), while opioid use in both of the first two weeks was strongly predictive of unsuccessful treatment outcome (negative predictive value (NPV) = 84%), especially when successful outcome was defined as total abstinence from opioids in weeks 9–12 (NPV = 94%). Conclusion Evaluating prescription opioid-dependent patients after two weeks of buprenorphine-naloxone treatment may help determine

  16. Psychological correlates of performance in female athletes during a 12-week off-season strength and conditioning program.

    PubMed

    Jones, Margaret T; Matthews, Tracey D; Murray, Mimi; Van Raalte, Judy; Jensen, Barbara E

    2010-03-01

    Examination of the relationship between performance testing and psychological measures before and after a 12-week strength and conditioning program was the study's purpose. Female NCAA Division-III soccer (n = 28), field hockey (n = 28), and softball (n = 19) athletes completed pre- and post-testing held 12 weeks apart. On day 1, athletes completed informed consent, 3 psychological measures (Profile of Mood States [POMS], Physical Self Perception Profile [PSPP], and Athlete's Self Perception of Physical Abilities [ASPPA]), and 2 strength tests (1 repetition maximum [1RM] bench, 1RM back squat). Day 2 consisted of the 30-yd sprint, pro agility run (PRO), vertical jump (VJ), and standing long jump (SLJ). All sports improved (p < 0.01) in 1RM bench and squat and reported increases in perceived Physical Strength on the PSPP (p < 0.01). Soccer athletes improved (p < 0.01) in VJ, SLJ, and PRO (p < 0.05). No differences were found in POMS scores. The POMS scores indicated that the athletes were not overtrained or experiencing staleness. A series of correlations showed relationships between physical and psychological measures. Specifically, Physical Strength was correlated with 1RM upper-body (r = 0.49, p < 0.01) and lower-body (r = 0.42, p < 0.01) strength. The PSPP Physical Strength was correlated with ASPPA ratings of upper-body (r = 0.68, p < 0.01) and lower-body (r = 0.57, p < 0.01) strength. The PSPP Sport Competence correlated with ASPPA ratings of power (r = 0.45, p < 0.01) and PRO (r = 0.38, p < 0.05). The study's results highlight the benefits of strength and conditioning. Furthermore, these results demonstrate how physical changes are related to athletes' physical self-perceptions and self-assessment of ability within their teams.

  17. Effect of 12-week dulaglutide therapy in Japanese patients with biopsy-proven non-alcoholic fatty liver disease and type 2 diabetes mellitus.

    PubMed

    Seko, Yuya; Sumida, Yoshio; Tanaka, Saiyu; Mori, Kojiroh; Taketani, Hiroyoshi; Ishiba, Hiroshi; Hara, Tasuku; Okajima, Akira; Umemura, Atsushi; Nishikawa, Taichiro; Yamaguchi, Kanji; Moriguchi, Michihisa; Kanemasa, Kazuyuki; Yasui, Kohichiroh; Imai, Shunsuke; Shimada, Keiji; Itoh, Yoshito

    2017-10-01

    No pharmacological therapies have been established for non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus (T2DM). The aim of this retrospective study is to evaluate the efficacy and safety of dulaglutide, a novel glucagon-like peptidase-1 receptor agonist, in Japanese NAFLD patients with T2DM. Fifteen biopsy-proven NAFLD patients with T2DM refractory to diet intervention who received once weekly dulaglutide 0.75 mg for 12 weeks were retrospectively enrolled after exclusion of two patients by 12 weeks. In five patients, transient elastography and body composition were also evaluated before and after the treatment. Not only body weight and hemoglobin A1c but also transaminase activities were significantly decreased after the 12-week therapy with dulaglutide. Total body fat mass and liver stiffness measurement also decreased after the treatment. Dulaglutide, a new glucagon-like peptidase-1 receptor agonist, could be a novel promising agent for the treatment for NAFLD patients with T2DM due to its efficacy in body weight reduction, the nature of weekly injection, and patient preference. Prospective randomized controlled trials are warranted to confirm this impact of dulaglutide on NAFLD with T2DM. © 2016 The Japan Society of Hepatology.

  18. A 12-Week Assessment of the Treatment of White Spot Lesions with CPP-ACP Paste and/or Fluoride Varnish

    PubMed Central

    Güçlü, Zeynep Aslı; Alaçam, Alev

    2016-01-01

    This 12-week clinical study evaluated the impact of 10% CPP-ACP and 5% sodium fluoride varnish regimes on the regression of nonorthodontic white spot lesions (WSLs). The study included 21 children with 101 WSLs who were randomised into four treatment regimes: weekly clinical applications of fluoride varnish for the first month (FV); twice daily self-applications of CPP-ACP paste (CPP-ACP); weekly applications of fluoride varnish for the first month and twice daily self-applications of CPP-ACP paste (CPP-ACP-FV); and no intervention (control). All groups undertook a standard oral hygiene protocol and weekly consultation. Visual appraisals and laser fluorescence (LF) measurements were made in weeks one and twelve. The majority of WSLs in the control and FV groups exhibited no shift in appearance, whereas, in the CPP-ACP and CPP-ACP-FV groups, the lesions predominantly regressed. The visual and LF assessments indicated that the extent of remineralisation afforded by the treatments was of the following order: control ~ FV < CPP-ACP ~ CPP-ACP-FV. Self-applications of CPP-ACP paste as an adjunct to standard oral hygiene significantly improved the appearance and remineralisation of WSLs. No advantage was observed for the use of fluoride varnish as a supplement to either the standard or CPP-ACP-enhanced oral hygiene regimes. PMID:27843950

  19. A 12-Week Assessment of the Treatment of White Spot Lesions with CPP-ACP Paste and/or Fluoride Varnish.

    PubMed

    Güçlü, Zeynep Aslı; Alaçam, Alev; Coleman, Nichola Jayne

    2016-01-01

    This 12-week clinical study evaluated the impact of 10% CPP-ACP and 5% sodium fluoride varnish regimes on the regression of nonorthodontic white spot lesions (WSLs). The study included 21 children with 101 WSLs who were randomised into four treatment regimes: weekly clinical applications of fluoride varnish for the first month (FV); twice daily self-applications of CPP-ACP paste (CPP-ACP); weekly applications of fluoride varnish for the first month and twice daily self-applications of CPP-ACP paste (CPP-ACP-FV); and no intervention (control). All groups undertook a standard oral hygiene protocol and weekly consultation. Visual appraisals and laser fluorescence (LF) measurements were made in weeks one and twelve. The majority of WSLs in the control and FV groups exhibited no shift in appearance, whereas, in the CPP-ACP and CPP-ACP-FV groups, the lesions predominantly regressed. The visual and LF assessments indicated that the extent of remineralisation afforded by the treatments was of the following order: control ~ FV < CPP-ACP ~ CPP-ACP-FV. Self-applications of CPP-ACP paste as an adjunct to standard oral hygiene significantly improved the appearance and remineralisation of WSLs. No advantage was observed for the use of fluoride varnish as a supplement to either the standard or CPP-ACP-enhanced oral hygiene regimes.

  20. Can the Functional Movement Screen™ be used to capture changes in spine and knee motion control following 12 weeks of training?

    PubMed

    Frost, David M; Beach, Tyson A C; Campbell, Troy L; Callaghan, Jack P; McGill, Stuart M

    2017-01-01

    To examine whether objective measures of spine and frontal plane knee motion exhibited during Functional Movement Screen™ (FMS) task performance changed following a movement-guided fitness (MOV) and conventional fitness (FIT) exercise intervention. Secondary analysis of a randomized controlled experiment. Before and after 12 weeks of exercise, participants' kinematics were quantified while performing the FMS and a series of general whole-body movement tasks. Biomechanics laboratory. Fifty-two firefighters were assigned to MOV, FIT, or a control (CON) group. Peak lumbar spine flexion/extension, lateral bend and axial twist, and frontal plane knee motion. The post-training kinematic changes exhibited by trainees while performing the FMS tasks were similar in magnitude (effect size < 0.8) to those exhibited by CON. However, when performing the battery of general whole-body movement tasks, only MOV showed significant improvements in spine and frontal plane knee motion control (effect size > 0.5). Whether graded qualitatively, or quantitatively via kinematic analyses, the FMS may not be a viable tool to detect movement-based exercise adaptations. Amendments to the FMS tasks and/or scoring method are needed before it can be used for reasons beyond appraising the ability to move freely, symmetrically, and without pain. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    PubMed

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases.

  2. Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic--a randomized, double-blind controlled study.

    PubMed

    Vanscheidt, Wolfgang; Harding, Keith; Téot, Luc; Siebert, Jörg

    2012-06-01

    The aim of this study was to evaluate the cytotoxic effect of octenidine dihydrochloride/phenoxyethanol (OHP) found in vitro by conducting a randomized, double-blind controlled clinical study focusing on its safe and effective use in chronic venous leg ulcers. In total, 126 male and female patients were treated with either OHP (n = 60) or Ringer solution (n = 66). The treatment lasted over a period of maximum 12 weeks. For the assessment of the wound-healing process, clinical outcome parameters were employed, that is, time span until 100% epithelization, wound status and the wound surface area were analysed. Side effects were recorded during the study period. The median time to complete ulcer healing was comparable between the OHP and Ringer solution groups (92 versus 87 days; P = 0·952), without being influenced by wound size or duration of the target ulcer (P-values: 0·947/0·978). In patients treated with OHP, fewer adverse events (AEs) were observed compared with the Ringer group (17% versus 29% of patients reported 20 versus 38 AEs). OHP is well suitable for the treatment of chronic wounds without cytotoxic effects. Furthermore, OHP does not impair the wound healing in chronic venous ulcers. © 2011 The Authors. © 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc.

  3. Maintenance of smoking cessation in the postpartum period: which interventions work best in the long-term?

    PubMed

    Su, Anny; Buttenheim, Alison M

    2014-04-01

    Smoking during pregnancy has been linked to a variety of adverse outcomes for both maternal and child health. Decades of studies have sought to increase cessation antepartum and reduce relapse postpartum. A number of effective interventions exist to significantly reduce smoking rates during pregnancy; however, less is known about how to prevent relapse in the postpartum period. This review investigates interventions to prevent relapse in the long-term postpartum period. We focus specifically on nonspontaneous quitters (individuals who quit smoking as a result of an external intervention) to reveal differences in long-term response to interventions for this population compared to spontaneous quitters. A systematic literature search yielded 32 relevant studies of pharmacological, behavioral, and incentives-based interventions. Results were compiled, analyzed, and compared in order to evaluate success factors in maintaining cessation postpartum. Though intervention groups showed consistently higher quit rates during pregnancy than control groups, none of the intervention types were effective at preventing relapse in the longer-term postpartum period. One study maintained significantly higher abstinence in the longer-term period postpartum using a mix of behavioral and incentives strategies. Additional research in this area is needed to identify optimal intervention strategies to reduce long-term postpartum relapse, particularly for nonspontaneous quitters.

  4. Effect of a vegetable-oil emulsion on body composition; a 12-week study in overweight women on a meal replacement therapy after an initial weight loss: a randomized controlled trial.

    PubMed

    Olsson, Johan; Sundberg, Birgitta; Viberg, Annika; Haenni, Arvo

    2011-06-01

    The maintenance of an obtained lower weight level is often found to be difficult. The aim of this study was to determine weight maintenance after an initial weight loss by consumption of a meal replacement with a vegetable-oil emulsion associated with prolonged satiety. After a 6-week weight loss period with very low calorie diet (VLCD), subjects with >5% body weight (BW) loss were randomized to a 12-week weight maintenance follow-up period, comparing a partial meal replacement diet containing a vegetable-oil emulsion (test) or dairy fat (control). Anthropometric data and safety variables were collected at baseline and after 4, 8 and 12 weeks. A significant weight loss was observed during the 12-week weight maintenance diet in the test and control group, respectively; 1.0 ± 2.1 kg (p < 0.05) versus 1.3 ± 2.1 kg (p < 0.05) with no significant difference between the groups. Body fat mass (BFM) decreased significantly (p < 0.05) in the test group (--1.7%) compared to the control group (--0.8%). Addition of a vegetable-oil emulsion to a meal replacement weight maintenance program after an initial weight loss using VLCD was associated with decreased BFM by 0.9% without any change in BW between the two groups.

  5. Primary prevention in health care employees: a prospective intervention study with a 3-year training period.

    PubMed

    Löffler, Harald; Bruckner, Thomas; Diepgen, Thomas; Effendy, Isaak

    2006-04-01

    Irritant contact dermatitis is a mayor problem in health care employees. Because educational programs have shown convincing success in certain occupations (e.g. in hairdressers), this study investigates the effect of a special training program in health care trainees. 521 trainees from 14 nursing schools in Central Germany were randomly divided in 2 groups, (i) an intervention group with a regular teaching protocol regarding all aspects of primary prevention and (ii) a control group without any further teaching. Morphological changes of the hands, use of hand care creams and knowledge regarding skin care were evaluated regularly during their 3 years lasting training period (1999-2002). In the intervention group, we found at the end of the 3-year training period a significant better skin condition of the hands than in the control group: a 3-year prevalence of morphological skin changes of 66.7% versus 89.3%. The unteached trainees (control group) had an odds ratio (OR) of 4.8 [95% confidential interval (CI): 2.9-7.8] for developing any skin changes on the hands after 3 years. Besides the effect of the teaching, the history of hand dermatitis before the study start was an independent risk factor for development of further hand dermatitis [OR 1.9, 95% CI: 1.0-3.6). Age and sex showed no influence on the skin condition. Atopic constitution had an influence on the development of skin changes only at the evaluation after 18 month. The observed effect in the intervention group may best be explained by different behaviour of the trainees, e.g. the amount of hand washing was reduced, while procedure of hand disinfection remained unchanged compared with the control group. However, the amount of used skin care cream did not differ between the both groups. This study shows that primary prevention of skin disease by regularly teaching during the training period of medical employees can effectively reduce the risk of development of irritant skin changes of the hands. Therefore

  6. Periodization

    PubMed Central

    Lorenz, Daniel S.; Reiman, Michael P.; Walker, John C.

    2010-01-01

    Background: Clinicians are constantly faced with the challenge of designing training programs for injured and noninjured athletes that maximize healing and optimize performance. Periodization is a concept of systematic progression—that is, resistance training programs that follow predictable patterns of change in training variables. The strength training literature is abundant with studies comparing periodization schemes on uninjured, trained, and untrained athletes. The rehabilitation literature, however, is scarce with information about how to optimally design resistance training programs based on periodization principles for injured athletes. The purpose of this review is to discuss relevant training variables and methods of periodization, as well as periodization program outcomes. A secondary purpose is to provide an anecdotal framework regarding implementation of periodization principles into rehabilitation programs. Evidence Acquisition: A Medline search from 1979 to 2009 was implemented with the keywords periodization, strength training, rehabilitation, endurance, power, hypertrophy, and resistance training with the Boolean term AND in all possible combinations in the English language. Each author also undertook independent hand searching of article references used in this review. Results: Based on the studies researched, periodized strength training regimens demonstrate improved outcomes as compared to nonperiodized programs. Conclusions: Despite the evidence in the strength training literature supporting periodization programs, there is a considerable lack of data in the rehabilitation literature about program design and successful implementation of periodization into rehabilitation programs. PMID:23015982

  7. A 12-Week Commercial Web-Based Weight-Loss Program for Overweight and Obese Adults: Randomized Controlled Trial Comparing Basic Versus Enhanced Features

    PubMed Central

    Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-01-01

    Background The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. Objective To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. Methods This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. Results We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: –0.72, SD 1.1 kg/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: –2.1, SD 3.3 kg, enhanced: –3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: –2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: –0.01, SD 0.02, enhanced: –0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. Conclusions A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve

  8. Novel Buccal Film Formulation of Buprenorphine-Naloxone for the Maintenance Treatment of Opioid Dependence: A 12-Week Conversion Study.

    PubMed

    Sullivan, James G; Webster, Lynn

    2015-05-01

    The purpose of this study was to provide a preliminary assessment of the safety, tolerability, symptom control, and acceptability of buprenorphine-naloxone buccal film (BBN) for the maintenance treatment of opioid dependence in patients converted from buprenorphine-naloxone sublingual tablet or film (SLBN), as well as to determine the conversion ratio for switching patients from SLBN to BBN. This open-label study included adult opioid-dependent subjects stabilized on 8/2 to 32/8 mg/d of SLBN for a minimum of 30 days. Study subjects were converted to a bioequivalent dose of BBN and maintained for 12 weeks. A total of 249 subjects (mean age 38.7 years, 65.9% male) were converted from SLBN to a single daily dose of BBN, and 79.1% completed the 12-week study. Adverse events and withdrawal symptoms led to discontinuation in 2.4% and 2.0% of BBN-treated subjects, respectively. Rates of constipation reported at baseline declined from 41% just before the initial BBN dose and within 24 hours of the last SLBN dose to 13% after 12 weeks of BBN treatment; treatment-emergent constipation was reported by 2.8% of BBN-treated subjects. Oral mucosal abnormalities were identified in 5% and 0.6% of systematic oral examinations in SLBN- and BBN-treated subjects, respectively. A total of 34 subjects had Clinical Opiate Withdrawal Scale total scores ranging from 10 to 25 (overall mean, 13.8) within 24 hours of taking their last SLBN dose, and scores for these subjects were reduced to a range of 0 to 3 (overall mean, 0.7) at 3 hours after the initial dose of BBN. Treatment compliance was high (108%); <1% of urine samples were buprenorphine-free, and 92.4% of BBN-treated subjects did not have a urine sample that tested positive for a non-prescribed opioid. A total of 91.3% subjects rated the taste of BBN as pleasant or neutral, and 82.5% rated BBN ease of use as easy or neutral. The overall mean final dose of BBN was 8.0/1.4 mg/d, yielding a 2:1 buprenorphine conversion ratio. Although

  9. Heart rate variability biofeedback intervention for reduction of psychological stress during the early postpartum period.

    PubMed

    Kudo, Naoko; Shinohara, Hitomi; Kodama, Hideya

    2014-12-01

    This study examined the effectiveness of heart rate variability (HRV) biofeedback intervention for reduction of psychological stress in women in the early postpartum period. On postpartum day 4, 55 healthy subjects received a brief explanation about HRV biofeedback using a portable device. Among them, 25 mothers who agreed to implement HRV biofeedback at home were grouped as the biofeedback group, and other 30 mothers were grouped as the control group. At 1 month postpartum, there was a significant decrease in total Edinburgh Postnatal Depression Scale score (P < 0.001) in the biofeedback group; this change was brought about mainly by decreases in items related to anxiety or difficulty sleeping. There was also a significant increase in standard deviation of the normal heartbeat interval (P < 0.01) of the resting HRV measures in the biofeedback group after adjusting for potential covariates. In conclusion, postpartum women who implemented HRV biofeedback after delivery were relatively free from anxiety and complained less of difficulties sleeping at 1 month postpartum. Although the positive effects of HRV biofeedback may be partly attributable to intervention effects, due to its clinical outcome, HRV biofeedback appears to be recommendable for many postpartum women as a feasible health-promoting measure after childbirth.

  10. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI.

    PubMed

    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-03-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu's were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this study

  11. Triple-Combination therapy with olmesartan, amlodipine, and hydrochlorothiazide in black and non-black study participants with hypertension: the TRINITY randomized, double-blind, 12-week, parallel-group study.

    PubMed

    Chrysant, Steven G; Littlejohn, Thomas; Izzo, Joseph L; Kereiakes, Dean J; Oparil, Suzanne; Melino, Michael; Lee, James; Fernandez, Victor; Heyrman, Reinilde

    2012-08-01

    Although awareness of hypertension in Black patients has increased, blood pressure (BP) is frequently inadequately controlled. This prespecified subgroup analysis of the TRINITY study evaluated the efficacy and safety of olmesartan medoxomil (OM) 40 mg, amlodipine besylate (AML) 10 mg, and hydrochlorothiazide (HCTZ) 25 mg triple-combination treatment compared with the component dual-combination treatments in Black and non-Black study participants. TRINITY was a 12-week, randomized, double-blind, parallel-group evaluation. The first patient was enrolled in May 2008 and the last patient completed the study in February 2009. The study consisted of a 3-week washout period for participants receiving antihypertensive therapy and a 12-week double-blind treatment period. For the treatment phase, all study participants were stratified by age, race, and diabetes mellitus status and randomized to a treatment sequence that led to their final treatment assignment, which they received from weeks 4 to 12 (OM 40 mg/AML 10 mg/HCTZ 25 mg, OM 40 mg/AML 10 mg, OM 40 mg/HCTZ 25 mg, or AML 10 mg/HCTZ 25 mg). In the first 2 weeks of the double-blind treatment period, all participants received either dual-combination treatment or placebo. Participants assigned to dual-combination treatment continued treatment until week 4, and participants receiving placebo were switched at week 2 to receive one of the dual-combination treatments until week 4. At week 4, participants either continued dual-combination treatment or randomly received triple-combination treatment until week 12. 317 clinical sites in the USA and Puerto Rico were included in the study. Study participants eligible for randomization (N = 2492) were ≥18 years of age with mean seated blood pressure (SeBP) ≥140/100 mmHg or ≥160/90 mmHg (off antihypertensive medication). The intervention was with dual- or triple-combination antihypertensive treatment: OM 40 mg/AML 10 mg/HCTZ 25 mg, OM 40 mg/AML 10 mg, OM 40 mg/HCTZ 25 mg, or

  12. Neonatal Bathing and Massage Intervention with Fathers, Behavioural Effects 12 Weeks after Birth of the First Baby: The Sunraysia Australia Intervention Project.

    ERIC Educational Resources Information Center

    Scholz, Kim; Samuels, Curtis A.

    1992-01-01

    Examined the effect on father-infant relationships of a parent training program on infant massage and bathing. Infants in the treatment group greeted fathers with more eye contact, smiles, vocalizing, reaching, and orienting responses and showed less avoidance behavior than did control group infants. Fathers in the treatment group showed greater…

  13. Neonatal Bathing and Massage Intervention with Fathers, Behavioural Effects 12 Weeks after Birth of the First Baby: The Sunraysia Australia Intervention Project.

    ERIC Educational Resources Information Center

    Scholz, Kim; Samuels, Curtis A.

    1992-01-01

    Examined the effect on father-infant relationships of a parent training program on infant massage and bathing. Infants in the treatment group greeted fathers with more eye contact, smiles, vocalizing, reaching, and orienting responses and showed less avoidance behavior than did control group infants. Fathers in the treatment group showed greater…

  14. DEXA-assessed regional body composition changes in young female military soldiers following 12-weeks of periodised training.

    PubMed

    Wood, Paola S; Krüger, Pieter E; Grant, Catharina C

    2010-04-01

    Dual-energy X-ray absorptiometry (DEXA) was used to assess whole body and regional soft tissue mass, fat mass and lean body mass compositional changes in 68 female recruits (age 20.8 +/- 1.14 years; body mass 59.5 +/- 8.79 kg; stature 159.57 +/- 5.53 cm) pre- and post 12-weeks of military basic training. A decrease in total body fat tissue mass (10.2%) and regional percent fat (10.9%) was measured with an increase in total lean body mass (8.7%). Of interest were the differences in the responses in the tissue composition of the arms (16.2% loss in fat mass with an 11.6% gain in lean mass), trunk (17.0% decrease in fat mass with a 10.4% increase in lean mass) and the legs (10.5% increase in lean mass but no change in fat mass). These findings show the importance of considering regional rather than whole body composition changes when assessing the effects of a training programme. STATEMENT OF RELEVANCE: Female soldiers experienced a change in total body fat tissue (-10.2%) and lean body mass (+8.7%) after basic training; however, no significant fat mass decrease was evident in the leg region. Regional rather than whole body composition changes need to be considered when assessing the effects of a training programme.

  15. Alcohol expectancy changes over a 12-week cognitive-behavioral therapy program are predictive of treatment success.

    PubMed

    Young, Ross McD; Connor, Jason P; Feeney, Gerald F X

    2011-01-01

    This study examines if outcome expectancies (perceived consequences of engaging in certain behavior) and self-efficacy expectancies (confidence in personal capacity to regulate behavior) contribute to treatment outcome for alcohol dependence. Few clinical studies have examined these constructs. The Drinking Expectancy Profile (DEP), a psychometric measure of alcohol expectancy and drinking refusal self-efficacy, was administered to 298 alcohol-dependent patients (207 males) at assessment and on completion of a 12-week cognitive-behavioral therapy alcohol abstinence program. Baseline measures of expectancy and self-efficacy were not strong predictors of outcome. However, for the 164 patients who completed treatment, all alcohol expectancy and self-efficacy factors of the DEP showed change over time. The DEP scores approximated community norms at the end of treatment. Discriminant analysis indicated that change in social pressure drinking refusal self-efficacy, sexual enhancement expectancies, and assertion expectancies successfully discriminated those who successfully completed treatment from those who did not. Future research should examine the basis of expectancies related to social functioning as a possible mechanism of treatment response and a means to enhance treatment outcome. Crown Copyright © 2011. Published by Elsevier Inc. All rights reserved.

  16. Treating Veterans With PTSD and Borderline Personality Symptoms in a 12-Week Intensive Outpatient Setting: Findings From a Pilot Program.

    PubMed

    Meyers, Laura; Voller, Emily K; McCallum, Ethan B; Thuras, Paul; Shallcross, Sandra; Velasquez, Tina; Meis, Laura

    2017-03-22

    Rates of comorbidity between borderline personality disorder and posttraumatic stress disorder (PTSD) are high in veteran populations, and clinicians are hesitant to treat PTSD given high rates of suicidality. Given promising early work integrating dialectical behavior therapy (DBT) and prolonged exposure (PE) therapy, we created a 12-week intensive outpatient program combining these two treatments. PE and DBT were provided concurrently to 33 veterans with PTSD symptoms and BPD symptoms at a large, midwestern Veteran Affairs medical center. Approximately half of the participants were male, with the majority identifying as Caucasian. Participants' ages ranged from 23 to 58 years, with a mean age of 43.21 years. The full-model of DBT was provided; PE was provided twice weekly for approximately 6 weeks of the program. Of participants, 22 veterans successfully completed the program with no dropout during PE. Large pre- to posttreatment effect sizes were found for decreases in PTSD symptoms (d = 1.61) and dysfunctional coping styles (d = 1.55), and an increase in the use of DBT skills (d = 1.02). A moderate effect size was found in the decrease of suicidal ideation (d = 0.64). The results of this pilot program suggest that PTSD can be safely and effectively treated among veterans with comorbid symptoms of borderline personality disorder through the combination of concurrent intensive DBT and PE.

  17. A physical fitness follow-up in children with cerebral palsy receiving 12-week individualized exercise training.

    PubMed

    Jeng, Shiau-Chian; Yeh, Kuo-Kuang; Liu, Wen-Yu; Huang, Wei-Pin; Chuang, Yu-Fen; Wong, Alice M K; Lin, Yang-Hua

    2013-11-01

    Physical fitness in children with cerebral palsy (CP) is lower than in their peers. A 12-week individualized home-based exercise program completed by 11 children with CP 10 years earlier showed a favorable effect on physical fitness performance. We follow-up the physical fitness of those 11 children with CP, and compare their physical fitness and health-related quality of life (HRQoL) to children with CP without exercise training matched with age and motor levels. Eleven children with CP in the 2003 program as a follow-up group (FUG) and 12 volunteers recruited as a control group (CG) participated in this study. Physical fitness measures, including cardiopulmonary endurance, muscle strength, body mass index (BMI), flexibility, agility, balance, and the SF-36 Taiwan version, were assessed in both groups. After 10 years, the FUG showed better physical fitness in cardiopulmonary endurance and muscle strength (p<.05). Compared to the CG, the FUG demonstrated better muscle strength, agility, and balance (p<.05). However, the HRQoL did not show a significant difference between the FUG and the CG. Individualized home-based exercise training is beneficial for children with CP. Over 10 years, the FUG was more devoted to physical activity than was the CG. Physical exercise may not directly affect the HRQoL in this study.

  18. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition

    PubMed Central

    Barbour, Jayne A.; Howe, Peter R. C.; Buckley, Jonathan D.; Bryan, Janet; Coates, Alison M.

    2015-01-01

    Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI) 31 ± 4 kg/m2) alternated either high oleic peanuts (15%–20% of energy) or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP), lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA) compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05), following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001), predominantly monounsaturated (increase 22 g, p < 0.05). Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg) in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation. PMID:26404365

  19. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition.

    PubMed

    Barbour, Jayne A; Howe, Peter R C; Buckley, Jonathan D; Bryan, Janet; Coates, Alison M

    2015-09-02

    Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI) 31 ± 4 kg/m²) alternated either high oleic peanuts (15%-20% of energy) or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP), lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA) compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05), following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001), predominantly monounsaturated (increase 22 g, p < 0.05). Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg) in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation.

  20. Evaluation of immediate and 12-week effects of a smartphone sun-safety mobile application: a randomized clinical trial.

    PubMed

    Buller, David B; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-05-01

    Mobile applications on smartphones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether recipients can be convinced to use them. To evaluate a smartphone mobile application (Solar Cell) delivering real-time advice about sun protection for a second time in a randomized clinical trial. A previous trial conducted in 2012 used a randomized pretest-posttest design. For the present trial, we collected data from a volunteer sample of 202 adults 18 years or older who owned a smartphone. Participants were recruited nationwide through online promotions. Screening procedures and a 3-week run-in period were added to increase the use of the mobile application. We conducted follow-ups at 3 and 8 weeks after randomization to examine the immediate and the longer-term effects of the intervention. Use of the mobile application. The application gave feedback on sun protection (ie, sun-safety practices and the risk for sunburn) and alerted users to apply or to reapply sunscreen and to get out of the sun. The application also displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Percentage of days with the use of sun protection, time spent outdoors in the midday sun (days and hours), and the number of sunburns in the last 3 months. Participants in the intervention group used wide-brimmed hats more at 7 weeks than control participants (23.8% vs 17.4%; F = 4.07; P = .045). Women who used the mobile application reported using all sun protection combined more than men (46.4% vs 43.3%; F = 1.49; P = .04), whereas men and older individuals reported less use of sunscreen (32.7% vs 35.5%; F = 5.36; P = .02) and hats (15.6% vs 17.9%; F = 4.72; P = .03). The mobile application initially appeared to confer weak improvement of sun protection. Use of the mobile application was greater than in a previous trial and was

  1. 12-week clinical evaluation of a rotation/oscillation power toothbrush versus a new sonic power toothbrush in reducing gingivitis and plaque.

    PubMed

    Klukowska, Malgorzata; Grender, Julie M; Goyal, C Ram; Mandl, Christian; Biesbrock, Aaron R

    2012-10-01

    To evaluate the efficacy of an advanced rotation/oscillation power toothbrush (Oral-B Triumph with SmartGuide) relative to a new sonic power toothbrush (Sonicare DiamondClean) in the reduction of gingivitis and plaque over a period of 12 weeks. This was a single-center, open-label, examiner-blind, two-treatment, parallel group, randomized study in which subjects brushed with their assigned toothbrush and a marketed dentifrice for 2 minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at baseline, Week 6 and Week 12 using the Modified Gingival Index (MGI), Number of Bleeding Sites, and Rustogi Modification of the Navy Plaque Index (RMNPI). Safety was also assessed at every visit. At the end of the study, subjects completed a consumer questionnaire to evaluate their brushing experience. In total, 130 subjects were randomized to treatment and completed the study (65 per group). The rotation/oscillation group had higher gingivitis reductions from baseline at Weeks 6 and 12 by 31.9% and 32.3%, respectively, for MGI and by 43.4% and 34.9%, respectively, for number of bleeding sites than the sonic group. Group differences at both Weeks 6 and 12 were highly significant (P < 0.001) for both MGI and number of bleeding sites. The rotation/oscillation group had higher RMNPI plaque reductions from baseline at Weeks 6 and 12 by 15.8% and 19.3%, respectively, for whole mouth; by 24.1% and 30.4% at the gumline; and by 22.9% and 24.4% in the approximal regions, than the sonic group. Comparisons between groups at Week 12 were highly significant (P < or = 0.002) for all three mouth areas; group differences at Week 6 were significant (P < 0.05) for whole mouth and approximal RMNPI. Analysis of the questionnaire data showed that subjects using the rotation/oscillation brush rated it higher for several key attributes than subjects in the sonic group. There were no safety concerns with either brush.

  2. Tracking Spinal Cord Injury: Differences in Cytokine Expression of IGF-1, TGF- B1, and sCD95l Can Be Measured in Blood Samples and Correspond to Neurological Remission in a 12-Week Follow-Up.

    PubMed

    Ferbert, Thomas; Child, Christopher; Graeser, Viola; Swing, Tyler; Akbar, Michael; Heller, Raban; Biglari, Bahram; Moghaddam, Arash

    2017-02-01

    Neuroinflammation presumably has an important impact on the secondary phase of spinal cord injury and is regulated by pro- and anti-inflammatory cytokines. We analyzed serum levels of three different cytokines (insulin-like-growth-factor [IGF]-1, tumor growth factor [TGF]-β1, and soluble CD 95 ligand [sCD95L]), in blood samples of 23 patients admitted with acute traumatic spinal cord injury between November 2010 and July 2013 with a follow-up period of 12 weeks. Quantification was performed using Human Quantikine Immunoassays, classification of neurological impairment was performed using the American Spinal Cord Injury Impairment Scale at time of admission and after 12 weeks. After an initial drop of all three cytokine serum levels, IGF-1, TGF-β1, and sCD95L showed significantly increased serum levels during the acute and sub-acute phases. For IGF-1 and sCD95L, we could also observe significantly higher serum levels in patients without neurological improvement compared with patients who had improvement after 12 weeks. In this study, we were able to show differences in cytokine serum levels in patients with different neurological outcome. Measuring the serum level patterns of IGF-1, TGF-β1, and sCD95L might be a useful tool for prognosis in patients with neurological improvement and tracking the pathophysiology in further studies. Further, our observations might link promising therapeutic efforts in numerous animal studies and future studies in human patients.

