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Sample records for 12-week randomized intervention-study

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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

  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. 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

  13. 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).

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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…

  19. 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)…

  20. 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)…

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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).

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  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

    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.

  18. 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

  19. 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

  20. 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

  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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    PubMed

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  17. 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

  18. 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…

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers: a 12-week, randomized, double-blind, placebo-controlled trial

    PubMed Central

    Münzel, Thomas; Meinertz, Thomas; Tebbe, Ulrich; Schneider, Heinrich Theodor; Stalleicken, Dirk; Wargenau, Manfred; Gori, Tommaso; Klingmann, Ingrid

    2014-01-01

    Background The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study (‘CLEOPATRA’ study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris. Methods and results A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n = 328) or placebo (n = 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 weeks of treatment. Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P = 0.423). In a pre-specified sub-analysis of patients with reduced exercise capacity (TED at baseline ≤9 min, n = 257), PETN appeared more effective than placebo treatment (P = 0.054). Superiority of PETN over placebo was evident in patients who were symptomatic at low exercise levels (n = 120; P = 0.017). Pentaerithrityl tetranitrate 80 mg b.i.d. was well tolerated, and the overall safety profile was comparable with placebo. Conclusion Although providing no additional benefit in unselected patients with known coronary artery disease, PETN therapy, administered in addition to modern anti-ischaemic therapy, could increase exercise tolerance in symptomatic patients with reduced exercise capacity. PMID:24071762

  4. Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers: a 12-week, randomized, double-blind, placebo-controlled trial.

    PubMed

    Münzel, Thomas; Meinertz, Thomas; Tebbe, Ulrich; Schneider, Heinrich Theodor; Stalleicken, Dirk; Wargenau, Manfred; Gori, Tommaso; Klingmann, Ingrid

    2014-04-01

    The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study ('CLEOPATRA' study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris. A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n = 328) or placebo (n = 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 weeks of treatment. Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P = 0.423). In a pre-specified sub-analysis of patients with reduced exercise capacity (TED at baseline ≤9 min, n = 257), PETN appeared more effective than placebo treatment (P = 0.054). Superiority of PETN over placebo was evident in patients who were symptomatic at low exercise levels (n = 120; P = 0.017). Pentaerithrityl tetranitrate 80 mg b.i.d. was well tolerated, and the overall safety profile was comparable with placebo. Although providing no additional benefit in unselected patients with known coronary artery disease, PETN therapy, administered in addition to modern anti-ischaemic therapy, could increase exercise tolerance in symptomatic patients with reduced exercise capacity.

  5. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study†

    PubMed Central

    Inagaki, N; Kondo, K; Yoshinari, T; Maruyama, N; Susuta, Y; Kuki, H

    2013-01-01

    Aims We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy. Methods Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests. Results Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug-related serious AEs were reported. There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio. Conclusions Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated. PMID:23782594

  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. Trospium chloride and oxybutynin hydrochloride in a german study of adults with urinary urge incontinence: results of a 12-week, multicenter, randomized, double-blind, parallel-group, flexible-dose noninferiority trial.

    PubMed

    Zellner, Michael; Madersbacher, Helmut; Palmtag, Hans; Stöhrer, Manfred; Bödeker, Rolf-Hasso

    2009-11-01

    The aims of this study were to determine whether oral trospium chloride is noninferior to oxy-butynin for urinary urge incontinence and to evaluate its efficacy, tolerability, and health-related quality of life parameters. In this randomized, double-blind, active-controlled, parallel-group, multicenter, Phase IIIb trial conducted in Germany, male and female outpatients aged >or=18 years with documented urinary frequency (>or=8 micturitions/24 hours) plus urge incontinence (>or=5 episodes/week) were randomized to receive oral treatment with trospium chloride 15 mg TID or oxybutynin hydrochloride 2.5 mg TID for 12 weeks. Daily doses could be adjusted upward after 4 weeks, to 90 mg of trospium (30 mg TID) and 15 mg of oxybutynin (5 mg TID), respectively, if needed. The absolute reduction in weekly episodes of urinary urge incontinence was evaluated as the primary efficacy variable. Secondary variables included the absolute reduction of micturitions per 24 hours, intensity of urgency, and mean voided volume. Qualitative symptom changes were recorded from the patients' entries in their micturition diaries at baseline, at week 4, and at week 12 of treatment. Subjective treatment outcome was assessed by patient ratings on a visual analog scale (VAS), the King's Health Questionnaire (KHQ), and the 36-Item Medical Outcomes Study Short-Form General Health Survey (SF-36); intensity of dry mouth was also recorded on a scale. Adverse events (AEs) were assessed. Of the 1658 patients treated, 828 patients (49.9%) received trospium 45 mg/d and 830 patients (50.1%) received oxybutynin 7.5 mg/d. After 4 weeks, daily doses were doubled in 29.2% (242/828) of patients in the trospium chloride group, and in 23.3% (193/830) of patients in the oxybutynin group, until the end of treatment. No clinically relevant differences in demographic characteristics were observed between the treatment groups. Trospium was noninferior to oxybutynin hydrochloride in terms of the reduction in the number

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.

    PubMed

    Egerdie, Russell Blair; Auerbach, Stephen; Roehrborn, Claus G; Costa, Pierre; Garza, Martin Sanchez; Esler, Anne L; Wong, David G; Secrest, Roberta J

    2012-01-01

    Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS. This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy. Men were ≥ 45 years old, sexually active, and experiencing ED for ≥ 3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation). The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed. Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo -3.8 ± 0.5, tadalafil 2.5 mg -4.6 ± 0.4, and 5 mg -6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters. Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through

  15. 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

  16. Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults.

    PubMed

    Kivitz, Alan; Fairfax, Michael; Sheldon, Eric A; Xiang, Qinfang; Jones, Beverly A; Gammaitoni, Arnold R; Gould, Errol M

    2008-12-01

    Cyclooxygenase-2 (COX-2) selective inhibitors and nonselective NSAIDs are commonly used to treat osteoarthritis (OA) of the knee. The aim of this study was to compare the effectiveness of the lidocaine patch 5% with that of celecoxib 200 mg/d in the treatment of OA-related knee pain; however, the study was terminated prematurely by the sponsor because of tolerability concerns regarding the class of COX-2 selective inhibitors. A post hoc analysis of the available data is presented here. This multicenter, randomized, open-label, active-controlled, parallel-group study included patients >or=18 years of age with unilateral or bilateral moderate to severe OA of the knee. Patients were randomized to receive treatment with either the lidocaine patch 5% or celecoxib 200 mg/d. The primary efficacy end point was change from baseline to 12 weeks in the Western Ontario and McMaster Universities (WOMAC) OA Index pain subscale. Secondary end points included additional WOMAC subscales and Brief Pain Inventory (BPI) measures. Because this trial was prematurely terminated, a post hoc analysis was performed using a random pattern-mixture model of all observed cases of the intent-to-treat population. A total of 143 patients were randomized to treatment (lidocaine patch 5%, 69 patients; mean [SD] age, 60.2 [11.4] years; 65.2% female; 66.7% white; weight, 94.1 [23.3] kg) or celecoxib 200 mg/d (74 patients; age, 58.2 [12.1] years; 63.5% female; 68.9% white; weight, 94.3 [22.5] kg). Baseline pain WOMAC OA subscale scores (lidocaine patch 5%, 12.087; celecoxib 200 mg/d, 12.514) and mean rates of change over time (baseline to week 2, -1.5916 vs -1.6513 per week; weeks 2-6, -0.0168 vs -0.119 per week; weeks 6-12, -0.1818 vs -0.1579 per week) were not significantly different between the 2 groups. Improvement in additional WOMAC subscales and in several BPI measures were not significantly different between the 2 groups. Treatment-related adverse events were reported in 8 patients in each

  17. 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

  18. Efficacy and Safety of MIN-101: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial of a New Drug in Development for the Treatment of Negative Symptoms in Schizophrenia.

    PubMed

    Davidson, Michael; Saoud, Jay; Staner, Corinne; Noel, Nadine; Luthringer, Elisabeth; Werner, Sandra; Reilly, Joseph; Schaffhauser, Jean-Yves; Rabinowitz, Jonathan; Weiser, Mark; Luthringer, Remy

    2017-07-28

    The authors assessed the efficacy, safety, and tolerability of MIN-101, a compound with affinities for sigma-2 and 5-HT2A receptors and no direct dopamine affinities, in comparison with placebo in treating negative symptoms in stabilized patients with schizophrenia. The trial enrolled 244 patients who had been symptomatically stable for at least 3 months and had scores of at least 20 on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). After at least 5 days' withdrawal from all antipsychotic medication, patients were randomly assigned to receive placebo or 32 mg/day or 64 mg/day of MIN-101 for 12 weeks. The primary outcome measure was the PANSS negative factor score (pentagonal structure model). Secondary outcome measures were PANSS total score and scores on the Clinical Global Impressions Scale (CGI), the Brief Negative Symptom Scale, the Brief Assessment of Cognition in Schizophrenia, and the Calgary Depression Scale for Schizophrenia. A statistically significant difference in PANSS negative factor score was observed, with lower scores for the MIN-101 32 mg/day and 64 mg/day groups compared with the placebo group (effect sizes, d=0.45 and d=0.57, respectively). Supporting these findings were similar effects on several of the secondary outcome measures, such as the PANSS negative symptom, total, and activation factor scores, the CGI severity item, and the Brief Negative Symptom Scale. There were no statistically significant differences in PANSS positive scale score between the MIN-101 and placebo groups. No clinically significant changes were observed in vital signs, routine laboratory values, weight, metabolic indices, and Abnormal Involuntary Movement Scale score. MIN-101 demonstrated statistically significant efficacy in reducing negative symptoms and good tolerability in stable schizophrenia patients.

  19. A 12-week, randomized, parallel-group, proof-of-concept study of tulobuterol patch and salmeterol inhaler as add-on therapy in adult-onset mild-to-moderate asthma.

    PubMed

    Inoue, Hideki; Niimi, Akio; Matsumoto, Hisako; Ito, Isao; Oguma, Tsuyoshi; Otsuka, Kojiro; Takeda, Tomoshi; Nakaji, Hitoshi; Tajiri, Tomoko; Iwata, Toshiyuki; Nagasaki, Tadao; Mishima, Michiaki

    2017-01-01

    Patch formulation of tulobuterol has been used in asthma treatment as a long-acting β2 -agonist (LABA) through sustained skin absorption. Its treatment efficacy, especially in small airways, remains poorly understood. The study aim was to investigate LABA add-on effects of tulobuterol patch (TP) and salmeterol inhaler (SA) on pulmonary function, asthma control and health status. Patients who had adult-onset under-control asthma, despite taking inhaled corticosteroids, were enrolled in a randomized, open-label, parallel-group, proof-of-concept study of 12-week add-on treatment with TP (n=16) or SA (n=17). Spirometry, impulse oscillometry (IOS), exhaled nitric oxide levels, and clinical questionnaires of asthma control, health status (St. George's Respiratory Questionnaire: SGRQ), and symptoms were evaluated every 4 weeks. Add-on treatment of SA significantly improved the spirometric indices of small airway obstruction (forced expiratory flow between 25% and 75% of FVC: FEF25-75 , and maximum expiratory flow at 25% of FVC: MEF25 ) and IOS indices of whole respiratory resistance (resistance at 5 Hz) as compared to TP. In intra-group comparisons, add-on treatment of TP improved the scores of the asthma control test and the total SGRQ, as well as the symptom and impact components of the SGRQ. SA add-on treatment improved FEV1 and IOS parameters of resistance at 20 Hz and reactance at 5 Hz. Neither of the treatments improved exhaled nitric oxide levels. In conclusion, add-on treatment of TP improved asthma control and health status, whereas SA improved pulmonary function measures associated with large and small airway involvement among patients with adult-onset mild-to-moderate asthma.

  20. PDE 5 inhibition with udenafil improves left ventricular systolic/diastolic functions and exercise capacity in patients with chronic heart failure with reduced ejection fraction; A 12-week, randomized, double-blind, placebo-controlled trial.

    PubMed

    Kim, Kyung-Hee; Kim, Hyung-Kwan; Hwang, In-Chang; Cho, Hyun-Jai; Je, Nari; Kwon, Oh-Min; Choi, Su-Jeong; Lee, Seung-Pyo; Kim, Yong-Jin; Sohn, Dae-Won

    2015-06-01

    Impaired nitric oxide-mediated pulmonary vascular tone is commonly found in heart failure with reduced ejection fraction (HFrEF), and is associated with derangement of left ventricular (LV) hemodynamics and decreased exercise capacity, which may be reversed by PDE5 inhibitor. This study investigated the effects of a new, long-acting PDE5 inhibitor on LV hemodynamics and exercise capacity in HFrEF. Patients with chronic HFrEF on optimal medical therapy for >30 days before enrollment were randomly assigned to placebo or udenafil at a dose of 50mg 2x/day for the first 4 weeks followed by 100mg 2x/day for the next 8 weeks. All patients underwent cardiopulmonary exercise echocardiography before and after the 12-week treatment. Improvement of subjective functional capacity was more frequently reported in the udenafil group (P = 0.002). Also, a higher increase in peak VO2 (Δpeak VO2, 21.6% (6.9 ~ 106.4%) vs 1.9% (-15.7 ~ 21.0%) in the placebo group, P = 0.04) and a larger decrease in ventilatory efficiency were observed in the udenafil group (Δ-6.4 ± 9.7 vs Δ1.9 ± 12.1 in the placebo group, P = 0.03). Regarding LV systolic function, the extent of increment in LV ejection fraction was significantly greater in the udenafil group (6.6 ± 6.4% vs 2.3 ± 4.8% in the placebo group, P = 0.02). In the udenafil group, an echocardiographic surrogate of LV filling pressure was more prominently decreased (P = 0.006) along with a significant reverse remodeling of left atrial volume index (57 ± 25mL at baseline to 44 ± 23 at 12th week, P = 0.04) and a progressive fall in B-type natriuretic peptide level (589 ± 679pg/mL at baseline to 220 ± 225pg/mL at 12th week, P < 0.001), indicating LV diastolic function improvement. Udenafil was well tolerated without excess of adverse events compared to placebo. Udenafil improves LV systolic/diastolic functions and exercise capacity in conjunction with established conventional pharmacotherapy, without significant adverse events in HFr

  1. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee

    PubMed Central

    Kneer, Werner; Rother, Matthias; Mazgareanu, Stefan; Seidel, Egbert J

    2013-01-01

    Objective To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033) in comparison with a ketoprofen-free vehicle (TDT 064) for the treatment of osteoarthritis (OA) of the knee. Methods Patients with knee OA (N = 866) were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index pain subscale score. The coprimary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy. The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT)-Osteoarthritis Research Society International (OARSI) responder rates. Results The WOMAC pain scores were reduced by approximately 50% or more in all four groups. The 100 and 50 mg ketoprofen groups, but not the 25 mg group, showed a superior reduction in the WOMAC pain score versus the TDT 064 group (100 mg: −57.4% [P = 0.0383]; 50 mg: −57.1% [P = 0.0204]; and 25 mg: −53.4% [P = 0.3616] versus TDT 064: −49.5%). The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score, whereas the patient global assessment of 50 mg ketoprofen group, but not the 100 or 25 mg group, was superior to that of the TDT 064 group (P = 0.0283). Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group, but were high in all groups (100 mg: 88.6%; 50 mg: 86.8%; 25 mg: 88.6%; and TDT 064: 77.5%). Dermal reactions were the only relevant drug-related adverse events in all four groups. Conclusion The 50 and 100 mg ketoprofen doses of IDEA-033 were only marginally superior to TDT 064 for reducing pain associated with knee OA. The study indicates a high treatment response to the topical

  2. Effects of atorvastatin 10 mg and fenofibrate 200 mg on the low-density lipoprotein profile in dyslipidemic patients: A 12-week, multicenter, randomized, open-label, parallel-group study

    PubMed Central

    Ansquer, Jean-Claude; Corda, Christophe; Le Malicot, Karine; Jessent, Valerie

    2009-01-01

    Background: Elevated plasma low-density lipoprotein cholesterol (LDL-C) concentrations are highly atherogenic, especially the small, dense LDL (sdLDL) species. Fenofibrate has been reported to shift the LDL profile by decreasing the sdLDL subfraction and increasing larger LDL subclasses. Atorvastatin, anantihyperlipidemic agent, has been reported to reduce plasma total cholesterol (TC) and triglyceride (TG) concentrations and thus could modify the LDL profile. Objective: The aim of this study was to compare the effects of fenofi brate and atorvastatin on standard lipid concentrations and the LDL profile. Methods: In this randomized, open-label, parallel-group study, men and women aged 18 to 79 years with type II primary dyslipidemia, defined as LDL-C ≥160 and TG 150 to 400 mg/dL, after a 4- to 6-week washout period while eating an appropriate diet, were randomized to receive either atorvastatin 10 mg once daily or fenofi-brate 200 mg once daily. Plasma lipid concentrations and cholesterol and apolipoprotein (apo) B (reflecting the LDL particle number) in each LDL subfraction prepared by ultracentrifiigation were determined at baseline and after 12 weeks of treatment. Tolerability was assessed using adverse events (AEs) obtained on laboratory analysis and vital sign measurement. Adherence was assessed by counting unused drug supplies. Results: A total of 165 patients (117 men, 48 women; mean [SD] age, 50.1 [10.7] years; mean TC concentration, 289 mg/dL) were randomized to receive atorvastatin (n = 81) or fenofibrate (n = 84). Compared with fenofibrate, atorvastatin was associated with a significantly greater mean (SD) percentage decrease in TC (27.0% [12.3%] vs 16.5% [12.9%]; P < 0.001), calculated LDL-C (35.4% [15.8%] vs 17.3% [17.2%]; P < 0.001), TC/high-density lipoprotein cholesterol (HDL-C) ratio (29.1% [16.3%] vs 22.9% [15.9%]; P = 0.001), and apoB (30.3% [12.7%] vs 19.6% [15.5%]; P < 0.001). Compared with atorvastatin, fenofibrate was associated with a

  3. 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.

  4. Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study.

