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Background: Fibromyalgia is a common pain condition that often leads to significant disability. Unfortunately, the effectiveness of most medications for fibromyalgia is limited, and there is a need for alternative, non-pharmacological therapies. Yoga and aerobic exercise are both evidence-based non-pharmacological treatments for fibromyalgia. However, no prior studies have directly compared the effectiveness of yoga vs. exercise. Objective: This article describes the study design and recruitment outcomes of the Pain Outcomes comparing Yoga vs. Structured Exercise (POYSE) Trial, a two-arm randomized comparative effectiveness trial. Methods: Veterans with fibromyalgia, defined by the 2010 American College of Rheumatology diagnostic criteria, who also experienced at least moderate pain severity were enrolled. The participants were randomized to a 12-week yoga-based or a structured exercise program (SEP) and will undergo comprehensive outcome assessments at baseline, 1, 3, 6, and 9 months by interviewers blinded to treatment assignment. The primary outcome will be the overall severity of fibromyalgia as measured by the total Fibromyalgia Impact Questionnaire-Revised. Secondary outcomes included depression, anxiety, health-related quality of life, pain beliefs, fatigue, sleep, and self-efficacy. Results: A total of 2,671 recruitment letters were sent to potential participants with fibromyalgia. Of the potential participants, 623 (23.3%) were able to be contacted by telephone and had their eligibility assessed. Three hundred seventy-one of those interviewed were found to be eligible (59.6%) and 256 (69.0%) agreed to participate and were randomized to the YOGA (n = 129) or the SEP (n = 127) arm of the trial. Conclusions: Clinicians are faced with numerous challenges in treating patients with fibromyalgia. The interventions being tested in the POYSE trial have the potential to provide primary care and other care settings with new treatment options for clinicians while simultaneously providing a much needed relief for patients suffering from fibromyalgia. Trial Registration: Funded by VA Rehabilitation Research and Development (D1100-R); Trial registration: ClinicalTrials.gov, NCT01797263.
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BACKGROUND AND PURPOSE: Balance impairment is common after stroke; modified yoga may be able to improve balance and other important poststroke variables. Scientific-evidence is needed to support such treatment interventions. The purpose of this study was to assess the impact of a yoga-based rehabilitation intervention on balance, balance self-efficacy, fear of falling (FoF), and quality of life after stroke. METHODS: This was a prospective, randomized, pilot study of yoga-based rehabilitation for people with chronic stroke. All yoga sessions were taught by a registered yoga therapist, occurred twice per week for 8 weeks and included seated, standing, and floor postures with relaxation and meditation. Balance was assessed with the Berg Balance Scale, balance self-efficacy with the Activities-specific Balance Confidence Scale, FoF with a dichotomous yes/no question, and quality of life with the Stroke Specific Quality of Life scale. RESULTS: There were no significant differences between wait-list control (n=10) and yoga (n=37) groups in baseline or follow-up scores. However, using within-group comparisons, yoga group data demonstrated significant improvement in balance (Berg Balance Scale, 41.3±11.7 vs 46.3±9.1; P<0.001) and FoF (51% vs 46% with FoF; P<0.001). CONCLUSIONS: A group yoga-based rehabilitation intervention for people with chronic stroke has potential in improving multiple poststroke variables. Group yoga may be complementary to rehabilitation, may be possible in medical-based and community-based settings, and may be cost-effective. Further testing of group yoga-based rehabilitation interventions is warranted. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique Identifier: NCT01109602.