  3. Evaluation of Immediate and 12-Week Effects of a Smartphone Sun-Safety Mobile Application: A Randomized Trial

    PubMed Central

    Buller, David B.; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-01-01

    Importance Mobile apps on smart phones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether Americans can be convinced to use them. Objective A smart phone mobile application delivering real-time sun protection advice was evaluated for a second time in a randomized trial. Design The trial conducted in 2013 utilized a randomized pretest-posttest controlled design. Screening procedures and a 3-week run-in period were added to increase use of the mobile app. Also, follow-ups at 3- and 8-weeks after randomization were conducted to examine immediate and longer-term effects. Setting Data was collected from participants recruited nationwide through online promotions. Participants A volunteer sample of adults aged 18 or older who owned an Android or iPhone smart phones. Intervention The mobile application gave feedback on sun protection (i.e., sun safety practices and sunburn risk) and alerted users to apply/reapply sunscreen and get out of the sun. Also, it displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Main Outcomes and Measures Percent of days using sun protection and days and minutes outdoors in the midday sun and number of sunburns in the past 3 months were assesed. Results Treatment group participants used wide-brimmed hats more at 7-weeks than controls. Women who used Solar Cell reported using all sun protection combined more than men but men and older individuals used sunscreen and hats less. Conclusions and Relevance The mobile application appeared to weakly improve sun protection initially. Use of the mobile application was higher than in a previous trial and associated with greater sun protection especially by women. Strategies to increase use are needed if the mobile app is to be effective deployed to the general adult population. PMID:25629819

  4. Long-term safety and efficacy of bilastine following up to 12 weeks or 52 weeks of treatment in Japanese patients with allergic rhinitis: Results of an open-label trial.

    PubMed

    Okubo, Kimihiro; Gotoh, Minoru; Togawa, Michinori; Saito, Akihiro; Ohashi, Yoshihiro

    2017-06-01

    Bilastine is a novel second-generation antihistamine. This open-label, single-arm, phase III study evaluated the safety and efficacy of long-term treatment with bilastine in Japanese patients with seasonal (SAR) or perennial allergic rhinitis (PAR). Patients with SAR or PAR who met the registration criteria and did not violate the exclusion criteria received bilastine (20mg, once daily) for 12 weeks (treatment period). Patients with PAR who met the transition criteria could elect to continue the bilastine treatment for an additional 40 weeks (continuous treatment period: a total of 52 weeks). Safety and tolerability were the primary outcomes, and the main secondary endpoint was to evaluate changes in efficacy variables from baseline measurements. Fifty-eight patients with SAR and 64 patients with PAR received bilastine (20mg/day) for 12 weeks. Fifty-five patients with PAR transitioned to the continuous treatment period. Adverse events (AEs) were reported by 17.2% of patients with SAR and by 31.3% of patients with PAR, and adverse drug reactions (ADRs) were reported by 6.3% of patients with PAR but by no patients with SAR during the 12-week treatment period. All of the ADRs were mild in severity. During the 52-week treatment period, AEs and ADRs were reported by 73.4% and 6.3% of patients with PAR, respectively. All of the ADRs occurred during the 12-week treatment period, and none during the continuous treatment period. The AEs were categorized using the System Organ Class of nervous system disorders; 4.7% of patients reported headache, but none reported somnolence. One serious AE was reported, but it was considered to be unrelated to the bilastine treatment. There were no deaths, and no patients withdrew from the study because of AEs. In patients with SAR, bilastine significantly decreased the total nasal symptom score (TNSS), total ocular symptom score (TOSS), and total symptom score (TSS) relative to baseline. Prolonged treatment with bilastine resulted in the

  5. Accuracy of self-reported intake of signature foods in a school meal intervention study: comparison between control and intervention period.

    PubMed

    Biltoft-Jensen, Anja; Damsgaard, Camilla Trab; Andersen, Rikke; Ygil, Karin Hess; Andersen, Elisabeth Wreford; Ege, Majken; Christensen, Tue; Sørensen, Louise Bergmann; Stark, Ken D; Tetens, Inge; Thorsen, Anne-Vibeke

    2015-08-28

    Bias in self-reported dietary intake is important when evaluating the effect of dietary interventions, particularly for intervention foods. However, few have investigated this in children, and none have investigated the reporting accuracy of fish intake in children using biomarkers. In a Danish school meal study, 8- to 11-year-old children (n 834) were served the New Nordic Diet (NND) for lunch. The present study examined the accuracy of self-reported intake of signature foods (berries, cabbage, root vegetables, legumes, herbs, potatoes, wild plants, mushrooms, nuts and fish) characterising the NND. Children, assisted by parents, self-reported their diet in a Web-based Dietary Assessment Software for Children during the intervention and control (packed lunch) periods. The reported fish intake by children was compared with their ranking according to fasting whole-blood EPA and DHA concentration and weight percentage using the Spearman correlations and cross-classification. Direct observation of school lunch intake (n 193) was used to score the accuracy of food-reporting as matches, intrusions, omissions and faults. The reporting of all lunch foods had higher percentage of matches compared with the reporting of signature foods in both periods, and the accuracy was higher during the control period compared with the intervention period. Both Spearman's rank correlations and linear mixed models demonstrated positive associations between EPA+DHA and reported fish intake. The direct observations showed that both reported and real intake of signature foods did increase during the intervention period. In conclusion, the self-reported data represented a true increase in the intake of signature foods and can be used to examine dietary intervention effects.

  6. Dose-dependent antihypertensive efficacy and tolerability of perindopril in a large, observational, 12-week, general practice-based study.

    PubMed

    Tsoukas, George; Anand, Sanjiv; Yang, Kwang

    2011-01-01

    Current guidelines recommend the use of full therapeutic dosages of antihypertensive agents, or combination therapy, to improve BP control of hypertensive patients in primary healthcare. The aim of this study was to assess the dose-dependent antihypertensive efficacy and safety of perindopril 4 and 8 mg/day in the clinical setting. The CONFIDENCE study was a prospective, observational, multicenter trial. This was a real-world, clinic-based, outpatient study involving 880 general practitioners/primary-care clinics and 113 specialists in Canada. The study included untreated or inadequately managed patients with hypertension (i.e. seated BP ≥ 140/90 mmHg, or ≥ 130/80 mmHg in the presence of diabetes mellitus, renal disease, or proteinuria) without coronary artery disease (CAD). Treatment consisted of perindopril 4 mg/day, uptitrated to 8 mg/day as required for BP control at visit 2, for 12 weeks. Among the patients already being treated at baseline, perindopril either directly replaced all previous ACE inhibitors or angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]), or was added to antihypertensive treatment with calcium channel blockers (CCBs), diuretics, or β-adrenoceptor antagonists (β-blockers). The primary outcomes were the mean changes in BP from baseline following treatment with perindopril 4 and 8 mg/day as well as the proportion of patients achieving BP control (BP <140/90 mmHg, or <130/80 mmHg in diabetic patients) in the intent-to-treat (ITT) population. Secondary analyses included the incidence of adverse events and compliance. A total of 8298 hypertensive patients entered the study: 56% with newly diagnosed hypertension and 44% with uncontrolled hypertension. Mean SBP/DBP decreased significantly from baseline (152.5  ±  10.8/89.5  ±  9 mmHg) over 12 weeks (-18.5/-9.7 mmHg; p < 0.001). At visit 2, 23% of patients were uptitrated to perindopril 8 mg/day, which resulted in an

  7. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    PubMed Central

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  8. Effects of a 12 Week SAQ Training Programme on Agility with and without the Ball among Young Soccer Players.

    PubMed

    Milanović, Zoran; Sporiš, Goran; Trajković, Nebojša; James, Nic; Samija, Krešimir

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p < 0.05) between pre and post training were evident for almost all measures of agility, with and without the ball, with the exception being the Sprint with backward and forward running. This suggests that SAQ training is an effective way of improving agility, with and without the ball, for young soccer players and can be included in physical conditioning programmes. Key pointsSAQ training appears to be an effective way of improving agility with and without the ball in young soccer playersSoccer coaches could use this training during pre-season and in-season trainingCompared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training.

  9. Effects of a 12 Week SAQ Training Programme on Agility with and without the Ball among Young Soccer Players

    PubMed Central

    Milanović, Zoran; Sporiš, Goran; Trajković, Nebojša; James, Nic; Šamija, Krešimir

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p < 0.05) between pre and post training were evident for almost all measures of agility, with and without the ball, with the exception being the Sprint with backward and forward running. This suggests that SAQ training is an effective way of improving agility, with and without the ball, for young soccer players and can be included in physical conditioning programmes. Key points SAQ training appears to be an effective way of improving agility with and without the ball in young soccer players Soccer coaches could use this training during pre-season and in-season training Compared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training PMID:24149731

  10. Duloxetine for the treatment of mood disorder in cancer patients: a 12-week case-control clinical trial.

    PubMed

    Torta, Riccardo; Leombruni, Paolo; Borio, Roberto; Castelli, Lorys

    2011-01-01

    The aim of this study was to investigate the efficacy and tolerability of duloxetine in cancer patients with mood disorder (MD) by means of a comparison with a matched control group of patients with MD without medical illness. Fifty-nine consecutive patients with MD were enrolled in this prospective case-control study and received duloxetine 60/120 mg per day for 12 weeks. Twenty-seven patients were affected by cancer, whereas 32 had an MD without cancer. All the patients were assessed by means of efficacy and effectiveness tolerability scales for depression (Montgomery-Asberg Depression Rating Scale and Hospital Anxiety and Depression Scale), anxiety (State-Trait Anxiety Inventory-Y1/Y2) and severity of symptoms (Clinical Global Impression (CGI)-Severity) at baseline (T0), after 4 weeks (T1) and 12 weeks (T2). The CGI-Improvement, CGI-Effectiveness Index and Dosage Record Treatment Emergent Symptom Scale were administered at T1 and T2. A significant global improvement in all the efficacy measures was found. The results showed no significant interaction 'Time X Group', suggesting a similar improvement in efficacy scores for cancer-depressed patients and depressed patients without cancer. No difference was found between the two groups with regard to drop-out percentage, effectiveness and tolerability. Although the results of this case-control study are preliminary, they suggest that duloxetine can be considered a good option for the treatment of MD in cancer patients. Copyright © 2011 John Wiley & Sons, Ltd.

  11. Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

    PubMed Central

    Mori, Katsuhito; Emoto, Masanori; Shoji, Tetsuo; Inaba, Masaaki

    2016-01-01

    Objective Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD). Research design and methods In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels. Results At week 12, the adjusted mean HbA1c levels had decreased by −0.60% after treatment with linagliptin and by −0.20% after treatment with voglibose (treatment difference: −0.40%, 95% CI −0.74% to −0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study. Conclusions In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD. Trial registration number UMIN000007635; results. PMID:27547421

  12. Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE).

    PubMed

    Motaweih, Ahmed K; Usova, Elena; Hussain, Wajid; Dello, Ziad; Petri, Thomas

    2016-01-01

    AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength. Patients with hypertension who received a daily nifedipine GITS dose of 60 mg, either at constant dose (n = 686) or up-titrated from 30 mg (n = 392), were analyzed. Target blood pressure (BP) was <140/90 mmHg (or <130/80 mmHg for those at high/very high cardiovascular risk). Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60 mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30-60 mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were -40.3/-20.7 mmHg and -35.6/-18.5 mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60 mg; 2.0%, 30-60 mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs. Combination therapy with nifedipine GITS 60 mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs.

  13. Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE)

    PubMed Central

    Motaweih, Ahmed K.; Usova, Elena; Hussain, Wajid; Dello, Ziad; Petri, Thomas

    2016-01-01

    Abstract Background: AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength. Methods: Patients with hypertension who received a daily nifedipine GITS dose of 60 mg, either at constant dose (n = 686) or up-titrated from 30 mg (n = 392), were analyzed. Target blood pressure (BP) was <140/90 mmHg (or <130/80 mmHg for those at high/very high cardiovascular risk). Results: Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60 mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30–60 mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were −40.3/−20.7 mmHg and −35.6/−18.5 mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60 mg; 2.0%, 30–60 mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs. Conclusion: Combination therapy with nifedipine GITS 60 mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs. PMID:26331311

  14. Contribution of magnetic resonance microscopy in the 12-week neurotoxicity evaluation of carbonyl sulfide in Fischer 344 rats.

    PubMed

    Sills, Robert C; Morgan, Daniel L; Herr, David W; Little, Peter B; George, Nneka M; Ton, Thai Vu; Love, Nancy E; Maronpot, Robert R; Johnson, G Allan

    2004-01-01

    In this carbonyl sulfide (COS) study, magnetic resonance microscopy (MRM) and detailed light microscopic evaluation effectively functioned in parallel to assure that the distribution and degree of pathology in the brain was accurately represented. MRM is a powerful imaging modality that allows for excellent identification of neuroanatomical structures coupled with the ability to acquire 200 or more cross-sectional images of the brain, and the ability to display them in multiple planes. F344 rats were exposed to 200-600 ppm COS for up to 12 weeks. Prior to MRM, rats were anesthetized and cardiac perfused with McDowell Trump's fixative containing a gadolinium MR contrast medium. Fixed specimens were scanned at the Duke Center for In Vivo Microscopy on a 9.4 Tesla magnetic resonance system adapted explicitly for microscopic imaging. An advantage of MRM in this study was the ability to identify lesions in rats that appeared clinically normal prior to sacrifice and the opportunity to identify lesions in areas of the brain which would not be included in conventional studies. Other advantages include the ability to examine the brain in multiple planes (transverse, dorsal, sagittal) and obtain and save the MRM images in a digital format that allows for postexperimental data processing and manipulation. MRM images were correlated with neuroanatomical and neuropathological findings. All suspected MRM images were compared to corresponding H&E slides. An important aspect of this study was that MRM was critical in defining our strategy for sectioning the brain, and for designing mechanistic studies (cytochrome oxidase evaluations) and functional assessments (electrophysiology studies) on specifically targeted anatomical sites following COS exposure.

  15. Emergency Department Use in the Perinatal Period: An Opportunity for Early Intervention.

    PubMed

    Malik, Saloni; Kothari, Catherine; MacCallum, Colleen; Liepman, Michael; Tareen, Shama; Rhodes, Karin V

    2017-08-12

    We characterize emergency department (ED) utilization among perinatal women and identify differences in risk factors and outcomes between women who use versus do not use the ED during the perinatal period. This is a retrospective cross-sectional study comparing patients who used the ED versus did not use the ED during the perinatal period. Patient data were collected from medical chart review and postpartum interviews. Of the 678 participants, 218 (33%) had at least 1 perinatal ED visit. Women who used the ED were more likely than those who did not to be adolescent (relative risk [RR] 2.23; 95% confidence interval [CI] 1.38 to 3.63), of minority race (RR 1.94; 95% CI 1.46 to 2.57), and Medicaid insured (RR 2.14; 95% CI 1.71 to 2.67). They were more likely to smoke prenatally (RR 3.42; 95% CI 2.34 to 4.99), to use recreational drugs prenatally (RR 3.53; 95% CI 1.78 to 7.03), and to have experienced domestic abuse (RR 1.78; 95% CI 1.12 to 2.83). They were more likely to have delayed entry to prenatal care (RR 2.01; 95% CI 1.46 to 2.77) and to experience postpartum depression (RR 2.97; 95% CI 1.90 to 4.64). Their infants were nearly twice as likely to be born prematurely (RR 1.92; 95% CI 1.07 to 3.47). Results highlight that pregnant patients using the ED are a high-risk, vulnerable population. Routine ED screening and linkage of this vulnerable population to early prenatal care and psychosocial interventions should be considered as a public health strategy worth investigating. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  16. Open-labelled observations of language dysfunction in old ischemic stroke patients with aphasia when given plant and marine-based nutrient supplements for 12 weeks.

    PubMed

    Lin, Guan-Yu; Chan, Hsiu-Yu; Cheng, Chun-An; Lin, Lan-Ping; Peng, Giia-Sheun; Hsiao, Pei-Min; Lin, Chun-Chieh; Lin, Chun-Chih; Lee, Jiunn-Tay

    2016-01-01

    This study aimed to explore the effect of functional foods on aphasia related to a previous ischemic stroke. When stroke-related neurological deficits result in physical dependency and poor selfcare that persists longer than 6 months, full recovery is almost impossible and the patient often requires long-term care. The functional foods, EASE123 and BioBalance#6, include numerous plant and marine-based nutrient supplements that could prove beneficial for such patients. This open-labelled study included 10 patients diagnosed with prior ischemic stroke and aphasia lasting longer than 6 months. Each patient was administered 6 tablets of EASE123 at 10:30 AM and at 90 minutes before sleeping, and 3 tablets of BioBalance# 6 at 2:30 PM. After a treatment period of 12 weeks, the patients were followed during a 4-week withdrawal period. Functional improvement was assessed by scores and subscores on the Concise Chinese Aphasia Test (CCAT) at weeks 4, 8, 12, and 16. Average total CCAT scores and matching ability improved significantly at weeks 4, 8, 12, and 16 (p<0.05). Simple response scores improved significantly at weeks 8 and 12 (p<0.05). Auditory comprehension improved significantly at weeks 4 and 12 (p<0.05), and reading comprehension, at week 12 (p<0.05). Repetition ability improved significantly at weeks 8, 12, and 16 (p<0.05), and spontaneous writing, at weeks 4, 12, and 16 (p<0.05). Matching, repetition, and average total CCAT scores improved over the course of the study. Therefore, 6 months after ischemic stroke, EASE123 and BioBalance# 6 administration may improve stroke-related aphasia.

  17. A Collaborative Care Telemedicine Intervention to Overcome Treatment Barriers for Latina Women with Depression during the Perinatal Period

    PubMed Central

    Baker-Ericzén, Mary J.; Connelly, Cynthia D.; Hazen, Andrea L.; Dueñas, Cecilia; Landsverk, John A.; Horwitz, Sarah McCue

    2013-01-01

    Maternal depression is highly prevalent (10 to 20%) during the perinatal period with rates as high as 35 to 40% for Latinas. However, few Latinas are either identified or treated during the perinatal period. To address these disparities, the Perinatal Mental Health Model (PMH) was designed to ameliorate the barriers that prevent adequate diagnoses and intervention. The PMH is a culturally sensitive, short-term telemedicine, and collaborative care intervention for addressing depression among Mexican American mothers. It attends to sociocultural and socioeconomic dimensions and is delivered by trained mental health advisors within obstetric care settings. This article describes the feasibility and acceptability of utilizing the PMH. Participants (n=79) were selected from a first year ongoing randomized trial in community obstetric clinics. The intervention seems feasible and acceptable; low-income Latinas, identified as depressed during the perinatal period, reported having access to a range of appropriate community services and high satisfaction. PMID:22709321

  18. A collaborative care telemedicine intervention to overcome treatment barriers for Latina women with depression during the perinatal period.

    PubMed

    Baker-Ericzén, Mary J; Connelly, Cynthia D; Hazen, Andrea L; Dueñas, Cecilia; Landsverk, John A; Horwitz, Sarah McCue

    2012-09-01

    Maternal depression is highly prevalent (10-20%) during the perinatal period, with rates as high as 35% to 40% for Latinas. However, few Latinas are either identified or treated during the perinatal period. The Perinatal Mental Health (PMH) model was designed to ameliorate the barriers that prevent adequate diagnoses and intervention. The PMH is a culturally sensitive, short-term telemedicine, collaborative care intervention for addressing depression among Mexican American mothers. It attends to sociocultural and socioeconomic dimensions and is delivered by trained mental health advisors in obstetric care settings. This article describes the feasibility and acceptability of using the PMH. Participants (N = 79) were selected from a 1st-year ongoing randomized trial in community obstetric clinics. The intervention seems feasible and acceptable; low-income Latinas, identified as depressed during the perinatal period, reported having access to a range of appropriate community services and high satisfaction.

  19. Impact of a 12-week aerobic exercise training program on anthropometric and metabolic parameters of a group of type 2 diabetes Cameroonian women aged ≥50 years

    PubMed Central

    Dahjio, Yves; Noubiap, Jean Jacques N.; Azabji-Kenfack, Marcel; Essouma, Mickael; Loni, Gabriel Ekali; Onana, Arnold Ewane; Dehayem, Mesmin; Mvom, Angeline; Tadjore, Maurice Njock

    2016-01-01

    Background We examined whether aerobic exercise could have an impact on anthropometric and metabolic parameters of type 2 diabetes mellitus (T2DM) Cameroonian women aged ≥50 years. Methods We enrolled 23 T2DM Cameroonian women aged ≥50 years regularly followed at the National Obesity Center of Yaounde, Cameroon, in a 12-week aerobic exercise program monitored by a pedometer. Exercise intensity was progressively set between 55% and 75% of maximum heart rate. We measured weight, body mass index (BMI), fat, lean mass, visceral fat, maximum oxygen uptake, glycaemia and insulin tolerance index at baseline, after six and twelve weeks. A mixed ANOVA model was used to evaluate changes of outcome measures over time. Results Total body weight was significantly reduced after 12 weeks (P<0.05), waist circumference after 6 and 12 weeks (P<0.05). There was an increase of the lean mass from 6 weeks (P<0.001) and a reduction of the mean visceral fat at 12 weeks (P<0.001). At the end of the program, the mean glycaemia was significantly decreased (P<0.05), and the maximum oxygen uptake was enhanced (P<0.05). Conclusions The 12-week aerobic exercise program improved the anthropometric and metabolic parameters as well as the aerobic capacity of T2DM Cameroonian women aged ≥50 years. PMID:27826567

  20. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women

    PubMed Central

    Lee, Ji hyeon; Vittinghoff, Eric; Fukuoka, Yoshimi

    2015-01-01

    Introduction Physical inactivity is prevalent in pregnant women, and innovative strategies to promote physical activity are strongly needed. The purpose of the study was to test a 12-week mobile health (mHealth) physical activity intervention for feasibility and potential efficacy. Methods Participants were recruited between December 2012 and February 2014 using diverse recruitment methods. Thirty pregnant women between 10 and 20 weeks of gestation were randomized to an intervention (mobile phone app plus Fitbit) or a control (Fitbit) group. Both conditions targeted gradual increases in physical activity. The mHealth intervention included daily messages and a mobile phone activity diary with automated feedback and self-monitoring systems. Results On monthly average, 4 women were screened for initial eligibility by telephone and 2.5 were randomized. Intervention participants had a 1096 ± 1898 step increase in daily steps compared to an increase of 259 ± 1604 steps in control participants at 12 weeks. The change between groups in weekly mean steps per day during the 12-week study period was not statistically significant (p = 0.38). The intervention group reported lower perceived barrier to being active, lack of energy, than the control group at 12-week visit (p = 0.02). The rates of responding to daily messages and using the daily diary through the mobile app declined during the 12 week study period. Discussion It was difficult to recruit and randomize inactive women who wanted to increase physical activity during pregnancy. Pregnant women who were motivated to increase physical activity might find using mobile technologies in assessing and promoting PA acceptable. Possible reasons for the non-significant treatment effect of the mHealth intervention on physical activity are discussed. Public awareness of safety and benefits of physical activity during pregnancy should be promoted. Clinicaltrials.Gov Identifier NCT01461707. PMID:26649879

  1. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women.

    PubMed

    Choi, JiWon; Lee, Ji Hyeon; Vittinghoff, Eric; Fukuoka, Yoshimi

    2016-05-01

    Physical inactivity is prevalent in pregnant women, and innovative strategies to promote physical activity are strongly needed. The purpose of the study was to test a 12-week mobile health (mHealth) physical activity intervention for feasibility and potential efficacy. Participants were recruited between December 2012 and February 2014 using diverse recruitment methods. Thirty pregnant women between 10 and 20 weeks of gestation were randomized to an intervention (mobile phone app plus Fitbit) or a control (Fitbit) group. Both conditions targeted gradual increases in physical activity. The mHealth intervention included daily messages and a mobile phone activity diary with automated feedback and self-monitoring systems. On monthly average, 4 women were screened for initial eligibility by telephone and 2.5 were randomized. Intervention participants had a 1096 ± 1898 step increase in daily steps compared to an increase of 259 ± 1604 steps in control participants at 12 weeks. The change between groups in weekly mean steps per day during the 12-week study period was not statistically significant (p = 0.38). The intervention group reported lower perceived barrier to being active, lack of energy, than the control group at 12-week visit (p = 0.02). The rates of responding to daily messages and using the daily diary through the mobile app declined during the 12 week study period. It was difficult to recruit and randomize inactive women who wanted to increase physical activity during pregnancy. Pregnant women who were motivated to increase physical activity might find using mobile technologies in assessing and promoting PA acceptable. Possible reasons for the non-significant treatment effect of the mHealth intervention on physical activity are discussed. Public awareness of safety and benefits of physical activity during pregnancy should be promoted. Clinicaltrials.Gov Identifier NCT01461707.

  2. Neuromotor Adverse Effects in 342 Youth During 12 Weeks of Naturalistic Treatment With 5 Second-Generation Antipsychotics.

    PubMed

    Carbon, Maren; Kapoor, Sandeep; Sheridan, Eva; Al-Jadiri, Aseel; Azzo, Sally; Sarkaria, Tania; Kane, John M; Saito, Ema; Correll, Christoph U

    2015-09-01

    Second-generation antipsychotic (SGA) effects in youth were monitored to quantify extrapyramidal side effects (EPS) and to identify risk profiles for treatment-emergent EPS. Data were analyzed for the nonrandomized, prospective Second-generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) inception cohort study. EPS were assessed at baseline and 4, 8, and 12 weeks after naturalistic SGA initiation for schizophrenia, mood, disruptive behavior, and autism spectrum disorders using the Simpson-Angus Scale (SAS), Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS), and Treatment Emergent Side Effect Scale. Drug-induced parkinsonism was defined by incident mean SAS score >0.33, anticholinergic initiation, or increasing total SAS score ≥2 in patients with baseline EPS. In 342 youth aged 13.6 ± 3.5 years (male = 58.2%, antipsychotic-naive = 65.8%), 15.2% developed drug-induced parkinsonism. Raw SGA-grouped drug-induced parkinsonism rates were as follows: quetiapine = 1.5%, olanzapine = 13.8%, risperidone = 16.1%, ziprasidone = 20.0%, and aripiprazole = 27.3%. SGA type, dose, higher age, and lower baseline functioning were jointly associated with drug-induced parkinsonism (R(2) = 0.18; p < .0001). Controlling for these factors, drug-induced parkinsonism rates were significantly lower only for quetiapine and olanzapine. Subjectively reported EPS (5%), EPS-related treatment discontinuation (3.3%), and anticholinergic initiation (3%) were infrequent. Anticholinergic initiation was most frequent with risperidone (10.2%; p = .0004). Treatment-emergent dyskinesia ranged from 4.5% (aripiprazole) to 15.5% (olanzapine). SGA type, younger age, white race/ethnicity, and baseline AIMS were jointly associated with treatment-emergent dyskinesia (R(2) = 0.31; p < .0001). Controlling for these factors, treatment-emergent dyskinesia rates differed among SGA subgroups, with higher rates with olanzapine and ziprasidone. At baseline

  3. Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study.

    PubMed

    Korn, Stephanie; Kerwin, Edward; Atis, Sibel; Amos, Carolynn; Owen, Roger; Lassen, Cheryl

    2011-05-01

    Indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of COPD. This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 μg once-daily to salmeterol 50 μg twice-daily in patients with moderate-to-severe COPD. Assessments included FEV(1) standardised area under curve (AUC) from 5 min to 11 h 45 min at Week 12 (primary endpoint), 24-h trough FEV(1) (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (key secondary endpoint), FEV(1) and FVC measured over 24-h, transition dyspnoea index (TDI) and rescue medication use. Of 1123 patients randomised 92.1% completed. Mean ± SD age was 62.8±8.78 years, post-bronchodilator FEV(1) 51.8±12.32% predicted, FEV(1)/FVC 50.6±9.54%. At Week 12, FEV(1) AUC(5 min-11 h 45 min) for indacaterol was statistically superior (p<0.001) to salmeterol (adjusted mean difference [95% CI] 57 [35, 79] mL), as was 24-h trough FEV(1) (60 [37, 83] mL, p<0.001). Indacaterol also showed statistical superiority over salmeterol in terms of FEV(1) and FVC measured over 24-h at Week 12. For TDI at Week 12, the mean total score was statistically superior for indacaterol versus salmeterol (difference 0.63 [0.30, 0.97], p<0.001), as was the percentage of patients with a clinically relevant (i.e., ≥1 point) change from baseline (69.4% vs 62.7%, p<0.05). For rescue medication, patients on indacaterol used fewer puffs/day (difference -0.18 [-0.36, 0.00] puffs/day, p<0.05) and had a greater percentage of days with no rescue use (difference 4.4 [0.6, 8.2], p<0.05). Once-daily indacaterol provided statistically superior bronchodilation with an improvement in breathlessness and rescue use compared with twice-daily salmeterol. ClinicalTrials.gov NCT00821093. Copyright © 2011 Elsevier Ltd. All rights reserved.

  4. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population.

    PubMed

    To, Yasuo; Kinoshita, Masaharu; Lee, Sang Haak; Hang, Liang-Wen; Ichinose, Masakazu; Fukuchi, Yoshinosuke; Kitawaki, Tetsuji; Okino, Naoko; Prasad, Niyati; Lawrence, David; Kramer, Benjamin

    2012-12-01

    This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β(2)-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan). Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected. Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol-placebo differences in trough FEV(1) at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior (p < 0.001) for indacaterol (150 μg, 300 μg) versus placebo in the two subgroups [0.19L, 0.20L (moderate); 0.15L, 0.19L (severe) respectively]. LSM TDI scores for both indacaterol doses versus placebo in both subgroups were statistically superior (p < 0.05) and clinically meaningful (≥1 unit). Both indacaterol doses showed improvements in LSM SGRQ total scores at Week 12 which exceeded the MCID (4 units) versus placebo in both subgroups, with indacaterol 300 μg-placebo difference in the severe subgroup being statistically significant (p < 0.01). Overall incidence of adverse events was lower with indacaterol than with placebo across both subgroups. Indacaterol demonstrated clinically relevant improvements versus placebo in lung function, dyspnea and health status in Asian COPD patients irrespective of disease severity. NCT00794157. Copyright © 2012 Elsevier Ltd. All rights reserved.

  5. Physiological adaptation after a 12-week physical activity program for patients with Prader-Willi syndrome: two case reports.

    PubMed

    Amaro, Alexandre Slowetzky; Teixeira, Maria Cristina Triguero Veloz; de Mesquita, Maria Luiza Guedes; Rodrigues, Graciele Massoli; Rubin, Daniela Andrea; Carreiro, Luiz Renato Rodrigues

    2016-06-23

    Physical activity programs are a powerful tool against several diseases including obesity and their comorbidities. Prader-Willi syndrome is the most common genetic disease associated with obesity, and brings with it behavioral and emotional problems that need complex management. Research into the effect of physical activity programs on Prader-Willi syndrome is limited and it is frequently argued that if a physical activity program is too complex, the participants are more likely to drop out. Therefore, in this study, we assessed the physiological adaptation effect of a physical activity program with increasing complexity and load, in a boy and a girl with Prader-Willi syndrome by assessing changes in lipid profile, body composition, and physical fitness parameters. Case 1 was an 11-year-old girl, mixed race (brown), with an intelligence quotient of 68, 52.0 % body fat, and a body mass index of 45.3 kg/m(2). The Prader-Willi syndrome diagnosis was made when she was 5-years old and was found to be due to an imprinting genomic defect. Case 2 was a 14-year-old boy, mixed race (brown), with an intelligence quotient of 74, 48.8 % body fat, and a body mass index of 37.3 kg/m(2). The diagnosis was made when he was 10-years old and was found to be caused by gene deletion. Both participants presented physical characteristics and behavior problems typical of Prader-Willi syndrome. Case 2 presented high blood pressure, high cholesterol and sleep apnea and had to use continuous positive airway pressure to sleep. Both participants were assessed for 12 weeks (three times a week) using a physical activity program designed to improve strength and muscle hypertrophy. The work load was progressively adjusted as necessary and new exercises were added to the program. Prior to the program, the participants' parents received instructions about managing problem behavior and advice about nutrition. After physical activity program several health markers assessed by biological tests and

  6. Trichloroethylene and trichloroethanol-induced formic aciduria and renal injury in male F-344 rats following 12 weeks exposure.

    PubMed

    Yaqoob, Noreen; Evans, Andrew; Foster, John R; Lock, Edward A

    2014-09-02

    Trichloroethylene (TCE) is widely used as a cleaning and decreasing agent and has been shown to cause liver tumours in rodents and a small incidence of renal tubule tumours in male rats. The basis for the renal tubule injury is believed to be related to metabolism of TCE via glutathione conjugation to yield the cysteine conjugate that can be activated by the enzyme cysteine conjugate β-lyase in the kidney. More recently TCE and its major metabolite trichloroethanol (TCE-OH) have been shown to cause formic aciduria which can cause renal injury after chronic exposure in rats. In this study we have compared the renal toxicity of TCE and TCE-OH in rats to try and ascertain whether the glutathione pathway or formic aciduria can account for the toxicity. Male rats were given TCE (500mg/kg/day) or TCE-OH at (100mg/kg/day) for 12 weeks and the extent of renal injury measured at several time points using biomarkers of nephrotoxicity and prior to termination assessing renal tubule cell proliferation. The extent of formic aciduria was also determined at several time points, while renal pathology and plasma urea and creatinine were determined at the end of the study. TCE produced a very mild increase in biomarkers of renal injury, total protein, and glucose over the first two weeks of exposure and increased Kim-1 and NAG in urine after 1 and 5 weeks exposure, while TCE-OH did not produce a consistent increase in these biomarkers in urine. However, both chemicals produced a marked and sustained increase in the excretion of formic acid in urine to a very similar extent. The activity of methionine synthase in the liver of TCE and TCE-OH treated rats was inhibited by about 50% indicative of a block in folate synthesis. Both renal pathology and renal tubule cell proliferation were reduced after TCE and TCE-OH treatment compared to controls. Our findings do not clearly identify the pathway which is responsible for the renal toxicity of TCE but do provide some support for metabolism

  7. Switching from clozapine to zotepine in patients with schizophrenia: a 12-week prospective, randomized, rater blind, and parallel study.