    PubMed

    Emery, Paul; Koncz, Tamas; Pan, Sharon; Lowry, Simon

    2008-01-01

    The hip is the second most common large joint that is affected by osteoarthritis (OA), with prevalence ranging from 3% to 11% in patients aged > or = 35 years. OA is often associated with significant pain, disability, and impaired quality of life. Treatment should be tailored according to the level of pain, disability, and handicap. Pharmacologic treatment options for hip OA include acetaminophen (recommended by the European League Against Rheumatism as a first-line treatment), NSAIDs such as diclofenac, and cyclooxygenase-2-selective NSAIDs such as celecoxib. The purpose of this study was to determine whether celecoxib 200 mg QD is noninferior to diclofenac 50 mg TID in the treatment of OA of the hip. This was a 12-week, randomized, double-blind, parallel-group, double-dummy, noninferiority study conducted at 40 centers in the United Kingdom. Patients with OA flare at baseline (determined by visual analog scale [VAS] measurement of > or = 40 to < 90 mm and patient's and physician's global assessments of arthritis ratings of "poor" or "very poor") and awaiting joint replacement surgery were randomized to receive celecoxib QD or diclofenac TID. Patients were excluded if surgery was anticipated within 8 weeks. The United Kingdom National Health Service initiatives on waiting-list times caused a reduction in the number of potential patients available for participation. Therefore, the study protocol was amended such that change from baseline to week 6 (as opposed to week 12) in the patient's assessment of arthritis pain on walking, measured by VAS (0-100 mm), was the primary outcome. Primary analysis was carried out on the evaluable population (subjects with baseline and week 6 arthritis pain on walking VAS scores and no major protocol deviations). Celecoxib was declared noninferior to diclofenac if the upper limit of the 2-sided 95% CI of the treatment difference (celecoxib vs diclofenac) in the mean change from baseline in VAS did not exceed 10 mm. Tolerability was

  5. Moderate Walking Enhances the Effects of an Energy-Restricted Diet on Fat Mass Loss and Serum Insulin in Overweight and Obese Adults in a 12-Week Randomized Controlled Trial.

    PubMed

    Kleist, Bernadette; Wahrburg, Ursel; Stehle, Peter; Schomaker, Ralph; Greiwing, Andreas; Stoffel-Wagner, Birgit; Egert, Sarah

    2017-08-09

    Background: Increased physical activity may be advantageous for weight loss.Objective: We investigated the effects of an energy-restricted diet with and without moderate walking on body weight, body composition, resting energy expenditure (REE), and endocrine and cardiometabolic risk variables in overweight and obese participants.Methods: A 12-wk, randomized, 2-arm, parallel, controlled, energy-restricted (500-800 kcal/d) dietary intervention study was conducted in 82 men and women [mean baseline characteristics: age, 39.4 y; weight, 99.3 kg; body mass index (in kg/m(2)), 31.9]. Participants were divided into 2 groups. One group received a hypoenergetic diet (DI) only (n = 44). The second group received the same DI and participated in a regular walking program of 2.5 h/wk (DI + walking; n = 38).Results: After the 12-wk intervention, body weight was significantly decreased in the DI + walking group and the DI group (-8.8 compared with -7.0 kg, P = 0.064 for intergroup differences). The decrease in body weight was accompanied by a significant reduction in total fat mass, which was significantly more pronounced in the DI + walking group than in the DI group (-6.4 ± 3.1 compared with -4.8 ± 3.0 kg; P = 0.020). REE after 12 wk was not significantly different compared with the baseline REE. Diastolic blood pressure, mean arterial pressure, LDL cholesterol, and non-HDL cholesterol were similarly significantly improved by both interventions. In the DI + walking group, insulin and the homeostasis model assessment of insulin resistance index were also significantly reduced. Serum free triiodothyronine was significantly decreased and serum cortisol was significantly increased in both groups.Conclusions: Participation in a 12-wk weight-loss study resulted in significant reductions in body weight and fat mass and was associated with significant improvements in biomarkers for cardiovascular disease risk. Moderate weight loss was not accompanied by a reduction in REE

  6. [The effect of Christmas joy on the mood among medical doctors - a randomized, blinded intervention study].

    PubMed

    Ilkjær, Christine; Møller, Marianne B; Lauridsen, Mette H; Ilkjær, Susanne; Hjortdal, Vibeke E

    2016-12-12

    Each December Santa's elves spread Christmas joy (JN). Laughter and humour may influence health and stress level. No other study has investigated the effect of JN on the good spirit (DGH) among healthcare professionals. We performed a single-centre blinded intervention study with crossover at three hospital departments. JN intervention of three days was randomized. Median ± standard deviation was given. The level of significance was p < 0.05. During a four-week period, we made 24 observations (response rate 67). The laugh index increased from 0.02 in November to 0.03 in December (without JN) and further to 0.05 with JN. At one department, the rise was significant. At a department without morning coffee, the DGH level raised after JN intervention corresponding to the level at the departments with morning coffee before JN intervention. Christmas atmosphere tended to increase DGH at the morning conferences. JN tended to have an additive effect. JN exposure may be beneficial. The study did not receive any funding. The trial was not registered and was kept secret for the participants in accordance with the tradition of Santa's elves.

  7. Reducing psychotropic pharmacotherapy in patients with severe mental illness: a cluster-randomized controlled intervention study

    PubMed Central

    Kilian, Reinhold; Sørensen, Helle Østermark; Eriksen, Susan Engelbrechsen; Davidsen, Annette Sofie; Jensen, Signe Olrik Wallenstein; Munk-Jørgensen, Povl

    2015-01-01

    Background: Many patients with mental illness receive psychotropic medicine in high dosages and from more than one drug. One of the consequences of this practice is obesity, which is a contributing factor to increased physical morbidity and premature death. Methods: Our study was a cluster-randomized intervention study involving 6 facilities and 174 patients diagnosed with severe mental illnesses (73% schizophrenia). The intervention period was 12 months and consisted of teaching sessions with the staff and evaluating the patients’ intake of psychotropic medication. At index, 44% met criteria for obesity and 76% met criteria for overweight. Waist circumferences were 108 cm for men and 108 cm for women. Olanzapine, clozapine and quetiapine were the most common prescribed antipsychotics. Mean values of daily doses of antipsychotic were 2.5. Results: The intervention showed no significant differences between the intervention and control group regarding psychotropic treatment. At follow up, independent of intervention, patients receiving antipsychotic polypharmacy had a larger waist circumference compared with patients receiving antipsychotic monotherapy of 9.8 cm (1.5–18.1) (p = 0.028). Discussion and conclusion: We found both a high prevalence of obesity and that the patients received treatment with antipsychotic polypharmaceutics in high dosages. Active awareness did not change practice and we must think of other ways to restrict treatment with psychotropics in this group of patients. PMID:26240746

  8. Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial.

    PubMed

    Simioni, Nicolas; Labreuche, Julien; Behal, Hélène; Cottencin, Olivier; Rolland, Benjamin

    2017-10-03

    The aim of this study was to evaluate whether a prolonged detoxification treatment could decrease the relapse rate at 3 months after alcohol cessation in alcohol-dependent individuals through decreasing the levels of postdetoxification craving and anxiety. Twenty-six adult patients with alcohol dependence (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) who began an outpatient alcohol cessation program with an initial drinking goal of abstinence were enrolled in a 3-month, parallel, randomized (1:1 ratio), controlled, open-label, pilot trial. Participants were randomized to receive a detoxification treatment of diazepam with a duration of 30 (n = 12) or 10 days (n = 14). All participants received BRENDA-based psychotherapy during follow-up. No significant between-group difference in relapse to any drinking was found at 3 months (P = 0.20). However, relapse to any heavy drinking at 3 months and regular drinking or heavy drinking during follow-up were significantly lower in the 30-day diazepam group (P = 0.009, P = 0.049, and P = 0.004, respectively). These differences were corroborated by significant differences in the alcohol-specific biological marker carbohydrate deficient transferrin at 3 months. Participants in the 30-day diazepam group also displayed significantly lower scores for alcohol craving (P = 0.007), self-reported anxiety (P = 0.024), and clinician-assessed anxiety (P = 0.002) throughout the follow-up. No serious adverse event was reported during the study. This study provides an evidence-based rationale for a double-blind, randomized, placebo-controlled trial to confirm the efficacy of such a procedure on short-term and mid-/long-term drinking outcomes after alcohol cessation in alcohol-dependent individuals.

  9. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    PubMed

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

  10. Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer for the treatment of acne vulgaris: a 12-week, randomized, double-blind study.

    PubMed

    Fleischer, Alan B; Shalita, Alan; Eichenfield, Lawrence F; Abramovits, William; Lucky, Anne; Garrett, Steven

    2010-01-01

    To evaluate the safety and efficacy of dapsone gel 5% in the treatment of acne when used in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer. This was a twelve-week, randomized, double-blind study. Patients aged 12 years and older (n=301) applied dapsone gel twice daily and were randomly assigned (1:1:1) to one of three additional treatments, applied once daily. By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions. However, the authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination). Patients treated with dapsone gel combined with adapalene showed a significantly better response in reduction in non-inflammatory and total acne lesion count than those who received the moisturizer combination. Local adverse reactions in all three treatment groups were minimal and generally mild in severity. Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris.

  11. 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.

  12. Depression Outcomes in Adults Attending Family Practice Were Not Improved by Screening, Stepped-Care, or Online CBT during a 12-Week Study when Compared to Controls in a Randomized Trial

    PubMed Central

    Silverstone, Peter H.; Rittenbach, Katherine; Suen, Victoria Y. M.; Moretzsohn, Andreia; Cribben, Ivor; Bercov, Marni; Allen, Andrea; Pryce, Catherine; Hamza, Deena M.; Trew, Michael

    2017-01-01

    There is uncertainty regarding possible benefits of screening for depression in family practice, as well as the most effective treatment approach when depression is identified. Here, we examined whether screening patients for depression in primary care, and then treating them with different modalities, was better than treatment-as-usual (TAU) alone. Screening was carried out for depression using the 9-item Patient Health Questionnaire (PHQ-9), with a score of ≥10 indicating significant depressive symptoms. PHQ-9 scores were given to family physicians prior to patients being seen (except for the Control group). Patients (n = 1,489) were randomized to one of four groups. Group #1 were controls (n = 432) in which PHQ-9 was administered, but results were not shared. Group #2 was screening followed by TAU (n = 426). Group #3 was screening followed by both TAU and the opportunity to use an online cognitive behavioral therapy (CBT) treatment program (n = 440). Group #4 utilized an evidence-based Stepped-care pathway for depression (n = 191, note that this was not available at all clinics). Of the study sample 889 (60%) completed a second PHQ-9 rating at 12 weeks. There were no statistically significant differences in baseline PHQ-9 scores between these groups. Compared to baseline, mean PHQ-9 scores decreased significantly in the depressed patients over 12 weeks, but there were no statistically significant differences between any groups at 12 weeks. Thus, for those who were depressed at baseline Control group (Group #1) scores decreased from 15.3 ± 4.2 to 4.0 ± 2.6 (p < 0.001), Screening group (Group #2) scores decreased from 15.5 ± 3.9 to 4.6 ± 3.0 (p < 0.001), Online CBT group (Group #3) scores decreased from 15.4 ± 3.8 to 3.4 ± 2.7 (p < 0.01), and the Stepped-care pathway group (Group #4) scores decreased from 15.3 ± 3.6 to 5.4 ± 2.8 (p < 0.05). In conclusion, these findings from this

  13. Depression Outcomes in Adults Attending Family Practice Were Not Improved by Screening, Stepped-Care, or Online CBT during a 12-Week Study when Compared to Controls in a Randomized Trial.

    PubMed

    Silverstone, Peter H; Rittenbach, Katherine; Suen, Victoria Y M; Moretzsohn, Andreia; Cribben, Ivor; Bercov, Marni; Allen, Andrea; Pryce, Catherine; Hamza, Deena M; Trew, Michael

    2017-01-01

    There is uncertainty regarding possible benefits of screening for depression in family practice, as well as the most effective treatment approach when depression is identified. Here, we examined whether screening patients for depression in primary care, and then treating them with different modalities, was better than treatment-as-usual (TAU) alone. Screening was carried out for depression using the 9-item Patient Health Questionnaire (PHQ-9), with a score of ≥10 indicating significant depressive symptoms. PHQ-9 scores were given to family physicians prior to patients being seen (except for the Control group). Patients (n = 1,489) were randomized to one of four groups. Group #1 were controls (n = 432) in which PHQ-9 was administered, but results were not shared. Group #2 was screening followed by TAU (n = 426). Group #3 was screening followed by both TAU and the opportunity to use an online cognitive behavioral therapy (CBT) treatment program (n = 440). Group #4 utilized an evidence-based Stepped-care pathway for depression (n = 191, note that this was not available at all clinics). Of the study sample 889 (60%) completed a second PHQ-9 rating at 12 weeks. There were no statistically significant differences in baseline PHQ-9 scores between these groups. Compared to baseline, mean PHQ-9 scores decreased significantly in the depressed patients over 12 weeks, but there were no statistically significant differences between any groups at 12 weeks. Thus, for those who were depressed at baseline Control group (Group #1) scores decreased from 15.3 ± 4.2 to 4.0 ± 2.6 (p < 0.001), Screening group (Group #2) scores decreased from 15.5 ± 3.9 to 4.6 ± 3.0 (p < 0.001), Online CBT group (Group #3) scores decreased from 15.4 ± 3.8 to 3.4 ± 2.7 (p < 0.01), and the Stepped-care pathway group (Group #4) scores decreased from 15.3 ± 3.6 to 5.4 ± 2.8 (p < 0.05). In conclusion, these findings from this

  14. Comparison of participants and non-participants in a randomized psychosocial intervention study among patients with malignant melanoma.

    PubMed

    Boesen, Ellen; Boesen, Sidsel; Christensen, Søren; Johansen, Christoffer

    2007-01-01

    The authors investigated barriers for entering a randomized psychosocial intervention study among patients with malignant melanoma. Data on age, sex, prognostic factors, social class, marital status, mood, coping, social relations, and social desirability from participants and non-participants were compared in a regression model. More patients in lower socioeconomic classes declined participation. Non-participation was associated with low levels of distress and adaptive coping and higher levels of empathy and congruence from spouses. The type of intervention offered in this study may have more appeal to patients belonging to higher socioeconomic classes.

  15. Improving Colorectal Cancer Screening in Asian Americans: Results of a Randomized Intervention Study

    PubMed Central

    Carney, Patricia A.; Lin, Frances Lee; Mongoue-Tchokote, Solange; Mori, Motomi; Leung, Holden; Lau, Christine; Le, TD; Lieberman, David A.

    2014-01-01

    Objective To test, using a randomized controlled trial design, the impact of an educational intervention delivered by specially trained community health workers among Chinese, Korean and Vietnamese participants aged 50–75 on knowledge, attitudes, beliefs and intention regarding colorectal cancer screening. Methods We collected baseline data on participants’ baseline demographic characteristics, knowledge, attitudes, beliefs about cancer, its risk factors and intention to keep up-to-date on cancer screening in the future. Fifteen intervention sessions were held between April and June of 2011. Follow-up surveys were administered in the post-test period to both intervention and control participants. Those randomized to the control group received educational pamphlets in their native language. Results The intervention had the greatest influence on the Chinese subgroup, which had improved scores relative to the control group for Perceived Behavior Control and Intentions (pre- vs. post- change in control group −0.16; change in intervention group 0.11, p=0.004), Behavioral Beliefs on Cancer Screening (pre- vs. post- change in control group −0.06; change in intervention group 0.24, p=0.0001), and for Attitudes Toward Behavior (pre- vs. post- change in control group −0.24; change in intervention group 0.35, p=<0.0001). The intervention had no effect on Behavioral Beliefs on Cancer, Control Beliefs, and Perceived Behavioral Control (Reliance on Family). Though intention to stay up-to-date for cancer screening increased in two study groups (Chinese and Vietnamese), these were not significant. Conclusions An educational program delivered by culturally specific community health educators using culturally appropriate language influences some knowledge, attitude and behavioral beliefs but not others. PMID:24595714

  16. An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial.

    PubMed

    Gladstone, Tracy G; Marko-Holguin, Monika; Rothberg, Phyllis; Nidetz, Jennifer; Diehl, Anne; DeFrino, Daniela T; Harris, Mary; Ching, Eumene; Eder, Milton; Canel, Jason; Bell, Carl; Beardslee, William R; Brown, C Hendricks; Griffiths, Kathleen; Van Voorhees, Benjamin W

    2015-05-01

    The high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system. We developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed. The current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model

  17. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  18. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  19. Improving parental stress levels among mothers living with HIV: a randomized control group intervention study.

    PubMed

    Johnson, Erica R; Davies, Susan L; Aban, Inmaculada; Mugavero, Michael J; Shrestha, Sadeep; Kempf, Mirjam-Colette

    2015-04-01

    Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85(th) and 90(th) percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH.

  20. Radon balneotherapy and physical activity for osteoporosis prevention: a randomized, placebo-controlled intervention study.

    PubMed

    Winklmayr, Martina; Kluge, Christian; Winklmayr, Wolfgang; Küchenhoff, Helmut; Steiner, Martina; Ritter, Markus; Hartl, Arnulf

    2015-03-01

    Low-dose radon hyperthermia balneo treatment (LDRnHBT) is applied as a traditional measure in the non-pharmacological treatment of rheumatic diseases in Europe. During the last decades, the main approach of LDRnHBT was focused on the treatment of musculoskeletal disorders, but scientific evidence for the biological background of LDRnHBT is weak. Recently, evidence emerged that LDRnHBT influences bone metabolism. We investigated, whether combined LDRnHBT and exercise treatment has an impact on bone metabolism and quality of life in a study population in an age group at risk for developing osteoporosis. This randomized, double-blind, placebo-controlled trial comprised guided hiking tours and hyperthermia treatment in either radon thermal water (LDRnHBT) or radon-free thermal water (PlaceboHBT). Markers of bone metabolism, quality of life and somatic complaints were evaluated. Statistics was performed by linear regression and a linear mixed model analysis. Significant changes over time were observed for most analytes investigated as well as an improvement in self-assessed health in both groups. No significant impact from the LDRnHBT could be observed. After 6 months, the LDRnHBT group showed a slightly stronger reduction of the osteoclast stimulating protein receptor activator of nuclear kB-ligand compared to the PlaceboHBT group, indicating a possible trend. A combined hyperthermia balneo and exercise treatment has significant immediate and long-term effects on regulators of bone metabolism as well as somatic complaints. LDRnHBT and placeboHBT yielded statistically equal outcomes.

