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Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study.

ABSTRACT: Lifestyle change is recommended as treatment for adults at risk for metabolic syndrome (MetS), although adoption of new behavioral patterns is limited. In addition, most existing lifestyle interventions do not address psychological stress or quality of life, both of which impact the burden of MetS. Yoga, a form of physical activity that incorporates psychological components (e.g., maintaining attention, relaxation), is a promising intervention for improving the burden of MetS. This randomized controlled trial assessed the feasibility and preliminary efficacy of a 12-week yoga program coupled with an evidence-based health education program (HED) compared to HED alone. A secondary, exploratory aim examined perceived stress, quality of life, and related psychological outcomes (mindfulness, perceived health competence, and mood). Sixty-seven adults at risk for MetS enrolled (mean age [SD]: 58 [10] years; 50% male; 79% non-Hispanic White). Preliminary results revealed significantly larger improvements in two quality of life domains (role-physical and general health perceptions) in the HED plus yoga group versus HED alone (ps < 0.05). This is the first study that implemented lifestyle education along with yoga to evaluate the potential unique effects of yoga on participants at risk for MetS. A larger clinical trial is warranted to further investigate these promising patient-reported outcomes.

SUBMITTER: Sohl SJ

PROVIDER: S-EPMC5101386 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study.

Sohl Stephanie J SJ Wallston Kenneth A KA Watkins Keiana K Birdee Gurjeet S GS

Evidence-based complementary and alternative medicine : eCAM 20161026

Lifestyle change is recommended as treatment for adults at risk for metabolic syndrome (MetS), although adoption of new behavioral patterns is limited. In addition, most existing lifestyle interventions do not address psychological stress or quality of life, both of which impact the burden of MetS. Yoga, a form of physical activity that incorporates psychological components (e.g., maintaining attention, relaxation), is a promising intervention for improving the burden of MetS. This randomized co ...[more]

PMID: 27847524

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Project description:BackgroundType 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity.MethodsThis was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat.ResultsThis study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight -0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference -4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI -0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study.ConclusionAmong Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being.Trial registrationClinicalTrials.gov Identified NCT00090506.

Project description:BackgroundConventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.MethodsInvestigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks.ResultsIn intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES.ConclusionIn adults with mild-to-moderate major depression, an 8-week hatha yoga intervention resulted in statistically and clinically significant reductions in depression severity.Trial registrationClinicalTrials.gov NCT01210651.

Project description:BACKGROUND:A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity. PATIENTS AND METHODS:Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform. RESULTS:One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P?=?0.983), in the overall number of AEs (P?=?0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P?=?0.009) and there was a tendency towards patients in the intervention group having more extra visits (P?=?0.156). CONCLUSION:It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded. TRIAL REGISTRATION:Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.

Project description:Chronic stimulation and dysregulation of the neuroendocrine system by stress may cause metabolic abnormalities. We estimated how much cortisol and psychosocial outcomes improved with a restorative yoga (relaxation) versus a low impact stretching intervention for individuals with the metabolic syndrome.We conducted a 1-year multi-center randomized controlled trial (6-month intervention and 6-month maintenance phase) of restorative yoga vs. stretching. Participants completed surveys to assess depression, social support, positive affect, and stress at baseline, 6 months and 12 months. For each assessment, we collected saliva at four points daily for three days and collected response to dexamethasone on the fourth day for analysis of diurnal cortisol dynamics. We analyzed our data using multivariate regression models, controlling for study site, medications (antidepressants, hormone therapy), body mass index, and baseline cortisol values.Psychosocial outcome measures were available for 171 study participants at baseline, 140 at 6 months, and 132 at 1 year. Complete cortisol data were available for 136 of 171 study participants (72 in restorative yoga and 64 in stretching) and were only available at baseline and 6 months. At 6 months, the stretching group had decreased cortisol at waking and bedtime compared to the restorative yoga group. The pattern of changes in stress mirrored this improvement, with the stretching group showing reductions in chronic stress severity and perseverative thoughts about their stress. Perceived stress decreased by 1.5 points (-0.4; 3.3, p=0.11) at 6 months, and by 2.0 points (0.1; 3.9, p=0.04) at 1 year in the stretching compared to restorative yoga groups. Post hoc analyses suggest that in the stretching group only, perceived increases in social support (particularly feelings of belonging), but not changes in stress were related to improved cortisol dynamics.We found significant decreases in salivary cortisol, chronic stress severity, and stress perception in the stretching group compared to the restorative yoga group. Group support during the interactive stretch classes may have contributed to these changes.

Dataset Information

Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study.

Publications

Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study.

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