    PubMed

    Lin, Chao-Cheng; Chiu, Hsien-Jane; Chen, Jen-Yeu; Liou, Ying-Jay; Wang, Ying-Chieh; Chen, Tzu-Ting; Bai, Ya-Mei

    2013-04-01

    Clozapine is the most effective antipsychotic for patients with treatment-refractory schizophrenia, but many adverse effects are noted. Clinicians usually hesitate to switch from clozapine to other antipsychotics because of the risk of a re-emergence or worsening of the psychosis, although empirical studies are very limited. Zotepine, an atypical antipsychotic with a pharmacologic profile similar to clozapine, was found to be an effective treatment for patients with treatment-resistant schizophrenia in Japan. This 12-week study is the first prospective, randomized, and rater-blind study to investigate the efficacy and tolerability of switching from clozapine to zotepine. Fifty-nine patients with schizophrenia, who had taken clozapine for at least 6 months with a Clinical Global Impression-Severity score of at least 3, were randomly allocated to the zotepine and the clozapine groups. At the end of the study, 52 patients (88%) had completed the trial. The 7 withdrawal cases were all in the zotepine group. The final mean (SD) dose of zotepine and clozapine was 397.1 (75.7) versus 377.1 (62.5) mg/d, respectively. Patients in the zotepine group showed a significant increase in the Brief Psychiatric Rating Scale [mean (SD), 4.7 (8.7) vs -1.3 (6.3); P = 0.005], more general adverse effects as revealed by the Udvalg for Kliniske Undersogelser Rating Scale [mean (SD), 1.74 (3.9) vs -0.2 (2.8); P = 0.039], more extrapyramidal adverse effects as demonstrated by the Simpson and Angus Scale [mean (SD), 1.29 (3.5) vs 0.17 (2.1); P = 0.022], an increased use of propranolol (37.1% vs 0%, P < 0.0001) and anticholinergics (25.7% vs 0%, P = 0.008), and an increased level of prolactin (29.6 vs -3.8 ng/ mL, P < 0.0005), compared with the clozapine group. The results suggested that switching from clozapine to zotepine treatment should be done with caution.

  8. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naïve and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis.

    PubMed

    El Raziky, M; Gamil, M; Ashour, M K; Sameea, E A; Doss, W; Hamada, Y; Van Dooren, G; DeMasi, R; Keim, S; Lonjon-Domanec, I; Hammad, R; Hashim, M S; Hassany, M; Waked, I

    2017-02-01

    The OSIRIS study investigated efficacy and safety of simeprevir plus sofosbuvir for eight or 12 weeks in hepatitis C virus (HCV) genotype 4-infected patients with METAVIR F0-F4 fibrosis. Sixty-three patients (33 treatment-naïve and 30 peg-interferon/ribavirin (Peg-IFN/RBV)-experienced) enrolled in a partly randomized, open-label, multicentre, phase IIa study. Patients with F0-F3 fibrosis were randomized (1:1) into two groups (A1 and A2), stratified according to treatment experience and METAVIR score, to receive either eight weeks (Group A1, n=20) or 12 weeks (Group A2, n=20) of treatment. Patients with compensated cirrhosis (METAVIR F4) received 12 weeks of treatment (Group B, n=23). Treatment comprised simeprevir 150 mg and sofosbuvir 400 mg daily. The primary efficacy endpoint was sustained virologic response 12 weeks after planned end of treatment (SVR12). Safety and tolerability were assessed throughout. Overall, 92% (95% CI: 82-97) of patients achieved SVR12; 75% (15/20) in Group A1 and 100% in groups A2 and B. Patients who did not achieve SVR12 (n=5) experienced viral relapse during the first 32 days following treatment and were all prior Peg-IFN/RBV null responders. The most commonly reported treatment-emergent adverse events (TEAEs) were asymptomatic lipase increase (14%), pruritus (14%), headache (13%) and hyperbilirubinaemia (11%). No patients discontinued due to TEAEs. In conclusion, simeprevir plus sofosbuvir for 12 weeks achieved a 100% SVR rate in HCV genotype 4-infected patients with or without compensated cirrhosis (ClinicalTrials.gov: NCT02278419). The AE and laboratory profile were favourable and consistent with previous data for simeprevir plus sofosbuvir in eight- and 12-week regimens.

  9. Effectiveness of 8- or 12-weeks of ledipasvir and sofosbuvir in real-world treatment-naïve, genotype 1 hepatitis C infected patients.

    PubMed

    Curry, M P; Tapper, E B; Bacon, B; Dieterich, D; Flamm, S L; Guest, L; Kowdley, K V; Lee, Y; Milligan, S; Tsai, N; Younossi, Z; Afdhal, N H

    2017-09-01

    Treatment of genotype 1 hepatitis C virus (HCV) infection with combination direct acting anti-virals is associated with very high rates of sustained virological response (SVR). Daily combination of ledipasvir and sofosbuvir for 12 weeks is approved for the treatment of genotype 1 HCV patients, though noncirrhotic patients who are naïve to treatment with a baseline HCV RNA <6 million IU/mL can be treated for 8 weeks. This guidance stemmed from a post hoc analysis of the ION 3 clinical trial, which demonstrated similar SVR for patients treated with ledipasvir and sofosbuvir with or without ribavirin for 8 or 12 weeks. To compare the SVR for 8 weeks vs 12 weeks of ledipasvir and sofosbuvir in HCV infected patients in a real-world setting. We performed an observational real-world cohort study of treatment success following 8 or 12 weeks of ledipasvir and sofosbuvir for treatment-naïve genotype 1 HCV patients. A total of 826 patients were treated for either 8 (n=252) or 12 weeks (n=574) with ledipasvir and sofosbuvir and achieved SVR rate of 95.3% and there was no statistical difference in SVR rates in the two groups irrespective of any clinical or virological variables. In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen. © 2017 John Wiley & Sons Ltd.

  10. The effect of 12 weeks Anethum graveolens (dill) on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial.

    PubMed

    Mansouri, Masoume; Nayebi, Neda; Keshtkar, Abasali; Hasani-Ranjbar, Shirin; Taheri, Eghbal; Larijani, Bagher

    2012-10-04

    The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill) extract, could improve metabolic components in patients with metabolic syndrome. A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III) were randomly assigned to either dill extract (n = 12) or placebo (n = 12) for 3 months. Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG) concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01) with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components.

  11. The effect of 12 weeks Anethum graveolens (dill) on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

    PubMed Central

    2012-01-01

    Background The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill) extract, could improve metabolic components in patients with metabolic syndrome. Methods A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III) were randomly assigned to either dill extract (n = 12) or placebo (n = 12) for 3 months. Results Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG) concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01) with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. Conclusion In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components. PMID:23351341

  12. Effect of 12-week-long aerobic training programme on body composition, aerobic capacity, complete blood count and blood lipid profile among young women

    PubMed Central

    Nowak, Robert; Jastrzębski, Zbigniew; Zarębska, Aleksandra; Bichowska, Marta; Drobnik-Kozakiewicz, Izabela; Radzimiński, Łukasz; Leońska-Duniec, Agata; Ficek, Krzysztof; Cięszczyk, Paweł

    2015-01-01

    Background Numerous data suggest that aerobic-type exercise improves lipoprotein-lipid profiles, cardiorespiratory fitness and body composition in young women. The aim of this study was to evaluate the biological response to high-low impact aerobic fitness among young women. Materials and methods Thirty-four young women aged 22 (19-24) years were divided into three groups: underweight (N = 10), normal weight (N = 12) and overweight (N = 12). Aerobic capacity, anthropometry and body composition together with complete blood count and lipid profile were determined before and after completion of a 12-week-long training period. Results The training programme caused a significant decrease in weight (by 4.3 kg, P = 0.003), body mass index (by 1.3 kg/m2, P = 0.003), free fat mass (by 2.1 kg, P = 0.002), total body water (by 0.4 kg, P = 0.036), percentage of fat (by 3 percent points, P = 0.002), all analyzed skinfolds thicknesses, as well as the lipid profile in overweight group, and no changes in normal weight group. Significant changes in weight (by 4.2 kg, P = 0.005), body mass index (by 0.9 kg/m2, P = 0.005), crus skinfold thickness (by 3.3 mm, P = 0.028), and in maximum oxygen uptake (by 2.49 mL/kg/min; P = 0.047) were observed among underweight women. No change in total blood count was observed in all groups. Conclusion Twelve-week-long fitness training programme of two alternating styles (low and high impact) has a beneficial effect on overweight young women. PMID:25672474

  13. Effect of 12-week-long aerobic training programme on body composition, aerobic capacity, complete blood count and blood lipid profile among young women.

    PubMed

    Kostrzewa-Nowak, Dorota; Nowak, Robert; Jastrzębski, Zbigniew; Zarębska, Aleksandra; Bichowska, Marta; Drobnik-Kozakiewicz, Izabela; Radzimiński, Łukasz; Leońska-Duniec, Agata; Ficek, Krzysztof; Cięszczyk, Paweł

    2015-01-01

    Numerous data suggest that aerobic-type exercise improves lipoprotein-lipid profiles, cardiorespiratory fitness and body composition in young women. The aim of this study was to evaluate the biological response to high-low impact aerobic fitness among young women. Thirty-four young women aged 22 (19-24) years were divided into three groups: underweight (N=10), normal weight (N=12) and overweight (N=12). Aerobic capacity, anthropometry and body composition together with complete blood count and lipid profile were determined before and after completion of a 12-week-long training period. The training programme caused a significant decrease in weight (by 4.3 kg, P=0.003), body mass index (by 1.3 kg/m2, P=0.003), free fat mass (by 2.1 kg, P=0.002), total body water (by 0.4 kg, P=0.036), percentage of fat (by 3 percent points, P=0.002), all analyzed skinfolds thicknesses, as well as the lipid profile in overweight group, and no changes in normal weight group. Significant changes in weight (by 4.2 kg, P=0.005), body mass index (by 0.9 kg/m2, P=0.005), crus skinfold thickness (by 3.3 mm, P=0.028), and in maximum oxygen uptake (by 2.49 mL/kg/min; P=0.047) were observed among underweight women. No change in total blood count was observed in all groups. Twelve-week-long fitness training programme of two alternating styles (low and high impact) has a beneficial effect on overweight young women.

  14. [Incidence, management and costs of adverse effects in chronic hepatitis C patients on triple therapy with telaprevir or boceprevir: first 12 weeks of treatment].

    PubMed

    Guglieri-López, Beatriz; Ventura-Cerdá, José Manuel; Gómez-Álvarez, Sandra; Climente-Martí, Mónica

    2015-05-01

    The aim of the study was to analyze the incidence, management and cost associated to hematological and dermatological adverse effects (AE) in chronic hepatitis C patients on triple therapy (TT) with telaprevir (TVR) or boceprevir (BOC). An analysis was made on the data recorded on patients who started treatment with TVR or BOC associated with peginterferon alfa and ribavirin in a 12-week follow-up period. Fifty-three patients were included (TVR n=36; BOC n=17). Thrombocytopenia (83% TVR vs. 88% BOC) followed by neutropenia (89% TVR vs. 82% BOC) were the most common AE. Dermatological AE were observed in 32% of patients. Eleven patients required treatment discontinuation (all of them received TVR), and toxicity was the main reason for discontinuation (64%). The percentage of patients who required supportive treatment for management of AE was 66%. The most used supportive treatment was erythropoietin. Eight patients required emergency health care, and 2 were hospitalized due to AE. Total cost of additional supportive resources was 32,522€ (625 [SD=876]€/patient) (TVR 759 [SD=1,022]€/patient vs. BOC 349 [SD=327]€/patient; P>.05). Patients with gradeiii-iv toxicity required greater supportive care with higher costs, compared to patients with gradei-ii toxicity (849 [SD=1,143]€/patient vs. 387 [SD=397]€/patient; P=.053). The addition of new protease inhibitors to conventional treatment leads to a higher incidence of hematological AE in our study, compared to data described in clinical trials. The elevated incidence of AE involves the use of supportive care, increasing total costs of therapy. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  15. The Effectiveness of Mindfulness-Based Interventions in the Perinatal Period: A Systematic Review and Meta-Analysis.

    PubMed

    Lever Taylor, Billie; Cavanagh, Kate; Strauss, Clara

    2016-01-01

    Perinatal mental health difficulties are associated with adverse consequences for parents and infants. However, the potential risks associated with the use of psychotropic medication for pregnant and breastfeeding women and the preferences expressed by women for non-pharmacological interventions mean it is important to ensure that effective psychological interventions are available. It has been argued that mindfulness-based interventions may offer a novel approach to treating perinatal mental health difficulties, but relatively little is known about their effectiveness with perinatal populations. This paper therefore presents a systematic review and meta-analysis of the effectiveness of mindfulness-based interventions for reducing depression, anxiety and stress and improving mindfulness skills in the perinatal period. A systematic review identified seventeen studies of mindfulness-based interventions in the perinatal period, including both controlled trials (n = 9) and pre-post uncontrolled studies (n = 8). Eight of these studies also included qualitative data. Hedge's g was used to assess uncontrolled and controlled effect sizes in separate meta-analyses, and a narrative synthesis of qualitative data was produced. Pre- to post-analyses showed significant reductions in depression, anxiety and stress and significant increases in mindfulness skills post intervention, each with small to medium effect sizes. Completion of the mindfulness-based interventions was reasonable with around three quarters of participants meeting study-defined criteria for engagement or completion where this was recorded. Qualitative data suggested that participants viewed mindfulness interventions positively. However, between-group analyses failed to find any significant post-intervention benefits for depression, anxiety or stress of mindfulness-based interventions in comparison to control conditions: effect sizes were negligible and it was conspicuous that intervention group participants did

  16. The Effectiveness of Mindfulness-Based Interventions in the Perinatal Period: A Systematic Review and Meta-Analysis

    PubMed Central

    Lever Taylor, Billie; Cavanagh, Kate; Strauss, Clara

    2016-01-01

    Perinatal mental health difficulties are associated with adverse consequences for parents and infants. However, the potential risks associated with the use of psychotropic medication for pregnant and breastfeeding women and the preferences expressed by women for non-pharmacological interventions mean it is important to ensure that effective psychological interventions are available. It has been argued that mindfulness-based interventions may offer a novel approach to treating perinatal mental health difficulties, but relatively little is known about their effectiveness with perinatal populations. This paper therefore presents a systematic review and meta-analysis of the effectiveness of mindfulness-based interventions for reducing depression, anxiety and stress and improving mindfulness skills in the perinatal period. A systematic review identified seventeen studies of mindfulness-based interventions in the perinatal period, including both controlled trials (n = 9) and pre-post uncontrolled studies (n = 8). Eight of these studies also included qualitative data. Hedge’s g was used to assess uncontrolled and controlled effect sizes in separate meta-analyses, and a narrative synthesis of qualitative data was produced. Pre- to post-analyses showed significant reductions in depression, anxiety and stress and significant increases in mindfulness skills post intervention, each with small to medium effect sizes. Completion of the mindfulness-based interventions was reasonable with around three quarters of participants meeting study-defined criteria for engagement or completion where this was recorded. Qualitative data suggested that participants viewed mindfulness interventions positively. However, between-group analyses failed to find any significant post-intervention benefits for depression, anxiety or stress of mindfulness-based interventions in comparison to control conditions: effect sizes were negligible and it was conspicuous that intervention group participants

  17. The Effectiveness of Interventions to Establish Smoke-Free Homes in Pregnancy and in the Neonatal Period: A Systematic Review

    ERIC Educational Resources Information Center

    Baxter, Susan; Blank, Lindsay; Everson-Hock, Emma S.; Burrows, Julia; Messina, Josie; GuillaUme, Louise; Goyder, Elizabeth

    2011-01-01

    This review considers the effectiveness of interventions to encourage the establishment of smoke-free homes during pregnancy and the neonatal period. A comprehensive search of the literature was undertaken to find relevant studies via electronic databases, citations and reference lists of included studies. The searches identified 17 papers that…

  18. The Effectiveness of Interventions to Establish Smoke-Free Homes in Pregnancy and in the Neonatal Period: A Systematic Review

    ERIC Educational Resources Information Center

    Baxter, Susan; Blank, Lindsay; Everson-Hock, Emma S.; Burrows, Julia; Messina, Josie; GuillaUme, Louise; Goyder, Elizabeth

    2011-01-01

    This review considers the effectiveness of interventions to encourage the establishment of smoke-free homes during pregnancy and the neonatal period. A comprehensive search of the literature was undertaken to find relevant studies via electronic databases, citations and reference lists of included studies. The searches identified 17 papers that…

  19. Scaling dynamic response and destructive metabolism in an immunosurveillant anti-tumor system modulated by different external periodic interventions.

    PubMed

    Shao, Yuanzhi; Hu, Wenyong; Zhong, Weirong; Li, Li

    2011-01-14

    On the basis of two universal power-law scaling laws, i.e. the scaling dynamic hysteresis in physics and the allometric scaling metabolism in biosystem, we studied the dynamic response and the evolution of an immunosurveillant anti-tumor system subjected to a periodic external intervention, which is equivalent to the scheme of a radiotherapy or chemotherapy, within the framework of the growth dynamics of tumor. Under the modulation of either an abrupt or a gradual change external intervention, the population density of tumors exhibits a dynamic hysteresis to the intervention. The area of dynamic hysteresis loop characterizes a sort of dissipative-therapeutic relationship of the dynamic responding of treated tumors with the dose consumption of accumulated external intervention per cycle of therapy. Scaling the area of dynamic hysteresis loops against the intensity of an external intervention, we deduced a characteristic quantity which was defined as the theoretical therapeutic effectiveness of treated tumor and related with the destructive metabolism of tumor under treatment. The calculated dose-effectiveness profiles, namely the dose cumulant per cycle of intervention versus the therapeutic effectiveness, could be well scaled into a universal quadratic formula regardless of either an abrupt or a gradual change intervention involved. We present a new concept, i.e., the therapy-effect matrix and the dose cumulant matrix, to expound the new finding observed in the growth and regression dynamics of a modulated anti-tumor system.

  20. Effects of a periodized small-sided game training intervention on physical performance in elite professional soccer.

    PubMed

    Owen, Adam L; Wong, Del P; Paul, Darren; Dellal, Alexandre

    2012-10-01

    The present study examined the effects of periodized small-sided game (SSG) training intervention during a 4-week in-season break on the physical performance changes (i.e., speed, aerobic performance, and repeated sprint ability) within elite European soccer players. Fifteen, elite, male, professional players (age: 24.5 ± 3.45 years; height: 181.1 ± 5.78 cm; body mass: 78.7 ± 7.67 kg; VO2max: 54.88 ± 5.25 ml·kg(-1)·min(-1)) from a Scottish Premier League team participated in 7 separate SSG sessions (3 vs. 3 plus goalkeepers) of which games lasted for a 3-minute duration for the selected number of games (ranged from 5 to 11) increasing over the intervention period. To examine the effects of the SSG intervention on physical performance changes, pre- and posttesting sessions took place over a 2-day period (day 1: anthropometry and repeated sprint ability [RSA] assessments; day 2: running economy [RE] and blood lactate assessments). Results show that the 4-week SSG training intervention induced significant improvement in RSA as indicated by faster 10-m sprint time (p < 0.05, small effect), total sprint time (p < 0.05, medium effect), and smaller percentage decrement score (p < 0.05, medium effect). Furthermore, the SSGs also led to an improvement in RE as indicated through significantly reduced VO2 and heart rate at running speed 9, 11, and 14 km·h(-1) (all p's < 0.05, large effects). In conclusion, the present study demonstrates that implementing a periodized SSG training intervention during the 4-week in-season break is capable of improving elite-level soccer players' physical fitness characteristics. Being able to develop physical characteristics in conjunction to technical and tactical elements of the game, within a relatively short period, makes SSGs an appealing proposition for fitness coaches, players, and technical coaches alike.

  1. Improving blood pressure control in end stage renal disease through a supportive educative nursing intervention.

    PubMed

    Kauric-Klein, Zorica

    2012-01-01

    Hypertension in patients on hemodialysis (HD) contributes significantly to their morbidity and mortality. This study examined whether a supportive nursing intervention incorporating monitoring, goal setting, and reinforcement can improve blood pressure (BP) control in a chronic HD population. A randomized controlled design was used and 118 participants were recruited from six HD units in the Detroit metro area. The intervention consisted of (1) BP education sessions; (2) a 12-week intervention, including monitoring, goal setting, and reinforcement; and (3) a 30-day post-intervention follow-up period. Participants in the treatment were asked to monitor their BP, sodium, and fluid intake weekly for 12 weeks in weekly logs. BP, fluid and sodium logs were reviewed weekly with the researcher to determine if goals were met or not met. Reinforcement was given for goals met and problem solving offered when goals were not met. The control group received standard care. Both systolic and diastolic BPs were significantly decreased in the treatment group.

  2. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis

    PubMed Central

    Ahn, Nayoung; Kim, Kijin

    2016-01-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels. PMID:27630402

  3. Effects of 12-week Tai Chi training on soleus H-reflex and muscle strength in older adults: a pilot study.

    PubMed

    Chen, Yung-Sheng; Crowley, Zachary; Zhou, Shi; Cartwright, Colleen

    2012-06-01

    The purpose of this study was to determine the effects of 12-week Tai Chi (TC) training on the soleus (SOL) H-reflex modulation and plantarflexion muscle strength in older adults. Twenty volunteers were assigned into training (N = 14; 72.2 ± 3.7 years of age) and control (N = 6; 74.2 ± 6.1 years of age) groups. The participants in the TC group practiced Yang style TC 1 h per session, 3 sessions per week, for 12 weeks, guided by a qualified TC instructor. The ratio of the maximal peak-to-peak amplitude of SOL H-reflex (H (max)) to M-wave (M (max)) was determined during bipedal standing under four sensory conditions: stable surface and eyes open (SO), stable surface and eyes closed (SC), unstable surface and eyes open (UO), and unstable surface and eyes closed (UC). The maximal isometric plantarflexion muscle strength was also assessed by using a dynamometer. The results showed that the SOL H (max)/M (max) ratio increased significantly after the 12 weeks of TC training under the SC (37.0%), UO (33.3%) and UC (36.0%) conditions (P < 0.05). The maximal plantarflexion strength also improved significantly after training (19.8%; P < 0.05). In contrast, the control group showed no significant changes in all measurements after the 12 weeks.

  4. A randomized 12-week study to compare the gingivitis and plaque reduction benefits of a rotation-oscillation power toothbrush and a sonic power toothbrush.

    PubMed

    Goyal, C R; Qaqish, J; He, Tao; Grender, Julie; Walters, Pat; Biesbrock, Aaron R

    2009-01-01

    Sonic and rotation-oscillation power toothbrushes are popular and effective, but have been shown to differ in relative benefits. The objective of this 12-week investigation was to compare the efficacy of a rotation-oscillation powered toothbrush and a newly introduced sonic toothbrush in the reduction of gingivitis and dental plaque. This was a randomized, controlled, examiner-blind, two-treatment, parallel-group study to assess gingivitis reduction and plaque reductions after twice-daily brushing with either the rotation-oscillation brush or the sonic toothbrush over 12 weeks. The Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) were used to determine gingivitis benefits at Week 6 and Week 12, and plaque was scored at these visits before and after supervised brushing using the Rustogi Modified Navy Plaque Index (RMNPI). In 171 evaluable subjects, gingivitis reduction benefits were significantly greater for the rotation-oscillation brush group than for those using the sonic toothbrush, with relative mean benefits favoring the rotation-oscillation brush of 29.4% for GBI and 8.2% for MGI at 12 weeks (p < or = 0.01). The rotation-oscillation brush produced significantly lower RMNPI plaque by 33.3% compared to the sonic toothbrush (p < 0.001) at Week 12. The rotation-oscillation power toothbrush was significantly more efficacious than the sonic toothbrush in removing plaque, in reducing gingivitis, and lowering the number of bleeding sites after 12 weeks of twice-daily brushing.

  5. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis.

    PubMed

    Ahn, Nayoung; Kim, Kijin

    2016-08-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels.

  6. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury.

    PubMed

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-09-22

    (1) BACKGROUND: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) METHODS: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) RESULTS: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) CONCLUSION: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  7. The Effects of 12 Weeks Regular Aerobic Exercise on Brain-derived Neurotrophic Factor and Inflammatory Factors in Juvenile Obesity and Type 2 Diabetes Mellitus.

    PubMed

    Lee, Sung Soo; Yoo, Jae Ho; Kang, Sung; Woo, Jin Hee; Shin, Ki Ok; Kim, Kwi Beak; Cho, Su Youn; Roh, Hee Tae; Kim, Young Il

    2014-08-01

    [Purpose] The purpose of this study was to investigate the effects of 12 weeks regular aerobic exercise on brain-derived neurotrophic factor (BDNF) and inflammatory factors in juvenile obesity and type 2 diabetes mellitus (T2DM). Obesity and T2DM, typically common among adults, have recently become more prevalent in the Korean juvenile population, affecting not only their lipid profiles and oxidant stress levels, but also their BDNF and inflammatory factor levels. [Subjects] This study enrolled 26 juveniles (boys = 15, girls = 9) who were assigned to a control group (CG, n = 11), obesity group (OG, n = 8), or T2DM group (TG, n = 7). [Methods] The outcome of a 40-60-minute aerobic exercise session that took place three times per week for 12 weeks at a maximum oxygen intake (VO2max) of 50~60% was investigated. [Results] The exercise resulted in a significant reduction in the resting serum BDNF and TrkB levels (baseline) among juveniles in the OG and TG as compared to those in the CG. Additionally, the 12 weeks of regular aerobic exercise led to significant reductions in body weight, body fat percentage, and body mass index in the OG and a significant increase of VO2max in the OG and TG. However, no significant differences in serum NGF or inflammatory factors were found among the three groups. There was a significant increase in resting serum BDNF levels following the 12 weeks regular exercise only in the OG. [Conclusion] While 12 weeks of regular aerobic exercise had a positive effect on body composition, and increased BDNF levels of juveniles in the OG, it did not affect the inflammatory factor levels and had no effect on the TG.

  8. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens

    PubMed Central

    Luetkemeyer, Anne F.; McDonald, Cheryl; Ramgopal, Moti; Noviello, Stephanie; Bhore, Rafia; Ackerman, Peter

    2016-01-01

    Background. Highly effective hepatitis C virus (HCV) direct-acting antiviral therapies that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens are needed. We evaluated the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (ARV) regimen in HIV-HCV-coinfected patients. Methods. In the randomized, open-label ALLY-2 study, HIV-HCV-coinfected patients received 8 or 12 weeks of once-daily DCV 60 mg (dose-adjusted as-necessary for concomitant ARVs) + SOF 400 mg. Results were stratified by ARV class for the 151 patients who received 12 weeks of DCV + SOF. Results. Fifty-one patients were HCV treatment experienced, 100 were treatment naive, 89% male and 33% black. HCV genotypes were: genotype 1a (GT1a; 69%), GT1b (15%), GT2 (8%), GT3 (6%), and GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across ARV regimens (P = .774): protease inhibitor-based, 97% (95% confidence interval [CI], 90%-99.7%); nonnucleoside reverse transcriptase inhibitor-based, 100% (95% CI, 91%-100%); and integrase inhibitor based, 95% (95% CI, 83%-99.4%). SVR12 among patients receiving either tenofovir disoproxil fumarate or abacavir as part of their antiretroviral therapy regimen was 98% (95% CI, 93%-99.5%) and 100% (95% CI, 85%-100%), respectively. Age, gender, race, cirrhosis, HCV treatment history, GT , and baseline HCV RNA did not affect SVR12. No discontinuations were attributed to treatment-related adverse events. Conclusions. DCV + SOF x12 weeks is a highly efficacious, all-oral, pan-GT HCV treatment for HIV-HCV coinfected patients across a broad range of ARV regimens. Clinical Trials Registration. NCT02032888. PMID:27025835

  9. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection.

    PubMed

    Gane, Edward J; Hyland, Robert H; Yang, Yin; Svarovskaia, Evguenia; Stamm, Luisa M; Brainard, Diana M; McHutchison, John G; Stedman, Catherine A M

    2017-05-01

    Patients with chronic hepatitis C virus (HCV) genotype 2 have high rates of response to treatment with sofosbuvir and ribavirin. However, ribavirin is associated with hemolytic events and is poorly tolerated by some patients. We evaluated the effectiveness of sofosbuvir and ledipasvir in treatment-naïve and treatment-experienced patients with HCV genotype 2, comparing 12 versus 8 weeks of treatment. This Phase 2, open-label study included 2 cohorts in New Zealand. The first received a fixed-dose combination tablet of ledipasvir-sofosbuvir (90/400 mg) once daily for 12 weeks. If this cohort had a 90% rate of sustained virologic response (SVR) 4 weeks after treatment, a second cohort receiving 8 weeks of ledipasvir-sofosbuvir was to be enrolled. The primary endpoint in both cohorts was the percentage of patients with HCV RNA <15 IU/mL 12 weeks after therapy (SVR12). SVR12 rates were 96% (25/26; 95% CI, 80%-100%) for 12 weeks and 74% (20/27; 95% CI, 54%-89%) for 8 weeks of ledipasvir-sofosbuvir. The single patient receiving 12 weeks of ledipasvir-sofosbuvir who did not reach SVR12 did not complete treatment because of withdrawing consent after receiving 1 dose of study drug. Six of the 7 patients who did not reach SVR12 after 8 weeks of treatment experienced virologic relapse after stopping therapy. The most common adverse events were headache (26% of patients), fatigue (21%), and nausea (17%). No patients discontinued treatment because of an adverse event. For treatment-naïve and -experienced patients, ledipasvir-sofosbuvir for 12 weeks is highly effective for the treatment of HCV genotype 2 (ClinicalTrials.gov: NCT02202980). Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

  10. Eight- or 12-Week Treatment of Hepatitis C with Ledipasvir/Sofosbuvir: Real-World Experience in a Large Integrated Health System.

    PubMed

    Lai, Jennifer B; Witt, Maxwell A; Pauly, Mary Patricia; Ready, Joanna; Allerton, Michael; Seo, Suk; Witt, David J

    2017-03-01

    Second-generation direct-acting antiviral agents are integral to treatment of hepatitis C (HCV) infection. Eight-week courses of ledipasvir/sofosbuvir (LDV/SOF) have been supported in some studies, but data are limited on efficacy in real-world use. Controversy exists regarding applicability of clinical trials to real-world effectiveness. We report virologic responses of patients with HCV genotype 1 infection receiving LDV/SOF for 8 or 12 weeks in a large integrated healthcare system. All patients receiving LDV/SOF, without ribavirin, were identified from pharmacy records, and outcomes are reported. Only treatment-naïve patients without evidence of cirrhosis and hepatitis C viral load less than 6 million IU/ml were candidates for 8-week therapy. Treatment was at clinician discretion, but delivered by a multidisciplinary team and reviewed for appropriateness and adherence to these criteria by one of the authors, all experienced in hepatitis C treatment. Sustained viral response at 12 weeks (SVR 12) was contrasted between those receiving 8 and those receiving 12 weeks of treatment. Completed prescriptions for LDV/SOF, without ribavirin, as of 30 September 2015 were identified in 1021 patients. Five patients discontinued therapy due to medical reasons and 35 had incomplete follow-up viral load data, thus there were 981 evaluable patients: 377 treated for 8 weeks and 604 treated for 12 weeks. SVR 12 was virtually identical at 93.6 and 93.5%, respectively. Baseline characteristics differed between the two groups, as only treatment-naïve, non-cirrhotic, non-HIV-infected patients were eligible for an 8-week course of therapy. Eight-week courses of LDV/SOF are comparable to 12-week courses in real-world use among selected patients supported by a multidisciplinary team.

  11. Middle-aged Female Depression in Perimenopausal Period and Square Dance Intervention.

    PubMed

    Gao, Lei; Zhang, Linlin; Qi, Hua; Petridis, Louyis

    2016-12-01

    Depression is one of the most common psychiatric illnesses among perimenopausal women. Currently, drug treatments for the disorder tend to have higher risks than other forms of treatment. On the contrary, aerobic exercise can effectively relieve menopausal syndrome among perimenopausal women. Square dance, a kind of aerobic exercise favored by middle-aged women in China, could be a beneficial intervention for perimenopausal depression. A total of 321 women in perimenopause were chosen from Nangang Community, DaoLi Community, and Daowai Community in Harbin, Heilongjiang Province, from September 2015 through April 2016. Of the women with depressive symptoms, 60 did not participate in square dance. The subjects were randomly assigned to the intervention group (n=26) and control group (n=24). Intervention group patients participated in guided square dance exercise 60-90 min at least 5 times per week at a regular time for 3 months. The women in the control group received no intervention. Of the screened subjects, 72 women (22.4%) suffered mild to severe depression; younger, working married women who square danced regularly presented a low depression rate (p<0.05). The depression index score of the intervention group after three months was 0.43±0.09, a statistically significant decrease (t=5.658, p<0.001). The difference in the depression index changes of the intervention and control group was also significant (t=5.407, p<0.001). The depression rate among women in perimenopause is high. Some intervention measures, such as promoting female employment, organizing collective activities for retired or unemployed women, and stabilizing family ties can prevent or improve the depression of women in perimenopause. Square dance can effectively reduce the depression levels of women in perimenopause.