  1. Red meat, dairy, and insulin sensitivity: a randomized crossover intervention study.

    PubMed

    Turner, Kirsty M; Keogh, Jennifer B; Clifton, Peter M

    2015-06-01

    Epidemiologic studies have linked high consumption of red and processed meat with risk of developing type 2 diabetes, whereas high dairy consumption has been associated with decreased risk, but interventions have been limited. We compared the effects on insulin sensitivity of consuming a diet high in lean red meat with minimal dairy, a diet high in primarily low-fat dairy (from milk, yogurt, or custard) with no red meat, and a control diet that contained neither red meat nor dairy. A randomized crossover study was undertaken with 47 overweight and obese men and women divided into 2 groups as follows: those with normal glucose tolerance and those with impaired fasting glucose or impaired glucose tolerance. Participants followed the 3 weight-stable dietary interventions for 4 wk with glucose, insulin, and C-peptide measured by using oral-glucose-tolerance tests at the end of each diet. Fasting insulin was significantly higher after the dairy diet than after the red meat diet (P < 0.01) with no change in fasting glucose resulting in a decrease in insulin sensitivity after the high-dairy diet (P < 0.05) as assessed by homeostasis model assessment of insulin resistance (HOMA-IR). A significant interaction between diet and sex was observed such that, in women alone, HOMA-IR was significantly lower after the red meat diet than after the dairy diet (1.33 ± 0.8 compared with 1.71 ± 0.8, respectively; P < 0.01). Insulin sensitivity calculated by using the Matsuda method was 14.7% lower in women after the dairy diet than after the red meat diet (P < 0.01) with no difference between diets in men. C-peptide was not different between diets. In contrast to some epidemiologic findings, these results suggest that high consumption of dairy reduces insulin sensitivity compared with a diet high in lean red meat in overweight and obese subjects, some of whom had glucose intolerance. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN

  2. Use of a randomized multiple baseline design: rationale and design of the spirited life holistic health intervention study.

    PubMed

    Proeschold-Bell, Rae Jean; Swift, Robin; Moore, H Edgar; Bennett, Gary; Li, Xiang-Fang; Blouin, Rachel; Williams, Virginia P; Williams, Redford B; Toole, David

    2013-07-01

    Clergy suffer from high rates of obesity, chronic disease, and depression, and simultaneously underestimate the toll these take on their daily functioning. Health interventions are needed for clergy and may be tailored to their occupational context and theological beliefs. Few studies have sought to improve clergy health. No prior studies have utilized a randomized design. Spirited Life is a randomized, multiple baseline study that offered enrollment to nearly all United Methodist Church clergy in North Carolina in fall 2010. A total of 1114 clergy (response rate = 64%) enrolled. Using a multiple baseline design, we randomized participants to three cohorts. Each cohort began the health intervention in one of three consecutive years. The third cohort served as a randomized waitlist control cohort, allowing comparisons between the first and third cohorts. The two-year Spirited Life intervention consists of: 1) a theological underpinning for health stewardship based on incarnation, grace, and response and delivered during workshops; 2) the stress management program Williams LifeSkills; 3) Naturally Slim, an online weight loss program; 4) phone contact with a Wellness Advocate; and 5) $500 small grants for health goals. Metabolic syndrome is the primary endpoint. Stress and depressive severity are secondary endpoints. We measured each construct before, twice during, and at the end of the two-year intervention. Study outcomes, to be published after follow-up data are gathered, will provide evidence of the effectiveness of the combined intervention components of Spirited Life. If successful, the intervention may be considered for use with other clergy and faith populations. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy.

    PubMed

    Gollhofer, Sandra M; Wiskemann, Joachim; Schmidt, Martina E; Klassen, Oliver; Ulrich, Cornelia M; Oelmann, Jan; Hof, Holger; Potthoff, Karin; Steindorf, Karen

    2015-03-27

    Over the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials. However, it has been argued that results may be biased by selective participation. Therefore, we investigated factors influencing participation in a randomized exercise intervention trial for breast cancer patients. Non-metastatic breast cancer patients were systematically screened for a randomized exercise intervention trial on cancer-related fatigue. Participants and nonparticipants were compared concerning sociodemographic characteristics (age, marital status, living status, travel time to the training facility), clinical data (body-mass-index, tumor stage, tumor size and lymph node status, comorbidities, chemotherapy), fatigue, and physical activity. Reasons for participation or declination were recorded. 117 patients (52 participants, 65 nonparticipants) were evaluable for analysis. Multiple regression analyses revealed significantly higher odds to decline participation among patients with longer travel time (p=0.0012), living alone (p=0.039), with more comorbidities (0.031), previous chemotherapy (p=0.0066), of age≥70 years (p=0.025), or being free of fatigue (p=0.0007). No associations were found with BMI or physical activity. By far the most frequently reported reason for declination of participation was too long commuting time to the training facility. Willingness of breast cancer patients to participate in a randomized exercise intervention study differed by sociodemographic factors and health status. Neither current physical activity level nor BMI appeared to be selective for participation. Reduction of personal inconveniences and time effort, e.g. by decentralized training facilities or flexible training schedules, seem most promising for enhancing participation in exercise intervention trials. Registered at ClinicalTrials.gov: NCT01468766 (October 2011).

  4. 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.

  5. 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.

  6. Changes in physical activity and sedentary behavior in a randomized trial of an internet-based versus workbook-based family intervention study.

    PubMed

    Catenacci, Victoria A; Barrett, Christopher; Odgen, Lorraine; Browning, Ray; Schaefer, Christine Adele; Hill, James; Wyatt, Holly

    2014-02-01

    The America on the Move (AOM) Family Intervention Program has been shown to prevent excess weight gain in overweight children. Providing intervention materials via the internet would have the potential to reach more families but may increase sedentary behavior. The purpose was to evaluate whether delivering the AOM Family Intervention via the internet versus printed workbook would have a similar impact on sedentary behaviors in children. 131 children (age 8-12) were randomized to receive the AOM Family Intervention via the internet or workbook for 12 weeks. Changes in objectively measured sedentary time and moderate-to vigorous physical activity (MVPA) as well as self-reported screen time were compared between groups. There were no significant differences between groups in screen time, sedentary time, or MVPA at the end of the 12 week intervention. Families receiving the intervention via the internet were more likely to remain in the study (98% vs. 82%, P = .016). Using the internet to deliver the lifestyle intervention did not increase sedentary behavior in children. Attrition rates were lower when the program was delivered by internet versus via printed materials. These results provide support for using the internet to deliver healthy lifestyle programs for children.

  7. 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

  8. 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.

  9. 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

  10. Beneficial effects of a high-protein, low-glycemic-load hypocaloric diet in overweight and obese women with polycystic ovary syndrome: a randomized controlled intervention study.

    PubMed

    Mehrabani, Homeira Hamayeli; Salehpour, Saghar; Amiri, Zohreh; Farahani, Sara Jalali; Meyer, Barbara J; Tahbaz, Farideh

    2012-04-01

    The recommended composition of a hypocaloric diet for obese women with polycystic ovary syndrome (PCOS) is unclear. The aim of this study was to investigate the effects of a high-protein, low-glycemic-load diet compared with a conventional hypocaloric diet on reproductive hormones, inflammatory markers, lipids, glucose, and insulin levels in obese women with PCOS. A total of 60 overweight and obese women with PCOS who did not use insulin-sensitizing agents were recruited and randomly assigned to 1 of the 2 hypocaloric diet groups for a single-blind clinical trial. The groups included a conventional hypocaloric diet (CHCD) (15% of daily energy from protein) and a modified hypocaloric diet (MHCD) with a high-protein, low-glycemic load (30% of daily energy from protein plus low-glycemic-load foods selected from a list) that was prescribed via counseling visits weekly during 12 weeks of study. Anthropometric assessments and biochemical measurements including reproductive hormones, inflammatory factors, lipids, glucose, and insulin were performed on fasting blood samples at baseline and after 12 weeks of dietary intervention. Weight loss was significant and similar in the 2 groups. Mean of testosterone in the MHCD and CHCD groups decreased from 1.78 ± 0.32 to 1.31 ± 0.26 ng/ml and from 1.51 ± 0.12 to 1.15 ± 0.11 ng/ml, respectively (p < 0.001). Follicle sensitizing hormone (FSH), luteinizing hormone (LH), and blood lipids concentrations were not changed except low-density lipoprotein cholesterol (LDL-C) was reduced by 24.5% ± 12.3% (p < 0.001 for both) after 12 weeks of intervention. MHCD resulted in a significant reduction in insulin level, homeostatic model assessment for insulin resistance (HOMA), and high-sensitivity C- reactive protein (hsCRP) concentration (p < 0.001). In this study both hypocaloric diets significantly led to reduced body weight and androgen levels in these two groups of women with PCOS. The combination of high-protein and low

  11. 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.

  12. Factors Associated with High Use of a Workplace Web-Based Stress Management Program in a Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Hasson, H.; Brown, C.; Hasson, D.

    2010-01-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program…

  13. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    ERIC Educational Resources Information Center

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  14. Learning Historical Thinking with Oral History Interviews: A Cluster Randomized Controlled Intervention Study of Oral History Interviews in History Lessons

    ERIC Educational Resources Information Center

    Bertram, Christiane; Wagner, Wolfgang; Trautwein, Ulrich

    2017-01-01

    The present study examined the effectiveness of the oral history approach with respect to students' historical competence. A total of 35 ninth-grade classes (N = 900) in Germany were randomly assigned to one of four conditions--live, video, text, or a (nontreated) control group--in a pretest, posttest, and follow-up design. Comparing the three…

  15. Improving the Design of Science Intervention Studies: An Empirical Investigation of Design Parameters for Planning Group Randomized Trials

    ERIC Educational Resources Information Center

    Westine, Carl; Spybrook, Jessaca

    2013-01-01

    The capacity of the field to conduct power analyses for group randomized trials (GRTs) of educational interventions has improved over the past decade (Authors, 2009). However, a power analysis depends on estimates of design parameters. Hence it is critical to build the empirical base of design parameters for GRTs across a variety of outcomes and…

  16. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    ERIC Educational Resources Information Center

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  17. Factors Associated with High Use of a Workplace Web-Based Stress Management Program in a Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Hasson, H.; Brown, C.; Hasson, D.

    2010-01-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program…

  18. 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.

  19. 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

  20. 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.

  1. 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

  2. Changing friend selection in middle school: A social network analysis of a randomized intervention study designed to prevent adolescent problem behavior

    PubMed Central

    DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J.

    2015-01-01

    Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends five years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum—one level of the Family Check-up model—on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n=500) was randomly assigned to the intervention and the other half (n=498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within School 1, but not within Schools 2 or 3. The effects of friend selection in School 1 translated into reductions in observed deviancy training five years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance five years later. PMID:26377235

  3. Changing Friend Selection in Middle School: A Social Network Analysis of a Randomized Intervention Study Designed to Prevent Adolescent Problem Behavior.

    PubMed

    DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J

    2016-04-01

    Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school-based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends 5 years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum-one level of the Family Check-up model-on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n = 500) was randomly assigned to the intervention, and the other half (n = 498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within school 1 but not within schools 2 or 3. The effects of friend selection in school 1 translated into reductions in observed deviancy training 5 years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study, the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance 5 years later.

  4. Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early-onset sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study.

    PubMed

    Stocker, Martin; Hop, Wim C J; van Rossum, Annemarie M C

    2010-12-08

    Early diagnosis and treatment of the newborn infant with suspected sepsis are essential to prevent severe and life threatening complications. Diagnosis of neonatal sepsis is difficult because of the variable and nonspecific clinical presentation. Therefore, many newborns with nonspecific symptoms are started on antibiotic treatment before the presence of sepsis has been proven. With our recently published single-centre intervention study we were able to show that Procalcitonin determinations allowed to shorten the duration of antibiotic therapy in newborns with suspected early-onset sepsis. The study is designed as randomized controlled international multicenter intervention trial on the efficacy and safety of Procalcitonin guided treatment. Term and near-term infants (gestational age ≥ 34 0/7 weeks) with suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy will be included. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the likelihood of infection (infection unlikely, possible, probable or proven). In the Procalcitonin group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive Procalcitonin values are within the normal range. Co-primary outcome measures are the duration of antibiotic therapy (superiority aspect of the trial) and the proportion of infants with a recurrence of infection requiring additional courses of antibiotic therapy and/or death in the first month of life (safety of study intervention, non-inferiority aspect of the trial). The number of infants to be included equals 800 per arm. With these numbers the power of the study to demonstrate superiority for duration of antibiotic therapy as well as non-inferiority regarding safety, i.e. excluding a disadvantage difference larger than 2% for the experimental arm, will both be greater than 80%. Benefit of the study is a possible limitation of unnecessary

  5. The impact of reduced worktime on sleep and perceived stress - a group randomized intervention study using diary data.

    PubMed

    Schiller, Helena; Lekander, Mats; Rajaleid, Kristiina; Hellgren, Carina; Åkerstedt, Torbjörn; Barck-Holst, Peter; Kecklund, Göran

    2017-03-01

    Objective Insufficient time for recovery between workdays may cause fatigue and disturbed sleep. This study evaluated the impact of an intervention that reduced weekly working hours by 25% on sleep, sleepiness and perceived stress for employees within the public sector. Method Participating workplaces (N=33) were randomized into intervention and control groups. Participants (N=580, 76% women) worked full-time at baseline. The intervention group (N=354) reduced worktime to 75% with preserved salary during 18 months. Data were collected at baseline and after 9 and 18 months follow-up. Sleep quality, sleep duration, sleepiness, perceived stress,and worries and stress at bedtime were measured with diary during one week per data collection. Result A multilevel mixed model showed that compared with the control group, at the 18-month follow-up, the intervention group had improved sleep quality and sleep duration (+23 minutes) and displayed reduced levels of sleepiness, perceived stress, and worries and stress at bedtime on workdays (P<0.002). The same effects were shown for days off (P<0.006), except for sleep length. Effect sizes were small (Cohen's f2<0.08). Adding gender, age, having children living at home, and baseline values of sleep quality and worries and stress at bedtime as additional between-group factors did not influence the results. Conclusion A 25% reduction of weekly work hours with retained salary resulted in beneficial effects on sleep, sleepiness and perceived stress both on workdays and days off. These effects were maintained over an 18-month period. This randomized intervention thus indicates that reduced worktime may improve recovery and perceived stress.

  6. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    PubMed Central

    Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-01-01

    Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial

  7. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial.

    PubMed

    Schotanus-Dijkstra, Marijke; Drossaert, Constance Hc; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-08-20

    Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. The Netherlands Trial Register NTR4297; http

  8. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    PubMed

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd.

  9. A randomized intervention study to evaluate whether electronic messaging can increase human papillomavirus vaccine completion and knowledge among college students.

    PubMed

    Richman, Alice R; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J

    2016-01-01

    To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Students were randomly assigned to the intervention or control group. Intervention participants received the electronic intervention (text/e-mail appointment reminders and education messages) and controls received standard-of-care. Baseline/follow-up survey data were collected. Main outcome measures included vaccine completion and knowledge. HPV vaccine completion across groups were not significantly different for HPV dose 2 (53% vs 52%) and dose 3 (34% vs 32%). Mean knowledge score at follow-up for intervention group was significantly higher (p = .01) than at baseline. No significant differences in knowledge were found for the control group. The biggest predictor of HPV vaccine completion was female gender. The intervention increased knowledge but not vaccine completion. More research with catch-up age populations is needed.

  10. Factors associated with high use of a workplace web-based stress management program in a randomized controlled intervention study.

    PubMed

    Hasson, H; Brown, C; Hasson, D

    2010-08-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program including health screening tool, diary and information about stress was offered to the control group. Additional materials, i.e. interactive, cognitive-based and classical stress management exercises and a chat room, were offered to the intervention group. Baseline data regarding participants' demographics, health (self-ratings and biological measures), lifestyle, work-related factors and group membership were analyzed to study determinants of employees' participation in the program during a period of 12 months. Multiple logistic regression analysis was used and found intervention group membership, being a woman, having at most a secondary education, regular physical exercise habits and having positive expectations of the program were significant predictors of high use. The findings demonstrate that the interactivity of a web-based program is an important factor for determining participation in a web-based worksite stress management program. Implications for those developing and implementing future web-based health promotion activities are discussed.

  11. The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

    NASA Technical Reports Server (NTRS)

    Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

    2011-01-01

    Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

  12. Changes in circulating satiety hormones in obese children: a randomized controlled physical activity-based intervention study.

    PubMed

    Balagopal, Prabhakaran Babu; Gidding, Samuel S; Buckloh, Lisa M; Yarandi, Hossein N; Sylvester, James E; George, Donald E; Funanage, Vicky L

    2010-09-01

    The aims of this study are to examine in children: (i) obesity-related alterations in satiety factors such as leptin, ghrelin, and obestatin; (ii) the link between satiety factors and cardiometabolic risk factors; and (iii) the impact of a physical activity-based lifestyle intervention on the levels of these satiety factors in the obese. We studied a total of 21 adolescents (BMI percentile, 99.0 +/- 0.6 for 15 obese and 56.2 +/- 1.1 for 6 lean). The obese subjects underwent a 3-month randomized controlled physical activity-based lifestyle intervention. Leptin, soluble leptin receptor (sOB-R), ghrelin, and obestatin levels were determined as the primary outcome measures. Other markers of cardiometabolic disease such as inflammation and insulin resistance were also determined. Body composition was measured by dual-energy X-ray absorptiometry. The concentrations of ghrelin, obestatin, and sOB-R were significantly lower in the obese children compared to the lean controls, whereas that of leptin was higher (all P < 0.05). Although intervention led to a net increase in obestatin (P < 0.01) and no change in ghrelin levels, the balance between ghrelin and obestatin (ratio of ghrelin to obestatin, G/O) decreased (P < 0.02). Intervention reduced leptin and increased sOB-R (P < 0.01 for both). Significant associations between satiety factors and other cardiometabolic risk factors were also observed. Taken together, alterations in the levels of satiety factors are evident early in the clinical course of obesity, but physical activity-based lifestyle intervention either prevented their continued increase or normalized their levels. These beneficial effects appear to aid in the maintenance of body weight and reduction in cardiovascular risk.

