Yoga for restless legs syndrome, a common and burdensome sleep disorder. A feasibility trial



 DESCRIPTION (provided by applicant): Restless legs syndrome (RLS) is a burdensome sleep disorder affecting an estimated 12% of the general population and 19.5% of primary care patients. Characterized by a distressing urge to move one's legs that is typically accompanied by unpleasant, often painful sensations, is worse at rest or at night, and is relieved by movement, RLS is associated with profound impairment of sleep, mood, and quality of life, and with significant health, societal and economic burden. While the etiology of RLS remains uncertain, recent research has linked RLS to increased cardiovascular disease risk, and implicated autonomic and metabolic dysregulation in RLS pathogenesis. To date, there is no cure for RLS. Existing drug treatments, aimed at symptom reduction, often diminish in efficacy with time and can carry serious side effects that are particularly problematic in older adults, a population disproportionately affected by RLS. There is clearly a need to investigate approaches to RLS treatment that are safe, sustainable, and suitable for long term use, and that not only alleviate symptoms but address apparent underlying risk factors. While relaxation therapies, including yoga, are often recommended for RLS patients, guidelines remain non-specific, and rigorous, supportive research is lacking. Our recent small pilot studies suggest that yoga may offer an acceptable, feasible and efficacious therapy for those with RLS, with participants showing improvements in RLS symptoms, sleep, and mood comparable to or greater than those reported in pharmaceutical trials. However, additional work is required before undertaking a larger rigorous trial to explore the efficacy of yoga for RLS management. This feasibility study will address the critical remaining issues, including feasibility and acceptability of a randomized controlled trial (RCT) comparing a 12 week yoga to a 12 week comparator program (i.e., acceptability of randomization and recruitment, retention, and adherence rates); treatment fidelity; effect sizes of these interventions for core outcomes; and acceptable doses of yoga for a trial. Our primary goal is to assess, in adults with symptomatic RLS, the acceptability and feasibility of a 12 week RCT comparing yoga to an attention control. Forty-four ambulatory, overall healthy adults aged = 21 years with confirmed moderate to severe RLS will be recruited and randomized to a 12 week beginner yoga program (n=22) or a standardized 12-week educational film program (N=22), modeled on interventions used in our previous trials. We will also determine effect sizes in core outcomes of the yoga and educational film programs; these data will be critical in powering future studies. Additional data will be collected on participant willingness to enroll in yoga programs of differing duration and intensity. The proposed study will provide opportunities for student exposure to and participation in all phases of clinical intervention research. Study findings will also allow us to evaluate and optimize the protocol design and performance, and to determine optimal sample sizes for a planned larger RCT investigating the efficacy of yoga for reducing RLS symptoms and associated burden in adults with this challenging and costly disorder.