  12. The role of screening, brief intervention, and referral to treatment in the perinatal period.

    PubMed

    Wright, Tricia E; Terplan, Mishka; Ondersma, Steven J; Boyce, Cheryl; Yonkers, Kimberly; Chang, Grace; Creanga, Andreea A

    2016-11-01

    Substance use during pregnancy is at least as common as many of the medical conditions screened for and managed during pregnancy. While harmful and costly, it is often ignored or managed poorly. Screening, brief intervention, and referral to treatment is an evidence-based approach to manage substance use. In September 2012, the US Centers for Disease Control and Prevention convened an Expert Meeting on Perinatal Illicit Drug Abuse to help address key issues around drug use in pregnancy in the United States. This article reflects the formal conclusions of the expert panel that discussed the use of screening, brief intervention, and referral to treatment during pregnancy. Screening for substance use during pregnancy should be universal. It allows stratification of women into zones of risk given their pattern of use. Low-risk women should receive brief advice, those classified as moderate risk should receive a brief intervention, whereas those who are high risk need referral to specialty care. A brief intervention is a patient-centered form of counseling using the principles of motivational interviewing. Screening, brief intervention, and referral to treatment has the potential to reduce the burden of substance use in pregnancy and should be integrated into prenatal care. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Development of Speech Fluency over a Short Period of Time: Effects of Pedagogic Intervention

    ERIC Educational Resources Information Center

    Tavakoli, Parvaneh; Campbell, Colin; McCormack, Joan

    2016-01-01

    This study investigates the effects of a short-term pedagogic intervention on development of second language (L2) fluency among learners studying English for academic purposes at a UK university. It also examines the interaction between development of fluency and complexity and accuracy. Through a pretest and posttest design, data were collected…

  14. Arousal, Attention, and Neurobehavioral Assessment in the Neonatal Period: Implications for Intervention and Policy

    ERIC Educational Resources Information Center

    Gardner, Judith M.; Karmel, Bernard Z.; Freedland, Robert L.; Lennon, Elizabeth M.; Flory, Michael J.; Miroshnichenko, Inna; Phan, Ha T. T.; Barone, Anthony; Harin, Anantham

    2006-01-01

    Neonatal assessments should provide valid estimates of behavior and neurological status, reflect recovery from acute effects, predict subsequent outcome, and point to specific intervention strategies for any problems noted. The authors report relations among measures designed to evaluate early behavioral capabilities and dysfunctions in areas…

  15. Arousal, Attention, and Neurobehavioral Assessment in the Neonatal Period: Implications for Intervention and Policy

    ERIC Educational Resources Information Center

    Gardner, Judith M.; Karmel, Bernard Z.; Freedland, Robert L.; Lennon, Elizabeth M.; Flory, Michael J.; Miroshnichenko, Inna; Phan, Ha T. T.; Barone, Anthony; Harin, Anantham

    2006-01-01

    Neonatal assessments should provide valid estimates of behavior and neurological status, reflect recovery from acute effects, predict subsequent outcome, and point to specific intervention strategies for any problems noted. The authors report relations among measures designed to evaluate early behavioral capabilities and dysfunctions in areas…

  16. Efficacy and safety of valsartan compared to enalapril in hypertensive children: a 12-week, randomized, double-blind, parallel-group study.

    PubMed

    Schaefer, Franz; Litwin, Mieczyslaw; Zachwieja, Jacek; Zurowska, Aleksandra; Turi, Sandor; Grosso, Amie; Pezous, Nicole; Kadwa, Mahomed

    2011-12-01

    This study compares efficacy and safety of valsartan with enalapril in hypertensive children aged 6-17 years. This was a 12-week, randomized, double-blind, parallel-group, active-controlled study. After a single-blind placebo run-in period (4-28 days), patients with mean sitting systolic blood pressure (BP) (MSSBP) at least 95th percentile for age, gender, and height were randomized to receive half the assigned dose for first week, and force-titrated to full dose for 11 weeks (≥18 to <35 kg - valsartan: 80 mg, enalapril: 10 mg; ≥35 to <80 kg - valsartan: 160 mg, enalapril: 20 mg; ≥80 to ≤160 kg - valsartan: 320 mg, enalapril: 40 mg). The primary efficacy variable was changed from baseline in MSSBP to show noninferiority of valsartan to enalapril. Other efficacy variables were changed from baseline in MSDBP, SBP control rate, and 24-h ambulatory BP parameters. Of 300 randomized patients, 281 (94%) completed the study. At week 12, MSSBP reductions were similar for valsartan and enalapril (primary endpoint of noninferiority, P < 0.0001). Least square mean BP reductions from baseline of -15.4/-9.4 mmHg were observed for valsartan compared with -14.1/-8.5 mmHg for enalapril. A similar proportion of patients achieved SBP control (valsartan: 67%; enalapril: 70%). In the subset of patients who underwent ambulatory BP assessments, valsartan provided greater reductions than enalapril in mean 24-h SBP (valsartan: -9.8 mmHg, enalapril: -7.2 mmHg: P = 0.03). The overall incidence of AEs was similar (valsartan 60%, enalapril 58%) with headache, cough, and nasopharyngitis reported most frequently. Valsartan and enalapril provided comparable BP reductions and effective BP control and were well tolerated in hypertensive children aged 6-17 years.

  17. Mortality benefits of vigorous air quality improvement interventions during the periods of APEC Blue and Parade Blue in Beijing, China.

    PubMed

    Lin, Hualiang; Liu, Tao; Fang, Fang; Xiao, Jianpeng; Zeng, Weilin; Li, Xing; Guo, Lingchuan; Tian, Linwei; Schootman, Mario; Stamatakis, Katherine A; Qian, Zhengmin; Ma, Wenjun

    2017-01-01

    Vigorous air pollution control measures were implemented during the 2014 Asia-Pacific Economic Cooperation and a large-scale military parade (described here as "APEC Blue" and "Parade Blue" periods) in Beijing, China. A natural experiment was conducted in a health impact assessment framework to estimate the number of deaths attributable to PM2.5, using concentration-response functions derived from previous studies conducted in Beijing, combined with the differences in PM2.5 concentrations between intervention and reference periods. Substantial reductions in daily PM2.5 concentrations were observed during both intervention periods. Using the same dates from the prior year as a reference, daily PM2.5 concentration decreased from 98.57 μg/m(3) to 47.53 μg/m(3) during "APEC Blue", and from 59.15 μg/m(3) to 17.07 μg/m(3) during the "Parade Blue". We estimated that 39-63 all-cause deaths (21-51 cardiovascular, 6-13 respiratory deaths) have been prevented during the APEC period; and 41-65 deaths (22-52 cardiovascular, 6-13 respiratory deaths) have been prevented during the Parade period. This study shows that substantial mortality reductions could be achieved by implementing stringent air pollution mitigation measures.

  18. A 12-Week Cycling Training Regimen Improves Gait and Executive Functions Concomitantly in People with Parkinson’s Disease

    PubMed Central

    Nadeau, Alexandra; Lungu, Ovidiu; Duchesne, Catherine; Robillard, Marie-Ève; Bore, Arnaud; Bobeuf, Florian; Plamondon, Réjean; Lafontaine, Anne-Louise; Gheysen, Freja; Bherer, Louis; Doyon, Julien

    2017-01-01

    Background: There is increasing evidence that executive functions and attention are associated with gait and balance, and that this link is especially prominent in older individuals or those who are afflicted by neurodegenerative diseases that affect cognition and/or motor functions. People with Parkinson’s disease (PD) often present gait disturbances, which can be reduced when PD patients engage in different types of physical exercise (PE), such as walking on a treadmill. Similarly, PE has also been found to improve executive functions in this population. Yet, no exercise intervention investigated simultaneously gait and non-motor symptoms (executive functions, motor learning) in PD patients. Objective: To assess the impact of aerobic exercise training (AET) using a stationary bicycle on a set of gait parameters (walking speed, cadence, step length, step width, single and double support time, as well as variability of step length, step width and double support time) and executive functions (cognitive inhibition and flexibility) in sedentary PD patients and healthy controls. Methods: Two groups, 19 PD patients (Hoehn and Yahr ≤2) and 20 healthy adults, matched on age and sedentary level, followed a 3-month stationary bicycle AET regimen. Results: Aerobic capacity, as well as performance of motor learning and on cognitive inhibition, increased significantly in both groups after the training regimen, but only PD patients improved their walking speed and cadence (all p < 0.05; with no change in the step length). Moreover, in PD patients, training-related improvements in aerobic capacity correlated positively with improvements in walking speed (r = 0.461, p < 0.05). Conclusion: AET using stationary bicycle can independently improve gait and cognitive inhibition in sedentary PD patients. Given that increases in walking speed were obtained through increases in cadence, with no change in step length, our findings suggest that gait improvements are specific to the type

  19. A 12-Week Cycling Training Regimen Improves Gait and Executive Functions Concomitantly in People with Parkinson's Disease.

    PubMed

    Nadeau, Alexandra; Lungu, Ovidiu; Duchesne, Catherine; Robillard, Marie-Ève; Bore, Arnaud; Bobeuf, Florian; Plamondon, Réjean; Lafontaine, Anne-Louise; Gheysen, Freja; Bherer, Louis; Doyon, Julien

    2016-01-01

    Background: There is increasing evidence that executive functions and attention are associated with gait and balance, and that this link is especially prominent in older individuals or those who are afflicted by neurodegenerative diseases that affect cognition and/or motor functions. People with Parkinson's disease (PD) often present gait disturbances, which can be reduced when PD patients engage in different types of physical exercise (PE), such as walking on a treadmill. Similarly, PE has also been found to improve executive functions in this population. Yet, no exercise intervention investigated simultaneously gait and non-motor symptoms (executive functions, motor learning) in PD patients. Objective: To assess the impact of aerobic exercise training (AET) using a stationary bicycle on a set of gait parameters (walking speed, cadence, step length, step width, single and double support time, as well as variability of step length, step width and double support time) and executive functions (cognitive inhibition and flexibility) in sedentary PD patients and healthy controls. Methods: Two groups, 19 PD patients (Hoehn and Yahr ≤2) and 20 healthy adults, matched on age and sedentary level, followed a 3-month stationary bicycle AET regimen. Results: Aerobic capacity, as well as performance of motor learning and on cognitive inhibition, increased significantly in both groups after the training regimen, but only PD patients improved their walking speed and cadence (all p < 0.05; with no change in the step length). Moreover, in PD patients, training-related improvements in aerobic capacity correlated positively with improvements in walking speed (r = 0.461, p < 0.05). Conclusion: AET using stationary bicycle can independently improve gait and cognitive inhibition in sedentary PD patients. Given that increases in walking speed were obtained through increases in cadence, with no change in step length, our findings suggest that gait improvements are specific to the type

  20. A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Eszopiclone 2 mg on Sleep/Wake Function in Older Adults with Primary and Comorbid Insomnia

    PubMed Central

    Ancoli-Israel, Sonia; Krystal, Andrew D.; McCall, W. Vaughn; Schaefer, Kendyl; Wilson, Amy; Claus, Raymond; Rubens, Robert; Roth, Thomas

    2010-01-01

    Background: Longer-term pharmacologic studies for insomnia in older individuals are sparse. Objective: To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia. Methods: Participants (65–85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) ≤ 6 h, and wake time after sleep onset (WASO) ≥ 45 min. Participants were randomized to 12 weeks of eszopiclone 2 mg (n = 194) or placebo (n = 194), followed by a 2-week single-blind placebo run-out. Subject-reported measures of sleep (sTST, sleep latency [sSL], sWASO) and daytime function (alertness, concentration, well-being, ability to function) were assessed. AEs were monitored. Results: Subjects treated with 2 mg eszopiclone slept longer at night on average and at every individual time point compared to baseline than placebo subjects, as measured by TST over the 12-week double-blind period (P < 0.0001). Mean sTST over the double-blind period for eszopiclone-treated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclone-treated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus a mean decrease of 19.92 min, respectively (P = 0.0014). Eszopiclone subjects also experienced a significantly greater decrease in WASO (mean decrease of 36.4 min) compared to placebo subjects (decrease of 14.8 min) (P < 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values ≤ 0.01), indicating no rebound. The most common AEs (≥ 5%) were headache (eszopiclone 13.9%, placebo 12.4%), unpleasant taste (12.4%, 1.5%), and nasopharyngitis (5.7%, 6.2%). Conclusion: In this Phase IV trial of older adults with insomnia, eszopiclone significantly improved patient-reported sleep and daytime function relative to placebo. Improvements occurred within the first week and

  1. In a randomized case-control trial with 10-years olds suffering from attention deficit/hyperactivity disorder (ADHD) sleep and psychological functioning improved during a 12-week sleep-training program.

    PubMed

    Keshavarzi, Zahra; Bajoghli, Hafez; Mohamadi, Mohammad Reza; Salmanian, Maryam; Kirov, Roumen; Gerber, Markus; Holsboer-Trachsler, Edith; Brand, Serge

    2014-12-01

    We tested the hypothesis that sleep training would improve emotional, social and behavioural functioning in children with attention-deficit/hyperactivity disorder (ADHD) compared to children with ADHD without such intervention and to healthy controls. Forty children with ADHD were randomly assigned to intervention and control conditions. Parents of 20 children with ADHD were instructed and thoroughly supervised in improving their children's sleep schedules and sleep behaviour. Parents of the other 20 children with ADHD and parents of 20 healthy children received general information about sleep hygiene. At baseline and 12 weeks later, parents and children completed questionnaires related to children's sleep and psychological functioning. Relative to the control groups, children in the intervention group improved sleep quantitatively and qualitatively (F values < 3.33, P values < 0.05). The intervention group children reported improvements in mood, emotions, and relationships (F values < 2.99, P values < 0.05). Parents reported that their children improved in physical and psychological wellbeing, mood, emotions, relationships, and social acceptance (F values < 3.02, P values < 0.05). Training and monitoring parents of children with ADHD in regulating and supervising children's sleep schedules leads to positive changes in the emotions, behaviour and social lives of these children.

  2. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial.

    PubMed

    Foley, J E; Bunck, M C; Möller-Goede, D L; Poelma, M; Nijpels, G; Eekhoff, E M; Schweizer, A; Heine, R J; Diamant, M

    2011-08-01

    Traditional blood glucose lowering agents do not prevent the progressive loss of beta cell function in patients with type 2 diabetes. The dipeptidylpeptidase (DPP)-4 inhibitor vildagliptin improves beta cell function both acutely and chronically (up to 2 years). Whether this effect persists after cessation of treatment remains unknown. Here, we assessed the insulin secretory capacity in drug-naive patients with type 2 diabetes after a 52 week treatment period with vildagliptin or placebo, and again after a 12 week washout period. This study was conducted at a single university medical centre, and was a double-blind, randomised clinical trial in 59 drug-naive patients with type 2 diabetes and mild hyperglycaemia to either vildagliptin 100 mg (n = 29) or placebo (n = 30). Randomisation was performed by a validated 1:1 system. Neither patient, nor caregiver, was informed about the assigned treatment. Inclusion criteria were drug-naive patients ≥30 years, with HbA(1c) ≤7.5% and BMI of 22-45 kg/m(2). The mildly hyperglycaemic patient population was chosen to minimise glucose toxicity as a confounding variable. Beta-cell function was measured during an arginine-stimulated hyperglycaemic clamp at week 0, week 52 and after a 12 week washout period. All patients with at least one post-randomisation measure were analysed (intent-to-treat). Fifty-two week vildagliptin 100 mg (n = 26) treatment increased the primary efficacy variable, combined hyperglycaemia and arginine-stimulated C-peptide secretion (AIR(arg)), by 5.0 ± 1.8 nmol/l × min, while it decreased by 0.8 ± 1.8 nmol/l × min with placebo (n = 25) (between-group difference p = 0.030). No significant between-group difference in AIR(arg) was seen after the 12 week washout period. The between-group difference adjusted mean 52 week changes from baseline was -0.19 ± 0.11, p = 0.098 and -0.22 ± 0.23%, p = 0.343 for HbA(1c) and fasting plasma glucose, respectively

  3. Behavioral Patterns and Associations with Glucose Control During 12-Week Randomized Free-Living Clinical Trial of Day and Night Hybrid Closed-Loop Insulin Delivery in Adults with Type 1 Diabetes.

    PubMed

    Emami, Ali; Willinska, Malgorzata E; Thabit, Hood; Leelarathna, Lalantha; Hartnell, Sara; Dellweg, Sibylle; Benesch, Carsten; Mader, Julia K; Holzer, Manuel; Kojzar, Harald; Pieber, Thomas R; Arnolds, Sabine; Evans, Mark L; Hovorka, Roman

    2017-07-01

    We evaluated patterns of meal intake, insulin bolus delivery, and fingerstick glucose measurements during hybrid closed-loop and sensor-augmented pump (SAP) therapy, including associations with glucose control. Data were retrospectively analyzed from pump-treated adults with type 1 diabetes who underwent, in random order, 12 weeks free-living closed-loop (n = 32) and 12 weeks SAP (n = 33) periods. We quantified daily patterns of main meals, snacks, prandial insulin boluses, correction boluses, and fingerstick glucose measurements by analyzing data recorded on the study glucometer and on study insulin pump. We analyzed 1942 closed-loop days and 2530 SAP days. The total number of insulin boluses was reduced during closed-loop versus SAP periods by mean 1.0 per day (95% confidence interval 0.6-1.4, P < 0.001) mainly because of a reduced number of correction boluses by mean 0.7 per day (0.4-1.0, P < 0.001). Other behavioral patterns were unchanged. The carbohydrate content of snacks but not the number of snacks was positively correlated with (1) glycemic variability as measured by standard deviation of sensor glucose (closed-loop P < 0.05; SAP P < 0.01), (2) mean sensor glucose (P < 0.05), and (3) postintervention HbA1c (P < 0.05). Behavioral patterns explained 47% of between-subject variance in glucose variability during SAP period and 30%-33% of variance of means sensor glucose and postintervention HbA1c. Fewer correction boluses are delivered during closed-loop period. The size of snacks appears to worsen glucose control possibly because of carbohydrate-rich content of snacks. Modifiable behavioral patterns may be important determinants of glucose control.

  4. Changes in clinical management and diagnosis following DaTscan SPECT imaging in patients with clinically uncertain parkinsonian syndromes: a 12-week follow-up study.

    PubMed

    Kupsch, Andreas; Bajaj, Nin; Weiland, Frederick; Tartaglione, Antonio; Klutmann, Susanne; Copp, Ronald; Sherwin, Paul; Tate, Ann; Grachev, Igor D

    2013-01-01

    An accurate diagnosis is important for timely and adequate treatment in patients with clinically uncertain parkinsonian syndrome (CUPS). The objective of this study was to assess safety and changes in clinical management, diagnosis and quality of life (QoL) at 4 and 12 weeks following DaTscan (ioflupane [(123)I] injection) imaging in patients with CUPS. This randomized, open-label, single-dose, multicenter trial was carried out in patients with CUPS who were randomized to either a DaTscan imaging group or to a control group without imaging. The main outcome measures were the proportions of patients with changes in clinical management and diagnosis from baseline through to 12 weeks after DaTscan. A total of 19 university hospital centers in Europe and the USA participated in the study. There were 267 patients enrolled and randomized (131 DaTscan, 136 control). Significantly more DaTscan patients had changes in clinical management after 12 weeks (p = 0.004) compared to the control group, and significantly more DaTscan patients had changes in diagnosis at 4 weeks and at 12 weeks (both p < 0.001) compared to control patients. No significant difference in total score for QoL was observed between groups during the study duration. DaTscan was safe and well-tolerated. No deaths, serious adverse events (AEs) or withdrawals due to AEs occurred during the study. One patient had a headache following treatment with a suspected relationship to DaTscan. DaTscan imaging significantly affected the clinical management and diagnosis of patients with CUPS. DaTscan is safe and well-tolerated and is a useful adjunct to differential diagnosis of CUPS. Copyright © 2012 S. Karger AG, Basel.

  5. Dairy food consumption and meal-induced cortisol response interact to influence weight loss in overweight women undergoing a 12-week meal-controlled weight loss intervention

    USDA-ARS?s Scientific Manuscript database

    Dairy foods enhance weight loss in animal models possibly by modifying the metabolic effects of cortisol. This study aimed to determine in overweight women (ages 20-45; n=51) whether inclusion of dairy foods in an energy-restricted diet affects basal and stimulated cortisol concentrations, and whet...

  6. Evaluation of Magnetic Resonance Imaging Responsiveness in Active Psoriatic Arthritis at Multiple Timepoints during the First 12 Weeks of Antitumor Necrosis Factor Therapy.

    PubMed

    Feletar, Marie; Hall, Stephen; Bird, Paul

    2016-01-01

    To assess the responsiveness of high- and low-field extremity magnetic resonance imaging (MRI) variables at multiple timepoints in the first 12 weeks post-antitumor necrosis factor (anti-TNF) therapy initiation in patients with psoriatic arthritis (PsA) and active dactylitis. Twelve patients with active PsA and clinical evidence of dactylitis involving at least 1 digit were recruited. Patients underwent sequential high-field conventional (1.5 Tesla) and extremity low-field MRI (0.2 Tesla) of the affected hand or foot, pre- and postgadolinium at baseline (pre-TNF), 2 weeks (post-TNF), 6 weeks, and 12 weeks. A blinded observer scored all images on 2 occasions using the PsA MRI scoring system. Eleven patients completed the study, but only 6 patients completed all high-field and low-field MRI assessments. MRI scores demonstrated rapid response to TNF inhibition with score reduction in tenosynovitis, synovitis, and osteitis at 2 weeks. Intraobserver reliability was good to excellent for all variables. High-field MRI demonstrated greater sensitivity to tenosynovitis, synovitis, and osteitis and greater responsiveness to change posttreatment. Treatment responses were maintained to 12 weeks. This study demonstrates the use of MRI in detecting early response to biologic therapy. MRI variables of tenosynovitis, synovitis, and osteitis demonstrated responsiveness posttherapy with high-field scores more responsive to change than low-field scores.

  7. The influence of a 12-week program of physical activity on changes in body composition and lipid and carbohydrate status in postmenopausal women

    PubMed Central

    Pilch, Wanda Barbara; Mucha, Dariusz Mikołaj; Pałka, Tomasz Adam; Suder, Agnieszka Ewa; Tyka, Anna Katarzyna; Tota, Łukasz Marcin; Ambroży, Tadeusz

    2015-01-01

    Introduction For years there have been studies on what kind of physical activity is optimal for maintaining proper health condition. Besides well known and approved endurance training of moderate intensity, an importance of interval exercise where short term, sudden intensification of work is performed at low endurance load is emphasized. The aim of the work was to assess the effects of a program of physical activity applied to postmenopausal women regarding improvement of their body composition and biochemical indices of lipid and carbohydrate status. Material and methods The program of physical activity contained 12-week trainings of Nordic walking (NW) and gymnastic-dance classes (G-D). The intensity of effort during the NW training was at the level of 60% HRmax, whereas intensity of G-D exercises was selected based on a subjective assessment of effort according to the scale of American College of Sports Medicine. Results The 12-week program of physical activity resulted in statistically significant lowering of total cholesterol and low density lipoprotein (LDL) fraction levels. An increase in high density lipoprotein (HDL) cholesterol level was observed, whereas the values of triacylglycerols (TG) did not change. The average fasting blood glucose level decreased significantly. Similar changes were noted for the insulin level. The analysed body biometrical-structural indices did not change significantly. Conclusions The applied 12-week program of physical activity without changes of dietary habits contributed to an improvement in plasma lipid profile and an increased insulin sensitivity, but it did not affect significantly body composition. PMID:26848294

  8. A cross-cultural comparison of the development of the social smile: a longitudinal study of maternal and infant imitation in 6- and 12-week-old infants.

    PubMed

    Wörmann, Viktoriya; Holodynski, Manfred; Kärtner, Joscha; Keller, Heidi

    2012-06-01

    Social smiling is universally regarded as being an infant's first facial expression of pleasure. Underlying co-constructivist emotion theories are the assumptions that the emergence of social smiling is bound to experiences of face-to-face interactions with caregivers and the impact of two developmental mechanisms--maternal and infant imitation. We analyzed mother-infant interactions from two different socio-cultural contexts and hypothesized that cross-cultural differences in face-to-face interactions determine the occurrence of both of these mechanisms and of the frequency of social smiling by 12-week-old infants. Twenty mother-infant dyads from a socio-cultural community with many face-to-face interactions (German families, Münster) were compared with 24 mother-infant dyads from a socio-cultural community with few such interactions (rural Nso families, Cameroon) when the infants were aged 6 and 12 weeks. When infants were 6 weeks old, mothers and their infants from both cultural communities smiled at each other for similar (albeit very short) amounts of time and used imitated each other's smiling similarly rarely. In contrast, when infants were 12 weeks old, mothers and their infants from Münster smiled at and imitated each other more often than did Nso mothers and their infants.

  9. Cyclophosphamide treatment of steroid dependent nephrotic syndrome: comparison of eight week with 12 week course. Report of Arbeitsgemeinschaft für Pädiatrische Nephrologie.

    PubMed Central

    1987-01-01

    In a prospective study (Cytotoxic Drug Study II), 18 children with steroid dependent nephrotic syndrome and steroid toxicity were treated with cyclophosphamide (2 mg/kg body weight/day) for 12 weeks in combination with reducing doses of prednisone (group A). This group was compared retrospectively with 18 children with steroid dependent nephrotic syndrome, studied as part of the Cytotoxic Drug Study I, and who had received cyclophosphamide for eight weeks (group B). There were no differences between the groups in age at the onset of the nephrotic syndrome, age at entry into the study, and duration of the nephrotic syndrome before entry into the study. The number of relapses during the six months before the treatment was the same in both groups. Two years after treatment 12 of 18 children treated with cyclophosphamide for 12 weeks were still in remission. By contrast, only four of of 18 children treated with cyclophosphamide for eight weeks were still in remission. The cumulative rates of sustained remissions were significantly higher (67% and 22%, respectively) in group A. All relapses were observed within 400 days of stopping cytotoxic treatment. No severe side effects of cyclophosphamide occurred up to two years after treatment had been stopped. We conclude that for children with steroid dependent nephrotic syndrome and steroid toxicity cyclophosphamide treatment should be prolonged to 12 weeks to increase the likelihood of a prolonged remission. PMID:3688915

  10. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury

    PubMed Central

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-01-01

    (1) Background: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) Methods: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) Results: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) Conclusion: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  11. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.

    PubMed

    Feld, Jordan J; Moreno, Christophe; Trinh, Roger; Tam, Edward; Bourgeois, Stefan; Horsmans, Yves; Elkhashab, Magdy; Bernstein, David E; Younes, Ziad; Reindollar, Robert W; Larsen, Lois; Fu, Bo; Howieson, Kevin; Polepally, Akshanth R; Pangerl, Andreas; Shulman, Nancy S; Poordad, Fred

    2016-02-01

    Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12weeks in patients with HCV genotype 1b infection and compensated cirrhosis. Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12weeks of ombitasvir/paritaprevir/ritonavir (25/150/100mg once daily) and dasabuvir (250mgtwicedaily). Key inclusion criteria were hemoglobin ⩾10g/dl, albumin ⩾2.8g/dl, platelet count ⩾25×10(9)/L, creatinine clearance ⩾30ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25IU/ml) 12weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90×10(9)/L, and 17% with albumin <3.5g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population. Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  12. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection.

    PubMed

    Gane, Edward J; Hyland, Robert H; An, Di; Svarovskaia, Evguenia; Pang, Phillip S; Brainard, Diana; Stedman, Catherine A

    2015-11-01

    We performed a phase 2 clinical trial to evaluate the efficacy and safety of ledipasvir and sofosbuvir, with or without ribavirin, in patients infected with hepatitis C virus (HCV) genotype 3 or 6. We performed an open-label study of 126 patients with HCV genotype 3 or 6 infections at 2 centers in New Zealand from April 2013 through October 2014. Subjects were assigned 1 of 4 groups that received 12 weeks of treatment. Previously untreated patients with HCV genotype 3 were randomly assigned to groups given fixed-dose combination tablet of ledipasvir and sofosbuvir (n = 25) or ledipasvir and sofosbuvir along with ribavirin (n = 26). Treatment-experienced patients with HCV genotype 3 (n = 50) received ledipasvir and sofosbuvir and ribavirin. Treatment-naïve or treatment-experienced patients with HCV genotype 6 (n = 25) received ledipasvir and sofosbuvir. The primary end point was the percentage of patients with HCV RNA ≤15 IU/mL 12 weeks after stopping therapy (sustained virologic response at 12 weeks [SVR12]). Among treatment-naïve genotype 3 patients, 16 of 25 (64%) receiving ledipasvir and sofosbuvir alone achieved SVR12 compared with all 26 patients (100%) receiving ledipasvir and sofosbuvir and ribavirin. Among treatment-experienced patients with HCV genotype 3, forty-one of fifty achieved an SVR12 (82%). Among patients with HCV genotype 6, the rate of SVR12 was 96% (24 of 25 patients). The most common adverse events were headache, upper respiratory infection, and fatigue. One patient with HCV genotype 3 discontinued ledipasvir and sofosbuvir because of an adverse event (diverticular perforation), which was not considered treatment related. In an uncontrolled, open-label trial, high rates of SVR12 were achieved by patients with HCV genotype 3 infection who received 12 weeks of ledipasvir and sofosbuvir plus ribavirin, and by patients with HCV genotype 6 infection who received 12 weeks of sofosbuvir and ledipasvir without ribavirin. Current guidelines do

  13. Nutritional Approach for Relief of Joint Discomfort: A 12-week, Open-case Series and Illustrative Case Report

    PubMed Central

    Lerman, Robert H.; Chang, Jyh-Lurn; Konda, Veera; Desai, Anuradha; Montalto, Michael B.

    2015-01-01

    Context Tetrahydro iso-α acids (THIAAs), derived from Humulus lupulus (hops), have demonstrated anti-inflammatory effects in vitro and in an animal model of rheumatoid arthritis (RA). Undenatured type 2 collagen has been found to be effective in clinical studies in RA and osteoarthritis (OA). Objective The study intended to evaluate the efficacy and safety of a proprietary tablet containing 150 mg of n-enriched THIAA (nTHIAA) and 10 mg of undenatured type 2 collagen (UC-II) (containing 25% UC-II) in patients with arthritis. Design The study was an open-label case series. This article also includes a case history for 1 participant. Setting The study was conducted at the Functional Medicine Research Center (FMRC) in Gig Harbor, WA, USA, from February 2013–June 2013. Participants Participants were 17 adults, 12 women, and 5 men aged 39–69 y, who had chronic joint pain involving various joints, 13 with probable OA and 4 with possible RA. Intervention Participants took 2 tablets of nTHIAA + UC-II 2 ×/d with meals for 12 wk. Outcome Measures Participants completed arthritis-related and quality-of-life questionnaires, at weeks 2, 4, 8, and 12: (1) the visual analog scale for pain (VAS-P); (2) the medical symptoms questionnaire (MSQ), with the analysis particularly focusing on the joint/muscle subscale and total scores; (3) the health and wellness outcome questionnaire (MOS-SF36), with the analysis particularly focusing on the physical and mental subscales; (4) the arthritis impact questionnaire (AIQ), with the analysis particularly focusing on the arthritis symptoms and daily living subscales; (5) the health assessment questionnaire (HAQ-DI) with the analysis particularly focusing on question 26 (Q26), which indicates overall pain during the week prior to the survey; and (6) the arthritis impact measurement scales 2 (AIMS2). At 12 wk, participants also completed the visual analog scale for efficacy (VAS-E). Results All participants completed the 12-wk evaluation

  14. Effects of a12-week endurance exercise program on adiposity and flexibility of Nigerian perimenopausal and postmenopausal women.

    PubMed

    Ogwumike, O O; Arowojolu, A O; Sanya, A O

    2011-12-20

    Menopause is a sign of aging in the woman. Loss of ovarian function induces a reduction in resting metabolic rate, physical energy expenditure, fat-free mass and abdominal adipose tissue accumulation. Location of adipose tissue deposit in abdominal region plays an important role in occurrence of hyperlipidemia, diabetes, hypertension and atherosclerosis. Although regular participation in physical exercise have been suggested to improve adiposity and body flexibility which are important health related components of physical fitness, few published studies are available on the effect of exercise on Nigerian menopausal women. This study investigated effects of a twelve-week endurance exercise program (EEP) on central and abdominal obesity as well as flexibility of perimenopausal and postmenopausal Nigerian women. The study employed a pretest- posttest control group design comprising a sample of 175 apparently healthy, literate, sedentary women within age range 40-59 years. They were workers in state and federal establishments in Ibadan North Local Government Area of Oyo State, Nigeria. Based on history of their last menstrual period, women with regular or irregular menstrual cycle status were allocated into perimenopausal group and those who no longer menstruated into postmenopausal group. A table of random numbers was used for further allocation into perimenopausal exercise group (PEMEG, 45), postmenopausal exercise group (POMEG, 45) perimenopausal control group (PEMCG, 42) and postmenopausal control group (POMCG, 43). Waist Hip Ratio (WHR), Body Mass Index (BMI) as well as Hip and Trunk Flexibility (HTF) were evaluated at baseline and 4weekly intervals until end of 12th week. EEP consisted of a 10-station circuit of cardiovascular endurance, flexibility, coordination, abdominal and pelvic floor muscle exercises. Data were analyzed using descriptive and inferential statistics. Mean age of participants was 52.3±4.1 years, 95% C.I (51.64-52.88) years. Significant

  15. 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.

  16. Assessing the effect of extrinsic incubation period (EIP) prolongation in controlling dengue transmission with wolbachia-infected mosquito intervention

    NASA Astrophysics Data System (ADS)

    Putri, Y. E.; Rozi, S.; Tasman, H.; Aldila, D.

    2017-03-01

    A mathematical model of dengue disease transmission with involving Extrinsic Incubation Period (EIP) effect as a consequence of wolbachia introduction into mossquito population will be discussed in this article. Mathematical model analysis to find equilibrium points, basic reproductive ratio (ℛ0), and criteria of endemic occurrence which depend on some parameters were performed. From analytical result, we find that ℛ0 hold an important role to determine the existence and local stability of equilibrium points. From sensitivity analysis of ℛ0 and numerical simulation, we conclude that prolongation of EIP with wolbachia intervention succeed to reduce number of infected human and mosquito significantly.