  13. Does exercise intensity affect blood pressure and heart rate in obese adolescents? A 6-month multidisciplinary randomized intervention study.

    PubMed

    Farah, B Q; Ritti-Dias, R M; Balagopal, P B; Hill, J O; Prado, W L

    2014-04-01

    Aerobic exercise improves cardiovascular health in general, but whether the impact varies with exercise intensity is not clear. The aim of the current study was to compare the effects of a high-intensity aerobic exercise training (HIT) vs. a low-intensity aerobic exercise training (LIT) on blood pressure (BP), heart rate (HR) and heart rate variability (HRV) in obese adolescents. Forty-three (13-18 years) Tanner stage (III-IV) matched obese adolescents were studied in a randomized trial of either HIT (corresponding to the ventilatory threshold I; n = 20) or LIT (corresponding to 20% below the ventilatory threshold I; n = 23) programme for a period of 6 months. All participants also received a multidisciplinary therapy that included nutritional, psychological and clinical counselling. Both HIT and LIT sessions were isocaloric, with energy expenditure set at 350 kcal. BP, HR and HRV were measured along with markers of body adiposity and insulin resistance before and after the respective interventions. The participants in both groups had similar physical and clinical characteristics. After the 6-month intervention, systolic, diastolic and mean BP decreased (P < 0.05, for all) similarly in both groups, whereas waist circumference, HR and HRV showed beneficial changes only in the HIT group (P < 0.05). Aerobic exercise training set at a high intensity compared with the low intensity appears to have additional benefits on abdominal obesity and cardiovascular health in that it enhances the parasympathetic and autonomic modulation of the heart in obese adolescents. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

  14. 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) .

  15. Phonological and articulation treatment approaches in Portuguese children with speech and language impairments: a randomized controlled intervention study.

    PubMed

    Lousada, M; Jesus, Luis M T; Capelas, S; Margaça, C; Simões, D; Valente, A; Hall, A; Joffe, V L

    2013-01-01

    In Portugal, the routine clinical practice of speech and language therapists (SLTs) in treating children with all types of speech sound disorder (SSD) continues to be articulation therapy (AT). There is limited use of phonological therapy (PT) or phonological awareness training in Portugal. Additionally, at an international level there is a focus on collecting information on and differentiating between the effectiveness of PT and AT for children with different types of phonologically based SSD, as well as on the role of phonological awareness in remediating SSD. It is important to collect more evidence for the most effective and efficient type of intervention approach for different SSDs and for these data to be collected from diverse linguistic and cultural perspectives. To evaluate the effectiveness of a PT and AT approach for treatment of 14 Portuguese children, aged 4.0-6.7 years, with a phonologically based SSD. The children were randomly assigned to one of the two treatment approaches (seven children in each group). All children were treated by the same SLT, blind to the aims of the study, over three blocks of a total of 25 weekly sessions of intervention. Outcome measures of phonological ability (percentage of consonants correct (PCC), percentage occurrence of different phonological processes and phonetic inventory) were taken before and after intervention. A qualitative assessment of intervention effectiveness from the perspective of the parents of participants was included. Both treatments were effective in improving the participants' speech, with the children receiving PT showing a more significant improvement in PCC score than those receiving the AT. Children in the PT group also showed greater generalization to untreated words than those receiving AT. Parents reported both intervention approaches to be as effective in improving their children's speech. The PT (combination of expressive phonological tasks, phonological awareness, listening and

  16. Inhibition of sweet chemosensory receptors alters insulin responses during glucose ingestion in healthy adults: a randomized crossover interventional study.

    PubMed

    Karimian Azari, Elnaz; Smith, Kathleen R; Yi, Fanchao; Osborne, Timothy F; Bizzotto, Roberto; Mari, Andrea; Pratley, Richard E; Kyriazis, George A

    2017-04-01

    Background: Glucose is a natural ligand for sweet taste receptors (STRs) that are expressed on the tongue and in the gastrointestinal tract. Whether STRs directly contribute to the regulation of glucose homeostasis in response to glucose ingestion is unclear.Objective: We sought to determine the metabolic effects of the pharmacologic inhibition of STRs in response to an oral glucose load in healthy lean participants.Design: Ten healthy lean participants with a body mass index (in kg/m(2)) of 22.4 ± 0.8 were subjected to an oral-glucose-tolerance test (OGTT) on 4 separate days with the use of a randomized crossover design. Ten minutes before the 75-g OGTT, participants consumed a preload solution of either 300 parts per million (ppm) saccharin or water with or without the addition of 500 ppm lactisole, a human-specific inhibitor of STRs. When present, lactisole was included in both the preload and OGTT solutions. We assessed plasma responses of glucose, insulin, C-peptide, glucagon, glucagon-like peptides 1 and 2, gastric inhibitory peptide, acetaminophen, and 3-O-methylglucose. With the use of mathematical modeling, we estimated gastric emptying, glucose absorption, β-cell function, insulin sensitivity and clearance, and the portal insulin:glucagon ratio.Results: The addition of lactisole to the OGTT caused increases in the plasma responses of insulin (P = 0.012), C-peptide (P = 0.004), and the insulin secretory rate (P = 0.020) compared with the control OGTT. The addition of lactisole also caused a slight reduction in the insulin sensitivity index independent of prior saccharin consumption (P < 0.025). The ingestion of saccharin before the OGTT did not alter any of the measured variables but eliminated the effects of lactisole on the OGTT.Conclusion: The pharmacologic inhibition of STRs in the gastrointestinal tract alters insulin responses during an oral glucose challenge in lean healthy participants. This trial was registered at clinicaltrials.gov as NCT

  17. 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.

  18. Effect of individualized worksite exercise training on aerobic capacity and muscle strength among construction workers--a randomized controlled intervention study.

    PubMed

    Gram, Bibi; Holtermann, Andreas; Søgaard, Karen; Sjøgaard, Gisela

    2012-09-01

    The combination of high physical work demands and low physical capacity has been shown to increase the risk for cardiovascular disease and musculoskeletal disorders. The aim of this study was to assess the physical capacity of construction workers and evaluate the effect of individually tailored exercise programs on their physical fitness and muscular capacity. The study was a randomized controlled trial of male constructions workers allocated to either an exercise or control group. The intervention lasted 12 weeks, and the exercise group trained 3 x 20 minutes a week. The participants completed health checks before and after the intervention period. Data from the first health check were used to tailor the exercise in the interventions. At baseline, participants had maximal oxygen consumption (VO(2max)) of 2.9 [standard deviation (SD) 0.7] l/min and body mass index (BMI) of 28.3 (SD 4.7). Compared to representative data on employees in Denmark (N=78), this study population (N=67) had significantly lower relative aerobic capacity [difference in z-score -1.13 , standard error (SE) 0.1, P<0.001] and higher BMI [difference in z-score 1.10, SE 0.2, P<0.001] at baseline. With respect to the intervention, group x time analyses showed a significant difference in estimated change in VO(2max)of 0.4 l/min for the exercise group and 0.0 l/min for the control group (P<0.001). Body mass and other general health measures remained unchanged. Training for 20 minutes, 3 times a week significantly increased VO(2max)with a clinically relevant magnitude regarding risk of cardiometabolic disorders. This study demonstrates a good effectiveness for integrating short exercise bouts into organizational routines among constructions workers.

  19. De-Escalation Strategies in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (BC): Final Analysis of the West German Study Group Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early BC HER2- and Hormone Receptor-Positive Phase II Randomized Trial-Efficacy, Safety, and Predictive Markers for 12 Weeks of Neoadjuvant Trastuzumab Emtansine With or Without Endocrine Therapy (ET) Versus Trastuzumab Plus ET.

    PubMed

    Harbeck, Nadia; Gluz, Oleg; Christgen, Matthias; Kates, Ronald Ernest; Braun, Michael; Küemmel, Sherko; Schumacher, Claudia; Potenberg, Jochem; Kraemer, Stefan; Kleine-Tebbe, Anke; Augustin, Doris; Aktas, Bahriye; Forstbauer, Helmut; Tio, Joke; von Schumann, Raquel; Liedtke, Cornelia; Grischke, Eva-Maria; Schumacher, Johannes; Wuerstlein, Rachel; Kreipe, Hans Heinrich; Nitz, Ulrike Anneliese

    2017-09-10

    Purpose Human epidermal growth factor receptor 2 (HER2)-positive/hormone receptor (HR)-positive breast cancer is a distinct subgroup associated with lower chemotherapy sensitivity and slightly better outcome than HER2-positive/HR-negative disease. Little is known about the efficacy of the combination of endocrine therapy (ET) with trastuzumab or with the potent antibody-cytotoxic, anti-HER2 compound trastuzumab emtansine (T-DM1) with or without ET for this subgroup. The West German Study Group trial, ADAPT (Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer) compares pathologic complete response (pCR) rates of T-DM1 versus trastuzumab with ET in early HER2-positive/HR-positive breast cancer. Patients and Methods In this prospective, neoadjuvant, phase II trial, 375 patients with early breast cancer with HER2-positive and HR-positive status (n = 463 screened) were randomly assigned to 12 weeks of T-DM1 with or without ET or to trastuzumab with ET. The primary end point was pCR (ypT0/is/ypN0). Early response was assessed in 3-week post-therapeutic core biopsies (proliferation decrease ≥ 30% Ki-67 or cellularity response). Secondary end points included safety and predictive impact of early response on pCR. Adjuvant therapy followed national standards. Results Baseline characteristics were well balanced among the arms. More than 90% of patients completed the therapy per protocol. pCR was observed in 41.0% of patients treated with T-DM1, 41.5% of patients treated with T-DM1 and ET, and 15.1% with trastuzumab and ET ( P < .001). Early responders (67% of patients with assessable response) achieved pCR in 35.7% compared with 19.8% in nonresponders (odds ratio, 2.2; 95% CI, 1.24 to 4.19). T-DM1 was associated with a significantly higher prevalence of grade 1 to 2 toxicities, especially thrombocytopenia, nausea, and elevation of liver enzymes. Overall toxicity was low; seventeen

  20. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study.

    PubMed

    Maersk, Maria; Belza, Anita; Stødkilde-Jørgensen, Hans; Ringgaard, Steffen; Chabanova, Elizaveta; Thomsen, Henrik; Pedersen, Steen B; Astrup, Arne; Richelsen, Bjørn

    2012-02-01

    The consumption of sucrose-sweetened soft drinks (SSSDs) has been associated with obesity, the metabolic syndrome, and cardiovascular disorders in observational and short-term intervention studies. Too few long-term intervention studies in humans have examined the effects of soft drinks. We compared the effects of SSSDs with those of isocaloric milk and a noncaloric soft drink on changes in total fat mass and ectopic fat deposition (in liver and muscle tissue). Overweight subjects (n = 47) were randomly assigned to 4 different test drinks (1 L/d for 6 mo): SSSD (regular cola), isocaloric semiskim milk, aspartame-sweetened diet cola, and water. The amount of intrahepatic fat and intramyocellular fat was measured with (1)H-magnetic resonance spectroscopy. Other endpoints were fat mass, fat distribution (dual-energy X-ray absorptiometry and magnetic resonance imaging), and metabolic risk factors. The relative changes between baseline and the end of 6-mo intervention were significantly higher in the regular cola group than in the 3 other groups for liver fat (132-143%, sex-adjusted mean; P < 0.01), skeletal muscle fat (117-221%; P < 0.05), visceral fat (24-31%; P < 0.05), blood triglycerides (32%; P < 0.01), and total cholesterol (11%; P < 0.01). Total fat mass was not significantly different between the 4 beverage groups. Milk and diet cola reduced systolic blood pressure by 10-15% compared with regular cola (P < 0.05). Otherwise, diet cola had effects similar to those of water. Daily intake of SSSDs for 6 mo increases ectopic fat accumulation and lipids compared with milk, diet cola, and water. Thus, daily intake of SSSDs is likely to enhance the risk of cardiovascular and metabolic diseases. This trial is registered at clinicaltrials.gov as NCT00777647.

  1. Nutritional evaluation of rapeseed protein compared to soy protein for quality, plasma amino acids, and nitrogen balance--a randomized cross-over intervention study in humans.

    PubMed

    Fleddermann, Manja; Fechner, Anita; Rößler, Andrea; Bähr, Melanie; Pastor, Anja; Liebert, Frank; Jahreis, Gerhard

    2013-08-01

    Plant proteins such as rapeseed have received little attention for human nutrition due to their high level of antinutritive compounds. Today, newer technologies can eliminate such compounds. The present intervention study aimed to evaluate nutritional and physiological properties of two manufactured canola proteins with special focus on their bioavailability in humans. 28 healthy male subjects (ø 25 years) consumed 30.0 g protein (canola protein isolate--CPI, canola protein hydrolyzate--CPH or soy protein isolate--SPI) in a randomized, double-blind, cross-over study. Blood samples were regularly drawn over the 8-h postprandial period and a 24-h urine sample was collected. True digestibility of the canola proteins determined in a separate rat assay showed 93.3% for CPI and 97.3% for CPH. In humans, consumption of either 30.0 g canola protein or soy protein mixed in a drink led to significant increases in plasma amino acids after 62.3 and 83.6 min, respectively. While the CPH produced an earlier response compared to CPI and SPI, total amino acid response (AUC for 8 h) was comparable between all interventions. The nitrogen balance between the three proteins tested showed no statistical differences. High digestibility of rapeseed protein was found in rats. In humans, this is the first intervention study showing rapeseed protein (both isolate and hydrolyzate) as having a high nutritional quality and can be considered to be as efficient as soy protein for a postprandial amino acid response. This trial was registered at ClinicalTrials.gov Identifier: NCT01481584. Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  2. Effect of sugar-sweetened beverages on body weight in children: design and baseline characteristics of the Double-blind, Randomized INtervention study in Kids.

    PubMed

    de Ruyter, Janne Catharine; Olthof, Margreet Renate; Kuijper, Lothar David Jan; Katan, Martijn Bernard

    2012-01-01

    Intake of sugar-sweetened beverages is associated with overweight in observational studies. A possible explanation is that liquid sugars do not satiate and that their intake is not compensated by reduced caloric intake from other foods. However, evidence from intervention studies for this hypothesis is inconclusive because previous studies were not blinded. Hence results may have been influenced by expectations and behavioral cues rather than by physiological mechanisms. We designed the Double-blind, Randomized INtervention study in Kids (DRINK) to examine the effect on body weight of covertly replacing sugar-sweetened by sugar-free beverages. Children were only eligible if they habitually drank sugar-sweetened beverages. We recruited 642 healthy children (mean age 8.2, range 4.8-11.9). We designed, tested and produced custom-made beverages containing 10% sugar and sugar-free beverages with the same sweet taste and look. Children receive one 250 mL can of study beverage daily for 18 months. We perform body measurements at 0, 6, 12 and 18 months. The primary outcome is the z-score of BMI for age. The maximum predicted difference in this score between groups is 0.72, which corresponds with a difference in body weight of 2.3 kg. The double-blind design eliminates behavioral factors that affect body weight. If children gain less body fat when drinking sugar-free than when drinking sugar-sweetened beverages that would show that liquid sugar indeed bypasses biological satiation mechanisms. It would also suggest that a reduction in liquid sugars could decrease body fat more effectively than reduction of other calorie sources. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

    PubMed

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-09-10

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study.

    PubMed

    Bohl, Mette; Bjørnshave, Ann; Rasmussen, Kia V; Schioldan, Anne Grethe; Amer, Bashar; Larsen, Mette K; Dalsgaard, Trine K; Holst, Jens J; Herrmann, Annkatrin; O'Neill, Sadhbh; O'Driscoll, Lorraine; Afman, Lydia; Jensen, Erik; Christensen, Merete M; Gregersen, Søren; Hermansen, Kjeld

    2015-04-01

    Abdominal obesity and exaggerated postprandial lipemia are independent risk factors for cardiovascular disease (CVD) and mortality, and both are affected by dietary behavior. We investigated whether dietary supplementation with whey protein and medium-chain saturated fatty acids (MC-SFAs) improved postprandial lipid metabolism in humans with abdominal obesity. We conducted a 12-wk, randomized, double-blinded, diet intervention study. Sixty-three adults were randomly allocated to one of 4 diets in a 2 × 2 factorial design. Participants consumed 60 g milk protein (whey or casein) and 63 g milk fat (with high or low MC-SFA content) daily. Before and after the intervention, a high-fat meal test was performed. We measured changes from baseline in fasting and postprandial triacylglycerol, apolipoprotein B-48 (apoB-48; reflecting chylomicrons of intestinal origin), free fatty acids (FFAs), insulin, glucose, glucagon, glucagon-like peptide 1 (GLP-1), and gastric inhibitory polypeptide (GIP). Furthermore, changes in the expression of adipose tissue genes involved in lipid metabolism were investigated. Two-factor ANOVA was used to examine the difference between protein types and fatty acid compositions, as well as any interaction between the two. Fifty-two participants completed the study. We found that the postprandial apoB-48 response decreased significantly after whey compared with casein (P = 0.025) independently of fatty acid composition. Furthermore, supplementation with casein resulted in a significant increase in the postprandial GLP-1 response compared with whey (P = 0.003). We found no difference in postprandial triacylglycerol, FFA, insulin, glucose, glucagon, or GIP related to protein type or MC-SFA content. We observed no interaction between milk protein and milk fat on postprandial lipemia. We found that a whey protein supplement decreased the postprandial chylomicron response compared with casein in persons with abdominal obesity, thereby indicating a

  9. Short-term effects of lunch on children's executive cognitive functioning: The randomized crossover Cognition Intervention Study Dortmund PLUS (CogniDo PLUS).