  17. An Evaluation of a Smartphone–Assisted Behavioral Weight Control Intervention for Adolescents: Pilot Study

    PubMed Central

    Duncombe, Kristina M; Lott, Mark A; Hunsaker, Sanita L; Duraccio, Kara M; Woolford, Susan J

    2016-01-01

    Background The efficacy of adolescent weight control treatments is modest, and effective treatments are costly and are not widely available. Smartphones may be an effective method for delivering critical components of behavioral weight control treatment including behavioral self-monitoring. Objective To examine the efficacy and acceptability of a smartphone assisted adolescent behavioral weight control intervention. Methods A total of 16 overweight or obese adolescents (mean age=14.29 years, standard deviation=1.12) received 12 weeks of combined treatment that consisted of weekly in-person group behavioral weight control treatment sessions plus smartphone self-monitoring and daily text messaging. Subsequently they received 12 weeks of electronic-only intervention, totaling 24 weeks of intervention. Results On average, participants attained modest but significant reductions in body mass index standard score (zBMI: 0.08 standard deviation units, t (13)=2.22, P=.04, d=0.63) over the in-person plus electronic-only intervention period but did not maintain treatment gains over the electronic-only intervention period. Participants self-monitored on approximately half of combined intervention days but less than 20% of electronic-only intervention days. Conclusions Smartphones likely hold promise as a component of adolescent weight control interventions but they may be less effective in helping adolescents maintain treatment gains after intensive interventions. PMID:27554704

  18. Effectiveness and tolerability of rosiglitazone on insulin resistance and body composition in nondiabetic Thai patients undergoing continuous ambulatory peritoneal dialysis: A 12-week pilot study

    PubMed Central

    Aramwit, Pornanong; Bunmee, Panipat; Supasyndh, Ouppatham

    2009-01-01

    Background: Patients with chronic renal insufficiency, especially those undergoing continuous ambulatory peritoneal dialysis (CAPD), normally have insulin resistance due to deficiencies in insulin secretion and degradation, as well as tissue resistance to insulin at both receptor and postreceptor levels. Objective: The aim of this study was to investigate the effectiveness and tolerability of rosiglitazone on insulin resistance and body composition in patients without diabetes mellitus (DM) undergoing CAPD. Methods: This pilot study included a pretest and posttest with a repeated-measure design in a small number of patients. CAPD patients without DM received rosiglitazone 2-mg tablets BID for 12 weeks. Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR) and bioelectrical impedance analysis (BIA) were used to assess insulin resistance and body composition, respectively. Tolerability was assessed using laboratory analyses as well as physical examination findings to evaluate peripheral edema. Peripheral edema was assessed by the study investigators. Results: Thirteen Thai patients (mean [SD] age, 54.17 [11.42] years [range, 35–85 years]; body mass index [BMI], >20 to <30 kg/m2; fasting blood glucose [FBG] concentration, <5.39 mmol/L) were included in the study. One patient was withdrawn due to illness unrelated to the study. No significant difference was found in FBG concentration between baseline and posttreatment (after 12 weeks of treatment) (5.45 [0.59] vs 5.24 [0.51] mmol/L), but fasting plasma insulin concentrations (28.50 [23.70] vs 10.15 [4.22] μIU/mL; P = 0.005) and HOMA-IR score (6.70 [5.23] vs 2.40 [1.15]; P = 0.011) were significantly lower. There were no significant changes in weight or BMI from baseline to posttreatment. Seven subjects (58.3%) experienced weight gain at week 4, while 2 patients (16.7%) still had weight gain after 12 weeks of treatment. A significant increase was found between baseline and posttreatment in total body

  19. A 12-week rehabilitation program improves body composition, pain sensation, and internal/external torques of baseball pitchers with shoulder impingement symptom

    PubMed Central

    Cha, Jun-Youl; Kim, Jae-Hak; Hong, Ju; Choi, Young-Tae; Kim, Min-Ho; Cho, Ji-Hyun; Ko, Il-Gyu; Jee, Yong-Seok

    2014-01-01

    The aim of this study was to investigate the effects of a 12-week rehabilitation program on body composition, shoulder pain, and isokinetic internal/external torques of pitchers with impingement syndrome. A total of 30 pitchers were divided into 2 groups: experimental group (EG, n = 16) and control group (CG, n= 14). The rehabilitation program consisted of physical therapy, warm-up, work-out, and cool-down. As results, body weight and fat mass of EG were decreased whereas muscle mass of EG was significantly increased after the experiment. The pain degrees in resting, normal daily activity, and strenuous activity on the numeric pain rating scale were significantly decreased in the EG. The internal and external peak torques (PTs) of uninvolved and involved sides of EG were increased in EG after 12 weeks. Such results provide a deficit ratio of both sides in EG close to normal values. The ratios of internal/external PTs in EG were also close to the reference values. The internal and external total works of both sides in EG were similar to the values of PT. The fatigue indices of internal and external rotators of both sides in EG were decreased. As a conclusion, a 12-week rehabilitation program reduced the shoulder pain, improved the body composition and enhanced the isokinetic shoulder internal/external rotators in EG with impingement symptoms. Also the study suggested that the rehabilitation program evened out the ratio between internal and external rotators and lowered the fatigue level after the experiment. PMID:24678503

  20. Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study.

    PubMed

    Tanaka, Yoshiya; Emoto, Kahaku; Cai, Zhihong; Aoki, Takehiro; Schlichting, Douglas; Rooney, Terence; Macias, William

    2016-03-01

    To evaluate efficacy and safety, baricitinib [Janus kinase (JAK) 1/JAK2 inhibitor] was compared with placebo in Japanese patients with active rheumatoid arthritis (RA) despite background treatment with methotrexate (MTX). This was a phase IIB, double-blind, randomized, placebo-controlled study (clinicaltrials.gov: NCT01469013). Patients had moderate to severe active adult-onset RA despite stable treatment with MTX. Patients (n = 145) were randomized in a 2:1:1:1:1 ratio to placebo or 1 mg, 2 mg, 4 mg, or 8 mg oral baricitinib daily for 12 weeks. The primary analysis compared the combined 4/8-mg dose groups with placebo for the American College of Rheumatology (ACR) 20 response rate at 12 weeks. Other outcomes included additional measures of disease activity, physical function, laboratory abnormalities, and adverse events. A significantly higher proportion of patients in the combined 4/8-mg baricitinib group (37/48, 77%) compared with the placebo group (15/49, 31%) had at least an ACR20 response after 12 weeks of treatment (p < 0.001). Significant improvements in disease activity, remission, and physical function were observed as early as Week 2 of treatment with baricitinib, particularly with daily doses of ≥ 4 mg. Only 1 patient receiving baricitinib discontinued because of an adverse event. Adverse event rates with baricitinib doses ≤ 4 mg daily were similar to placebo, but there was a higher incidence of adverse events and laboratory abnormalities in the 8-mg group. In this phase II study, baricitinib was well tolerated and rapidly improved the signs, symptoms, and physical function of Japanese patients with active RA, supporting continued development of baricitinib (clinicaltrials.gov NCT01469013).

  1. Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study

    PubMed Central

    Hawkey, C J; Laine, L; Simon, T; Quan, H; Shingo, S; Evans, J

    2003-01-01

    Background: Previous studies in patients with osteoarthritis have suggested that the selective cyclooxygenase (COX)-2 inhibitor rofecoxib results in less gastrointestinal damage than non-selective non-steroidal antiinflammatory drugs (NSAIDs). This study compared the incidence of endoscopically detected gastroduodenal ulcers in rheumatoid arthritis patients treated with rofecoxib or a non-selective NSAID. Methods: In this multicentre, randomised, double blind, 12 week study, patients with rheumatoid arthritis were allocated to rofecoxib 50 mg once daily (n=219), naproxen 500 mg twice daily (n=220), or placebo (n=221). Endoscopy was performed at baseline and at six and 12 weeks. Lifetable analysis and log rank tests were used to analyse the incidence of gastroduodenal ulcers ≥3 mm. Gastric or duodenal ulcers ≥5 mm and erosions were also evaluated as secondary end points. Tolerability was assessed by adverse events. Results: The cumulative incidence of ulcers ≥3 mm at 12 weeks was significantly higher in patients on naproxen (25.5%) than in patients receiving rofecoxib (6.8%; difference 18.7% (95% confidence interval (CI) 11.7%, 25.7%); p<0.001) or placebo (2.9%; difference 22.6% (95% CI 16.1%, 29.1%); p<0.001). The difference between rofecoxib (6.8%) and placebo (2.9%) did not reach statistical significance (p=0.066). Results were similar for ulcers ≥5 mm and for mean changes from baseline in the number of gastroduodenal erosions. The overall incidence of clinical adverse events was similar among treatment groups (61% of patients on placebo, 62% in patients on rofecoxib, and 66% in patients on naproxen). Conclusions: Rofecoxib 50 mg daily (twice the dose recommended for this patient population) resulted in a lower incidence of endoscopically detected gastroduodenal ulcers and erosions than treatment with naproxen 500 mg twice daily. PMID:12740337

  2. Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial.

    PubMed

    Dinesh, T; Gaur, Gs; Sharma, Vk; Madanmohan, T; Harichandra Kumar, Kt; Bhavanani, Ab

    2015-01-01

    Pranayamas are breathing techniques that exert profound physiological effects on pulmonary, cardiovascular, and mental functions. Previous studies demonstrate that different types of pranayamas produce divergent effects. The aim was to compare the effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers. This study was carried out in Departments of Physiology and ACYTER, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry in 2011. Ninety one healthy volunteers were randomized into slow pranayama group (SPG), n =29, fast pranayama group (FPG), n = 32 and control groups (CG) (n = 30). Supervised pranayama training (SPG: Nadisodhana, Pranav pranayama and Savitri pranayama; FPG: Kapalabhati, Bhastrika and Kukkriya pranayama) was given for 30 min/day, thrice/week for 12 weeks by certified yoga instructors. Pulmonary function parameters (PFT) such as forced vital capacity (FVC), forced expiratory volume in first second (FEV1), ratio between FEV1 and FVC (FEV1 /FVC), peak expiratory flow rate (PEFR), maximum voluntary ventilation (MVV), and forced expiratory flow25-75 (FEF25-75), were recorded at baseline and after 12 weeks of pranayama training using the computerized spirometer (Micro laboratory V1.32, England). In SPG, PEFR, and FEF25-75 improved significantly (P < 0.05) while other parameters (FVC, FEV1, FEV1 /FVC, and MVV) showed only marginal improvements. In FPG, FEV1 /FVC, PEFR, and FEF25-75 parameters improved significantly (P < 0.05), while FVC, FEV1, and MVV did not show significant (P > 0.05) change. No significant change was observed in CG. Twelve weeks of pranayama training in young subjects showed improvement in the commonly measured PFT. This indicates that pranayama training improved pulmonary function and that this was more pronounced in the FPG.

  3. GLP-1-Based Therapies Have No Microvascular Effects in Type 2 Diabetes Mellitus: An Acute and 12-Week Randomized, Double-Blind, Placebo-Controlled Trial.

    PubMed

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Diamant, Michaela; Serné, Erik H; van Raalte, Daniël H

    2016-10-01

    To assess the effects of glucagon-like peptide (GLP)-1-based therapies (ie, GLP-1 receptor agonists and dipeptidyl peptidase-4 inhibitors) on microvascular function in patients with type 2 diabetes mellitus. We studied 57 patients with type 2 diabetes mellitus (mean±SD age: 62.8±6.9 years; body mass index: 31.8±4.1 kg/m(2); HbA1c [glycated hemoglobin] 7.3±0.6%) in an acute and 12-week randomized, placebo-controlled, double-blind trial conducted at the Diabetes Center of the VU University Medical Center. In the acute study, the GLP-1 receptor agonist exenatide (therapeutic concentrations) or placebo (saline 0.9%) was administered intravenously. During the 12-week study, patients received the GLP-1 receptor agonist liraglutide (1.8 mg daily), the dipeptidyl peptidase-4 inhibitor sitagliptin (100 mg daily), or matching placebos. Capillary perfusion was assessed by nailfold skin capillary videomicroscopy and vasomotion by laser Doppler fluxmetry, in the fasting state and after a high-fat mixed meal. In neither study, treatment affected fasting or postprandial capillary perfusion compared with placebo (P>0.05). In the fasting state, acute exenatide infusion increased neurogenic vasomotion domain power, while reducing myogenic domain power (both P<0.05). After the meal, exenatide increased endothelial domain power (P<0.05). In the 12-week study, no effects on vasomotion were observed. Despite modest changes in vasomotion, suggestive of sympathetic nervous system activation and improved endothelial function, acute exenatide infusion does not affect skin capillary perfusion in type 2 diabetes mellitus. Twelve-week treatment with liraglutide or sitagliptin has no effect on capillary perfusion or vasomotion in these patients. Our data suggest that the effects of GLP-1-based therapies on glucose are not mediated through microvascular responses. © 2016 American Heart Association, Inc.

  4. Does 12 weeks of regular standing prevent loss of ankle mobility and bone mineral density in people with recent spinal cord injuries?

    PubMed

    Ben, Marsha; Harvey, Lisa; Denis, Sophie; Glinsky, Joanne; Goehl, Gerlinde; Chee, Shane; Herbert, Robert D

    2005-01-01

    The purpose of this study was to determine the effects of a 12-week standing program on ankle mobility and femur bone mineral density in patients with lower limb paralysis following recent spinal cord injury. An assessor-blinded within-subject randomised controlled trial was undertaken. Twenty patients with lower limb paralysis following a recent spinal cord injury were recruited. Subjects stood weight-bearing through one leg on a tilt-table for 30 minutes, three times each week for 12 weeks. By standing on one leg a large dorsiflexion stretch was applied to the ankle and an axial load was applied to the bones of the weight-bearing leg. Ankle mobility and femur bone mineral density of both legs were measured at the beginning and end of the study. Ankle mobility (range of motion) was measured with the application of a 17 Nm dorsiflexion torque. Femur bone mineral density was measured using dual energy X-ray absorptiometry (DEXA). The effect of standing was estimated from the difference between legs in mean change of ankle mobility and femur bone mineral density. The results indicated a mean treatment effect on ankle mobility of 4 degrees (95% CI 2 to 6 degrees) and on femur bone mineral density of 0.005 g/cm(2) (95% CI -0.015 to 0.025 g/cm(2)). Tilt-table standing for 30 minutes, three times per week for 12 weeks has a small effect on ankle mobility, and little or no effect on femur bone mineral density. It is unclear whether clinicians and patients would consider such effects to be clinically worthwhile.

  5. Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    PubMed

    Jeon, Hong Jin; Woo, Jong-Min; Lee, Seung-Hwan; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Fava, Maurizio; Mischoulon, David; Kim, Ji-Hae; Heo, Jung-Yoon; Yu, Bum-Hee

    2014-04-01

    Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear. This study compares neurocognitive effects of tianeptine and escitalopram in MDD. Patients with MDD (N = 164) were randomly assigned in a 1:1 ratio to either tianeptine (37.5 mg/d) or escitalopram (10 mg/d) for 12 weeks. Outcome measures included clinical improvement, subjective cognitive impairment on memory and concentration, the Mini-Mental State Examination, the Continuous Performance Test, the Verbal Learning Test, and the Raven Progressive Matrices, assessed every 4 weeks. After 12 weeks, the tianeptine group showed significant improvement in commission errors (P = 0.002), verbal immediate memory (P < 0.0001), Mini-Mental State Examination (P < 0.0001), delayed memory (P < 0.0001), and reasoning ability (P = 0.0010), whereas the escitalopram group improved in delayed memory and reasoning ability but not in the other measures. Both groups significantly improved in subjective cognitive impairment in memory (P < 0.0001) and concentration (P < 0.0001). Mixed effects model repeated measures analyses revealed that the tianeptine group had a significant improvement in scores of commission errors (F = 6.64, P = 0.011) and verbal immediate memory (F = 4.39, P = 0.038) from baseline to 12 weeks, compared with the escitalopram group, after controlling for age, sex, education years, baseline scores, and changes of depression severity. The treatment of MDD with tianeptine led to more improvements in neurocognitive functions, especially in commission errors and verbal immediate memory, compared with escitalopram, after controlling for changes in depression severity. Both drugs improved subjective cognitive impairment of memory and concentration.

  6. Early changes in bone density, microarchitecture, bone resorption, and inflammation predict the clinical outcome 12 weeks after conservatively treated distal radius fractures: an exploratory study.

    PubMed

    Meyer, Ursina; de Jong, Joost J; Bours, Sandrine G P; Keszei, András P; Arts, Jacobus J; Brink, Peter R G; Menheere, Paul; van Geel, Tineke A C M; van Rietbergen, Bert; van den Bergh, Joop P W; Geusens, Piet P; Willems, Paul C

    2014-09-01

    Fracture healing is an active process with early changes in bone and inflammation. We performed an exploratory study evaluating the association between early changes in densitometric, structural, biomechanical, and biochemical bone parameters during the first weeks of fracture healing and wrist-specific pain and disability at 12 weeks in postmenopausal women with a conservatively treated distal radius fracture. Eighteen patients (aged 64 ± 8 years) were evaluated at 1 to 2 and 3 to 4 weeks postfracture, using high-resolution peripheral quantitative computed tomography (HR-pQCT), micro-finite element analysis, serum procollagen type-I N-terminal propeptide (P1NP), carboxy-terminal telopeptide of type I collagen (ICTP), and high-sensitive C-reactive protein (hsCRP). After 12 weeks, patients rated their pain and disability using Patient Rated Wrist Evaluation (PRWE) questionnaire. Additionally, Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire and active wrist range of motion was evaluated. Linear regression models were used to study the relationship between changes in bone parameters and in hsCRP from visit 1 to 2 and PRWE score after 12 weeks. A lower PRWE outcome, indicating better outcome, was significantly related to an early increase in trabecular bone mineral density (BMD) (β -0.96 [95% CI -1.75 to -0.16], R(2)  = 0.37), in torsional stiffness (-0.14 [-0.28 to -0.004], R(2)  = 0.31), and to an early decrease in trabecular separation (209 [15 to 402], R(2)  = 0.33) and in ICTP (12.1 [0.0 to 24.1], R(2)  = 0.34). Similar results were found for QuickDASH. Higher total dorsal and palmar flexion range of motion was significantly related to early increase in hsCRP (9.62 [3.90 to 15.34], R(2)  = 0.52). This exploratory study indicates that the assessment of early changes in trabecular BMD, trabecular separation, calculated torsional stiffness, bone resorption marker ICTP, and hsCRP after a distal radius fracture provides

  7. Residual {sup 18}F-FDG-PET Uptake 12 Weeks After Stereotactic Ablative Radiotherapy for Stage I Non-Small-Cell Lung Cancer Predicts Local Control

    SciTech Connect

    Bollineni, Vikram Rao; Widder, Joachim; Pruim, Jan; Langendijk, Johannes A.; Wiegman, Erwin M.

    2012-07-15

    Purpose: To investigate the prognostic value of [{sup 18}F]fluorodeoxyglucose positron emission tomography (FDG-PET) uptake at 12 weeks after stereotactic ablative radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC). Methods and Materials: From November 2006 to February 2010, 132 medically inoperable patients with proven Stage I NSCLC or FDG-PET-positive primary lung tumors were analyzed retrospectively. SABR consisted of 60 Gy delivered in 3 to 8 fractions. Maximum standardized uptake value (SUV{sub max}) of the treated lesion was assessed 12 weeks after SABR, using FDG-PET. Patients were subsequently followed at regular intervals using computed tomography (CT) scans. Association between post-SABR SUV{sub max} and local control (LC), mediastinal failure, distant failure, overall survival (OS), and disease-specific survival (DSS) was examined. Results: Median follow-up time was 17 months (range, 3-40 months). Median lesion size was 25 mm (range, 9-70 mm). There were 6 local failures: 15 mediastinal failures, 15 distant failures, 13 disease-related deaths, and 16 deaths from intercurrent diseases. Glucose corrected post-SABR median SUV{sub max} was 3.0 (range, 0.55-14.50). Using SUV{sub max} 5.0 as a cutoff, the 2-year LC was 80% versus 97.7% for high versus low SUV{sub max}, yielding an adjusted subhazard ratio (SHR) for high post-SABR SUV{sub max} of 7.3 (95% confidence interval [CI], 1.4-38.5; p = 0.019). Two-year DSS rates were 74% versus 91%, respectively, for high and low SUV{sub max} values (SHR, 2.2; 95% CI, 0.8-6.3; p = 0.113). Two-year OS was 62% versus 81% (hazard ratio [HR], 1.6; 95% CI, 0.7-3.7; p = 0.268). Conclusions: Residual FDG uptake (SUV{sub max} {>=}5.0) 12 weeks after SABR signifies increased risk of local failure. A single FDG-PET scan at 12 weeks could be used to tailor further follow-up according to the risk of failure, especially in patients potentially eligible for salvage surgery.

  8. Romanian Special Course, 12 Weeks.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    The format of the first volume in this five-volume accelerated course in Romanian consists of (1) a dialog , which introduces new structures and vocabulary, (2) a dialog translation, (3) grammar drills, (4) a reading, (5) comprehension questions and answers based on the reading, and (6) a vocabulary listing for the lesson. Later volumes include…

  9. Gluteal and posterior thigh pain in the postoperative period and the need for intervention after sacrospinous ligament colpopexy.

    PubMed

    Unger, Cecile A; Walters, Mark D

    2014-01-01

    Sacrospinous ligament (SSL) colpopexy is a transvaginal surgical option for the treatment of vaginal apex prolapse. The objective of this study was to determine the rate of gluteal and posterior thigh pain after SSL colpopexy using the Capio device in the immediate postoperative period, at the 6-week postoperative visit, and to determine the risk of needing intervention for this type of pain. This was a retrospective cohort study of women who underwent SSL colpopexy with the Capio device for the treatment of vaginal apex prolapse between 2007 and 2012. The electronic inpatient and outpatient medical record was queried for demographic, intraoperative, and immediate and 6-week postoperative data. Two hundred forty-two subjects underwent SSL colpopexy with the Capio device for vaginal apex prolapse. Mean age and body mass index were 66 (10) years and 28.7 (5.4) kg/m, respectively. One hundred thirty-four (55.4%) subjects were found to have immediate gluteal or posterior thigh pain and 36 (15.3%) were found to have persistent pain at 6 weeks. Five (2.1%; 95% confidence interval, 0.8%-4.7%) subjects required intervention: physical therapy (3), trigger point injection (1), both (1), and no patients required reoperation. Concomitant midurethral sling placement was associated with pain at 6 weeks (P = 0.008). Need for intervention was associated with the number of sutures placed (2 or 3 vs 4; P = 0.03). Concomitant hysterectomy and approach to SSL colpopexy were not associated with gluteal or posterior thigh pain. The rate of immediate postoperative gluteal and posterior thigh pain is high in patients undergoing SSL colpopexy for vaginal apex prolapse; however, the rate of pain at 6 weeks is much lower, and the need for intervention is even lower.

  10. Low baseline interleukin-17A levels are associated with better treatment response at 12 weeks to tocilizumab therapy in rheumatoid arthritis patients.

    PubMed

    Lee, Sang Jin; Park, Won; Park, Sung Hwan; Shim, Seung-Cheol; Baek, Han Joo; Yoo, Dae-Hyun; Kim, Hyun Ah; Lee, Soo Kon; Leee, Yun Jong; Park, Young Eun; Cha, Hoon-Suk; Park, Jin Kyun; Lee, Eun Young; Lee, Eun Bong; Song, Yeong Wook

    2015-01-01

    T helper 17-related cytokines have been implicated in rheumatoid arthritis (RA) pathogenesis. The study aimed to identify cytokines associated with the treatment response of RA patients to tocilizumab (TCZ), a humanized monoclonal antibody against the interleukin- (IL-) 6 receptor. As an independent substudy of the 24-week, randomized, double-blinded CWP-TCZ301 trial of TCZ in RA patients with an inadequate response to disease-modifying antirheumatic drugs, serum levels of cytokines including tumor necrosis factor-alpha, IL-17A, IL-21, IL-23, IL-6, and soluble IL-6 receptor were measured. Baseline IL-17A levels were significantly lower in RA patients who achieved disease activity score 28 (DAS28) remission at 12 weeks of TCZ treatment, compared to patients not in remission. Patients were stratified into IL-17A low group and IL-17A high group. Significantly more patients in the IL-17A low group achieved remission as compared to the IL-17A high group (47.6 versus 17.4%, P = 0.032). DAS28 improvement was significantly better in the IL-17A low group than in the IL-17A high group at 12 weeks (P = 0.045) and 24 weeks (P = 0.046) after adjustment. Other baseline cytokines were not associated with treatment response to TCZ. The data demonstrate that low baseline IL-17A levels are associated with better clinical response to TCZ treatment in RA patients.

  11. Adding memantine to rivastigmine therapy in patients with mild-to-moderate alzheimer's disease: results of a 12-week, open-label pilot study.

    PubMed

    Riepe, Matthias W; Adler, Georg; Ibach, Bernd; Weinkauf, Birgit; Gunay, Ibrahim; Tracik, Ferenc

    2006-01-01

    At present, inhibition of cholines-terase is the treatment of choice for subjects with mild-to-moderate Alzheimer's disease (AD). Memantine, a noncompetitive antagonist at N-methyl-d-aspartate receptors, is currently used to treat subjects with moderate-to-severe AD. The goal of this multicenter, open-label pilot study was to investigate whether combination therapy with memantine added to rivastigmine is safe and beneficial in subjects with mild-to-moderate AD. Patients with a DSM-IV diagnosis of dementia of the Alzheimer's type (N = 95), who were treated with rivastigmine (6-12 mg/day) for a maximum duration of 24 weeks prior to baseline, received memantine (5-20 mg/day) in combination with rivastigmine for 12 weeks. The primary efficacy variable was the change in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score at the end of 12 weeks compared with baseline. The study was conducted between September 15, 2003, and May 27, 2004. There was a statistically significant difference between baseline and week 12 for the ADAS-cog total score, showing a positive effect of combination therapy. Combination therapy did not evidence any unexpected safety concerns and was well-tolerated by most patients. Memantine in combination with rivastigmine appears to be safe and beneficial in patients with mild-to-moderate AD. Our results need to be confirmed in a large, long-term, randomized, double-blind, placebo-controlled clinical trial.

  12. Effects of a 12-week Rehabilitation Program with Music & Exercise Groups on Range of Motion in Young Children with Severe Burns

    PubMed Central

    Neugebauer, Christine Tuden; Serghiou, Michael; Herndon, David N.; Suman, Oscar E.

    2013-01-01

    Previous studies indicate that rehabilitation programs supplemented with a strength and endurance-based exercise program improve lean body mass, pulmonary function, endurance, strength, and functional outcomes in severely burned children over the age of 7-years when compared to standard of care. To date, supplemental exercise programming for severely burned children under the age of 7-years has not yet been explored. The purpose of this study was to determine if a 12-week rehabilitation program supplemented with music & exercise, was more effective in improving functional outcomes than the standard of care alone. METHODS This is a descriptive study that measured elbow and knee range of motion (ROM) in 24 severely burned children between ages two and six years. Groups were compared for demographics as well as active and passive ROM to bilateral elbows and knees. A total of 15 patients completed the rehabilitation with supplemental music and exercise, and data was compared to 9 patients who received standard of care. RESULTS Patients receiving the 12-week program significantly improved ROM in all joints assessed except for one. Patients receiving standard of care showed a significant improvement in only one of the joints assessed. CONCLUSION Providing a structured supplemental music and exercise program in conjunction with occupational and physical therapy seems to improve both passive and active ROM to a greater extent than the standard of care alone. PMID:18849852

  13. Effects of a 12-week rehabilitation program with music & exercise groups on range of motion in young children with severe burns.

    PubMed

    Neugebauer, Christine Tuden; Serghiou, Michael; Herndon, David N; Suman, Oscar E

    2008-01-01

    Previous studies indicate that rehabilitation programs supplemented with a strength and endurance-based exercise program improve lean body mass, pulmonary function, endurance, strength, and functional outcomes in severely burned children over the age of 7-years when compared with standard of care (SOC). To date, supplemental exercise programming for severely burned children under the age of 7-years has not yet been explored. The purpose of this study was to determine if a 12-week rehabilitation program supplemented with music & exercise, was more effective in improving functional outcomes than the SOC alone. This is a descriptive study that measured elbow and knee range of motion (ROM) in 24 severely burned children between ages 2 and 6 years. Groups were compared for demographics as well as active and passive ROM to bilateral elbows and knees. A total of 15 patients completed the rehabilitation with supplemental music and exercise, and data was compared with 9 patients who received SOC. Patients receiving the 12-week program significantly improved ROM in all joints assessed except for one. Patients receiving SOC showed a significant improvement in only one of the joints assessed. Providing a structured supplemental music and exercise program in conjunction with occupational and physical therapy seems to improve both passive and active ROM to a greater extent than the SOC alone.

  14. Low-dose memantine attenuated methadone dose in opioid-dependent patients: a 12-week double-blind randomized controlled trial.

    PubMed

    Lee, Sheng-Yu; Chen, Shiou-Lan; Chang, Yun-Hsuan; Chen, Po See; Huang, San-Yuan; Tzeng, Nian-Sheng; Wang, Liang-Jen; Lee, I Hui; Wang, Tzu-Yun; Chen, Kao Chin; Yang, Yen Kuang; Hong, Jau-Shyong; Lu, Ru-Band

    2015-05-19

    Low-dose memantine might have anti-inflammatory and neurotrophic effects mechanistically remote from an NMDA receptor. We investigated whether add-on memantine reduced cytokine levels and benefitted patients with opioid dependence undergoing methadone maintenance therapy (MMT) in a randomized, double-blind, controlled 12-week study. Patients were randomly assigned to a group: Memantine (5 mg/day) (n = 53) or Placebo (n = 75). The methadone dose required and retention in treatment were monitored. Plasma tumor necrosis factor (TNF)-α, C-reactive protein (CRP), interleukin (IL)-6, IL-8, transforming growth factor (TGF)-β1, and brain-derived neurotrophic factor (BDNF) levels were examined during weeks 0, 1, 4, 8, and 12. General linear mixed models were used to examine therapeutic effect. After 12 weeks, Memantine-group required a somewhat lower methadone dose than did Placebo-group (P = 0.039). They also had significantly lower plasma TNF-α and significantly higher TGF-β1 levels. We provide evidence of the benefit of add-on memantine in opioid dependent patients undergoing MMT.

  15. Triple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study.

    PubMed

    Oparil, Suzanne; Melino, Michael; Lee, James; Fernandez, Victor; Heyrman, Reinilde

    2010-07-01

    Patients with hypertension may require a combination of > or =2 antihypertensive agents to achieve blood pressure (BP) control. The aim of this study was to determine whether a triple combination of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) had a clinically significant benefit compared with dual combinations of the individual components in patients with moderate to severe hypertension. This was a multicenter, randomized, doubleblind, parallel-group study in which triple combination treatment with OM 40 mg + AML 10 mg + HCTZ 25 mg was compared with dual combinations of the individual components-OM 40 mg/AML 10 mg in fixed-dose combination, OM 40 mg/HCTZ 25 mg in fixed-dose combination, and AML 10 mg + HCTZ 25 mg-in patients aged > or =18 years who had a mean seated BP > or =140/100 mm Hg or > or =160/90 mm Hg. The study consisted of a 3-week washout period with no study medication and a 12-week double-blind treatment period. In the first 2 weeks of the double-blind treatment period, all patients were randomized to receive dual combination treatment or placebo. All patients assigned to a dual combination treatment group continued the assigned treatment until week 4, and all patients assigned to placebo were switched at week 2 to receive 1 of the dual combination treatments until week 4. At week 4, patients either continued dual combination treatment or switched to triple combination treatment until week 12. The primary end point was the change in seated diastolic BP (SeDBP) from baseline to week 12; SeDBP reduction of > or =2 mm Hg was considered a clinically significant benefit. Secondary efficacy end points included the change in seated systolic BP (SeSBP) at week 12 and the percentages of patients achieving BP targets of <140/90 mm Hg, <120/80 mm Hg, SeSBP <140 mm Hg, and SeDBP <90 mm Hg at week 12. The tolerability of the treatments was also evaluated based on adverse events (AEs), clinical laboratory evaluations

  16. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.

    PubMed

    Martel, Céline; Labrie, Fernand; Archer, David F; Ke, Yuyong; Gonthier, Renaud; Simard, Jean-Nicolas; Lavoie, Lyne; Vaillancourt, Mario; Montesino, Marlene; Balser, John; Moyneur, Érick

    2016-05-01

    This study integrates all data obtained in women aged 40-80years enrolled with moderate to severe symptoms of vulvovaginal atrophy (VVA) who received daily intravaginal administration of 0.50% (6.5mg) dehydroepiandrosterone (DHEA; prasterone) for 12weeks (n=723; ITT-S population) as compared with placebo (n=266; ITT-S population). To this end, serum steroid levels (DHEA, DHEA-sulfate (DHEA-S), androst-5-ene-3β, 17β-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17β-diol 17-glucuronide (3α-diol-17G)) were measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry (LC-MS/MS) following validation performed according to the FDA guidelines [1-6]. In agreement with the mechanisms of intracrinology where DHEA is exclusively transformed intracellularly into active sex steroids which act and are inactivated locally before being released as glucuronided or sulfated metabolites for elimination by the kidneys and liver, all sex steroids remained well within normal postmenopausal values following administration of intravaginal DHEA. Serum estradiol, the most relevant sex steroid, was measured after 12weeks of treatment at 3.36pg/ml (cITT-S population) or 19% below the normal postmenopausal value of 4.17pg/ml. On the other hand, serum E1-S, the best recognized marker of global estrogenic activity, shows an average value of 209pg/ml at 12 weeks compared to 220pg/ml in normal postmenopausal women. Moreover, serum ADT-G, the main metabolite of androgens, also remains well within normal postmenopausal values. The present data shows that a low daily intravaginal dose (6.5mg) of DHEA (prasterone) which is efficacious on the symptoms and signs of VVA, permits to achieve the desired local efficacy without systemic exposure, in agreement with the stringent mechanisms of menopause established after 500 million years of

  17. Telaprevir combination therapy in HCV/HIV co-infected patients (INSIGHT study): sustained virologic response at 12 weeks final analysis

    PubMed Central

    Montes, Marisa; Nelson, Mark; Marie Girard, Pierre; Sasadeusz, Joe; Horban, Andrzej; Grinsztejn, Beatriz; Zakharova, Natalia; Rivero, Antonio; Lathouwers, Erkki; Janssen, Katrien; Ouwerkerk-Mahadevan, Sivi; Witek, James

    2014-01-01

    Introduction We report the SVR12 final analysis of a phase 3 study of telaprevir in combination with peginterferon (P)/ribavirin (R) in HCV-genotype 1, treatment-naïve and -experienced patients with HCV/HIV co-infection (INSIGHT). Materials and Methods Patients receiving stable, suppressive HIV antiretroviral (ARV) therapy, containing atazanavir/ritonavir, efavirenz, darunavir/ritonavir, raltegravir, etravirine or rilpivirine, received telaprevir 750 mg q8h (1125 mg q8h if on efavirenz) plus P (180 µg once-weekly) and R (800 mg/day) for 12 weeks, followed by an additional 12 weeks (non-cirrhotic HCV treatment-naïve and relapse patients with extended rapid viral response [eRVR]) or 36 weeks (all others) of PR alone. Analysis was performed when all patients had completed the follow-up visit of 12 weeks after last planned dose. Results One hundred sixty-two patients were enrolled and treated (65 efavirenz, 59 atazanavir/ritonavir, 17 darunavir/ritonavir, 17 raltegravir, 4 etravirine). Mean age was 45 years, 78% were male, 92% were Caucasian; mean CD4 count was 687 cells/mm3. Sixty four patients (40%) were HCV treatment-naïve and 98 (60%) were treatment experienced (29 relapsers, 18 partial responders and 51 null responders). 64% were subtype 1a. 30% had bridging fibrosis (17%) or cirrhosis (13%). 19% of patients discontinued telaprevir, including 9% due to an adverse event (AE), 8% reaching a virologic endpoint and 2% for other reasons (non compliance or not defined). Treatment responses are shown in Table 1. There were no HIV RNA breakthroughs. Most frequently reported (≥20% patients) AEs were pruritus 43%; fatigue 27%; rash 34%, anorectal events 30% and influenza-like illness (25%). Anemia was reported in 15% of patients; grade ≥3 haemoglobin decrease occurred in 2.5% of patients. 6% of patients experienced serious AEs. Conclusions In this phase 3 study of HIV-infected, HCV treatment-naïve and -experienced patients, 49% achieved eRVR and 57% reached SVR12

  18. The effect of 1g of acetaminophen twice daily for 12 weeks on alanine transaminase levels--A randomized placebo-controlled trial.