    PubMed

    Schröder, Maike; Müller, Katrin; Falkenstein, Michael; Stehle, Peter; Kersting, Mathilde; Libuda, Lars

    2015-12-01

    Studies indicate that eating lunch impairs some aspects of adults' cognitive functioning. However, the short-term effects of lunch on children's executive functions (EF) have not been examined. The Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated (a) short-term effects of lunch on EF in children and (b) whether the postprandial cortisol increase mediates putative lunch effects on EF performance. 5th and 6th grade students of a comprehensive school in Gelsenkirchen (Germany) participated in the randomized crossover intervention study. On Day 1 of the study, Group 1 did not eat lunch,whereas Group 2 received lunch ad libitum. One week later on Day 2 the groups were treated vice versa. At the beginning of the afternoon lessons, the EF parameters task switching,working memory updating and inhibition were tested using a computerized test battery. Saliva samples were used to measure cortisol directly before lunch and again at the beginning of the cognitive assessment. Of the 215 initially recruited children 21 dropped out of the study due to illness or absence on one of the two test days. Lower ratios of false alarms in the working memory updating function were observed when children who ate lunch than for children who had no lunch (8.2% (lunch) versus 9.4% (no lunch), p b 0.01). Parameters of task switching and inhibition did not differ between children who ate lunch compared to children who had no lunch. Stratification according to postprandial cortisol increase showed that the subgroup with a high increase had lower ratios of false alarms after eating lunch, while false alarm values did not change in the group with a low increase. In contrast to findings in adults, the results indicate that children's EF are not impaired by lunch under true-to-life conditions. On the contrary, the current study even indicates beneficial effects of lunch intake for the working memory updating. The postprandial cortisol increase in the range observed in our sample

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia.

    PubMed

    Peters, Ruth M H; Dadun; Zweekhorst, Marjolein B M; Bunders, Joske F G; Irwanto; van Brakel, Wim H

    2015-01-01

    Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a 'contact intervention'. This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called 'contact events'. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p < 0.001, effect size = 0.75) compared to the score at baseline (n = 213); for the SDS this was 3.56 (p < 0.001, effect size = 0.81). About 75% of those attending a contact event said they shared the information with others (median 10 persons). The contact intervention was effective in increasing knowledge and improving public attitudes regarding leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to reduce stigma against other neglected tropical diseases and conditions

  17. Details of development of the resource for adults with asthma in the RAISIN (randomized trial of an asthma internet self-management intervention) study.

    PubMed

    Morrison, Deborah; Mair, Frances S; Chaudhuri, Rekha; McGee-Lennon, Marilyn; Thomas, Mike; Thomson, Neil C; Yardley, Lucy; Wyke, Sally

    2015-07-28

    Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called 'Living well with Asthma', as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study. We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development. The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and

  18. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia

    PubMed Central

    Peters, Ruth M. H.; Dadun; Zweekhorst, Marjolein B. M.; Bunders, Joske F. G.; Irwanto; van Brakel, Wim H.

    2015-01-01

    Background Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’. Methods/Principal Findings This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called ‘contact events’. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p <0.001, effect size = 0.75) compared to the score at baseline (n = 213); for the SDS this was 3.56 (p <0.001, effect size = 0.81). About 75% of those attending a contact event said they shared the information with others (median 10 persons). Conclusions/Significance The contact intervention was effective in increasing knowledge and improving public attitudes regarding leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to

  19. Randomized intervention study of solar disinfection of drinking water in the prevention of dysentery in Kenyan children aged under 5 years.

    PubMed

    du Preez, Martella; Conroy, Ronan M; Ligondo, Sophie; Hennessy, James; Elmore-Meegan, Michael; Soita, Allan; McGuigan, Kevin G

    2011-11-01

    We report the results of a randomized controlled intervention study (September 2007 to March 2009) investigating the effect of solar disinfection (SODIS) of drinking water on the incidence of dysentery, nondysentery diarrhea, and anthropometric measurements of height and weight among children of age 6 months to 5 years living in peri-urban and rural communities in Nakuru, Kenya. We compared 555 children in 404 households using SODIS with 534 children in 361 households with no intervention. Dysentery was recorded using a pictorial diary. Incidence rate ratios (IRR) for both number of days and episodes of dysentery and nondysentery diarrhea were significantly (P < 0.001) reduced by use of solar disinfection: dysentery days IRR = 0.56 (95% CI 0.40 to 0.79); dysentery episodes IRR = 0.55 (95% CI 0.42 to 0.73); nondysentery days IRR = 0.70 (95% CI 0.59 to 0.84); nondysentery episodes IRR = 0.73 (95% CI 0.63 to 0.84). Anthropometry measurements of weight and height showed median height-for-age was significantly increased in those on SODIS, corresponding to an average of 0.8 cm over a 1-year period over the group as a whole (95% CI 0.7 to 1.6 cm, P = 0.031). Median weight-for-age was higher in those on SODIS, corresponding to a 0.23 kg difference in weight over the same period; however, the confidence interval spanned zero and the effect fell short of statistical significance (95% CI -0.02 to 0.47 kg, P = 0.068). SODIS and control households did not differ in the microbial quality of their untreated household water over the follow-up period (P = 0.119), but E. coli concentrations in SODIS bottles were significantly lower than those in storage containers over all follow-up visits (P < 0.001). This is the first trial to show evidence of the effect of SODIS on childhood anthropometry, compared with children in the control group and should alleviate concerns expressed by some commentators that the lower rates of dysentery associated with SODIS are the product of biased

  20. 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.

  1. 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.

  2. 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…

  3. 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…

  4. 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…

  5. 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…

  6. 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.

  7. 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…

  8. 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…

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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

  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. 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

  4. 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

  5. Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study protocol for a randomized controlled trial.

    PubMed

    Guo, Ming; Zi, Ming-Jie; Xi, Rui-Xi; Yang, Qiao-Ning; Bai, Rui-Na; Zhang, Yi-Sheng; Wang, Yu-Hua; Wang, Pei-Li; Shi, Da-Zhuo

    2016-08-18

    The risk of cardiovascular events remains high in patients with coronary heart disease (CHD) after successful percutaneous coronary intervention (PCI). Panax quinquefolius saponin, a major component of Xinyue capsule, has been used to treat patients with CHD. The aim of this study is to evaluate the efficacy and safety of Xinyue capsules in patients with CHD after PCI. This study is a multicenter, placebo-controlled, double-blind, randomized controlled clinical trial. A total of 1100 participants are randomly allocated to two groups: the intervention group and a placebo group. The intervention group receives Xinyue capsules plus conventional treatment, and the placebo group receives placebo capsules plus conventional treatment. The patients receive either Xinyue or placebo capsules three times daily (1.8 g/day) for up to 24 weeks. The primary outcome measure is the time from randomization to the first occurrence of major adverse cardiovascular events. The secondary outcome measure is the time from randomization to the first occurrence of stroke, pulmonary embolism, and peripheral vascular events, as well as death due to any cause. All outcome measures will be assessed at 12, 24, 36, and 48 weeks after randomization. Adverse events will be monitored during the trial. The aim of this study is to evaluate the effects of Xinyue capsules on patients with CHD after interventional treatment. The results of this trial will provide critical evidence regarding Chinese herbal medicine treatment for CHD. Chinese Clinical Trials Registry identifier ChiCTR-IPR-14005475. Registered on 10 November 2014.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. A randomized trial to assess effectiveness and cost in clinical practice: rationale and design of the Cholesterol Reduction Intervention Study (CRIS).

    PubMed

    Oster, G; Borok, G M; Menzin, J; Heys, J F; Epstein, R S; Quinn, V; Benson, V V; Dudl, R J; Epstein, A

    1995-02-01

    To compare the effectiveness and costs of two alternative approaches to the treatment of hypercholesterolemia, a prospective randomized trial is being undertaken at Southern California Kaiser Permanente, a large health maintenance organization. Six hundred and twelve patients with postdiet LDL cholesterol (LDL-C) levels in the range of 190-230 mg/dl (or 160-230 mg/dl for those with coronary heart disease or two or more coronary risk factors) were randomized to a stepped-care regimen (initial treatment with niacin followed by other agents if needed) or to initial use of lovastatin, an HMG-CoA reductase inhibitor. All patients are being followed for 1 year. The study seeks to approximate conditions of typical clinical practice: provider compliance with these plans of treatment is encouraged but not enforced and patients pay for medication as they customarily would. Principal outcomes of interest include the proportion of participants who achieve goal LDL-C at one year, the mean change in total cholesterol and LDL-C levels between baseline and the end of follow-up, and the costs of cholesterol-lowering therapy.

  13. 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.

  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. [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.

  16. Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

    PubMed

    Carney, Patricia A; Tucker, Erin K; Newby, Timothy A; Beer, Tomasz M

    2014-03-01

    This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at week 3 and 95.5% in the Late Group at week 6). Within group pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p = 0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials.

  17. The influence of ventilation strategies and anesthetic techniques on regional cerebral oximetry in the beach chair position: a prospective interventional study with a randomized comparison of two anesthetics

    PubMed Central

    Picton, Paul; Dering, Andrew; Alexander, Amir; Neff, Mary; Miller, Bruce S.; Shanks, Amy; Housey, Michelle; Mashour, George A.

    2015-01-01

    Background Beach chair positioning during general anesthesia is associated with cerebral oxygen desaturation. Changes in cerebral oxygenation resulting from the interaction of inspired oxygen fraction, end-tidal carbon dioxide and anesthetic choice have not been fully evaluated in anesthetized patients in the beach chair position. Methods This was a prospective interventional within-group study of patients undergoing shoulder surgery in the beach chair position that incorporated a randomized comparison between two anesthetics. Fifty-six patients were randomized to receive desflurane or total intravenous anesthesia with propofol. Following induction of anesthesia and positioning, inspired oxygen fraction (Fio2) and minute ventilation were sequentially adjusted for all patients. Regional cerebral oxygenation (rSO2) was the primary outcome and was recorded at each of five set points. Results While maintaining Fio2 at 0.3 and end tidal carbon dioxide (PETCO2) at 30mmHg there was a decrease in rSO2 from 68%, SD 12 to 61%, SD 12 (p<0.001) following beach chair positioning. The combined interventions of increasing Fio2 to 1.0 and increasing Petco2 to 45mmHg resulted in a 14% point improvement in rSO2 to 75%, SD 12 (p <0.001) for patients anesthetized in the beach chair position. There was no significant interaction effect of the anesthetic at the study intervention points. Conclusions Increasing Fio2 and Petco2 resulted in a significant increase in rSO2 that overcomes desaturation in patients anesthetized in the beach chair position and that appears independent of anesthetic choice. PMID:26244887

  18. Influence of Ventilation Strategies and Anesthetic Techniques on Regional Cerebral Oximetry in the Beach Chair Position: A Prospective Interventional Study with a Randomized Comparison of Two Anesthetics.

    PubMed

    Picton, Paul; Dering, Andrew; Alexander, Amir; Neff, Mary; Miller, Bruce S; Shanks, Amy; Housey, Michelle; Mashour, George A

    2015-10-01

    Beach chair positioning during general anesthesia is associated with cerebral oxygen desaturation. Changes in cerebral oxygenation resulting from the interaction of inspired oxygen fraction (FIO2), end-tidal carbon dioxide (PETCO2), and anesthetic choice have not been fully evaluated in anesthetized patients in the beach chair position. This is a prospective interventional within-group study of patients undergoing shoulder surgery in the beach chair position that incorporated a randomized comparison between two anesthetics. Fifty-six patients were randomized to receive desflurane or total intravenous anesthesia with propofol. Following induction of anesthesia and positioning, FIO2 and minute ventilation were sequentially adjusted for all patients. Regional cerebral oxygenation (rSO2) was the primary outcome and was recorded at each of five set points. While maintaining FIO2 at 0.3 and PETCO2 at 30 mmHg, there was a decrease in rSO2 from 68% (SD, 12) to 61% (SD, 12) (P < 0.001) following beach chair positioning. The combined interventions of increasing FIO2 to 1.0 and increasing PETCO2 to 45 mmHg resulted in a 14% point improvement in rSO2 to 75% (SD, 12) (P <0.001) for patients anesthetized in the beach chair position. There was no significant interaction effect of the anesthetic at the study intervention points. Increasing FIO2 and PETCO2 resulted in a significant increase in rSO2 that overcomes desaturation in patients anesthetized in the beach chair position and that appears independent of anesthetic choice.

  19. Feasibility, Acceptability and Findings from a Pilot Randomized Controlled Intervention Study on the Impact of a Book Designed to Inform Patients about Cancer Clinical Trials

    PubMed Central

    Carney, Patricia A.; Tucker, Erin K.; Newby, Timothy A.; Beer, Tomasz M.

    2014-01-01

    Objective To assess the feasibility, acceptability and changes in knowledge among cancer patients assigned to receive a 160 page book on experimental cancer therapies and clinical trials. Methods We enrolled 20 patients with cancer who had never participated in a clinical trial, and randomly assigned them to receive the book either during Week 1or Week 4 of the study. We collected baseline patient demographic and cancer related information as well as knowledge about cancer clinical trials at Week 0. Follow-up surveys were administered at Weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book Early (at Week 1) to those who received it Later (at Week 4). Results One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by Week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at Week 3 and 95.5% in the Late Group at Week 6). Within group pair-wise comparisons found significant difference between baseline and Week 6 in content-specific knowledge scores among participants in the Late Group (79% vs. 92.1%, p=0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Conclusions Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials. PMID:24127249

  20. Reducing antibiotic prescriptions for acute cough by motivating GPs to change their attitudes to communication and empowering patients: a cluster-randomized intervention study.

    PubMed

    Altiner, Attila; Brockmann, Silke; Sielk, Martin; Wilm, Stefan; Wegscheider, Karl; Abholz, Heinz-Harald

    2007-09-01

    Assessing the efficacy of an educational intervention that aimed to reduce unnecessary antibiotic prescriptions in primary care by motivating GPs to change their attitudes to communication and by empowering patients. One hundred and four GPs in North-Rhine/Westphalia-Lippe, Germany were cluster-randomized into intervention and control. GPs randomized to receive the intervention were visited by peers. The intervention strategy was focused on the communication within the encounter, not on sharing knowledge about antibiotic prescribing. Leaflets and posters were provided that aimed at patient empowerment, thus enabling patients to raise the topic of antibiotic prescriptions themselves. Eighty-six GPs (83%) remained in the study at 6 weeks and 61 GPs (59%) at 12 months. Antibiotic prescription rates within the control group were 54.7% at baseline and 36.4% within the intervention group at baseline. Generalized estimating equation models were applied. Baseline imbalances and confounding variables were controlled by adjustment. After the intervention, the ORs for the prescription of an antibiotic dropped to 0.58 [95% CI: (0.43;0.78), P < 0.001] after 6 weeks and were 0.72 [95% CI: (0.54;0.97), P = 0.028] after 12 months in the intervention group. In the control group, the ORs rose to 1.52 [95% CI: (1.19;1.95), P = 0.001] after 6 weeks and were 1.31 [95% CI: (1.01;1.71), P = 0.044] after 12 months; these ORs correspond to an approximately 60% relative reduction in antibiotic prescription rates at 6 weeks and a persistent 40% relative reduction at 12 months. An interventional strategy that focused on doctor-patient communication and patient empowerment is an effective concept to reduce antibiotic prescriptions in primary care.

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. Cognitive computer training in children with attention deficit hyperactivity disorder (ADHD) versus no intervention: study protocol for a randomized controlled trial.

    PubMed

    Bikic, Aida; Leckman, James F; Lindschou, Jane; Christensen, Torben Ø; Dalsgaard, Søren

    2015-10-24

    Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by symptoms of inattention and impulsivity and/or hyperactivity and a range of cognitive dysfunctions. Pharmacological treatment may be beneficial; however, many affected individuals continue to have difficulties with cognitive functions despite medical treatment, and up to 30 % do not respond to pharmacological treatment. Inadequate medical compliance and the long-term effects of treatment make it necessary to explore nonpharmacological and supplementary treatments for ADHD. Treatment of cognitive dysfunctions may prove particularly important because of the impact of these dysfunctions on the ability to cope with everyday life. Lately, several trials have shown promising results for cognitive computer training, often referred to as cognitive training, which focuses on particular parts of cognition, mostly on the working memory or attention but with poor generalization of training on other cognitive functions and functional outcome. Children with ADHD have a variety of cognitive dysfunctions, and it is important that cognitive training target multiple cognitive functions. This multicenter randomized clinical superiority trial aims to investigate the effect of "ACTIVATE™," a computer program designed to improve a range of cognitive skills and ADHD symptoms. A total of 122 children with ADHD, aged 6 to 13 years, will be randomized to an intervention or a control group. The intervention group will be asked to use ACTIVATE™ at home 40 minutes per day, 6 days per week for 8 weeks. Both intervention and control group will receive treatment as usual. Outcome measures will assess cognitive functions, symptoms, and behavioral and functional measures before and after the 8 weeks of training and in a 12- and 24-week follow-up. Results of this trial will provide useful information on the effectiveness of computer training focusing on several cognitive functions. Cognitive

  8. Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study.

    PubMed

    Ruzek, Josef I; Rosen, Raymond C; Marceau, Lisa; Larson, Mary Jo; Garvert, Donn W; Smith, Lauren; Stoddard, Anne

    2012-05-14

    This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems.

  9. Does work-site physical activity improve self-reported psychosocial workplace factors and job satisfaction? A randomized controlled intervention study.

    PubMed

    Roessler, K K; Rugulies, R; Bilberg, R; Andersen, L L; Zebis, M K; Sjøgaard, G

    2013-11-01

    To investigate whether a work-site strength-training program has a positive effect on self-reported psychosocial workplace factors and job satisfaction. We conducted a randomized controlled trial among laboratory technicians implementing neck and shoulder exercises for pain relief, with 199 participants in the training group and 228 in the control group. Influence at work, sense of community, time pressure, and job satisfaction were measured with the Copenhagen Psychosocial Questionnaire at baseline and post-intervention after 20 weeks. There was no statistically significant change in any of the four variables in the training group from baseline to follow-up (all p ≥ 0.39). When we used MANOVA to test for between-group effects over time, we did not find any statistically significant result (all p > 0.14). This study does not provide evidence for an effect of a work-site strength-training program on self-reported psychosocial workplace factors and job satisfaction.

  10. Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

    PubMed Central

    2012-01-01

    This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

  11. Effect of drinking on adiponectin in healthy men and women: a randomized intervention study of water, ethanol, red wine, and beer with or without alcohol.

    PubMed

    Imhof, Armin; Plamper, Ines; Maier, Steffen; Trischler, Gerlinde; Koenig, Wolfgang

    2009-06-01

    Moderate alcohol consumption is associated with reduced incidence of type 2 diabetes and cardiovascular mortality and increases adiponectin concentrations, but effects might differ according to sex and beverage consumed. A total of 72 healthy individuals (22-56 years) were enrolled in this randomized controlled crossover trial. After washout, two interventions for 3 weeks followed: ethanol (concentration 12.5%), beer (5.6%), or red wine (12.5%) equivalent to 30 g ethanol/day for men and 20 g/day for women or the same de-alcoholized beverages or water. Adiponectin was measured by sandwich enzyme-linked immunosorbent assay. Among women, adiponectin significantly increased after consuming red wine (29.8%, P < 0.05) and increased among men after ethanol solution (17.4%, P < 0.05) and consuming beer (16.1%, P < 0.05). De-alcoholized beverages had no substantial effect on adiponectin concentrations. Moderate amounts of ethanol-containing beverages increased adiponectin concentrations, but sex-specific effects might depend on type of beverage consumed.

  12. Facilitators and barriers influencing the readiness to receive dental implants in a geriatric institutionalised population-A randomized non-invasive interventional study.

    PubMed

    Merz, Miriam A; Terheyden, Hendrik; Huber, Christian G; Seixas, Azizi A; Schoetzau, Andreas; Schneeberger, Andres R

    2017-09-01

    Although elderly people have many serious dental issues and are in need of prosthesis, few opt for dental implants. The aim of this study was to investigate barriers that prevent elderly people from receiving dental implants. Specifically, we examined (i) whether the message was delivered before or after the interview had an impact, and (ii) whether it did matter who delivered the message. Sixty-six residents from seven residential homes in the Canton of Grisons, Switzerland were included. The sample was randomized to a treatment group that received comprehensive education about dental implants before the interview and a control group that received education after completing the questionnaire. The sample consisted of 54 women (81.8%) and 12 males (18.2%) with an average age of 86.2 years. Education before the interview did not show any impact on the attitude towards dental implants. Main reasons for a negative attitude towards implants were old age and high costs. Participants who received information about implants from their relatives and their own dentist and not from the study dentist were significantly more willing to receive implants. Providing an adequate education about benefits and risks of receiving dental implants does not change the attitude towards dental implants. The source of information/messenger does influence attitudes towards implants. If the person delivering the education and information is a relative or a known medical person, the person's attitude is more likely to change as compared to people receiving the information from an unrelated person. © 2017 John Wiley & Sons A/S and The Gerodontology Association. Published by John Wiley & Sons Ltd.

  13. Intake and time dependence of blueberry flavonoid-induced improvements in vascular function: a randomized, controlled, double-blind, crossover intervention study with mechanistic insights into biological activity.

    PubMed

    Rodriguez-Mateos, Ana; Rendeiro, Catarina; Bergillos-Meca, Triana; Tabatabaee, Setareh; George, Trevor W; Heiss, Christian; Spencer, Jeremy Pe

    2013-11-01

    There are very limited data regarding the effects of blueberry flavonoid intake on vascular function in healthy humans. We investigated the impact of blueberry flavonoid intake on endothelial function in healthy men and assessed potential mechanisms of action by the assessment of circulating metabolites and neutrophil NADPH oxidase activity. Two randomized, controlled, double-blind, crossover human-intervention trials were conducted with 21 healthy men. Initially, the impact of blueberry flavonoid intake on flow-mediated dilation (FMD) and polyphenol absorption and metabolism was assessed at baseline and 1, 2, 4, and 6 h after consumption of blueberry containing 766, 1278, and 1791 mg total blueberry polyphenols or a macronutrient- and micronutrient-matched control drink (0 mg total blueberry polyphenols). Second, an intake-dependence study was conducted (from baseline to 1 h) with 319, 637, 766, 1278, and 1791 mg total blueberry polyphenols and a control. We observed a biphasic time-dependent increase in FMD, with significant increases at 1-2 and 6 h after consumption of blueberry polyphenols. No significant intake-dependence was observed between 766 and 1791 mg. However, at 1 h after consumption, FMD increased dose dependently to ≤766 mg total blueberry polyphenol intake, after which FMD plateaued. Increases in FMD were closely linked to increases in circulating metabolites and by decreases in neutrophil NADPH oxidase activity at 1-2 and 6 h. Blueberry intake acutely improves vascular function in healthy men in a time- and intake-dependent manner. These benefits may be mechanistically linked to the actions of circulating phenolic metabolites on neutrophil NADPH oxidase activity. This trial was registered at clinicaltrials.gov as NCT01292954 and NCT01829542.

  14. Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861

    PubMed Central

    Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

    2005-01-01

    Background The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. Methods A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23–64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. Results After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor α (TNFα) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. Conclusion The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today. PMID:16042796

  15. Psychophysiological effects of a web-based stress management system: a prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861].

    PubMed

    Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

    2005-07-25

    The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor alpha (TNFalpha) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

  16. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Trial registration Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 PMID:24135085

  17. 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.

  18. Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: A three-year, prospective, randomized, clinical-based, Mediterranean lifestyle interventional study with parallel groups.

    PubMed

    Pérez-Ferre, Natalia; Del Valle, Laura; Torrejón, Maria José; Barca, Idoya; Calvo, María Isabel; Matía, Pilar; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2015-08-01

    Women with prior gestational diabetes mellitus (GDM) have a high risk of developing type 2 diabetes mellitus (DM2) in later life. The study aim was to evaluate the efficacy of a lifestyle intervention for the prevention of glucose disorders (impaired fasting glucose, impaired glucose tolerance or DM2) in women with prior GDM. A total of 260 women with prior GDM who presented with normal fasting plasma glucose at six to twelve weeks postpartum were randomized into two groups: a Mediterranean lifestyle intervention group (n = 130) who underwent an educational program on nutrition and a monitored physical activity program and a control group (n = 130) with a conventional follow-up. A total of 237 women completed the three-year follow-up (126 in the intervention group and 111 in the control group). Their glucose disorders rates, clinical and metabolic changes and rates of adherence to the Mediterranean lifestyle were analyzed. Less women in the intervention group (42.8%) developed glucose disorders at the end of the three-year follow-up period compared with the control group (56.75%), p < 0.05. The multivariate analysis indicated a reduction in the rate of glucose disorders with a BMI of less than 27 kg/m(2) (OR 0.28; 0.12-0.65; p < 0.003), low fat intake pattern (OR 0.30; 0.13-0.70; p < 0.005), low saturated fat pattern (OR 0.30; 0.13-0.69; p < 0.005) and healthy fat pattern (OR 0.34; 0.12-0.94; p < 0.04). Lifestyle intervention was effective for the prevention of glucose disorders in women with prior GDM. Body weight gain and an unhealthy fat intake pattern were found to be the most predictive factors for the development of glucose disorders. Current Controlled trials: ISRCTN24165302. http://www.controlled-trials.com/isrctn/pf/24165302. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  19. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points– a randomized intervention study

    PubMed Central

    2012-01-01

    Background In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study explored muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes. Methods Seventy-seven female office workers (25-46yrs) with and without neck/shoulder pain were observed with respect to self-reported pain (NRS-101), pressure-pain threshold (PPT), maximum voluntary contraction (Fmax) and rate of force development (RFD) at baseline (pre-intervention), immediately post-intervention and 48 hours post-intervention. Symptomatic and asymptomatic participant groups were each randomized into two treatment sub-groups (superficial (SDN) and deep dry needling (DDN)) after baseline testing. At 48 hours post-intervention participants were asked whether delayed onset muscle soreness (DOMS) and/or post-needling soreness had developed. Results Muscle contractile characteristics did not differ between groups at baseline. Forty-six individuals developed muscle soreness (39 from mechanical testing and seven from needling). No inter-group differences were observed post-intervention for Fmax or RFD for the four sub-groups. Over the observation period, symptomatic participants reported less pain from both SDN (p= 0.003) and DDN (p=0.011). However, PPT levels were reduced for all participants (p=0.029). Those reporting DOMS experienced significant decreases in PPT, irrespective of symptom state or intervention (p=0.001). Conclusions In selected female neck/shoulder pain sufferers, maximum voluntary contraction and rapid force generation of the upper Trapezius was not influenced by clinically relevant self-reported pain or the presence of diagnostically relevant MFTrPs. Dry needling, deep or superficial, did not affect measured functional outcomes over the 48-hour observation period. DOMS affected participants uniformly irrespective of pain, MFTrP status or intervention

  20. Increased masticatory activity and quality of life in elderly persons with dementia-a longitudinal matched cluster randomized single-blind multicenter intervention study

    PubMed Central

    2013-01-01

    Background Worldwide, millions of people are suffering from dementia and this number is rising. An index of quality of life (QoL) can describe the impact a disease or treatment has on a person’s wellbeing. QoL comprises many variables, including physical health and function, and mental health and function. QoL is related to masticatory ability and physical activity. Animal studies show that disruption of mastication due to loss of teeth or a soft diet leads to memory loss and learning problems. Since these are common complaints in dementia, it is hypothesized that improvement of masticatory function and normalization of diet consistency can increase QoL in elderly persons suffering from dementia. Therefore, the goal of the present study is to examine whether an increase in masticatory activity, achieved by increased food consistency and enhancement of masticatory function through improved oral health care has a positive effect on QoL, including cognition, mood, activities of daily living (ADL), and circadian rhythm in elderly persons with dementia. Methods and design The described study is a prospective longitudinal matched cluster randomized single-blind multicenter study. Participants are elderly persons living in the Netherlands, suffering from dementia and receiving psychogeriatric care. An intervention group will receive improved oral health care and a diet of increased consistency. A control group receives care as usual. Participants will be assessed four times; outcome variables besides QoL are cognition, mood, independence, rest-activity rhythm, blood pressure, and masticatory function. Discussion This research protocol investigates the effect of an intervention executed by daily caregivers. The intervention will increase masticatory activity, which is achieved by three different actions, (providing oral health care, increasing food consistency, or a combination of both). There is a certain amount of variety in the nature of the interventions due to local

  1. 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.

  2. 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.

  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. 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.

  7. [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.

  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. 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

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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

  2. 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.

  3. Early management of type 2 diabetes based on a SMBG strategy: the way to diabetes regression--the St Carlos study : a 3-year, prospective, randomized, clinic-based, interventional study with parallel groups.

    PubMed

    García de la Torre, Nuria; Durán, Alejandra; Del Valle, Laura; Fuentes, Manuel; Barca, Idoya; Martín, Patricia; Montañez, Carmen; Perez-Ferre, Natalia; Abad, Rosario; Sanz, Fuencisla; Galindo, Mercedes; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2013-08-01

    The aims are to define the regression rate in newly diagnosed type 2 diabetes after lifestyle intervention and pharmacological therapy based on a SMBG (self-monitoring of blood glucose) strategy in routine practice as compared to standard HbA1c-based treatment and to assess whether a supervised exercise program has additional effects. St Carlos study is a 3-year, prospective, randomized, clinic-based, interventional study with three parallel groups. Hundred and ninety-five patients were randomized to the SMBG intervention group [I group; n = 130; Ia: SMBG (n = 65) and Ib: SMBG + supervised exercise (n = 65)] and to the HbA1c control group (C group) (n = 65). The primary outcome was to estimate the regression rate of type 2 diabetes (HbA1c <6 % on metformin treatment). After 3 years of follow-up, diabetes regression was achieved by 56 patients, 6 (9.2 %) from the C group, 21 (32.3 %) from the Ia group and 29 (44.6 %) from the Ib group. RR (95 % CI) for diabetes regression in the intervention group (Ia + Ib) was 4.5 (2.1-9); p < 0.001 and remained after stratification by gender, age and BMI. This difference was associated with healthier changes in lifestyle and greater weight loss. RR for a weight loss >4 kg was 3.6 (1.8-7); p < 0.001. This study shows that the use of SMBG in an educational program effectively increases the regression rate in newly diagnosed type 2 diabetic patients after 3 years of follow-up. These data suggest that SMBG-based programs should be extended to primary care settings where diabetic patients are usually attended.

  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. Counteracting Age-related Loss of Skeletal Muscle Mass: a clinical and ethnological trial on the role of protein supplementation and training load (CALM Intervention Study): study protocol for a randomized controlled trial.

    PubMed

    Bechshøft, Rasmus Leidesdorff; Reitelseder, Søren; Højfeldt, Grith; Castro-Mejía, Josué Leonardo; Khakimov, Bekzod; Ahmad, Hajar Fauzan Bin; Kjær, Michael; Engelsen, Søren Balling; Johansen, Susanne Margrete Bølling; Rasmussen, Morten Arendt; Lassen, Aske Juul; Jensen, Tenna; Beyer, Nina; Serena, Anja; Perez-Cueto, Frederico Jose Armando; Nielsen, Dennis Sandris; Jespersen, Astrid Pernille; Holm, Lars

    2016-08-09

    Aging is associated with decreased muscle mass and functional capacity, which in turn decrease quality of life. The number of citizens over the age of 65 years in the Western world will increase by 50 % over the next four decades, and this demographic shift brings forth new challenges at both societal and individual levels. Only a few longitudinal studies have been reported, but whey protein supplementation seems to improve muscle mass and function, and its combination with heavy strength training appears even more effective. However, heavy resistance training may reduce adherence to training, thereby attenuating the overall benefits of training. We hypothesize that light load resistance training is more efficient when both adherence and physical improvement are considered longitudinally. We launched the interdisciplinary project on Counteracting Age-related Loss of Skeletal Muscle Mass (CALM) to investigate the impact of lifestyle changes on physical and functional outcomes as well as everyday practices and habits in a qualitative context. We will randomize 205 participants older than 65 years to be given 1 year of two daily nutrient supplements with 10 g of sucrose and 20 g of either collagen protein, carbohydrates, or whey. Further, two groups will perform either heavy progressive resistance training or light load training on top of the whey supplement. The primary outcome of the CALM Intervention Study is the change in thigh cross-sectional area. Moreover, we will evaluate changes in physical performance, muscle fiber type and acute anabolic response to whey protein ingestion, sensory adaptation, gut microbiome, and a range of other measures, combined with questionnaires on life quality and qualitative interviews with selected subjects. The CALM Intervention Study will generate scientific evidence and recommendations to counteract age-related loss of skeletal muscle mass in elderly individuals. ClinicalTrials.gov NCT02034760 . Registered on 10 January 2014

  6. Multi-component access to a community-based weight loss program: 12 week results

    USDA-ARS?s Scientific Manuscript database

    The current study examined weight loss between a comprehensive lifestyle modification program (Weight Watchers PointsPlus program) that included three ways to access and a self-help (SH) condition. A total of 293 participants were randomized to either a Weight Watchers condition (WW) (n=148) or a SH...

  7. 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…

  8. 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…

  9. 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.

  10. 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…

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. Efficacy of Neonatal HBV Vaccination on Liver Cancer and Other Liver Diseases over 30-Year Follow-up of the Qidong Hepatitis B Intervention Study: A Cluster Randomized Controlled Trial

    PubMed Central

    Fan, Chunsun; Zhan, Qimin; Wang, Yuting; Lu, Jianhua; Lu, Ling-ling; Ni, Zhengping; Huang, Fei; Yao, Hongyu; Zhu, Jian; Fan, Jian; Zhu, Yuanrong; Wu, Zhiyuan; Liu, Guoting; Gao, Wenhong; Zang, Mengya; Wang, Dongmei; Dai, Min; Hsia, Chu Chieh; Zhang, Yawei; Sun, Zongtang

    2014-01-01

    Background Neonatal hepatitis B vaccination has been implemented worldwide to prevent hepatitis B virus (HBV) infections. Its long-term protective efficacy on primary liver cancer (PLC) and other liver diseases has not been fully examined. Methods and Findings The Qidong Hepatitis B Intervention Study, a population-based, cluster randomized, controlled trial between 1985 and 1990 in Qidong, China, included 39,292 newborns who were randomly assigned to the vaccination group in which 38,366 participants completed the HBV vaccination series and 34,441 newborns who were randomly assigned to the control group in which the participants received neither a vaccine nor a placebo. However, 23,368 (67.8%) participants in the control group received catch-up vaccination at age 10–14 years. By December 2013, a total of 3,895 (10.2%) in the vaccination group and 3,898 (11.3%) in the control group were lost to follow-up. Information on PLC incidence and liver disease mortality were collected through linkage of all remaining cohort members to a well-established population-based tumor registry until December 31, 2013. Two cross-sectional surveys on HBV surface antigen (HBsAg) seroprevalence were conducted in 1996–2000 and 2008–2012. The participation rates of the two surveys were 57.5% (21,770) and 50.7% (17,204) in the vaccination group and 36.3% (12,184) and 58.6% (17,395) in the control group, respectively. Using intention-to-treat analysis, we found that the incidence rate of PLC and the mortality rates of severe end-stage liver diseases and infant fulminant hepatitis were significantly lower in the vaccination group than the control group with efficacies of 84% (95% CI 23%–97%), 70% (95% CI 15%–89%), and 69% (95% CI 34%–85%), respectively. The estimated efficacy of catch-up vaccination on HBsAg seroprevalence in early adulthood was 21% (95% CI 10%–30%), substantially weaker than that of the neonatal vaccination (72%, 95% CI 68%–75%). Receiving a booster at age

  1. Efficacy of neonatal HBV vaccination on liver cancer and other liver diseases over 30-year follow-up of the Qidong hepatitis B intervention study: a cluster randomized controlled trial.