    PubMed

    Ioannides, Sally J; Siebers, Robert; Perrin, Kyle; Weatherall, Mark; Crane, Julian; Travers, Justin; Shirtcliffe, Philippa; Beasley, Richard

    2015-07-01

    Acetaminophen is often used on a regular, daily basis for the treatment of chronic pain; however, the safety of regular acetaminophen is still debated. This study determined whether 12 weeks of treatment with acetaminophen at half the maximum recommended daily dose causes an increase in alanine transaminase (ALT) in healthy adults participating in a clinical trial of the effect of acetaminophen on asthma control and severity. 94 healthy adults aged 18-65 years with mild to moderate asthma and with no history of previous liver dysfunction and an ALT within 1.5 times the upper limit of normal at baseline participated in a randomized, double-blind, placebo-controlled, parallel-group, clinical trial of 1g of acetaminophen twice daily or placebo twice daily for 12 weeks. Liver function monitoring was undertaken at baseline, weeks 2, 4, 6 and 12. The primary outcome variable was mean ALT levels at week 12 compared to baseline in the acetaminophen group versus placebo group. 94 participants were randomized and commenced study treatment. One participant in each treatment group was withdrawn due to an increase in ALT to greater than three times the upper limit of normal. Mean ALT at week 12 was 25.4I U/L (SD 9.7) in the acetaminophen group (N=31) and 19.0 IU/L (SD 6.0) in the placebo group (N=54). After controlling for baseline this represented a statistically significant difference of 3.6 IU/L (95% CI 1.3 to 6.0, P=0.003). There was no progressive increase in ALT demonstrated throughout the trial. Regular, daily use of acetaminophen at half the maximum recommended daily dose for 12 weeks in a healthy adult population is associated with a small elevation in mean ALT of no probable clinical significance. Further assessment of the effects on liver function of the maximum recommended dose of acetaminophen is required. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  19. Preoperative Interventions and Charges in the 2-Year Period Before Unicompartmental Knee Arthroplasty: What Happens Before Surgery.

    PubMed

    Bradley, Alexander T; Cohen, Jeremiah R; Lieberman, Jay R

    2017-06-03

    This study investigated preoperative interventions and their costs in the 2-year period before a patient undergoing a unicompartmental knee arthroplasty (UKA). A retrospective cohort analysis of patients undergoing UKA between 2009 and 2011 was conducted using the PearlDiver Patient Record Database to track inpatient and outpatient billing records. One thousand eight hundred forty-one patients from Medicare and 4704 patients from United Healthcare underwent UKA between 2009 and 2011. In the 2 years before UKA, the per patient average charge was $3919.96 for Medicare patients and $5219.14 for United Healthcare patients, with 21.7% of Medicare-associated charges and 28.2% of United Healthcare-associated charges occurring within 3 months of surgery. In the 2-year period before surgery, 65.5% of Medicare patients and 53.6% of United Healthcare patients received an intra-articular injection, with 29.1% (Medicare) and 46.0% (United Healthcare) of these injections occurring within 3 months of surgery. In addition, 15.1% of Medicare patients and 20.7% of United Healthcare patients underwent an arthroscopy, with between 32.4% and 43.8% of these occurring in the final 6 months before UKA. Preoperative interventions (ie, imaging, procedures, physical therapy, and injections) occur at a high frequency in close proximity to UKA resulting in substantial costs. The development of algorithms to guide management of these patients is critical in reducing costs before UKA. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Comparison of 2 Dosages of Intraarticular Triamcinolone for the Treatment of Knee Arthritis: Results of a 12-week Randomized Controlled Clinical Trial.

    PubMed

    Popma, Jan Willem; Snel, Frank W; Haagsma, Cees J; Brummelhuis-Visser, Petra; Oldenhof, Hans G J; van der Palen, Job; van de Laar, Mart A F J

    2015-10-01

    To determine whether a double dose of intraarticular triamcinolone acetonide is more effective for knee arthritis than a 40-mg dose. In this 12-week randomized controlled clinical trial, 40 mg and 80 mg of intraarticular triamcinolone acetonide were compared in patients with knee arthritis. Evaluated variables included a Likert burden scale, visual analog scale pain scale, degree of arthritis activity, presence of swelling, and presence of functional limitation. Ninety-seven patients were randomized. No significant differences were observed between the groups regarding any outcomes. An 80-mg dose of triamcinolone acetonide had no additional benefit compared with 40 mg as treatment for knee arthritis. Nederlands Trial Register; trial registration number: NTR2298.

  1. Benefits of a 12-week lifestyle modification program including diet and combined aerobic and resistance exercise on albuminuria in diabetic and non-diabetic Japanese populations.

    PubMed

    Yamamoto-Kabasawa, Keiko; Hosojima, Michihiro; Yata, Yusuke; Saito, Mariko; Tanaka, Noriko; Tanaka, Junta; Tanabe, Naohito; Narita, Ichiei; Arakawa, Masaaki; Saito, Akihiko

    2015-12-01

    Albuminuria is a biomarker for chronic kidney disease and an independent predictor of cardiovascular and all-cause mortality. A recent meta-analysis concluded that these risks increase with urinary albumin concentration, even when below the microalbuminuria threshold. Thus, minimizing urinary albumin may be a valuable therapeutic goal regardless of disease status. We investigated the benefits and safety of a 12-week lifestyle modification program including diet and combined aerobic and resistance exercise for reducing albuminuria in 295 normoalbuminuric or microalbuminuric Japanese adults, including 30 with type 2 diabetes mellitus (T2DM), 104 with metabolic syndrome (MS), and 145 with hypertension (HT). In the study population, the urinary albumin:creatinine ratio (UACR) was reduced significantly (ΔUACR -3.8 ± 16.8 mg/g, P < 0.001) with no change in estimated glomerular filtration rate (eGFR) (ΔeGFR -0.4 ± 7.4 mL/min/1.73 m(2), P = 0.343). The reduction in UACR was associated with decreased fasting plasma glucose (P < 0.05). The UACR was also reduced in the T2DM, MS, and HT groups with no change in eGFR. Reduced UACR was associated with decreased fasting plasma glucose in the MS group and decreased systolic blood pressure in the HT group. The UACR was also reduced in 46 subjects using renin-angiotensin system inhibitors with no change in eGFR. Our 12-week lifestyle modification program reduced UACR, maintained eGFR, and improved multiple fitness findings in Japanese subjects including T2DM, MS, and HT patients.

  2. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial.

    PubMed

    Pinkerton, JoAnn V; Constantine, Ginger; Hwang, Eunhee; Cheng, Ru-Fong J

    2013-01-01

    The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week. Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined. The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P < 0.001) and week 12 (P < 0.001). On week 12, desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, -4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, -0.28 [12%] per day). MCID-a reduction of 5.35 moderate and severe hot flashes per day-was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P < 0.001). In all, 17.2% (67/390) of participants discontinued, 10.0% (20/200) of participants taking desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012). Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID.

  3. Efficacy of indacaterol 75 μg once-daily on dyspnea and health status: results of two double-blind, placebo-controlled 12-week studies.

    PubMed

    Gotfried, Mark H; Kerwin, Edward M; Lawrence, David; Lassen, Cheryl; Kramer, Benjamin

    2012-12-01

    Indacaterol is an inhaled, once-daily, long-acting ®(2)-agonist for the treatment of COPD. Most previous studies were conducted with doses of 150 and/or 300 μg once-daily, and data with the 75 μg dose are limited. Two identically designed studies were, therefore, conducted to evaluate the efficacy and safety of the 75 μg once-daily dose. In two double-blind studies conducted in the USA, patients with moderate-to-severe COPD were randomized to treatment with indacaterol 75 μg once-daily (n = 163 and 159) or matching placebo (n = 160 and 159) for 12 weeks. The primary variable was forced expiratory volume in 1 s measured 24 h post-dose after 12 weeks (reported elsewhere). This report describes secondary efficacy endpoints, including transition dyspnea index (TDI) and St George's Respiratory Questionnaire (SGRQ) total scores, and the percentages of patients with improvements of or above the minimal clinically important difference (MCID; ≥1 in TDI score and ≥4 in SGRQ score). Differences between indacaterol and placebo for TDI total score at week 12 were 1.23 (p < 0.001) and 0.45 (p = 0.16), with odds ratios for achieving the MCID of 2.19 (p = 0.002) and 1.58 (p = 0.065). SGRQ total score decreased (improved) from baseline by 5.8 and 4.9 units with indacaterol at week 12 (2.0 and 0.9 with placebo), with odds ratios for achieving the MCID of 1.80 (p = 0.024) and 1.71 (p = 0.031). Patients receiving indacaterol had statistically significant or numerical improvements in diary-derived symptom variables compared with placebo. Treatment with indacaterol 75 μg may provide useful improvements in patient-reported outcomes in patients with moderate-to-severe COPD.

  4. Self-rating level of perceived exertion for guiding exercise intensity during a 12-week cardiac rehabilitation programme and the influence of heart rate reducing medication.

    PubMed

    Tang, Lars H; Zwisler, Ann-Dorthe; Taylor, Rod S; Doherty, Patrick; Zangger, Graziella; Berg, Selina K; Langberg, Henning

    2016-08-01

    To investigate whether self-rating level of perceived exertion can adequately guide exercise intensity during a 12-week cardiac rehabilitation programme. Linear regression analysis using rehabilitation data from two randomised controlled trials. Patients undergoing radiofrequency ablation for atrial fibrillation or following heart valve surgery and participating in exercise-based rehabilitation were included. The 12-week rehabilitation outpatient programme comprised three weekly training sessions, each consisting of 20min aerobic exercise divided into three steps. Patients were asked to base their exercise intensity for each step on a predefined rating of perceived exertion specified in a training diary. Exercise intensity was objectively measured by heart rate during the last 2min for each exercise step. Comparative analysis and linear regression of the rating of perceived exertion and heart rate were performed. A total of 2622 ratings of perceived exertion were collected from 874 training sessions in 97 patients. Heart rate and rating of perceived exertion were associated both across all three exercise steps and individually for each step, with a mean of 6 to7bpm per 1-point difference in the rating of perceived exertion (p<0.001). Adjusting for rate-reducing medication slightly improved the strength of the association. The association between change in the rating of perceived exertion and change in heart rate indicates that a diary-led and self-regulated model using rating of perceived exertion can help guide exercise intensity in everyday clinical practice among patients with heart disease, irrespective if they are taking heart rate-reducing medication. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  5. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.

    PubMed

    Szegedi, Armin; Calabrese, Joseph R; Stet, Let; Mackle, Mary; Zhao, Jun; Panagides, John

    2012-02-01

    In a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily asenapine 5 or 10 mg (n = 158) or placebo (n = 166). The primary efficacy end point was change from baseline Young Mania Rating Scale (YMRS) total score at week 3. Secondary outcomes included YMRS response and remission and Clinical Global Impression for Bipolar Disorder and Montgomery-Asberg Depression Rating Scale score changes. Patients completing the core study were eligible for a 40-week double-blind extension assessing safety and tolerability. Adjunctive asenapine significantly improved mania versus placebo at week 3 (primary end point) and weeks 2 to 12. The YMRS response rates were similar at week 3 but significantly better with asenapine at week 12. The YMRS remission rates and changes from baseline on Clinical Global Impression for Bipolar Disorder for mania and overall illness were significantly better with asenapine at weeks 3 and 12. No other statistically significant differences on secondary outcomes were observed. Only a small number of patients entered the extension, making firm statistical conclusions on efficacy difficult. Treatment-emergent adverse events reported by 5% or more of asenapine patients and at twice the incidence of placebo were sedation, somnolence, depression/depressive symptoms, oral hypoesthesia, and increased weight in the 12-week core study. Adjunctive asenapine to lithium or valproate was more effective than mood stabilizer monotherapy in the core study and was well tolerated for up to 52 weeks.

  6. Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study

    PubMed Central

    Tsifetaki, N; Kitsos, G; Paschides, C; Alamanos, Y; Eftaxias, V; Voulgari, P; Psilas, K; Drosos, A

    2003-01-01

    Objective: To evaluate the efficacy and side effects of oral pilocarpine for the treatment of ocular symptoms in patients with primary Sjögren's syndrome (SS). Methods: A 12 week, single centre, randomised controlled study was performed. Twenty nine patients were randomly assigned to receive oral pilocarpine (5 mg twice a day), 28 only artificial tears, and 28 inferior puncta occlusion. Patients receiving oral pilocarpine and those with inferior puncta occlusion also received artificial tears. Patients were evaluated at baseline and throughout the study for their subjective global assessment of dry eyes and for their objective assessment of dry eyes (Schirmer's-I test, rose bengal test, and imprint test). Results: Patients taking oral pilocarpine had significant improvement in subjective global assessment of dry eyes, as was evaluated by improvement of >55 mm on a visual analogue scale (VAS) for responses to the eye questionnaire, compared with patients treated with artificial tears (p<0.001) and those with inferior puncta occlusion (p<0.05). Furthermore, patients receiving oral pilocarpine also showed greater objective improvement, as measured by the rose bengal test (p<0.05), while Schirmer's-I test showed no differences between the treated groups. Commonly reported adverse events were headache, increased sweating, nausea, and vomiting in the pilocarpine group, while one patient in the inferior puncta occlusion group had blepharitis and was withdrawn from the study. Conclusion: 10 mg of pilocarpine daily given to patients with SS for 12 weeks had a beneficial effect on subjective eye symptoms, as evaluated by improvement >55 mm on a VAS. Additionally, an improvement of rose bengal staining was noted, but an increase in tear production, as measured by the Schirmer-I test, was not substantiated. PMID:14644860

  7. Opioid addicted buprenorphine injectors: drug use during and after 12-weeks of buprenorphine-naloxone or methadone in the Republic of Georgia.

    PubMed

    Piralishvili, Gvantsa; Otiashvili, David; Sikharulidze, Zura; Kamkamidze, George; Poole, Sabrina; Woody, George E

    2015-03-01

    The aim of this study is to assess the prevalence of non-opioid drug use among opioid-addicted, buprenorphine injecting individuals in Georgia, during and after a 12-week course of buprenorphine-naloxone (Suboxone®) or methadone. Randomized controlled trial with daily observed Suboxone® or methadone and weekly counseling, urine tests and timeline followback (TLFB) in weeks 0-12 and 20, and the Addiction Severity Index (ASI) at weeks 0, 4, 8, 12, 20. Of the 80 patients (40/group, 4 women), 68 (85%) completed the 12-weeks of study treatment and 66 (82.5%) completed the 20-week follow-up. At baseline, injecting more than one drug in the last 30 days was reported by 68.4% of patients in the methadone and 72.5% in the Suboxone® groups. Drug use was markedly reduced in both treatment conditions but there were significant differences in the prevalence of specific drugs with more opioid (1.5 vs. 0.2%; p=0.03), less amphetamine (0.2 vs. 2.8%; p<0.001) and less marijuana (1.7 vs. 10.2%; p<0.001) positive urine tests in the methadone vs. Suboxone® groups. At the 20-week follow-up, TLFB results on the 34 that continued methadone or the 3 on Suboxone® showed less opioid (5.6 vs. 27.6%; p<0.001), illicit buprenorphine (2.7 vs. 13.8%; p=0.005), benzodiazepine (13.5 vs. 34.5%; p<0.001), and marijuana (2.8 vs. 20.7%; p<0.001) use than the 29 who did not continue opioid substitution therapy. Despite small but significant differences in opioid and other drug use, both treatments were highly effective in reducing opioid and non-opioid drug use. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Concentration- and time-dependent genomic changes in the mouse urinary bladder following exposure to arsenate in drinking water for up to 12 weeks.

    PubMed

    Clewell, H J; Thomas, R S; Kenyon, E M; Hughes, M F; Adair, B M; Gentry, P R; Yager, J W

    2011-10-01

    Inorganic arsenic (As(i)) is a known human bladder carcinogen. The objective of this study was to examine the concentration dependence of the genomic response to As(i) in the urinary bladders of mice. C57BL/6J mice were exposed for 1 or 12 weeks to arsenate in drinking water at concentrations of 0.5, 2, 10, and 50 mg As/l. Urinary bladders were analyzed using gene expression microarrays. A consistent reversal was observed in the direction of gene expression change: from predominantly decreased expression at 1 week to predominantly increased expression at 12 weeks. These results are consistent with evidence from in vitro studies of an acute adaptive response that is suppressed on longer exposure due to downregulation of Fos. Pathways with the highest enrichment in gene expression changes were associated with epithelial-to-mesenchymal transition, inflammation, and proliferation. Benchmark dose (BMD) analysis determined that the lowest median BMD values for pathways were above 5 mg As/l, despite the fact that pathway enrichment was observed at the 0.5 mg As/l exposure concentration. This disparity may result from the nonmonotonic nature of the concentration-responses for the expression changes of a number of genes, as evidenced by the much fewer gene expression changes at 2 mg As/l compared with lower or higher concentrations. Pathway categories with concentration-related gene expression changes included cellular morphogenesis, inflammation, apoptosis/survival, cell cycle control, and DNA damage response. The results of this study provide evidence of a concentration-dependent transition in the mode of action for the subchronic effects of As(i) in mouse bladder cells in the vicinity of 2 mg As(i)/l.

  9. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment

    PubMed Central

    2013-01-01

    Background Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. Methods/Design In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During

  10. The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis

    PubMed Central

    Fenton, Carol; James, Matthew; Tang, Karen L.

    2017-01-01

    Background. The recommended therapy for patients with chronic hepatitis C (CHC), genotype 1, who have cirrhosis and have failed prior therapy is 12 weeks of sofosbuvir (SOF), ledipasvir (LDV), and ribavirin (RBV). This recommendation is based on expert opinion, and the efficacy of 12 weeks of SOF/LDV compared to SOF/LDV/RBV in this patient population has not yet been established. Methods. We conducted a systematic review and meta-analysis. Two investigators independently searched electronic databases and relevant conference proceedings for randomized controlled trials comparing rates of sustained virologic response 12 weeks after therapy (SVR12) when using 12 weeks of SOF/LDV versus 12 weeks of SOF/LDV/RBV in patients with CHC, genotype 1, who have cirrhosis and failed previous therapy. Results. Our search strategy yielded 596 studies of which four met criteria for inclusion. The pooled RR of not achieving SVR12 with SOF/LDV versus SOF/LDV/RBV was 1.21 (95% CI: 0.42–3.48). Adverse events were lower in the SOF/LDV compared to the SOF/LDV/RBV arms (pooled RR: 0.11, 95% CI: 0.04–0.29). Conclusions. Our findings suggest that 12 weeks of SOF/LDV cannot be considered noninferior to 12 weeks of SOF/LDV/RBV to achieve SVR12 in patients with CHC who have cirrhosis and failed prior therapy. PMID:28367429

  11. Prophylactic exercises among head and neck cancer patients during and after swallowing sparing intensity modulated radiation: adherence and exercise performance levels of a 12-week guided home-based program.

    PubMed

    Cnossen, Ingrid C; van Uden-Kraan, Cornelia F; Witte, Birgit I; Aalders, Yke J; de Goede, Cees J T; de Bree, Remco; Doornaert, Patricia; Rietveld, Derek H F; Buter, Jan; Langendijk, Johannes A; Leemans, C René; Verdonck-de Leeuw, Irma M

    2017-02-01

    The background and purpose of this paper is to investigate adherence, exercise performance levels and associated factors in head and neck cancer (HNC) patients participating in a guided home-based prophylactic exercise program during and after treatment [swallowing sparing intensity modulated radiation therapy (SW-IMRT)]. Fifty patients were included in the study. Adherence was defined as the percentage of patients who kept up exercising; exercise performance level was categorized as low: ≤1, moderate: 1-2, and high: ≥2 time(s) per day, on average. Associations between 6- and 12-week exercise performance levels and age, gender, tumour site and stage, treatment, intervention format (online or booklet), number of coaching sessions, and baseline HNC symptoms (EORTC-QLQ-H&N35) were investigated. Adherence rate at 6 weeks was 70% and decreased to 38% at 12 weeks. In addition, exercise performance levels decreased over time (during 6 weeks: 34% moderate and 26% high; during 12 weeks: 28% moderate and 18% high). The addition of chemotherapy to SW-IMRT [(C)SW-IMRT] significantly deteriorated exercise performance level. Adherence to a guided home-based prophylactic exercise program was high during (C)SW-IMRT, but dropped afterwards. Exercise performance level was negatively affected by chemotherapy in combination with SW-IMRT.

  12. The effect of a 12-week low glycaemic index diet on heart disease risk factors and 24 h glycaemic response in healthy middle-aged volunteers at risk of heart disease: a pilot study.

    PubMed

    Philippou, E; McGowan, B M C; Brynes, A E; Dornhorst, A; Leeds, A R; Frost, G S

    2008-01-01

    To compare the effects of two energy-restricted healthy diets, one with a low GI and one with a high GI, on heart disease risk factors and weight loss in subjects at risk of heart disease. A 12-week randomized parallel study of low and high GI, healthy eating diets was carried out. The study was carried out at the Hammersmith Hospital. Eighteen subjects were recruited by advertisement and randomized to one of the two diets. Fourteen completed the study but one was excluded from the final analysis. At randomization, subjects were advised to follow the intervention diet for 12 weeks. Before randomization and on completion of the study, anthropometrics, fasting cholesterol and glucose blood tests and 24-h glucose measurements were taken using a continuous glucose monitoring system (CGMS). Statistical analysis was carried out using non-parametric tests. Median (IQR) are presented. A significantly different dietary GI was achieved in the low GI (median: 51.3 (IQR: 51.0-52.0) compared to the high GI (59.3 (59.2-64.0) (P=0.032) group. By week 12, both groups reduced their energy intake by: low GI group: (-)167 ((-)312-(-)123) kcal/day (P=0018) vs high GI group: (-)596 ((-)625-(-)516) (P=0.018) kcal/day, the difference between the groups being significant (P=0.010). However, only the low GI group lost weight ((-)4.0 ((-)4.4-(-)2.4) kg (P=0.018) whereas the high GI group did not significantly change in weight ((-)1.5 ((-)3.6-0.8) kg (P=0.463). By week 12, the low GI group also had a significantly lower 24-h area under the curve (AUC) (7556 (7315-8434) vs 8841 (8424-8846) mmol-h/l (P=0.045) and overnight AUC (2429 (2423-2714) vs 3000 (2805-3072) mmol-h/l (P=0.006) glucose as measured by CGMS. There were no differences in the other heart disease risk factors assessed. This pilot study provides some evidence that consuming a low GI diet in addition to weight loss and healthy eating may reduce cardiovascular risk. Other potential benefits of GI might have been masked by weight

  13. Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia

    PubMed Central

    Krystal, Andrew D.; Durrence, H. Heith; Scharf, Martin; Jochelson, Philip; Rogowski, Roberta; Ludington, Elizabeth; Roth, Thomas

    2010-01-01

    Study Objectives: To evaluate the efficacy and safety of doxepin 1 mg and 3 mg in elderly subjects with chronic primary insomnia. Design and Methods: The study was a randomized, double-blind, parallel-group, placebo-controlled trial. Subjects meeting DSM-IV-TR criteria for primary insomnia were randomized to 12 weeks of nightly treatment with doxepin (DXP) 1 mg (n = 77) or 3 mg (n = 82), or placebo (PBO; n = 81). Efficacy was assessed using polysomnography (PSG), patient reports, and clinician ratings. Objective efficacy data are reported for Nights (N) 1, 29, and 85; subjective efficacy data during Weeks 1, 4, and 12; and Clinical Global Impression (CGI) scale and Patient Global Impression (PGI) scale data after Weeks 2, 4, and 12 of treatment. Safety assessments were conducted throughout the study. Results: DXP 3 mg led to significant improvement versus PBO on N1 in wake time after sleep onset (WASO; P < 0.0001; primary endpoint), total sleep time (TST; P < 0.0001), overall sleep efficiency (SE; P < 0.0001), SE in the last quarter of the night (P < 0.0001), and SE in Hour 8 (P < 0.0001). These improvements were sustained at N85 for all variables, with significance maintained for WASO, TST, overall SE, and SE in the last quarter of the night. DXP 3 mg significantly improved patient-reported latency to sleep onset (Weeks 1, 4, and 12), subjective TST (Weeks 1, 4, and 12), and sleep quality (Weeks 1, 4, and 12). Several global outcome-related variables were significantly improved, including the severity and improvement items of the CGI (Weeks 2, 4, and 12), and all 5 items of the PGI (Week 12; 4 items after Weeks 2 and 4). Significant improvements were observed for DXP 1 mg for several measures including WASO, TST, overall SE, and SE in the last quarter of the night at several time points. Rates of discontinuation were low, and the safety profiles were comparable across the 3 treatment groups. There were no significant next-day residual effects; additionally, there

  14. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    PubMed Central

    Myers, Jonathan S; Vold, Steven; Zaman, Fiaz; Williams, Julia M; Hollander, David A

    2014-01-01

    Background The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma. Methods Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented. Results Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm. Conclusion Many patients who do not reach their target IOP on latanoprost can achieve additional IOP

  15. A 12-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush with self-adjusting technology in reducing plaque and gingivitis.

    PubMed

    Klukowska, Malgorzata; Grender, Julie M; Conde, Erinn; Goyal, C Ram

    2013-01-01

    The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis. This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI. Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p < 0.001). The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI (31% and 29% at Weeks 4 and 12, respectively; p < 0.001), GBI (17% at Week 12; p = 0.047), and total number of bleeding sites (48% and 30% at Weeks 4 and 12, respectively; p = 0.002), and produced statistically

  16. Comparison of fluticasone/formoterol with budesonide/formoterol pMDI in adults with moderate to severe persistent asthma: Results from a 12-week randomized controlled trial.

    PubMed

    Balki, Akash; Balamurugan, S; Bardapurkar, Suhas; Dalal, Sonia; Singh, Ajeet; Singh, B P; Vaidya, Abhijit; Gogtay, Jaideep A

    2017-09-07

    Combination therapy of inhaled corticosteroid/long acting β2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo(®)) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks. This study enrolled patients between 18 and 65 years. The primary end-point was to demonstrate non-inferiority for the mean change in the pre-dose morning peak expiratory flow values (PEF). The secondary end-points included lung function assessments, number of symptom-free days and nights, rescue medication use, day-and night-time symptom scores and safety evaluation. Two hundred and thirty-two patients were randomized to either flu/form (n = 117) or bud/form (n = 115). At the end of 12 weeks, flu/form was non-inferior to bud/form with regards to the primary end-point of morning PEF (48.07 L/min vs. 49.03 L/min, p > 0.05). These improvements were statistically significant (p < 0.0001) vs baseline. Similar improvements were observed between the two groups for secondary efficacy end-points including FEV1, symptom-free nights, rescue medication use, day-and night-time symptom scores (p > 0.05). Flu/form exhibited a safety profile comparable to that of bud/form. Fluticasone/formoterol combination administered through a pMDI is as efficacious and well-tolerated as budesonide/formoterol and offers a new therapeutic option for patients with moderate to severe persistent asthma. Copyright © 2017. Published by Elsevier Ltd.

  17. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study

    PubMed Central

    Kerwin, Edward M; Kalberg, Chris J; Galkin, Dmitry V; Zhu, Chang-Qing; Church, Alison; Riley, John H; Fahy, William A

    2017-01-01

    Introduction Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO). Methods In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%–70% of predicted; modified Medical Research Council [mMRC] score ≥1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point), 0–3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI), St George’s Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs). Results Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45–131]; P<0.001) and FEV1 after 5 min on Day 1 (50 mL [95% CI: 27–72]; P<0.001). Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: −0.1 puffs/d [95% CI: −0.2–0.0]; P≤0.05). More patients achieved clinically meaningful improvements in TDI score (≥1 unit) with UMEC/VI (63%) versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21–2.64]; P≤0.01). Improvements in SGRQ and CAT scores were similar between treatments. The incidence of AEs was similar with UMEC/VI (30%) and TIO (31%). Conclusion UMEC/VI step-up therapy provides clinical benefit over TIO monotherapy in patients with moderate COPD who are symptomatic on TIO alone. PMID:28280319

  18. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study

    PubMed Central

    2010-01-01

    Background Decreased bone mineral density and osteoporosis in postmenopausal women represents a growing source of physical limitations and financial concerns in our aging population. While appropriate medical treatments such as bisphosphonate drugs and hormone replacement therapy exist, they are associated with serious side effects such as osteonecrosis of the jaw or increased cardiovascular risk. In addition to calcium and vitamin D supplementation, previous studies have demonstrated a beneficial effect of dietary silicon on bone health. This study evaluated the absorption of silicon from bottled artesian aquifer water and its effect on markers of bone metabolism. Methods Seventeen postmenopausal women with low bone mass, but without osteopenia or osteoporosis as determined by dual x-ray absorptiometry (DEXA) were randomized to drink one liter daily of either purified water of low-silicon content (PW) or silicon-rich artesian aquifer water (SW) (86 mg/L silica) for 12 weeks. Urinary silicon and serum markers of bone metabolism were measured at baseline and after 12 weeks and analyzed with two-sided t-tests with p < 0.05 defined as significant. Results The urinary silicon level increased significantly from 0.016 ± 0.010 mg/mg creatinine at baseline to 0.037 ± 0.014 mg/mg creatinine at week 12 in the SW group (p = 0.003), but there was no change for the PW group (0.010 ± 0.004 mg/mg creatinine at baseline vs. 0.009 ± 0.006 mg/mg creatinine at week 12, p = 0.679). The urinary silicon for the SW group was significantly higher in the silicon-rich water group compared to the purified water group (p < 0.01). NTx, a urinary marker of bone resorption did not change during the study and was not affected by the silicon water supplementation. No significant change was observed in the serum markers of bone formation compared to baseline measurements for either group. Conclusions These findings indicate that bottled water from artesian aquifers is a safe and effective way

  19. IS INCREASED HCV CASE-FINDING COMBINED WITH CURRENT OR 8–12 WEEK DAA THERAPY COST-EFFECTIVE IN UK PRISONS? A PREVENTION BENEFIT ANALYSIS

    PubMed Central

    Martin, Natasha K; Vickerman, Peter; Brew, Iain F; Williamson, Joan; Miners, Alec; Irving, William L; Saksena, Sushma; Hutchinson, Sharon J; Mandal, Sema; O’Moore, Eamonn; Hickman, Matthew

    2016-01-01

    Background Prisoners have a high prevalence of Hepatitis C virus (HCV), but case-finding may not have been cost-effective because treatment often exceeded average prison stay combined with a lack of continuity-of-care. We assess the cost-effectiveness of increased HCV case-finding and treatment in UK prisons using short-course therapies. Methods A dynamic HCV transmission model assesses the cost-effectiveness of doubling HCV case-finding (achieved through introducing opt-out HCV testing in UK pilot prisons) and increasing treatment in UK prisons, compared to status-quo voluntary risk-based testing (6% prison entrants/year), using currently recommended therapies (8–24 weeks) or IFN-free DAAs (8–12 weeks, 95% SVR, £3300/wk). Costs (GBP£) and health utilities (quality-adjusted life-years, QALYs) were used to calculate mean incremental cost-effectiveness ratios (ICERs). We assume 56% referral and 2.5%/25% of referred people who inject drugs (PWID)/exPWID treated within 2 months of diagnosis in prison. PWID and ex/nonPWID are in prison an average 4/8 months, respectively. Results Doubling prison testing rates with existing treatments produces a mean ICER of £19,850/QALY gained compared to current testing/treatment, and is 45% likely to be cost-effective under a £20,000 willingness-to-pay (WTP) threshold. Switching to 8–12 week IFN-free DAAs in prisons could increase cost-effectiveness (ICER £15,090/QALY gained). Excluding prevention benefit decreases cost-effectiveness. If >10% referred PWID are treated in prison (2.5% base-case), either treatment could be highly cost-effective (ICER<£13,000). HCV case-finding and IFN-free DAAs could be highly cost-effective if DAA cost is 10% lower or 8 weeks duration. Conclusions Increased HCV testing in UK prisons (such as through opt-out testing) is borderline cost-effective compared to status-quo voluntary risk-based testing under a £20,000 WTP with current treatments, but likely to be cost-effective if short

  20. Motivation and ability to walk for a food reward in fast- and slow-growing broilers to 12 weeks of age.

    PubMed

    Bokkers, Eddie A M; Koene, Paul

    2004-09-30

    Poor physical abilities of broilers may prevent them from performing behaviours for which they are motivated. The aim of this study was to measure the influence of physical ability and motivation on the performance of broilers in short physical tasks. We tested birds from a fast- and a slow-growing broiler strain in a runway to 12 weeks of age. To manipulate motivation, half of the birds of each strain was feed deprived for 3h and the other half for 24h before testing. Each bird was tested in a control and a slalom runway test once a week. With a similar motivation, slow growers had a shorter latency to start walking and walked faster through the runway than fast growers in both tests. In fast growers walking speed decreased faster with age than in slow growers. Slow growers vocalised more in both tests. In the slalom test, 24h deprived birds vocalised more than 3h deprived birds. Although the fast and slow growers have a different genetic background, the results indicated that motivation is the dominant determinative factor for walking in birds with a low body weight, while physical ability is the dominant determinative factor for walking in birds with a high body weight.