    PubMed

    Qu, Chunfeng; Chen, Taoyang; Fan, Chunsun; Zhan, Qimin; Wang, Yuting; Lu, Jianhua; Lu, Ling-ling; Ni, Zhengping; Huang, Fei; Yao, Hongyu; Zhu, Jian; Fan, Jian; Zhu, Yuanrong; Wu, Zhiyuan; Liu, Guoting; Gao, Wenhong; Zang, Mengya; Wang, Dongmei; Dai, Min; Hsia, Chu Chieh; Zhang, Yawei; Sun, Zongtang

    2014-12-01

    Neonatal hepatitis B vaccination has been implemented worldwide to prevent hepatitis B virus (HBV) infections. Its long-term protective efficacy on primary liver cancer (PLC) and other liver diseases has not been fully examined. The Qidong Hepatitis B Intervention Study, a population-based, cluster randomized, controlled trial between 1985 and 1990 in Qidong, China, included 39,292 newborns who were randomly assigned to the vaccination group in which 38,366 participants completed the HBV vaccination series and 34,441 newborns who were randomly assigned to the control group in which the participants received neither a vaccine nor a placebo. However, 23,368 (67.8%) participants in the control group received catch-up vaccination at age 10-14 years. By December 2013, a total of 3,895 (10.2%) in the vaccination group and 3,898 (11.3%) in the control group were lost to follow-up. Information on PLC incidence and liver disease mortality were collected through linkage of all remaining cohort members to a well-established population-based tumor registry until December 31, 2013. Two cross-sectional surveys on HBV surface antigen (HBsAg) seroprevalence were conducted in 1996-2000 and 2008-2012. The participation rates of the two surveys were 57.5% (21,770) and 50.7% (17,204) in the vaccination group and 36.3% (12,184) and 58.6% (17,395) in the control group, respectively. Using intention-to-treat analysis, we found that the incidence rate of PLC and the mortality rates of severe end-stage liver diseases and infant fulminant hepatitis were significantly lower in the vaccination group than the control group with efficacies of 84% (95% CI 23%-97%), 70% (95% CI 15%-89%), and 69% (95% CI 34%-85%), respectively. The estimated efficacy of catch-up vaccination on HBsAg seroprevalence in early adulthood was 21% (95% CI 10%-30%), substantially weaker than that of the neonatal vaccination (72%, 95% CI 68%-75%). Receiving a booster at age 10-14 years decreased HBsAg seroprevalence if

  2. 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.

  3. [Efficiency of novel splash-proof ventilator circuit component on VAP and the colonization of multiple-drug resistant bacteria prevention in patients undergoing mechanical ventilation: a prospective randomized controlled intervention study with 318 patients].

    PubMed

    Xu, Songao; Yu, Huijie; Sun, Hui; Zhu, Xiangyun; Xu, Xiaoqin; Xu, Jun; Cao, Weizhong

    2017-01-01

    To investigate the efficiency of closed tracheal suction system (CTSS) using novel splash-proof ventilator circuit component on ventilator-associated pneumonia (VAP) and the colonization of multiple-drug resistant bacteria (MDR) in patients undergoing mechanical ventilation (MV) prevention. A prospective single-blinded randomized parallel controlled intervention study was conducted. 330 severe patients admitted to the intensive care unit (ICU) of the First Hospital of Jiaxing from January 2014 to May 2016 were enrolled, and they were divided into open tracheal suction group, closed tracheal suction group, and splash-proof suction group on average by random number table. The patients in the three groups used conventional ventilator circuit component, conventional CTSS, and CTSS with a novel splash-proof ventilator circuit component for MV and sputum suction, respectively. The incidence of VAP, airway bacterial colonization rate, MDR and fungi colonization rate, duration of MV, length of ICU and hospitalization stay, and financial expenditure during hospitalization, as well as the in-hospital prognosis were recorded. After excluding patients who did not meet the inclusion criteria, incomplete data, backed out and so on, 318 patients were enrolled in the analysis finally. Compared with the open tracheal suction group, the total incidence of VAP was decreased in the closed tracheal suction group and splash-proof suction group [20.95% (22/105), 21.90% (23/105) vs. 29.63% (32/108)], but no statistical difference was found (both P > 0.05), and the incidence of VAP infections/1 000 MV days showed the same change tendency (cases: 14.56, 17.35 vs. 23.07). The rate of airway bacterial colonization and the rate of MDR colonization in the open tracheal suction group and splash-proof suction group were remarkably lower than those of closed tracheal suction group [32.41% (35/108), 28.57% (30/105) vs. 46.67% (49/105), 20.37% (22/108), 15.24% (16/105) vs. 39.05% (41/105)] with

  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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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…

  15. 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…

  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. 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.

  20. 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…

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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.

  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. [Improving health care practices and organization: methodology for intervention studies].

    PubMed

    Zaugg, Vincent; Savoldelli, Virginie; Sabatier, Brigitte; Durieux, Pierre

    2014-01-01

    Interventions designed to improve professional practices and healthcare organization are regularly implemented in all health systems. Their effectiveness on quality of care should be properly evaluated prior to their widespread implementation. Intervention studies can be conducted for this purpose according to a rigorous methodology in order to provide results with a good level of evidence. This article describes the main phases of an intervention study, including definition of the intervention, choice of study design, outcomes assessment, and writing of the report. It also addresses methodological issues of intervention studies designed to improve quality of care, such as cluster-randomization or the use of quasi-experimental designs. One of the specific features of these studies is that professionals are the targets, while patients are the beneficiaries of the intervention. A good knowledge of the specific features of studies designed to improve quality of care is essential to conduct research, or to evaluate the quality of the evidence from published studies.

  12. Pulsed low-intensity ultrasound therapy for chronic lateral epicondylitis: a randomized controlled trial.

    PubMed

    D'Vaz, A P; Ostor, A J K; Speed, C A; Jenner, J R; Bradley, M; Prevost, A T; Hazleman, B L

    2006-05-01

    Pulsed low-intensity ultrasound therapy (LIUS) has been found to be beneficial in accelerating fracture healing and has produced positive results in animal tendon repair. In the light of this we undertook a randomized, double-blind, placebo controlled trial to assess the effectiveness of LIUS vs placebo therapy daily for 12 weeks in patients with chronic lateral epicondylitis (LE). Patients with LE of at least 6 weeks' duration were recruited from general practice, physiotherapy and rheumatology clinics, and had to have failed at least one first-line treatment including non steroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injection. Participants were assigned either active LIUS or placebo. Treatment was self-administered daily for 20 min over a 12-week period. The primary end-point was a 50% improvement from baseline in elbow pain measured at 12 weeks using a patient-completed visual analogue scale. Fifty-five subjects aged 18-80 were recruited over a 9-month period. In the active group 64% (16/25) achieved at least 50% improvement from baseline in elbow pain at 12 weeks compared with 57% (13/23) in the placebo group (difference of 7%; 95% confidence interval -20 to 35%). However, this was not statistically significant (chi(2) = 0.28, P = 0.60). In this study LIUS was no more effective for a large treatment effect than placebo for recalcitrant LE. This is in keeping with other interventional studies for the condition.

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. Quality assurance in non-interventional studies.

    PubMed

    Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

    2009-11-09

    Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres - in between 2% and 5% of the centres depending on the number of participating centres. Before start of

  10. 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.

  11. Consumption of cranberry polyphenols enhances human γδ-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study

    PubMed Central

    2013-01-01

    Background Our main objective was to evaluate the ability of cranberry phytochemicals to modify immunity, specifically γδ-T cell proliferation, after daily consumption of a cranberry beverage, and its effect on health outcomes related to cold and influenza symptoms. Methods The study was a randomized, double-blind, placebo-controlled, parallel intervention. Subjects drank a low calorie cranberry beverage (450 ml) made with a juice-derived, powdered cranberry fraction (n = 22) or a placebo beverage (n = 23), daily, for 10 wk. PBMC were cultured for six days with autologous serum and PHA-L stimulation. Cold and influenza symptoms were self-reported. Results The proliferation index of γδ-T cells in culture was almost five times higher after 10 wk of cranberry beverage consumption (p <0.001). In the cranberry beverage group, the incidence of illness was not reduced, however significantly fewer symptoms of illness were reported (p = 0.031). Conclusions Consumption of the cranberry beverage modified the ex vivo proliferation of γδ-T cells. As these cells are located in the epithelium and serve as a first line of defense, improving their function may be related to reducing the number of symptoms associated with a cold and flu. Trial registration ClinicalTrials.gov Identifier: NCT01398150. PMID:24330619

  12. Impact of Maternal Education about Complementary Feeding on Their Infants' Nutritional Outcomes in Low- and Middle-income Households: A Community-based Randomized Interventional Study in Karachi, Pakistan

    PubMed Central

    Saleem, Ali Faisal; Mahmud, Sadia; Baig-Ansari, Naila

    2014-01-01

    ABSTRACT This cluster-randomized interventional trial at peri-urban settings of Karachi was conducted to evaluate the impact of maternal educational messages regarding appropriate complementary feeding (CF) on the nutritional status of their infants after 30 weeks of educational interventions delivered by trained community health workers. Mothers in the intervention group received three education modules about breastfeeding (BF) and appropriate CF at a baseline visit and two subsequent visits 10 weeks apart. The control group received advice about BF according to national guidelines. Infants' growth [weight, length, and mid-upper arm-circumference (MUAC), stunting, wasting, and underweight] were measured at four time points. At the end of the study, infants in the intervention group had a higher mean weight of 350 g (p=0.001); length of 0.66 cm (p=0.001), and MUAC of 0.46 cm (p=0.002) compared to the controls; proportionate reduction of stunting and underweight were 10% (84% vs 74%; ORadj 8.36 (5.6-12.42) and 5% (25% vs 20%; ORadj 0.75 (0.4-1.79) in the intervention compared to the control group. For relatively food-secure populations, educational interventions about appropriate CF to mothers had a direct positive impact on linear growth of their infants. PMID:25895196

  13. Impact of maternal education about complementary feeding on their infants' nutritional outcomes in low- and middle-income households: a community-based randomized interventional study in Karachi, Pakistan.

    PubMed

    Saleem, Ali Faisal; Mahmud, Sadia; Baig-Ansari, Naila; Zaidi, Anita K M

    2014-12-01

    This cluster-randomized interventional trial at periurban settings of Karachi was conducted to evaluate the impact of maternal educational messages regarding appropriate complementary feeding (CF) on the nutritional status of their infants after 30 weeks of educational interventions delivered by trained community health workers. Mothers in the intervention group received three education modules about breastfeeding (BF) and appropriate CF at a baseline visit and two subsequent visits 10 weeks apart. The control group received advice about BF according to national guidelines. Infants' growth [weight, length, and mid-upper arm-circumference (MUAC), stunting, wasting, and underweight] were measured at four time points. At the end of the study, infants in the intervention group had a higher mean weight of 350 g (p=0.001); length of 0.66 cm (p=0.001), and MUAC of 0.46 cm (p=0.002) compared to the controls; proportionate reduction of stunting and underweight were 10% (84% vs. 74%; OR(adj) 8.36 (5.6-12.42) and 5% (25% vs. 20%; OR(adj) 0.75 (0.4-1.79) in the intervention compared to the control group. For relatively food-secure populations, educational interventions about appropriate CF to mothers had a direct positive impact on linear growth of their infants.

  14. Design and implementation of Pharyngeal electrical Stimulation for early de-cannulation in TRACheotomized (PHAST-TRAC) stroke patients with neurogenic dysphagia: a prospective randomized single-blinded interventional study.

    PubMed

    Dziewas, Rainer; Mistry, Satish; Hamdy, Shaheen; Minnerup, Jens; Van Der Tweel, Ingeborg; Schäbitz, Wolf; Bath, Philip M

    2017-06-01

    Rationale Ongoing dysphagia in stroke patients weaned from mechanical ventilation often requires long-term tracheotomy to protect the airway from aspiration. In a recently reported single-centre pilot study, a significantly larger proportion (75%) of tracheotomized dysphagic stroke patients regained sufficient control of airway management allowing tracheotomy tube removal (decannulation) 24-72 h after pharyngeal electrical stimulation (PES) compared to controls who received standard therapy over the same time period (20%). Aim To assess the safety and efficacy of PES in accelerating dysphagia rehabilitation and enabling decannulation of tracheotomized stroke patients. Design International multi-centre prospective randomized controlled single-blind trial in approximately 126 ICU patients (the 90th percentile of the calculated maximum sample size). Study outcomes Primary outcome: proportion of stroke patients considered safe for decannulation 24-72 h after PES compared to control patients who do not receive PES. Key secondary outcomes focus on: dysphagia severity, decannulation rates, decannulation rate after a repeat PES treatment in patients persistently dysphagic after an initial PES treatment, stroke severity, duration of ICU-stay, occurrence of adverse events including pneumonia and need for recannulation over 30 days or until hospital discharge (if earlier). Discussion Dysphagia and related airway complications are reported as one of the main reasons for stroke patients remaining tracheotomized once successfully weaned from ventilation. This study will evaluate if PES can improve airway safety sufficiently enough to allow earlier tracheotomy tube removal.

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. CHARITY: Chagas cardiomyopathy bisoprolol intervention study: a randomized double-blind placebo force-titration controlled study with Bisoprolol in patients with chronic heart failure secondary to Chagas cardiomyopathy [NCT00323973

    PubMed Central

    Quiros, Franklin R; Morillo, Carlos A; Casas, Juan P; Cubillos, Luz A; Silva, Federico A

    2006-01-01

    Background Chagas' disease is the major cause of disability secondary to tropical diseases in young adults from Latin America, and around 20 million people are currently infected by T. cruzi. Heart failure due to Chagas cardiomyopathy is the main clinical presenation in Colombia. Heart failure due to Chagas' disease may respond to digoxin, diuretics and vasodilator therapy. Beta-adrenoreceptor antagonism seems to protect against the increased risk of cardiac arrhythmia and sudden death due to chronic sympathetic stimulation. The aim of this study is to evaluate the effects of the selective beta-adrenergic receptor blocker Bisoprolol on cardiovascular mortality, hospital readmission due to progressive heart failure and functional status in patients with heart failure secondary to Chagas' cardiomyopathy. Methods/design A cohort of 500 T. cruzi seropositive patients (250 per arm) will be selected from several institutions in Colombia. During the pretreatment period an initial evaluation visit will be scheduled in which participants will sign consent forms and baseline measurements and tests will be conducted including blood pressure measurements, twelve-lead ECG and left ventricular ejection fraction assessment by 2D echocardiography. Quality of life questionnaire will be performed two weeks apart during baseline examination using the "Minnesota living with heart failure" questionnaire. A minimum of two 6 minutes corridor walk test once a week over a two-week period will be performed to measure functional class. During the treatment period patients will be randomly assigned to receive Bisoprolol or placebo, initially taking a total daily dose of 2.5 mgrs qd. The dose will be increased every two weeks to 5, 7.5 and 10 mgrs qd (maximum maintenance dose). Follow-up assessment will include clinical check-up, and blood collection for future measurements of inflammatory reactants and markers. Quality of life measurements will be obtained at six months. This study will allow

  1. Effects of supplementing n-3 fatty acid enriched eggs and walnuts on cardiovascular disease risk markers in healthy free-living lacto-ovo-vegetarians: a randomized, crossover, free-living intervention study.

    PubMed

    Burns-Whitmore, Bonny; Haddad, Ella; Sabaté, Joan; Rajaram, Sujatha

    2014-03-27

    Plant and marine n-3 fatty acids (FA) may favorably modify select markers of cardiovascular disease risk. Whether supplementing the habitual diet of lacto-ovo-vegetarians (LOV) with walnuts (containing α-linolenic acid, ALA) and n-3 FA enriched eggs (containing primarily docosahexaenoic acid, DHA and ALA) would have equivalent effects on CVD risk factors is explored in this study. In this study, 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements: n-3 FA enriched egg (6/week), walnuts (28.4 g, 6/week) or a standard egg, 6/week (control) for 8 weeks each with 4-wk washout between treatments. Erythrocyte membrane fatty acids, serum lipids and inflammatory markers were measured at the end of each treatment. Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment. Walnut treatment lowered serum triacylglycerol, total cholesterol and Apo B (p < 0.05) compared to the standard egg but not the n-3 FA enriched egg treatment. However, walnut treatment significantly reduced total: HDL cholesterol ratio compared to both egg treatments. There were no differences between treatments for any of the inflammatory markers. For LOV, a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA. However for producing an overall favorable blood lipid profile, daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian.

  2. Effects of Charitable Versus Monetary Incentives on the Acceptance of and Adherence to a Pedometer-Based Health Intervention: Study Protocol and Baseline Characteristics of a Cluster-Randomized Controlled Trial

    PubMed Central

    Kramer, Jan-Niklas; Kehr, Flavius; Wahle, Fabian; Elser, Niklas; Fleisch, Elgar

    2016-01-01

    Background Research has so far benefited from the use of pedometers in physical activity interventions. However, when public health institutions (eg, insurance companies) implement pedometer-based interventions in practice, people may refrain from participating due to privacy concerns. This might greatly limit the applicability of such interventions. Financial incentives have been successfully used to influence both health behavior and privacy concerns, and may thus have a beneficial effect on the acceptance of pedometer-based interventions. Objective This paper presents the design and baseline characteristics of a cluster-randomized controlled trial that seeks to examine the effect of financial incentives on the acceptance of and adherence to a pedometer-based physical activity intervention offered by a health insurance company. Methods More than 18,000 customers of a large Swiss health insurance company were allocated to a financial incentive, a charitable incentive, or a control group and invited to participate in a health prevention program. Participants used a pedometer to track their daily physical activity over the course of 6 months. A Web-based questionnaire was administered at the beginning and at the end of the intervention and additional data was provided by the insurance company. The primary outcome of the study will be the participation rate, secondary outcomes will be adherence to the prevention program, physical activity, and health status of the participants among others. Results Baseline characteristics indicate that residence of participants, baseline physical activity, and subjective health should be used as covariates in the statistical analysis of the secondary outcomes of the study. Conclusions This is the first study in western cultures testing the effectiveness of financial incentives with regard to a pedometer-based health intervention offered by a large health insurer to their customers. Given that the incentives prove to be effective

  3. Effects of supplementing n-3 fatty acid enriched eggs and walnuts on cardiovascular disease risk markers in healthy free-living lacto-ovo-vegetarians: a randomized, crossover, free-living intervention study

    PubMed Central

    2014-01-01

    Background Plant and marine n-3 fatty acids (FA) may favorably modify select markers of cardiovascular disease risk. Whether supplementing the habitual diet of lacto-ovo-vegetarians (LOV) with walnuts (containing α-linolenic acid, ALA) and n-3 FA enriched eggs (containing primarily docosahexaenoic acid, DHA and ALA) would have equivalent effects on CVD risk factors is explored in this study. Methods In this study, 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements: n-3 FA enriched egg (6/week), walnuts (28.4 g, 6/week) or a standard egg, 6/week (control) for 8 weeks each with 4-wk washout between treatments. Erythrocyte membrane fatty acids, serum lipids and inflammatory markers were measured at the end of each treatment. Results Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment. Walnut treatment lowered serum triacylglycerol, total cholesterol and Apo B (p < 0.05) compared to the standard egg but not the n-3 FA enriched egg treatment. However, walnut treatment significantly reduced total: HDL cholesterol ratio compared to both egg treatments. There were no differences between treatments for any of the inflammatory markers. Conclusions For LOV, a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA. However for producing an overall favorable blood lipid profile, daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian. PMID:24673793

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. A 12-week clinical study assessing the clinical effects on plaque metabolism of a dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride.