  1. Intestinal colonisation patterns in breastfed and formula-fed infants during the first 12 weeks of life reveal sequential microbiota signatures.

    PubMed

    Timmerman, Harro M; Rutten, Nicole B M M; Boekhorst, Jos; Saulnier, Delphine M; Kortman, Guus A M; Contractor, Nikhat; Kullen, Martin; Floris, Esther; Harmsen, Hermie J M; Vlieger, Arine M; Kleerebezem, Michiel; Rijkers, Ger T

    2017-08-21

    The establishment of the infant gut microbiota is a highly dynamic process dependent on extrinsic and intrinsic factors. We characterized the faecal microbiota of 4 breastfed infants and 4 formula-fed infants at 17 consecutive time points during the first 12 weeks of life. Microbiota composition was analysed by a combination of 16S rRNA gene sequencing and quantitative PCR (qPCR). In this dataset, individuality was a major driver of microbiota composition (P = 0.002) and was more pronounced in breastfed infants. A developmental signature could be distinguished, characterized by sequential colonisation of i) intrauterine/vaginal birth associated taxa, ii) skin derived taxa and other typical early colonisers such as Streptococcus and Enterobacteriaceae, iii) domination of Bifidobacteriaceae, and iv) the appearance of adultlike taxa, particularly species associated with Blautia, Eggerthella, and the potential pathobiont Clostridium difficile. Low abundance of potential pathogens was detected by 16S profiling and confirmed by qPCR. Incidence and dominance of skin and breast milk associated microbes were increased in the gut microbiome of breastfed infants compared to formula-fed infants. The approaches in this study indicate that microbiota development of breastfed and formula-fed infants proceeds according to similar developmental stages with microbiota signatures that include stage-specific species.

  2. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR) and Superoxide dismutase (SOD) is significant only for cigarette smokers (CS) and hookah smokers (HS) groups. The Malondialdehyde (MDA) decrease and α-tocopherol increase are significant only for HS group. GPx was increased in NS, CS and HS by 2.6% (p< 0.01), 2% (p< 0.05) and 1.7% (p< 0.05) respectively. Likewise, significant improvements of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and TC / HDL-C ratio were observed in three groups. En contrast no significant changes were recorded in triglycerides (TG). Also, significant reduction of total cholesterol (TC) for CS group (p< 0.01) and HS groups (p< 0.05). This continuous training program appears to have an important role in lipid levels improving and oxidative stress attenuation. PMID:26121249

  3. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial.

    PubMed

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners.

  4. A 12-week dose-escalating study of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese hemodialysis patients
.

    PubMed

    Yokoyama, Keitaro; Fukagawa, Masafumi; Shigematsu, Takashi; Akiba, Takashi; Fujii, Akifumi; Odani, Motoi; Akizawa, Tadao

    2017-08-01

    To evaluate dose-escalation of etelcalcetide (ONO-5163/AMG 416), a novel, intravenous (IV), long-acting calcium-sensing receptor agonist, for treatment of secondary hyperparathyroidism (SHPT) in Japanese hemodialysis patients. In this multicenter study, IV injections of etelcalcetide (3 times a week for 12 weeks) were administered, with dose escalation every 4 weeks depending on changes in serum intact parathyroid hormone (iPTH) and corrected calcium (cCa). A total of 24 patients participated in this study. Serum iPTH was reduced in a time- and dose-dependent manner, with reductions (in pg/mL) at 12 weeks of -226.1 ± 125.3, -362.5 ± 161.5, and -412.4 ± 130.2, respectively, for maximum doses of 5, 10, and 15 mg. At the end of the treatment, 50% of patients had serum iPTH levels within the target range (60 - 240 pg/mL). Serum cCa and phosphorus were reduced in parallel with iPTH. Adverse events (AEs) occurred in 20 patients (83.3%). The most frequently observed AEs (> 10%) were either mild or moderate nasopharyngitis (29.2%), decreased serum calcium (16.7%), and vomiting (12.5%). Dose-escalated triweekly etelcalcetide was effective for SHPT in Japanese hemodialysis patients and was satisfactorily tolerated.
.

  5. Is increased hepatitis C virus case-finding combined with current or 8-week to 12-week direct-acting antiviral therapy cost-effective in UK prisons? A prevention benefit analysis.

    PubMed

    Martin, Natasha K; Vickerman, Peter; Brew, Iain F; Williamson, Joan; Miners, Alec; Irving, William L; Saksena, Sushma; Hutchinson, Sharon J; Mandal, Sema; O'Moore, Eamonn; Hickman, Matthew

    2016-06-01

    Prisoners have a high prevalence of hepatitis C virus (HCV), but case-finding may not have been cost-effective because treatment often exceeded average prison stay combined with a lack of continuity of care. We assessed the cost-effectiveness of increased HCV case-finding and treatment in UK prisons using short-course therapies. A dynamic HCV transmission model assesses the cost-effectiveness of doubling HCV case-finding (achieved through introducing opt-out HCV testing in UK pilot prisons) and increasing treatment in UK prisons compared to status quo voluntary risk-based testing (6% prison entrants/year), using currently recommended therapies (8-24 weeks) or interferon (IFN)-free direct-acting antivirals (DAAs; 8-12 weeks, 95% sustained virological response, £3300/week). Costs (British pounds, £) and health utilities (quality-adjusted life years) were used to calculate mean incremental cost-effectiveness ratios (ICERs). We assumed 56% referral and 2.5%/25% of referred people who inject drugs (PWID)/ex-PWID treated within 2 months of diagnosis in prison. PWID and ex-PWID or non-PWID are in prison an average 4 and 8 months, respectively. Doubling prison testing rates with existing treatments produces a mean ICER of £19,850/quality-adjusted life years gained compared to current testing/treatment and is 45% likely to be cost-effective under a £20,000 willingness-to-pay threshold. Switching to 8-week to 12-week IFN-free DAAs in prisons could increase cost-effectiveness (ICER £15,090/quality-adjusted life years gained). Excluding prevention benefit decreases cost-effectiveness. If >10% referred PWID are treated in prison (2.5% base case), either treatment could be highly cost-effective (ICER<£13,000). HCV case-finding and IFN-free DAAs could be highly cost-effective if DAA cost is 10% lower or with 8 weeks' duration. Increased HCV testing in UK prisons (such as through opt-out testing) is borderline cost-effective compared to status quo voluntary risk

  6. A Bayesian micro-simulation to evaluate the cost-effectiveness of interventions for mastitis control during the dry period in UK dairy herds.

    PubMed

    Down, P M; Bradley, A J; Breen, J E; Browne, W J; Kypraios, T; Green, M J

    2016-10-01

    Importance of the dry period with respect to mastitis control is now well established although the precise interventions that reduce the risk of acquiring intramammary infections during this time are not clearly understood. There are very few intervention studies that have measured the clinical efficacy of specific mastitis interventions within a cost-effectiveness framework so there remains a large degree of uncertainty about the impact of a specific intervention and its costeffectiveness. The aim of this study was to use a Bayesian framework to investigate the cost-effectiveness of mastitis controls during the dry period. Data were assimilated from 77 UK dairy farms that participated in a British national mastitis control programme during 2009-2012 in which the majority of intramammary infections were acquired during the dry period. The data consisted of clinical mastitis (CM) and somatic cell count (SCC) records, herd management practices and details of interventions that were implemented by the farmer as part of the control plan. The outcomes used to measure the effectiveness of the interventions were i) changes in the incidence rate of clinical mastitis during the first 30days after calving and ii) the rate at which cows gained new infections during the dry period (measured by SCC changes across the dry period from <200,000cells/ml to >200,000cells/ml). A Bayesian one-step microsimulation model was constructed such that posterior predictions from the model incorporated uncertainty in all parameters. The incremental net benefit was calculated across 10,000 Markov chain Monte Carlo iterations, to estimate the cost-benefit (and associated uncertainty) of each mastitis intervention. Interventions identified as being cost-effective in most circumstances included selecting dry-cow therapy at the cow level, dry-cow rations formulated by a qualified nutritionist, use of individual calving pens, first milking cows within 24h of calving and spreading bedding evenly in

  7. Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia.

    PubMed

    Krystal, Andrew D; Durrence, H Heith; Scharf, Martin; Jochelson, Philip; Rogowski, Roberta; Ludington, Elizabeth; Roth, Thomas

    2010-11-01

    to evaluate the efficacy and safety of doxepin 1 mg and 3 mg in elderly subjects with chronic primary insomnia. the study was a randomized, double-blind, parallel-group, placebo-controlled trial. Subjects meeting DSM-IV-TR criteria for primary insomnia were randomized to 12 weeks of nightly treatment with doxepin (DXP) 1 mg (n = 77) or 3 mg (n = 82), or placebo (PBO; n = 81). Efficacy was assessed using polysomnography (PSG), patient reports, and clinician ratings. Objective efficacy data are reported for Nights (N) 1, 29, and 85; subjective efficacy data during Weeks 1, 4, and 12; and Clinical Global Impression (CGI) scale and Patient Global Impression (PGI) scale data after Weeks 2, 4, and 12 of treatment. Safety assessments were conducted throughout the study. DXP 3 mg led to significant improvement versus PBO on N1 in wake time after sleep onset (WASO; P < 0.0001; primary endpoint), total sleep time (TST; P < 0.0001), overall sleep efficiency (SE; P < 0.0001), SE in the last quarter of the night (P < 0.0001), and SE in Hour 8 (P < 0.0001). These improvements were sustained at N85 for all variables, with significance maintained for WASO, TST, overall SE, and SE in the last quarter of the night. DXP 3 mg significantly improved patient-reported latency to sleep onset (Weeks 1, 4, and 12), subjective TST (Weeks 1, 4, and 12), and sleep quality (Weeks 1, 4, and 12). Several global outcome-related variables were significantly improved, including the severity and improvement items of the CGI (Weeks 2, 4, and 12), and all 5 items of the PGI (Week 12; 4 items after Weeks 2 and 4). Significant improvements were observed for DXP 1 mg for several measures including WASO, TST, overall SE, and SE in the last quarter of the night at several time points. Rates of discontinuation were low, and the safety profiles were comparable across the 3 treatment groups. There were no significant next-day residual effects; additionally, there were no reports of memory impairment, complex

  8. The effects of improved metabolic risk factors on bone turnover markers after 12 weeks of simvastatin treatment with or without exercise.

    PubMed

    Jiang, Jun; Boyle, Leryn J; Mikus, Catherine R; Oberlin, Douglas J; Fletcher, Justin A; Thyfault, John P; Hinton, Pamela S

    2014-11-01

    Emerging evidence supports an association between metabolic risk factors and bone turnover. Statins and exercise independently improve metabolic risk factors; however whether improvements in metabolic risk factor affects bone turnover is unknown. The purpose of the present study was to: 1) evaluate the relationship between metabolic risk factors and bone turnover; and 2) determine if improvements in metabolic risk factors after 12 weeks of statin treatment, exercise or the combination affect bone turnover. Fifty participants with ≥2 metabolic syndrome defining characteristics were randomly assigned to one of three groups: statin (STAT: simvastatin, 40 mg/day), exercise (EX: brisk walking and/or slow jogging, 45 minutes/day, 5 days/week), or the combination (STAT+EX). Body composition and whole body bone mineral density were measured with dual energy X-ray absorptiometry. Serum markers of bone formation (bone specific alkaline phosphatase, BAP; osteocalcin, OC), resorption (C-terminal peptide of type I collagen, CTX) and metabolic risk factors were determined. Two-factor (time, group) repeated-measures ANCOVA was used to examine changes of metabolic risk factors and bone turnover. General linear models were used to determine the effect of pre-treatment metabolic risk factors on post-treatment bone turnover marker outcomes. Participants with ≥4 metabolic syndrome defining characteristics had lower pre-treatment OC than those with 3 or fewer. OC was negatively correlated with glucose, and CTX was positively correlated with cholesterol. STAT or STAT+EX lowered total and LDL cholesterol. The OC to CTX ratio decreased in all groups with no other significant changes in bone turnover. Higher pre-treatment insulin or body fat predicted a greater CTX reduction and a greater BAP/CTX increase. Metabolic risk factors were negatively associated with bone turnover markers. Short-term statin treatment with or without exercise lowered cholesterol and all treatments had a small

  9. Fluoxetine versus sertraline in the treatment of patients with undifferentiated somatoform disorder: a randomized, open-label, 12-week, parallel-group trial.

    PubMed

    Han, Changsu; Pae, Chi-Un; Lee, Bun Hee; Ko, Young-Hoon; Masand, Prakash S; Patkar, Ashwin A; Jung, In-Kwa

    2008-02-15

    The present study was conducted to compare the effectiveness and tolerability of fluoxetine and sertraline in the treatment of undifferentiated somatoform disorder (USD), using the Patient Health Questionnaire (PHQ-15), which was specifically designed for assessing the severity of somatic symptoms. A randomized, 12-week, open-label trial of fluoxetine (10-60 mg/d) and sertraline (25-350 mg/d) in patients with USD was conducted. Six visits, at baseline and weeks 1, 2, 4, 8, and 12, were scheduled. Assessments for effectiveness and tolerability were conducted at each visit. The primary effectiveness measure was the mean change in PHQ-15 total score, from baseline to the end of treatment. Secondary effectiveness measures were the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ-12), from baseline to the end of treatment. A total of 45 subjects were enrolled; of them, 28 were randomly assigned to receive fluoxetine and 17 to receive sertraline. The total score on the PHQ-15 from baseline to the end of treatment significantly decreased in the fluoxetine (-10.7, p<0.0001) and sertraline (-10.3, p<0.0001) treatment groups, with no between-group difference (F=0.0701, p=0.7924). Overall, both treatments were well tolerated and no serious adverse event was reported. This study suggests that both agents may have a potential role in the treatment of USD. A double-blind, placebo-controlled trial and/or head-to-head comparison study with larger samples are required to draw more definite conclusions.

  10. Quercetin and Green Tea Extract Supplementation Downregulates Genes Related to Tissue Inflammatory Responses to a 12-Week High Fat-Diet in Mice.

    PubMed

    Cialdella-Kam, Lynn; Ghosh, Sujoy; Meaney, Mary Pat; Knab, Amy M; Shanely, R Andrew; Nieman, David C

    2017-07-19

    Quercetin (Q) and green tea extract (E) are reported to counter insulin resistance and inflammation and favorably alter fat metabolism. We investigated whether a mixture of E + Q (EQ) could synergistically influence metabolic and inflammation endpoints in a high-fat diet (HFD) fed to mice. Male C57BL/6 mice (n = 40) were put on HFD (fat = 60%kcal) for 12 weeks and randomly assigned to Q (25 mg/kg of body weight (BW)/day), E (3 mg of epigallocatechin gallate/kg BW/day), EQ, or control groups for four weeks. At 16 weeks, insulin sensitivity was measured via the glucose tolerance test (GTT), followed by area-under-the-curve (AUC) estimations. Plasma cytokines and quercetin were also measured, along with whole genome transcriptome analysis and real-time polymerase chain reaction (qPCR) on adipose, liver, and skeletal muscle tissues. Univariate analyses were conducted via analysis of variance (ANOVA), and whole-genome expression profiles were examined via gene set enrichment. At 16 weeks, plasma quercetin levels were higher in Q and EQ groups vs. the control and E groups (p < 0.05). Plasma cytokines were similar among groups (p > 0.05). AUC estimations for GTT was 14% lower for Q vs. E (p = 0.0311), but non-significant from control (p = 0.0809). Genes for cholesterol metabolism and immune and inflammatory response were downregulated in Q and EQ groups vs. control in adipose tissue and soleus muscle tissue. These data support an anti-inflammatory role for Q and EQ, a result best captured when measured with tissue gene downregulation in comparison to changes in plasma cytokine levels.

  11. Reduced muscular fatigue after a 12-week leucine-rich amino acid supplementation combined with moderate training in elderly: a randomised, placebo-controlled, double-blind trial.

    PubMed

    Reule, Claudia A; Scholz, Claudia; Schoen, Christiane; Brown, Niklas; Siepelmeyer, Anne; Alt, Wilfried W

    2016-01-01

    Age-related muscle loss is characterised by a progressing decrease in muscle mass, strength and function. Besides resistance training and physical activity, appropriate nutrition that is rich in protein, especially branched-chain amino acids, is very important to support training effects and positively influence the protein synthesis to degradation ratio. The purpose of this study was to evaluate the effect of a 12-week leucine-rich amino acid supplementation in combination with moderate training. Forty-eight healthy subjects exercised for 30 min three times per week and received either a leucine-rich amino acid supplementation or a placebo. Before and after supplementation, volunteers performed an exhaustive eccentric exercise protocol. Maximal concentric strength, muscle soreness, creatine kinase (CK), type II collagen collagenase cleavage neoepitope (C2C), C propeptide of type II procollagen (CP2) and safety assessments were performed before exercise and after 3, 24, 48 and 72 hours. The supplementation with leucine resulted in reduced loss of strength at 0 and 3 hours after downhill walking compared with the placebo (p=0.0439). The reduction of C2C/CP2 ratio deflection was significantly increased (p=0.038) due to leucine compared with the placebo. The same tendency could be observed for the recovery phase. No significant supplement effects for muscle soreness and CK could be observed. The principle findings show that leucine-rich amino acid supplementation can counteract the negative effects of eccentric exercise. The treatment resulted in a reduction of exercise-induced strength loss.

  12. Reduced muscular fatigue after a 12-week leucine-rich amino acid supplementation combined with moderate training in elderly: a randomised, placebo-controlled, double-blind trial

    PubMed Central

    Reule, Claudia A; Scholz, Claudia; Schoen, Christiane; Brown, Niklas; Siepelmeyer, Anne; Alt, Wilfried W

    2016-01-01

    Background Age-related muscle loss is characterised by a progressing decrease in muscle mass, strength and function. Besides resistance training and physical activity, appropriate nutrition that is rich in protein, especially branched-chain amino acids, is very important to support training effects and positively influence the protein synthesis to degradation ratio. Aim The purpose of this study was to evaluate the effect of a 12-week leucine-rich amino acid supplementation in combination with moderate training. Methods Forty-eight healthy subjects exercised for 30 min three times per week and received either a leucine-rich amino acid supplementation or a placebo. Before and after supplementation, volunteers performed an exhaustive eccentric exercise protocol. Maximal concentric strength, muscle soreness, creatine kinase (CK), type II collagen collagenase cleavage neoepitope (C2C), C propeptide of type II procollagen (CP2) and safety assessments were performed before exercise and after 3, 24, 48 and 72 hours. Results The supplementation with leucine resulted in reduced loss of strength at 0 and 3 hours after downhill walking compared with the placebo (p=0.0439). The reduction of C2C/CP2 ratio deflection was significantly increased (p=0.038) due to leucine compared with the placebo. The same tendency could be observed for the recovery phase. No significant supplement effects for muscle soreness and CK could be observed. Conclusion The principle findings show that leucine-rich amino acid supplementation can counteract the negative effects of eccentric exercise. The treatment resulted in a reduction of exercise-induced strength loss. PMID:28879028

  13. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries

    PubMed Central

    Trenkwalder, C; Garcia-Borreguero, D; Montagna, P; Lainey, E; de Weerd, A W; Tidswell, P; Saletu-Zyhlarz, G; Telstad, W; Ferini-Strambi, L

    2004-01-01

    Objective: To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome. Methods: A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of ⩾15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25–4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed. Results: 112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache. Conclusions: Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated. PMID:14707315

  14. Modest weight loss through a 12-week weight management program with behavioral modification seems to attenuate inflammatory responses in young obese Koreans.

    PubMed

    Lee, AeJin; Jeon, Kyeong Jin; Kim, Min Soo; Kim, Hye-Kyeong; Han, Sung Nim

    2015-04-01

    Obesity has been reported to impair immune functions and lead to low-grade long-term inflammation; however, studies that have investigated the impact of weight loss on these among the young and slightly obese are limited. Thus, we investigated the effect of a 12-week weight management program with behavioral modifications on cell-mediated immune functions and inflammatory responses in young obese participants. Our hypothesis was that weight loss would result in improved immune functions and decreased inflammatory responses. Sixty-four participants (45 obese and 19 normal weight) finished the program. Obese (body mass index ≥25) participants took part in 5 group education and 6 individual counseling sessions. Normal-weight (body mass index 18.5-23) participants only attended 6 individual sessions. The goal for the obese was to lose 0.5 kg/wk by reducing their intake by 300 to 500 kcal/d and increasing their physical activity. Program participation resulted in a modest but significant decrease in weight (2.7 ± 0.4 kg, P < .001) and lipopolysaccharide-stimulated interleukin-1β production (from 0.85 ± 0.07 to 0.67 ± 0.07 ng/mL, P < .05) in the obese. In the obese group, increase in phytohemagglutinin-stimulated interleukin-10 production, a TH2 and anti-inflammatory cytokine, approached significance after program participation (from 6181 ± 475 to 6970 ± 632 pg/mL, P = .06). No significant changes in proliferative responses to the optimal concentration of concanavalin A or phytohemagglutinin were observed in the obese after program participation. Collectively, modest weight loss did not change the cell-mediated immune functions significantly but did attenuate the inflammatory response in young and otherwise healthy obese adults. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in patients with major depressive disorder: a 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial.

    PubMed

    Jeon, Hong Jin; Fava, Maurizio; Mischoulon, David; Baer, Lee; Clain, Alisabet; Doorley, James; DiPierro, Moneika; Cardoos, Amber; Papakostas, George I

    2014-11-01

    The aim of this study was to evaluate efficacy of ziprasidone monotherapy for major depressive disorder (MDD) with and without psychomotor symptoms. In accordance with the sequential parallel comparison design, 106 MDD patients (age 44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was carried out on 12-week double-blind treatment with either ziprasidone (40-160 mg/day) or placebo, divided into two phases of 6 weeks each to the assigned treatment sequences, drug/drug, placebo/placebo, and placebo/drug. Psychomotor symptoms were evaluated on the basis of the Mini-International Neuropsychiatric Interview at baseline. Efficacy assessments, on the basis of the 17-item Hamilton Depression Rating Scale (HDRS-17) and the Quick Inventory of Depressive Symptomatology Scale, Self-Rated (QIDS-SR), were performed every week throughout the trial. In phase I, ziprasidone monotherapy produced significant improvement in patients with psychomotor symptoms compared with placebo on the basis of HDRS-17 (F=5.95, P=0.017) and QIDS-SR (F=5.26, P=0.025) scores, whereas no significant changes were found in HDRS-17 (F=2.32, P=0.15) and QIDS-SR (F=3.70, P=0.074) scores in patients without psychomotor symptoms. In phase II, ziprasidone monotherapy produced no significant differences compared with placebo. In the pooled analysis, ziprasidone monotherapy showed significance according to QIDS-SR (Z=2.00, P=0.046) and a trend toward statistical significance according to the HDRS-17 (Z=1.66, P=0.10) in patients with psychomotor symptoms. Ziprasidone monotherapy may produce significant improvement compared with placebo in MDD patients with psychomotor symptoms.

  16. Psychological interventions to reduce suicidality in high-risk patients with major depression: a randomized controlled trial

    PubMed Central

    Celano, C. M.; Beale, E. E.; Mastromauro, C. A.; Stewart, J. G.; Millstein, R. A.; Auerbach, R. P.; Bedoya, C. A.; Huffman, J. C.

    2016-01-01

    Background Positive psychological constructs have been associated with reduced suicidal ideation, and interventions to cultivate positive feelings have the potential to reduce suicide risk. This study compares the efficacy of a 6-week, telephone-based positive psychology (PP) intervention against a cognition-focused (CF) control intervention among patients recently hospitalized for depression and suicidal ideation or behavior. Method A total of 65 adults with a current major depressive episode reporting suicidal ideation or a recent suicide attempt were enrolled from participating in-patient psychiatric units. Prior to discharge, participants were randomized to the PP (n = 32) or CF (n = 33) intervention. In both interventions, participants received a treatment manual, performed weekly PP (e.g. gratitude letter) or CF (e.g. recalling daily events) exercises, and completed weekly one-on-one telephone sessions over 6 weeks. Between-group differences in hopelessness (primary outcome), depression, suicidality and positive psychological constructs at 6 and 12 weeks were tested using mixed-effects models accounting for intensity of post-hospitalization psychiatric treatment. Results Compared with PP, the CF intervention was associated with significantly greater improvements in hopelessness at 6 weeks (β = −3.15, 95% confidence interval −6.18 to −0.12, effect size = −0.84, p = 0.04), but not 12 weeks. Similarly, the CF intervention led to greater improvements in depression, suicidal ideation, optimism and gratitude at 6 and 12 weeks. Conclusions Contrary to our hypothesis, the CF intervention was superior to PP in improving hopelessness, other suicide risk factors and positive psychological constructs during a key post-discharge period among suicidal patients with depression. Further study of this CF intervention is warranted in populations at high suicide risk. PMID:27876105

  17. Weight loss for women with and without polycystic ovary syndrome following a very low-calorie diet in a community-based setting with trained facilitators for 12 weeks

    PubMed Central

    Nikokavoura, Efsevia A; Johnston, Kelly L; Broom, John; Wrieden, Wendy L; Rolland, Catherine

    2015-01-01

    Background Polycystic ovary syndrome (PCOS) affects between 2% and 26% of reproductive-age women in the UK, and accounts for up to 75% of anovulatory infertility. The major symptoms include ovarian disruption, hyperandrogenism, insulin resistance, and polycystic ovaries. Interestingly, at least half of the women with PCOS are obese, with the excess weight playing a pathogenic role in the development and progress of the syndrome. The first-line treatment option for overweight/obese women with PCOS is diet and lifestyle interventions; however, optimal dietary guidelines are missing. Although many different dietary approaches have been investigated, data on the effectiveness of very low-calorie diets on PCOS are very limited. Materials and methods The aim of this paper was to investigate how overweight/obese women with PCOS responded to LighterLife Total, a commercial very low-calorie diet, in conjunction with group behavioral change sessions when compared to women without PCOS (non-PCOS). Results PCOS (n=508) and non-PCOS (n=508) participants were matched for age (age ±1 unit) and body mass index (body mass index ±1 unit). A 12-week completers analysis showed that the total weight loss did not differ significantly between PCOS (n=137) and non-PCOS participants (n=137) (−18.5±6.6 kg vs −19.4±5.7 kg, P=0.190). Similarly, the percentage of weight loss achieved by both groups was not significantly different (PCOS 17.1%±5.6% vs non-PCOS 18.2%±4.4%, P=0.08). Conclusion Overall, LighterLife Total could be an effective weight-loss strategy in overweight/obese women with PCOS. However, further investigations are needed to achieve a thorough way of understanding the physiology of weight loss in PCOS. PMID:26508882

  18. Safety and efficacy of exercise training in adults with Pompe disease: evalution of endurance, muscle strength and core stability before and after a 12 week training program.

    PubMed

    van den Berg, Linda E M; Favejee, Marein M; Wens, Stephan C A; Kruijshaar, Michelle E; Praet, Stephan F E; Reuser, Arnold J J; Bussmann, Johannes B J; van Doorn, Pieter A; van der Ploeg, Ans T

    2015-07-19

    Pompe disease is a proximal myopathy. We investigated whether exercise training is a safe and useful adjuvant therapy for adult Pompe patients, receiving enzyme replacement therapy. Training comprised 36 sessions of standardized aerobic, resistance and core stability exercises over 12 weeks. Before and after, the primary outcome measures safety, endurance (aerobic exercise capacity and distance walked on the 6 min walk test) and muscle strength, and secondary outcome measures core stability, muscle function and body composition, were evaluated. Of 25 patients enrolled, 23 successfully completed the training. Improvements in endurance were shown by increases in maximum workload capacity (110 W before to 122 W after training, [95 % CI of the difference 6 · 0 to 19 · 7]), maximal oxygen uptake capacity (69 · 4 % and 75 · 9 % of normal, [2 · 5 to 10 · 4]), and maximum walking distance (6 min walk test: 492 meters and 508, [-4 · 4 to 27 · 7] ). There were increases in muscle strength of the hip flexors (156 · 4 N to 180 · 7 N [1 · 6 to 13 · 6) and shoulder abductors (143 · 1 N to 150 · 7 N [13 · 2 to 35 · 2]). As an important finding in secondary outcome measures the number of patients who were able to perform the core stability exercises rose, as did the core stability balancing time (p < 0.05, for all four exercises). Functional tests showed small reductions in the time needed to climb four steps (2 · 4 sec to 2 · 1, [- 0 · 54 to -0 · 04 ]) and rise to standing position (5 · 8 sec to 4 · 8, [-2 · 0 to 0 · 0]), while time to run, the quick motor function test results and body composition remained unchanged. Our study shows that a combination of aerobic, strength and core stability exercises is feasible, safe and beneficial to adults with Pompe disease.

  19. Pistachio nuts reduce triglycerides and body weight by comparison to refined carbohydrate snack in obese subjects on a 12-week weight loss program.

    PubMed

    Li, Zhaoping; Song, Rubens; Nguyen, Christine; Zerlin, Alona; Karp, Hannah; Naowamondhol, Kris; Thames, Gail; Gao, Kun; Li, Luyi; Tseng, Chi-Hong; Henning, Susanne M; Heber, David

    2010-06-01

    There is a widely held view that, due to high fat content, snacking on nuts will lead to weight gain, ultimately causing unhealthy changes in lipid profiles. This study is designed to study the effects of pistachio snack consumption on body weight and lipid levels in obese participants under real-world conditions. Participants were randomly assigned to consume 1 of 2 isocaloric weight reduction diets for 12 weeks, with each providing 500 cal per day less than resting metabolic rate. Each diet included an afternoon snack of either 53 g (240 cal) of salted pistachios (n  =  31) or 56 g of salted pretzels (220 cal; n  =  28). Both groups lost weight during the 12-week study (time trend, p < 0.001), but there were significant differences in the changes in body mass index between the pretzel and pistachio groups (pistachio, 30.1 ± 0.4 to 28.8 ± 0.4 vs. pretzel, 30.9 ± 0.4 to 30.3 ± 0.5). At 6 and 12 weeks, triglycerides were significantly lower in the pistachio group compared with the pretzel group (88.04 ± 9.80 mg/dL vs. 144.56 ± 18.86 mg/dL, p  =  0.01 at 6 weeks and 88.10 ± 6.78 mg/dL vs. 132.15 ± 16.76 mg/dL, p  =  0.02 at 12 weeks), and there was a time trend difference between the 2 groups over the 12 weeks (p < 0.01). There were no significant differences in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, insulin, or glucose between the 2 groups. Pistachios can be consumed as a portion-controlled snack for individuals restricting calories to lose weight without concern that pistachios will cause weight gain. By comparison to refined carbohydrate snacks such as pretzels, pistachios may have beneficial effects on triglycerides as well.

  20. Impact of ixekizumab on facial psoriasis and related quality of life measures in moderate-to-severe psoriasis patients: 12-week results from two phase III trials.

    PubMed

    Paul, C; Guenther, L; Torii, H; Sofen, H; Burge, R; Lin, C Y; Potts Bleakman, A; Mallbris, L; Poulin, Y

    2017-09-07

    Facial psoriasis was reported in 17-68% of patients with psoriasis and shown to have a negative impact on patients' personal and health-related quality of life (HRQoL). To explore the association of facial psoriasis with patients' HRQoL and to assess the relationship between ixekizumab (IXE) and improvement in facial psoriasis and changes in HRQoL. This work reports the combined results of two phase III multicentre, randomized, double-blind, placebo-controlled, active-comparator trials in patients with moderate-to-severe psoriasis. Patients received placebo, etanercept (ETN; 50 mg twice weekly) or IXE [80 mg every 4 weeks (Q4W) or every 2 weeks (Q2W)] for up to 12 weeks following an initial 160-mg dose. HRQoL parameters were analysed based on facial psoriasis status at baseline using analysis of covariance models. Improvement was assessed as percentage of patients with no facial psoriasis. The combined database included 1133 patients with facial psoriasis and 1437 without. Patients treated with IXE whose facial psoriasis cleared had improved Dermatology Life Quality Index 0.1 responses (P < 0.01) compared with patients with facial psoriasis at Week 12. At Week 12, clearance of facial psoriasis compared with the presence of facial psoriasis was independently associated with significantly better improvement in Psoriasis Skin Appearance Bothersomeness scores in the IXE Q2W treatment group (P < 0.01). At Week 12, facial clearance and overall Psoriasis Area Severity Index (PASI) improvement were observed in significant numbers of patients treated with IXE compared with ETN and placebo. Facial psoriasis clearance at Week 12 in patients treated with IXE or ETN was positively associated with PASI75 and PASI90 achievement. Facial psoriasis had a larger negative impact on HRQoL than no facial psoriasis. Facial psoriasis clearance was associated with improved HRQoL. Significantly more IXE-treated patients had rapid facial clearance vs. ETN and PBO, which led to better

  1. Yokukansan (TJ-54) for treatment of pervasive developmental disorder not otherwise specified and Asperger's disorder: a 12-week prospective, open-label study.

    PubMed

    Miyaoka, Tsuyoshi; Wake, Rei; Furuya, Motohide; Liaury, Kristian; Ieda, Masa; Kawakami, Kazunori; Tsuchie, Keiko; Inagaki, Takuji; Horiguchi, Jun

    2012-11-29

    Numerous medications have been tested on patients with pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder. Although many of these medications have been demonstrated to be useful, no clear primary treatment for PDD-NOS and Asperger's disorder has emerged. Despite the efficacy of some of the medicines, the acceptability and side effects have proven to be barriers to their use. Recent studies indicate that the traditional Japanese herbal medicine yokukansan (TJ-54) may be safe and useful in treating behavioral and psychological symptoms in dementia and some neuropsychiatric disorders. We aimed at evaluating both the efficacy and safety of TJ-54 in patients with well-defined PDD-NOS and Asperger's disorder. This was a 12-week prospective, open-label investigation of TJ-54 in 40 children, adolescents, and adults diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Severity of Illness Scale (CGI-S) and the Aberrant Behavior Checklist-Iritability subscale score (ABC-I). Forty subjects, ages 8-40 years (mean 22.7 ± 7.3 years) received a mean final TJ-54 dosage of 6.4 ± 1.3 g/day (range 2.5-7.5 g/day). Full-scale intelligence quotient (IQ) scores ranged from 70 to 110 (mean 88.9 ± 13.2). Thirty-six (90%) of 40 subjects showed fewer interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-S of 1 or 2 (normal, not at all ill or borderline mentally ill) and a 80% or greater improvement on the ABC-I. The mean CGI-S score at baseline was 6.8 ± 0.8 whereas scores at end point was 1.9 ± 0.1 (< 0.0001). ABC-I scores ranged from 11 to 29 (mean 17.4 ± 3.66) at baseline, whereas scores at week 12 ranged from 0 to 5 (mean 0.93 ± 0.97) (p <0.0001). TJ-54 was well tolerated. No subject exited the study due to a drug-related adverse event. These preliminary data suggest that TJ-54 may be effective and well tolerated for treatment of

  2. Effectiveness of an internet-based intervention enhancing Finnish parents' parenting satisfaction and parenting self-efficacy during the postpartum period.

    PubMed

    Salonen, Anne H; Kaunonen, Marja; Astedt-Kurki, Päivi; Järvenpää, Anna-Liisa; Isoaho, Hannu; Tarkka, Marja-Terttu

    2011-12-01

    The postpartum period presents several challenges related to learning infant care tasks, getting to know the infant and fulfilling self-expectations as parents. There is a need to evaluate the effectiveness of information-technology-based interventions that support parenting during this period. To evaluate the effectiveness of an internet-based intervention to support mothers' and fathers' parenting satisfaction and parenting self-efficacy (PSE). A quasi-experimental design with a non-equivalent control group and repeated measures. Two public maternity hospitals (intervention/control) in southern Finland. A convenience sample of mothers and/or fathers (n = 1300 families). The inclusion criteria were primipara or multipara, and at least one parent willing to participate. Multiple birth, non-Finnish speaking and early discharge parents receiving home visits were excluded. A total of 500 mothers and 242 fathers returned complete sets of questionnaires. The intervention offered online support for parenting, breast feeding and infant care beginning from the middle of pregnancy. It comprised an information database, a peer discussion forum and expert advice. Outcomes were measured by the Evaluation Subscale of the What Being the Parent of a New Baby is Like-Revised and parenting self-efficacy instruments after childbirth and six to eight weeks post partum. Both intervention and control mothers' parenting satisfaction and PSE increased significantly during the postpartum period. Fathers' parenting satisfaction and PSE also increased, but this change was only significant in the case of PSE. Both parents felt that their affective skills related to PSE were the weakest after childbirth. During the postpartum period, affective skills improved more than cognitive and behavioural skills. Different groups of mothers and different groups of fathers showed an equally positive change in parenting satisfaction and PSE. Both intervention and control mothers' and fathers' parenting

  3. Efficacy and tolerability balance of oxycodone/naloxone and tapentadol in chronic low back pain with a neuropathic component: a blinded end point analysis of randomly selected routine data from 12-week prospective open-label observations

    PubMed Central

    Ueberall, Michael A; Mueller-Schwefe, Gerhard H H

    2016-01-01

    Objective To evaluate the benefit–risk profile (BRP) of oxycodone/naloxone (OXN) and tapentadol (TAP) in patients with chronic low back pain (cLBP) with a neuropathic component (NC) in routine clinical practice. Methods This was a blinded end point analysis of randomly selected 12-week routine/open-label data of the German Pain Registry on adult patients with cLBP-NC who initiated an index treatment in compliance with the current German prescribing information between 1st January and 31st October 2015 (OXN/TAP, n=128/133). Primary end point was defined as a composite of three efficacy components (≥30% improvement of pain, pain-related disability, and quality of life each at the end of observation vs baseline) and three tolerability components (normal bowel function, absence of either central nervous system side effects, and treatment-emergent adverse event [TEAE]-related treatment discontinuation during the observation period) adopted to reflect BRP assessments under real-life conditions. Results Demographic as well as baseline and pretreatment characteristics were comparable for the randomly selected data sets of both index groups without any indicators for critical selection biases. Treatment with OXN resulted formally in a BRP noninferior to that of TAP and showed a significantly higher primary end point response vs TAP (39.8% vs 25.6%, odds ratio: 1.93; P=0.014), due to superior analgesic effects. Between-group differences increased with stricter response definitions for all three efficacy components in favor of OXN: ≥30%/≥50%/≥70% response rates for OXN vs TAP were seen for pain intensity in 85.2%/67.2%/39.1% vs 83.5%/54.1%/15.8% (P= ns/0.031/<0.001), for pain-related disability in 78.1%/64.8%/43.8% vs 66.9%/50.4%/24.8% (P=0.043/0.018/0.001), and for quality of life in 76.6%/68.0%/50.0% vs 63.9%/54.1%/34.6% (P=0.026/0.022/0.017). Overall, OXN vs TAP treatments were well tolerated, and proportions of patients who either maintained a normal bowel

  4. The Impacts of Physical Activity Intervention on Physical and Cognitive Outcomes in Children with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Pan, Chien-Yu; Chu, Chia-Hua; Tsai, Chia-Liang; Sung, Ming-Chih; Huang, Chu-Yang; Ma, Wei-Ya

    2017-01-01

    This study examined the effects of a 12-week physical activity intervention on the motor skill proficiency and executive function of 22 boys (aged 9.08 ± 1.75 years) with autism spectrum disorder. In Phase I of the 12 weeks, 11 boys with autism spectrum disorder (Group A) received the intervention, whereas the other 11 boys with autism spectrum…

  5. The Impacts of Physical Activity Intervention on Physical and Cognitive Outcomes in Children with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Pan, Chien-Yu; Chu, Chia-Hua; Tsai, Chia-Liang; Sung, Ming-Chih; Huang, Chu-Yang; Ma, Wei-Ya

    2017-01-01

    This study examined the effects of a 12-week physical activity intervention on the motor skill proficiency and executive function of 22 boys (aged 9.08 ± 1.75 years) with autism spectrum disorder. In Phase I of the 12 weeks, 11 boys with autism spectrum disorder (Group A) received the intervention, whereas the other 11 boys with autism spectrum…

  6. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

    PubMed Central

    Asselah, Tarik; Moreno, Christophe; Sarrazin, Christoph; Gschwantler, Michael; Foster, Graham R.; Craxí, Antonio; Buggisch, Peter; Ryan, Robert; Lenz, Oliver; Scott, Jane; Van Dooren, Gino; Lonjon-Domanec, Isabelle; Schlag, Michael; Buti, Maria

    2016-01-01

    Background Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0–F2 fibrosis, patients with HCV-RNA <25 IU/mL (detectable/undetectable) at Week 2, and undetectable HCV-RNA at Weeks 4 and 8, stopped all treatment at Week 12. All other patients continued PR for a further 12 weeks. Baseline factors significantly associated with SVR12 were identified through logistic regression. Results Of 163 patients who participated in the study, 123 (75%) qualified for 12-week treatment; of these, 81 (66%) achieved SVR12. Baseline factors positively associated with SVR12 rates in patients receiving the 12-week regimen were: IL28B CC genotype: (94% SVR12); HCV RNA ≤800,000 IU/mL (82%); F0–F1 fibrosis (74%). Among all 163 patients, 94% experienced ≥1 adverse event (AE), 4% a serious AE, and 2.5% discontinued due to an AE. Reduced impairment in patient-reported outcomes was observed in the 12-week vs >12-week regimen. Conclusions Overall SVR12 rate (66%) was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen. Trial Registration ClinicalTrials.gov NCT01846832 PMID:27428331

  7. Efficacy and safety of indacaterol 150 μg once-daily in COPD: a double-blind, randomised, 12-week study

    PubMed Central

    2010-01-01

    Background Indacaterol is a novel, once-daily (o.d.) inhaled, long-acting β2-agonist in development for chronic obstructive pulmonary disease (COPD). This 12-week, double-blind study compared the efficacy, safety, and tolerability of indacaterol to that of placebo in patients with moderate-to-severe COPD. Methods Efficacy variables included 24-h trough FEV1 (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (primary endpoint) and after Day 1, and the percentage of COPD days with poor control (i.e., worsening symptoms). Safety was assessed by adverse events (AEs), mean serum potassium and blood glucose, QTc (Fridericia), and vital signs. Results Patients were randomised (n = 416, mean age 63 years) to receive either indacaterol 150 μg o.d. (n = 211) or placebo (n = 205) via a single-dose dry-powder inhaler; 87.5% completed the study. Trough FEV1 (LSM ± SEM) at Week 12 was 1.48 ± 0.018 L for indacaterol and 1.35 ± 0.019 L for placebo, a clinically relevant difference of 130 ± 24 mL (p < 0.001). Trough FEV1 after one dose was significantly higher with indacaterol than placebo (p < 0.001). Indacaterol demonstrated significantly higher peak FEV1 than placebo, both on Day 1 and at Week 12, with indacaterol-placebo differences (LSM ± SEM) of 190 ± 28 (p < 0.001) and 160 ± 28 mL (p < 0.001), respectively. Standardised AUC measurements for FEV1 (between 5 min and 4 h, 5 min and 1 h, and 1 and 4 h post-dose) at Week 12 were all significantly greater with indacaterol than placebo (p < 0.001), with LSM (± SEM) differences of 170 ± 24, 180 ± 24, and 170 ± 24 mL, respectively. Indacaterol significantly reduced the percentage of days of poor control versus placebo by 22.5% (p < 0.001) and was also associated with significantly reduced use of rescue medication (p < 0.001). The overall rates of AEs were comparable between the groups (indacaterol 49.3%, placebo 46.8%), with the most common AEs being COPD worsening (indacaterol 8.5%, placebo 12.2%) and cough

  8. Optimal recall period for caregiver-reported illness in risk factor and intervention studies: a multicountry study.

    PubMed

    Arnold, Benjamin F; Galiani, Sebastian; Ram, Pavani K; Hubbard, Alan E; Briceño, Bertha; Gertler, Paul J; Colford, John M

    2013-02-15

    Many community-based studies of acute child illness rely on cases reported by caregivers. In prior investigations, researchers noted a reporting bias when longer illness recall periods were used. The use of recall periods longer than 2-3 days has been discouraged to minimize this reporting bias. In the present study, we sought to determine the optimal recall period for illness measurement when accounting for both bias and variance. Using data from 12,191 children less than 24 months of age collected in 2008-2009 from Himachal Pradesh in India, Madhya Pradesh in India, Indonesia, Peru, and Senegal, we calculated bias, variance, and mean squared error for estimates of the prevalence ratio between groups defined by anemia, stunting, and underweight status to identify optimal recall periods for caregiver-reported diarrhea, cough, and fever. There was little bias in the prevalence ratio when a 7-day recall period was used (<10% in 35 of 45 scenarios), and the mean squared error was usually minimized with recall periods of 6 or more days. Shortening the recall period from 7 days to 2 days required sample-size increases of 52%-92% for diarrhea, 47%-61% for cough, and 102%-206% for fever. In contrast to the current practice of using 2-day recall periods, this work suggests that studies should measure caregiver-reported illness with a 7-day recall period.

  9. Impact of a worksite behavioral skills intervention.

    PubMed

    Nichols, J F; Wellman, E; Caparosa, S; Sallis, J F; Calfas, K J; Rowe, R

    2000-01-01

    Sixty-four male and female sedentary employees were randomly assigned to an intervention group or control group to determine the effects of behavioral skill training on adoption and maintenance of exercise. Both received a 9-month membership at a local fitness facility. The control group received a 12-week semistructured course, which included a facility orientation and three meetings with a personal trainer. The intervention group received a 12-week behavioral skills course and were encouraged to participate in a 12-week semistructured exercise course followed by a 3-month problem-solving support intervention. Both groups improved their daily energy expenditure, the amount of moderate and vigorous activity they performed, and their strength and flexibility. The study sample was too small to show substantial differences between the intervention and control group. Changes in mediator variables were mixed.

  10. The Perinatal Period: Early Intervention for Mental Health. Clinical Approaches to Early Intervention in Child and Adolescent Mental Health, Volume 4.

    ERIC Educational Resources Information Center

    Kowalenko, Nick; Barnett, Bryanne; Fowler, Cathrine; Matthey, Stephen

    The perinatal period offers a unique opportunity for enhancing the mental health of women and their families. Women come into frequent contact with health professionals during this time and the enhancement of their emotional well being can promote their own, their infant's, and their partner's health. The aim of this book is to assist health…

  11. Effects of a 12-Week Physical Activity Protocol Delivered by YMCA After-School Counselors (Youth Fit for Life) on Fitness and Self-Efficacy Changes in 5-12-Year-Old Boys and Girls

    ERIC Educational Resources Information Center

    Annesi, James J.; Westcott, Wayne L.; Faigenbaum, Avery D.; Unruh, Jennifer L.

    2005-01-01

    To address reduced physical education (PE) in elementary schools, a 12-week physical activity protocol was tested on 5-12-year-old, primarily African American, girls (n = 226) and boys (n = 344) at 14 YMCA after-school care sites. The 3 times/week, 45-min session curriculum included cardiovascular, resistance, and flexibility training, in which…

  12. Effects of a 12-Week Physical Activity Protocol Delivered by YMCA After-School Counselors (Youth Fit for Life) on Fitness and Self-Efficacy Changes in 5-12-Year-Old Boys and Girls

    ERIC Educational Resources Information Center

    Annesi, James J.; Westcott, Wayne L.; Faigenbaum, Avery D.; Unruh, Jennifer L.

    2005-01-01

    To address reduced physical education (PE) in elementary schools, a 12-week physical activity protocol was tested on 5-12-year-old, primarily African American, girls (n = 226) and boys (n = 344) at 14 YMCA after-school care sites. The 3 times/week, 45-min session curriculum included cardiovascular, resistance, and flexibility training, in which…

  13. Evaluation of an early exercise intervention after thoracotomy for non-small cell lung cancer (NSCLC), effects on quality of life, muscle strength and exercise tolerance: randomised controlled trial.

    PubMed

    Arbane, Gill; Tropman, David; Jackson, David; Garrod, Rachel

    2011-02-01

    Deterioration in exercise tolerance and impairment in quality of life (QoL) are common consequences of lobectomy. This study evaluates additional exercise and strength training after lung resection on QoL, exercise tolerance and muscle strength. Fifty-three (28 male) patients attending thoracotomy for lung cancer, mean age, range 64 (32-82) years; mean pack years (SD) 31.9 (26.8); BMI 25.6 (4.2); FEV1 2.0 (0.7) l were randomised to control (usual care) or intervention (twice daily training plus usual care). After discharge the intervention group received monthly home visits and weekly telephone calls, the control group received monthly telephone calls up to 12 weeks. Assessment pre-operatively, 5 day and 12 weeks post-operatively consisted of quadriceps strength using magnetic stimulation, 6 Minute Walking Distance (6MWD) and QoL-EORTC-QLQ-LC13. QoL was unchanged over 12 weeks; 6MWD showed significant deterioration at 5 days post-operatively compared with pre-operatively, mean difference (SD)-131.6 (101.8) m and -128.0 (90.7) m in active and control groups respectively (p=0.89 between groups) which returned to pre-operative levels by 12 weeks in both groups. Quadriceps strength over the 5 day in-patient period showed a decrease of -8.3 (11.3) kg in the control group compared to increase of 4.0 (21.2) kg in the intervention group (p=0.04 between groups). Strength training after thoracotomy successfully prevented the fall in quadriceps strength seen in controls, however, there was no effect on 6MWD or QoL. 6MWD returned to pre-operative levels by 12 weeks regardless of additional support offered.

  14. Comparative analysis of the effects of two chest physical therapy interventions in patients with bronchiolitis during hospitalization period.

    PubMed

    Remondini, Renata; Santos, Adriana Zamprônio dos; Castro, Giselle de; Prado, Cristiane do; Silva Filho, Luiz Vicente Ribeiro Ferreira da

    2014-01-01

    To evaluate and compare the effects of two chest physiotherapy interventions in patients hospitalized due to acute bronchiolitis. Prospective randomized study with a sample of 83 calls for 29 patients aged between 3 months and 1 year hospitalized for acute bronchiolitis. Patients were distributed randomly into two groups: Group 1, submitted to postural drainage, tapping and tracheal aspiration; and Group 2, submitted to postural drainage, expiratory acceleration flow and tracheal aspiration. Assessments were made before and 10 and 60 minutes after the end of therapy. Patients also underwent drug treatment. The endpoint was to compare two physical therapy interventions as to clinical improvement in infants with acute bronchiolitis by means of oxygen saturation and the Respiratory Distress Assessment Instrument score. The parents/guardians was requested to answer a questionnaire about the treatment applied before the last evaluation in order to measure their satisfaction related to the interventions made. The groups were similar regarding the use of antibiotics and bronchodilators. A greater number of patients used corticosteroids in Group 2. A relevant improvement was observed on Respiratory Distress Assessment Instrument score with physical therapy, with reduction of the score 10 minutes after interventions, and the same score 60 minutes later, with no differences between techniques applied. There was no significant variation of pulse oximetry after chest physiotherapy. Most items assessed by the questionnaire had satisfactory answers. No differences were observed between groups regarding the items assessed (time required to discharge from study, pulse oximetry in room air and disease severity according to the Respiratory Distress Assessment Instrument score). Parents answered positively about the effects of therapy in the majority of items in the questionnaire, both for the expiratory acceleration flow technique and for tapping.

  15. Comparative analysis of the effects of two chest physical therapy interventions in patients with bronchiolitis during hospitalization period

    PubMed Central

    Remondini, Renata; dos Santos, Adriana Zamprônio; de Castro, Giselle; do Prado, Cristiane; da Silva, Luiz Vicente Ribeiro Ferreira

    2014-01-01

    Objective To evaluate and compare the effects of two chest physiotherapy interventions in patients hospitalized due to acute bronchiolitis. Methods Prospective randomized study with a sample of 83 calls for 29 patients aged between 3 months and 1 year hospitalized for acute bronchiolitis. Patients were distributed randomly into two groups: Group 1, submitted to postural drainage, tapping and tracheal aspiration; and Group 2, submitted to postural drainage, expiratory acceleration flow and tracheal aspiration. Assessments were made before and 10 and 60 minutes after the end of therapy. Patients also underwent drug treatment. The endpoint was to compare two physical therapy interventions as to clinical improvement in infants with acute bronchiolitis by means of oxygen saturation and the Respiratory Distress Assessment Instrument score. The parents/guardians was requested to answer a questionnaire about the treatment applied before the last evaluation in order to measure their satisfaction related to the interventions made. Results The groups were similar regarding the use of antibiotics and bronchodilators. A greater number of patients used corticosteroids in Group 2. A relevant improvement was observed on Respiratory Distress Assessment Instrument score with physical therapy, with reduction of the score 10 minutes after interventions, and the same score 60 minutes later, with no differences between techniques applied. There was no significant variation of pulse oximetry after chest physiotherapy. Most items assessed by the questionnaire had satisfactory answers. Conclusion No differences were observed between groups regarding the items assessed (time required to discharge from study, pulse oximetry in room air and disease severity according to the Respiratory Distress Assessment Instrument score). Parents answered positively about the effects of therapy in the majority of items in the questionnaire, both for the expiratory acceleration flow technique and for tapping

  16. Effects of Glycine max (L.) Merr. soy isoflavone vaginal gel on epithelium morphology and estrogen receptor expression in postmenopausal women: a 12-week, randomized, double-blind, placebo-controlled trial.

    PubMed

    Lima, Sônia Maria Rolim Rosa; Bernardo, Bianca Franco Augusto; Yamada, Silvia Saito; Reis, Benedito Fabiano; da Silva, Gustavo Maximiliano Dutra; Galvão, Maria Antonieta Longo

    2014-07-01

    Evaluate the effects of vaginal administration of isoflavones derived from Glycine max (L.) Merr. as a treatment option for vaginal atrophy, on the morphology and expression of estrogen receptors in vaginal epithelium of postmenopausal women. The double-blind, randomized, placebo-controlled, clinical trial. Sixty women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel. After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. Vaginal pH was measured at the beginning and end of therapy. Microbiopsies in vaginal fornix were performed before the treatment and after 12 weeks of treatment. Isoflavone vaginal gel was effective for relief of vaginal dryness and dyspareunia symptons and an increase in the intermediate and superficial cells was noted. The vaginal pH in the isoflavone group was 7.1 at baseline and 5.4 after 12 weeks, whereas in the placebo group there was no significant change. A significant increase in thickness after treatment was detected in the Isoflavone Group. The percentage of estrogen receptor positive cells in vaginal epithelium for the Isoflavone Group ranged from 58.5% at the beginning of treatment to 82.6% after 12 weeks. These results were superior to placebo gel. Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms, maturation values, vaginal pH, morphology and expression of estrogen receptors in vaginal epithelium. Isoflavones proved good treatment options for relief of vulvovaginal atrophy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations.

    PubMed

    Granholm, Eric; Ben-Zeev, Dror; Link, Peter C; Bradshaw, Kristen R; Holden, Jason L

    2012-05-01

    Mobile Assessment and Treatment for Schizophrenia (MATS) employs ambulatory monitoring methods and cognitive behavioral therapy interventions to assess and improve outcomes in consumers with schizophrenia through mobile phone text messaging. Three MATS interventions were developed to target medication adherence, socialization, and auditory hallucinations. Participants received up to 840 text messages over a 12-week intervention period. Fifty-five consumers with schizophrenia or schizoaffective disorder were enrolled, but 13 consumers with more severe negative symptoms, lower functioning, and lower premorbid IQ did not complete the intervention, despite repeated prompting and training. For completers, the average valid response rate for 216 outcome assessment questions over the 12-week period was 86%, and 86% of phones were returned undamaged. Medication adherence improved significantly, but only for individuals who were living independently. Number of social interactions increased significantly and a significant reduction in severity of hallucinations was found. In addition, the probability of endorsing attitudes that could interfere with improvement in these outcomes was also significantly reduced in MATS. Lab-based assessments of more general symptoms and functioning did not change significantly. This pilot study demonstrated that low-intensity text-messaging interventions like MATS are feasible and effective interventions to improve several important outcomes, especially for higher functioning consumers with schizophrenia.

  18. Mobile Assessment and Treatment for Schizophrenia (MATS): A Pilot Trial of An Interactive Text-Messaging Intervention for Medication Adherence, Socialization, and Auditory Hallucinations

    PubMed Central

    Granholm, Eric; Ben-Zeev, Dror; Bradshaw, Kristen R.; Holden, Jason L.

    2012-01-01

    Mobile Assessment and Treatment for Schizophrenia (MATS) employs ambulatory monitoring methods and cognitive behavioral therapy interventions to assess and improve outcomes in consumers with schizophrenia through mobile phone text messaging. Three MATS interventions were developed to target medication adherence, socialization, and auditory hallucinations. Participants received up to 840 text messages over a 12-week intervention period. Fifty-five consumers with schizophrenia or schizoaffective disorder were enrolled, but 13 consumers with more severe negative symptoms, lower functioning, and lower premorbid IQ did not complete the intervention, despite repeated prompting and training. For completers, the average valid response rate for 216 outcome assessment questions over the 12-week period was 86%, and 86% of phones were returned undamaged. Medication adherence improved significantly, but only for individuals who were living independently. Number of social interactions increased significantly and a significant reduction in severity of hallucinations was found. In addition, the probability of endorsing attitudes that could interfere with improvement in these outcomes was also significantly reduced in MATS. Lab-based assessments of more general symptoms and functioning did not change significantly. This pilot study demonstrated that low-intensity text-messaging interventions like MATS are feasible and effective interventions to improve several important outcomes, especially for higher functioning consumers with schizophrenia. PMID:22080492

  19. What are the high risk periods for incident substance use and transitions to abuse and dependence? Implications for early intervention and prevention.

    PubMed

    Wittchen, H-U; Behrendt, S; Höfler, M; Perkonigg, A; Lieb, R; Bühringer, G; Beesdo, K

    2008-06-01

    For a better understanding of the evolution of addictive disorders and the timely initiation of early intervention and prevention, we have to learn when and how quickly the critical transitions from first substance use (SU) to regular use and from first SU and regular SU to abuse and dependence occur. Little data are currently available on the transitions to substance use disorders (SUDs) across the spectrum of legal and illegal drugs taking into account gender differences. It is the aim of this paper to describe the high density incidence and transition periods of SU and SUD for alcohol, nicotine, cannabis and other illicit drugs for young males and females. A sample of (N = 3021) community subjects aged 14-24 at baseline were followed-up prospectively over 10-years. SU and SUD were assessed using the DSM-IV/M-CIDI. Ages 10-16 are the high risk period for first alcohol and nicotine use (up to 38% of subjects start before age 14). Onset of illegal SU occurs later. Substantial proportions of transitions to regular SU and SUD occur in the first three years after SU onset. Only few gender differences were found for time patterns of SU/SUD incidence and transition. Except for alcohol the time windows for targeted intervention to prevent progression to malignant patterns in adolescence are critically small, leaving little time for targeted intervention to prevent transition. The fast transitions to abuse and dependence in adolescence may be indicative for the increased vulnerability to substance effects in this time period. Basic research on the determinants of transitions should thus target this period in adolescence. 2008 John Wiley & Sons, Ltd

  20. A racket-sport intervention improves behavioral and cognitive performance in children with attention-deficit/hyperactivity disorder.

    PubMed

    Pan, Chien-Yu; Chu, Chia-Hua; Tsai, Chia-Liang; Lo, Shen-Yu; Cheng, Yun-Wen; Liu, Yu-Jen

    2016-10-01

    The present study assessed the effects of a 12-week table tennis exercise on motor skills, social behaviors, and executive functions in children with attention deficit hyperactivity disorder (ADHD). In the first 12-week phase, 16 children (group I) received the intervention, whereas 16 children (group II) did not. A second 12-week phase immediately followed with the treatments reversed. Improvements were observed in executive functions in both groups after the intervention. After the first 12-week phase, some motor and behavioral functions improved in group I. After the second 12-week phase, similar improvements were noted for group II, and the intervention effects achieved in the first phase were persisted in group I. The racket-sport intervention is valuable in promoting motor skills, social behaviors, and executive functions and should be included within the standard-of-care treatment for children with ADHD. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Nutritional intervention and physical training in malnourished frail community-dwelling elderly persons carried out by trained lay “buddies”: study protocol of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background In elderly persons frailty and malnutrition are very common and can lead to serious health hazards such as increased mortality, morbidity, dependency, institutionalization and a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system. Physical training and adequate nutrition may improve this situation. Methods/design In this randomized controlled trial, 80 malnourished frail community-dwelling patients (≥ 65 years) hospitalized at wards for internal medicine are recruited. Additionally, 80 lay volunteers (≥ 50 years), named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in four standardized training sessions. These buddies visit the malnourished frail persons at home twice a week for about one hour during an initial period of 10–12 weeks. While participants allocated to the intervention group (n = 40) receive intervention to improve their fluid intake, protein and energy intake, perform strength training and try to increase their baseline activities, the control group (n = 40) only gets home visits without any intervention. After 10–12 weeks, both, the intervention and the control group, receive the nutritional intervention and the physical training. Health, nutritional and frailty status, physical fitness, body composition and chronic inflammation of buddies and frail persons are recorded before the intervention, after 10–12 weeks, 6 and 12 months. Discussion To your knowledge this trial is the first of its kind to provide nutritional and physical activity interventions to malnourished frail community-dwelling persons by trained lay buddies, in which an improvement of the frail persons´ and the buddies’ health status is measured. This study assesses the efficacy of such an intervention and may offer new perspectives for the management of frailty and malnutrition. Trail

  2. A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

    PubMed

    Roure, Romain; Nollent, Virginie; Dayan, Liliane; Camel, Etienne; Bertin, Christiane

    2016-06-01

    The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged

  3. Effects of Whey, Soy or Leucine Supplementation with 12 Weeks of Resistance Training on Strength, Body Composition, and Skeletal Muscle and Adipose Tissue Histological Attributes in College-Aged Males.

    PubMed

    Mobley, C Brooks; Haun, Cody T; Roberson, Paul A; Mumford, Petey W; Romero, Matthew A; Kephart, Wesley C; Anderson, Richard G; Vann, Christopher G; Osburn, Shelby C; Pledge, Coree D; Martin, Jeffrey S; Young, Kaelin C; Goodlett, Michael D; Pascoe, David D; Lockwood, Christopher M; Roberts, Michael D

    2017-09-04

    We sought to determine the effects of L-leucine (LEU) or different protein supplements standardized to LEU (~3.0 g/serving) on changes in body composition, strength, and histological attributes in skeletal muscle and adipose tissue. Seventy-five untrained, college-aged males (mean ± standard error of the mean (SE); age = 21 ± 1 years, body mass = 79.2 ± 0.3 kg) were randomly assigned to an isocaloric, lipid-, and organoleptically-matched maltodextrin placebo (PLA, n = 15), LEU (n = 14), whey protein concentrate (WPC, n = 17), whey protein hydrolysate (WPH, n = 14), or soy protein concentrate (SPC, n = 15) group. Participants performed whole-body resistance training three days per week for 12 weeks while consuming supplements twice daily. Skeletal muscle and subcutaneous (SQ) fat biopsies were obtained at baseline (T1) and ~72 h following the last day of training (T39). Tissue samples were analyzed for changes in type I and II fiber cross sectional area (CSA), non-fiber specific satellite cell count, and SQ adipocyte CSA. On average, all supplement groups including PLA exhibited similar training volumes and experienced statistically similar increases in total body skeletal muscle mass determined by dual X-ray absorptiometry (+2.2 kg; time p = 0.024) and type I and II fiber CSA increases (+394 μm² and +927 μm²; time p < 0.001 and 0.024, respectively). Notably, all groups reported increasing Calorie intakes ~600-800 kcal/day from T1 to T39 (time p < 0.001), and all groups consumed at least 1.1 g/kg/day of protein at T1 and 1.3 g/kg/day at T39. There was a training, but no supplementation, effect regarding the reduction in SQ adipocyte CSA (-210 μm²; time p = 0.001). Interestingly, satellite cell counts within the WPC (p < 0.05) and WPH (p < 0.05) groups were greater at T39 relative to T1. In summary, LEU or protein supplementation (standardized to LEU content) does not provide added benefit in increasing whole-body skeletal muscle mass or strength above PLA

  4. A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

    PubMed

    Skau, Jutta K H; Nordin, Awatef Binti Amer; Cheah, Julius C H; Ali, Roslinah; Zainal, Ramli; Aris, Tahir; Ali, Zainudin Mohd; Matzen, Priya; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark A; Norris, Shane A

    2016-04-27

    Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14

  5. Developing a Fitbit-supported lifestyle physical activity intervention for depressed alcohol dependent women.

    PubMed

    Abrantes, Ana M; Blevins, Claire E; Battle, Cynthia L; Read, Jennifer P; Gordon, Alan L; Stein, Michael D

    2017-09-01

    Women in alcohol treatment are more likely to relapse when in unpleasant, negative emotional states. Given the demonstrated benefits of exercise for decreasing depression, negative affect, and urges to drink, helping women engage in a lifestyle physical activity (LPA) intervention in early recovery may provide them a tool they can utilize "in the moment" in order to cope with negative emotional states and alcohol craving when relapse risk is highest. New digital fitness technologies (e.g., Fitbit activity monitor with web and mobile applications) may facilitate increases in physical activity (PA) through goal setting and self-monitoring. We piloted a 12-week LPA+Fitbit intervention focused on strategically using bouts of PA to cope with affect and alcohol cravings to prevent relapse in 20 depressed women (mean age=39.5years) in alcohol treatment. Participants wore their Fitbit on 73% of days during the intervention period. An average of 9174 steps/day were taken on the days the Fitbit was worn. Participants completed 4.7 of the 6 scheduled phone PA counseling sessions (78%). Among women who completed the intervention (n=15), 44% remained abstinent throughout the entire course of treatment. On average, women were abstinent on 95% of days during the 12-week intervention. Participants reported an increase in using PA to cope with either negative affect or urges to drink from baseline to end of treatment (p<0.05). Further, participants reported high satisfaction with the LPA+Fitbit intervention and with the Fitbit tracker. Further research is needed to evaluate the LPA+Fitbit intervention in a more rigorous randomized controlled trial. If the LPA+Fitbit intervention proves to be helpful during early recovery, this simple, low-cost and easily transported intervention can provide a much-needed alternate coping strategy to help reduce relapse risk among women in alcohol treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial.

    PubMed

    Álvarez, Cristian; Ramírez-Campillo, Rodrigo; Ramírez-Vélez, Robinson; Izquierdo, Mikel

    2017-04-01

    Our aim was to investigate the effects and prevalence of nonresponders (NR) to high-intensity interval training (HIIT) and resistance training (RT) in women with insulin resistance on cardiometabolic health parameters. Sedentary overweight/obese insulin-resistant women (age = 33.5 ± 6.5 yr; body mass index = 29.9 ± 3.7 kg/m(2)) were randomly assigned to a triweekly HIIT program (HIIT; n = 18) or resistance training (RT; n = 17). Anthropometry (body mass, fat mass, muscle mass, waist circumference, and skinfold thickness), cardiovascular (blood pressure), metabolic [fasting glucose, fasting insulin, and homeostatic model of insulin resistance (HOMA-IR)], as well as muscle strength, and endurance performance covariables were measured before and after 12 wk in both intervention groups. The interindividual variability to exercise training of the subjects was categorized as responders and NR using as cut points two times the typical error of measurement in mean outcomes. After intervention, significant reduction in waist circumference, skinfold thicknesses, fat mass, blood pressure, fasting glucose, insulin, and HOMA-IR (P < 0.05) were identified to HIIT and RT group, respectively. Both HIIT and RT groups exhibited a significant decrease in the endurance performance, whereas only RT exhibited increased muscle strength. Significant differences in the NR prevalence between the HIIT and RT groups were identified for a decrease in fat mass (HIIT 33.3% vs. RT 70.5%; P = 0.028), muscle mass (HIIT 100% vs. RT 52.9%; P = 0.001), and tricipital skinfold (HIIT 5.5% vs. RT 29.4%; P < 0.041). For diastolic blood pressure, significant differences were observed in the NR prevalence between the HIIT and RT groups (55.5% vs. 94.1; P = 0.009). However, there were no differences in the NR prevalence between HIIT and RT for decreasing fasting glucose. Twelve weeks of HIIT and RT have similar effects and NR prevalence to improve glucose control variables; however, there is different NR

  7. Modification of structu