    PubMed

    Santarpia, R Peter; Lavender, Stacey; Gittins, Elizabeth; Vandeven, Mark; Cummins, Diane; Sullivan, Richard

    2014-04-01

    To evaluate the clinical effect on plaque metabolism of a dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride compared to a commercially available dentifrice containing 1,450 ppm fluoride in a silica base. A 12-week, parallel, randomized, double-blind study using 48 subjects was conducted at the Colgate-Palmolive Technology Center (Piscataway, NJ, USA). One group used a test dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride as sodium monofluorophosphate (MFP), and the other group used a commercial silica dentifrice with 1,450 ppm fluoride as sodium fluoride (NaF) as a control. Plaque metabolism analyses were conducted at baseline and after 2, 4, 6, 8, and 12 weeks of assigned product use. The plaque analyses included pH measurements before and after a sucrose rinse, ammonia production and lactic acid production. Subjects using the test dentifrice had significantly higher plaque pH values before (P< or = 0.01) and after (P< or = 0.045) a sucrose challenge than those using the commercially available control dentifrice. Subjects using the test dentifrice also produced higher levels of ammonia and lower levels of lactic acid compared to subjects using the control dentifrice.

  10. Differential therapeutic effects of 12-week treatment of atomoxetine and methylphenidate on drug-naïve children with attention deficit/hyperactivity disorder: A counting Stroop functional MRI study.

    PubMed

    Chou, Tai-Li; Chia, Seng; Shang, Chi-Yung; Gau, Susan Shur-Fen

    2015-12-01

    Methylphenidate and atomoxetine are effective in treating attention-deficit/hyperactivity disorder (ADHD) with underlying distinct pharmacological mechanisms. To relate neural mechanisms to clinical response, we conducted a comparative trial to differentiate the changes in brain activation of drug-naïve children with ADHD when performing neuropsychological tasks after 12 weeks of pharmacotherapy. We randomized 50 drug-naïve children with ADHD, aged 7-17, to treatment with methylphenidate (n=25) or atomoxetine (n=25). These children were scanned twice with functional magnetic resonance imaging (fMRI) during the counting Stroop task before and after treatment. Focused attention and impulsivity were assessed twice by using the Conner's Continuous Performance Test (CCPT). The final sample for fMRI analysis comprised 20 in the methylphenidate group and 22 in the atomoxetine group. Atomoxetine decreased activations in the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex, which correlated with improvement in focused attention assessed by the CCPT. In contrast, methylphenidate increased activations in the inferior frontal gyrus, which correlated with the decreasing severity of impulsivity assessed by the CCPT. The current findings suggest that differential therapeutic effects on neuronal changes induced by 12-week treatment atomoxetine and methylphenidate may contribute to behavioral improvement.

  11. Scaling-up an efficacious school-based physical activity intervention: Study protocol for the 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) cluster randomized controlled trial and scale-up implementation evaluation.

    PubMed

    Lonsdale, Chris; Sanders, Taren; Cohen, Kristen E; Parker, Philip; Noetel, Michael; Hartwig, Tim; Vasoncellos, Diego; Kirwan, Morwenna; Morgan, Philip; Salmon, Jo; Moodie, Marj; McKay, Heather; Bennie, Andrew; Plotnikoff, Ron; Cinelli, Renata L; Greene, David; Peralta, Louisa R; Cliff, Dylan P; Kolt, Gregory S; Gore, Jennifer M; Gao, Lan; Lubans, David R

    2016-08-24

    Despite the health benefits of regular physical activity, most children are insufficiently active. Schools are ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. The aim of this project is to modify, scale up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children's physical activity, fundamental movement skills and cardiorespiratory fitness. The 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) study will focus largely on online delivery to enhance translational capacity. The intervention will be implemented at school and teacher levels, and will include six components: (i) quality physical education and school sport, (ii) classroom movement breaks, (iii) physically active homework, (iv) active playgrounds, (v) community physical activity links and (vi) parent/caregiver engagement. Experienced physical education teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e., Kindergarten - Year 6). These activities will be supported by online learning and resources. Teachers will then deliver the iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools across New South Wales (NSW), Australia. A cluster randomized controlled trial (RCT), involving a representative sample of 20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions), will assess effectiveness and cost-effectiveness at 12 and 24 months. Students' cardiorespiratory fitness will be the primary outcome in this trial. Key secondary outcomes will include students' moderate-to-vigorous physical activity (via accelerometers), fundamental movement skill proficiency, enjoyment of physical education and

  12. Does school-based physical activity decrease overweight and obesity in children aged 6-9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic.

    PubMed

    Sigmund, Erik; El Ansari, Walid; Sigmundová, Dagmar

    2012-07-29

    Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of control children (p < 0

  13. Does school-based physical activity decrease overweight and obesity in children aged 6–9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic

    PubMed Central

    2012-01-01

    Background Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Methods Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. Results There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of

  14. 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.

  15. 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.

  16. 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

  17. Effects of 12 weeks of Nordic Walking and XCO Walking training on the endurance capacity of older adults.

    PubMed

    Morat, Tobias; Krueger, Jenny; Gaedtke, Angus; Preuss, Manuela; Latsch, Joachim; Predel, Hans-Georg

    2017-01-01

    Several studies have already examined the positive effects of various forms of endurance training in patient groups and in healthy adults up to 60 years old. The aim of this study was to analyse the effects of Nordic Walking (NW) and XCO Walking (XCO) training on endurance capacity in healthy older adults, aged 60 years and older. Twenty-three older participants (mean age: 69.9 ± 5.4 years) were randomly assigned to either the NW group or the XCO group. All participants were measured before and after the 12 weeks of endurance training (2 sessions/week) to examine oxygen uptake (VO2) and energy consumption during an outdoor field test. In addition, heart rates were recorded and lactate samples were collected. NW mainly demonstrated some significant (p < 0.05) decreases in heart rate, lactate concentration at lower to moderate walking speeds, whereas XCO Walking revealed significant (p < 0.05) decreases in lactate concentration and VO2 at low to higher walking speeds. NW as well as XCO training increase the efficiency of the cardio-vascular system in older subjects. Both training approaches are suitable options for endurance training, which may serve to counteract age- and inactivity-related decreases in cardio-vascular functioning as well as aid in maintaining overall performance in older adults.

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. Safety and efficacy of 12-week or longer indacaterol treatment in moderate-to-severe COPD patients: a systematic review.

    PubMed

    Jiang, Fa-Ming; Liang, Zong-An; Zheng, Qiao-Ling; Wang, Rong-Chun; Luo, Jian; Li, Chun-Tao

    2013-04-01

    This is a meta-analysis of the safety and efficacy of indacaterol in chronic obstructive pulmonary disease (COPD) with treatment duration of ≥12 weeks. Randomized controlled trials (RCTs) reported in English (to September 30, 2012) were identified from PubMed, the Cochrane Library, Embase, websites, reference lists, and manual searches. Two reviewers independently assessed the quality of the trials and extracted information. Five RCTs were eligible. Five involved indacaterol, two salmeterol, one formoterol, and one tiotropium. Four studies had placebos. Using trough forced expiratory volume in 1 s as a measure of therapeutic effect, indacaterol was superior to the other β2-agonists, tiotropium, and placebo at weeks 12, 26, and 52. Indacaterol had a greater effect on the transition dyspnoea index compared with placebo, formoterol, and salmeterol, but not open-label tiotropium. In reducing the as-needed use of salbutamol, indacaterol were superior to placebo, tiotropium, and formoterol, but not salmeterol (5, 95 % confidence interval (CI), -2.15, 12.15). Indacaterol improved St George's Respiratory Questionnaire scores more than placebo and open-label tiotropium, but not formoterol. Indacaterol seemed to cause more adverse events than placebo only at a dose of 600 μg daily and a duration of 52 weeks (risk ratio 1.15; 95 % CI, 1.04, 1.26). The total and serious adverse events and adverse events leading to discontinuation were comparable with open-label tiotropium and the β2-agonists. Indacaterol is effective and well-tolerated as a bronchodilator for the maintenance of moderate to severe COPD.

  6. Comparison of metabolic effects of aripiprazole, quetiapine and ziprasidone after 12 weeks of treatment in first treated episode of psychosis.

    PubMed

    Pérez-Iglesias, Rocio; Ortiz-Garcia de la Foz, Victor; Martínez García, Obdulia; Amado, Jose Antonio; Garcia-Unzueta, M Teresa; Ayesa-Arriola, Rosa; Suarez-Pinilla, Paula; Tabares-Seisdedos, Rafael; Crespo-Facorro, Benedicto

    2014-10-01

    This randomized open-label study compared the incidence of metabolic side effects of aripiprazole, ziprasidone and quetiapine in a population of medication-naïve first-episode psychosis patients. A total of 202 subjects were enrolled. Body weight, body mass index, leptin, fasting lipids and fasting glycaemic parameters were measured at baseline and at 3 months follow-up. A hundred and sixty-six patients completed the follow-up and were included in the analyses. A high proportion of patients experienced a significant weight increase (>7% of their baseline weight): 23% ziprasidone (n=12), 32% with quetiapine (n=16) and 45% with aripiprazole (n=31). Patients treated with aripiprazole gained significantly more weight than the patients in the ziprasidone group (1.2 kg [SD=4.1] versus 4.3 kg [SD=4.8], respectively). The increase in leptin levels was greater in women treated with aripiprazole than in those treated with ziprasidone (p=0.030). Mean prolactin levels significantly increased in patients treated with quetiapine and ziprasidone but not in those treated with aripiprazole. Patients treated with quetiapine and aripiprazole showed a significant increase in total cholesterol and LDL-cholesterol plasma levels. Quetiapine-treated patients resulted in a higher increase in LDL-cholesterol than patients treated with ziprasidone (p=0.021). No other significant differences between groups were found. No significant changes in glycaemic parameters were observed. Our results suggest that ziprasidone has a lower liability for inducing weight gain and lipid abnormalities than aripiprazole or quetiapine.

  7. Observational and interventional study design types; an overview

    PubMed Central

    Thiese, Matthew S.

    2014-01-01

    The appropriate choice in study design is essential for the successful execution of biomedical and public health research. There are many study designs to choose from within two broad categories of observational and interventional studies. Each design has its own strengths and weaknesses, and the need to understand these limitations is necessary to arrive at correct study conclusions. Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods. Observational study designs include ecological designs, cross sectional, case-control, case-crossover, retrospective and prospective cohorts. An important subset of observational studies is diagnostic study designs, which evaluate the accuracy of diagnostic procedures and tests as compared to other diagnostic measures. These include diagnostic accuracy designs, diagnostic cohort designs, and diagnostic randomized controlled trials. Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease. Each study design has specific outcome measures that rely on the type and quality of data utilized. Additionally, each study design has potential limitations that are more severe and need to be addressed in the design phase of the study. This manuscript is meant to provide an overview of study design types, strengths and weaknesses of common observational and interventional study designs. PMID:24969913

  8. 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

  9. 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.

  10. The role of preschool teacher-child interactions in academic adjustment: An intervention study with Playing-2-gether.

    PubMed

    Van Craeyevelt, Sanne; Verschueren, Karine; Vancraeyveldt, Caroline; Wouters, Sofie; Colpin, Hilde

    2017-09-01

    Social relationships can serve as important risk or protective factors for child development in general, and academic adjustment in particular. This study investigated the role of teacher-child interactions in academic adjustment among preschool boys at risk of externalizing behaviour, using a randomized controlled trial study with Playing-2-gether (P2G), a 12-week indicated two-component intervention aimed at improving the affective quality of the teacher-child relationship and teacher behaviour management. In a sample of 175 preschool boys showing signs of externalizing behaviour (Mage  = 4 years, 9 months, SDage  = 7 months) and their teachers, we investigated P2G effects on academic engagement as well as on language achievement. Academic engagement was rated by teachers at three occasions within one school year (T1 = pretest, T3 = post-test, and T2 = in-between intervention components). Language achievement was assessed by researchers at pre- and post-test, using a standardized test. Cross-lagged path analyses revealed a direct intervention effect of P2G on academic engagement at Time 2. In addition, a significant indirect intervention effect was found on academic engagement at Time 3 through academic engagement at Time 2. Finally, academic engagement at Time 2 was found to predict language achievement at post-test. A marginally significant indirect intervention effect was found on language achievement at Time 3, through academic engagement at Time 2. This intervention study suggests that teacher-child interactions predict academic engagement over time, which in turn improves language achievement among preschool boys at risk of externalizing behaviour. © 2017 The British Psychological Society.

  11. 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

  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

    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

  13. 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

  14. 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

  15. 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

  16. Consuming a hypocaloric high fat low carbohydrate diet for 12 weeks lowers C-reactive protein, and raises serum adiponectin and high density lipoprotein-cholesterol in obese subjects

    PubMed Central

    Ruth, Megan R.; Port, Ava M.; Shah, Mitali; Bourland, Ashley C.; Istfan, Nawfal W.; Nelson, Kerrie P.; Gokce, Noyan; Apovian, Caroline M.

    2013-01-01

    Objective High fat, low carbohydrate (HFLC) diets have become popular tools for weight management. We sought to determine the effects of a HFLC diet compared to a low fat high carbohydrate (LFHC) diet on the change in weight loss, cardiovascular risk factors and inflammation in subjects with obesity. Methods Obese subjects (29.0–44.6 kg/m2) recruited from Boston Medical Center were randomized to a hypocaloric LFHC (n=26) or HFLC (n=29) diet for 12 weeks. Results The age range of subjects was 21–62 years. As a percentage of daily calories, the HFLC group consumed 33.5% protein, 56.0% fat and 9.6% carbohydrate and the LFHC group consumed 22.0% protein, 25.0% fat and 55.7% carbohydrate. The change in percent body weight, lean and fat mass, blood pressure, flow mediated dilation, hip:waist ratio, hemoglobin A1C, fasting insulin and glucose, and glucose and insulin response to a 2 h oral glucose tolerance test did not differ (P>0.05) between diets after 12 weeks. The HFLC group had greater mean decreases in serum triglyceride (P=0.07), and hs-CRP (P=0.03), and greater mean increases in HDL cholesterol (P=0.004), and total adiponectin (P=0.045) relative to the LFHC. Secreted adipose tissue adiponectin or TNF-α did not differ after weight loss for either diet. Conclusions Relative to the LFHC group, the HFLC group had greater improvements in blood lipids and systemic inflammation with similar changes in body weight and composition. This small-scale study suggests that HFLC diets may be more beneficial to cardiovascular health and inflammation in free-living obese adults compared to LFHC diets. PMID:24075505

  17. 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

  18. 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

  19. 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

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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%).

  5. 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

  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. Cutoff Designs for Community-Based Intervention Studies

    PubMed Central

    Pennell, Michael L.; Hade, Erinn M.; Murray, David M.; Rhoda, Dale A.

    2011-01-01

    Summary Public health interventions are often designed to target communities defined either geographically (e.g., cities, counties) or socially (e.g., schools or workplaces). The group randomized trial (GRT) is regarded as the gold standard for evaluating these interventions. However, community leaders may object to randomization as some groups may be denied a potentially beneficial intervention. Under a regression discontinuity design (RDD), individuals may be assigned to treatment based on the levels of a pretest measure, thereby allowing those most in need of the treatment to receive it. In this article, we consider analysis, power, and sample size issues in applying the RDD and related cutoff designs in community-based intervention studies. We examine the power of these designs as a function of intraclass correlation, number of groups, and number of members per group and compare results to the traditional GRT. PMID:21500240

  9. 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…

  10. 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.

  11. 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

  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. 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. 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.

  16. 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.

  17. Efficacy and tolerability of indacaterol 75 μg once daily in patients aged ≥40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies.

    PubMed

    Kerwin, Edward M; Gotfried, Mark H; Lawrence, David; Lassen, Cheryl; Kramer, Benjamin

    2011-12-01

    Indacaterol is the first once-daily, long-acting, inhaled β(2)-agonist bronchodilator for maintenance treatment of chronic obstructive pulmonary disease (COPD). Two studies (previously reported in a Congress abstract) were performed in 2010 to provide efficacy and tolerability data to support the application for approval in the United States of indacaterol 75 μg once daily, a dose lower than that previously investigated in most studies. The primary objective was to evaluate the efficacy of indacaterol 75 μg once daily in terms of 24-hour post-dose ("trough") forced expiratory volume in the first second of respiration (FEV(1)) compared with placebo after 12 weeks of treatment. Patients with moderate to severe COPD were randomized to receive double-blind treatment with indacaterol 75 μg once daily (n = 163 and 159) or placebo (n = 160 and 159) for 12 weeks. In addition to trough FEV(1) after 12 weeks, rescue albuterol use, health status (St. George's Respiratory Questionnaire [SGRQ]), and tolerability were evaluated. Clinically relevant differences between active and placebo treatments were defined as ≥120 mL for trough FEV(1) and a decrease of ≥4 units in SGRQ total score. Of patients enrolled in the 2 studies, 54% were men, and 90% and 94% were white, with mean age 64 and 61 years. Mean duration of COPD was 7 years; smoking history was 52 pack-years; and 45% and 37% of patients were receiving inhaled corticosteroid therapy. At week 12, indacaterol demonstrated clinically relevant bronchodilator efficacy, increasing trough FEV(1) by ≥120 mL versus placebo (P < 0.001), with significant bronchodilation maintained at all time points from 5 minutes to 24 hours post-dose. Over 12 weeks, relative to placebo, in patients receiving indacaterol therapy, rescue albuterol use was reduced by 1.2 and 0.7 puffs per day (P < 0.01), and the percentage of rescue-free days was increased by 13.7 and 8.4 (P < 0.01). At week 12, the SGRQ total score differed in the indacaterol

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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 w