Abstract
Objectives: The primary objectives of this pilot trial were to assess the study feasibility and acceptability of the 12-week yoga and educational film programs for the management of restless legs syndrome (RLS) in preparation for a future randomized controlled trial (RCT). Materials and Methods: This pilot, parallel-arm, randomized feasibility trial was conducted at two sites, Morgantown, WV and Columbus, OH. Yoga group participants attended 75-min Iyengar yoga classes, twice weekly for 4 weeks, then once a week for 8 weeks (16 total classes), and completed a 30-min homework routine on nonclass days. Educational film group participants attended once weekly, 75-min classes (12 total classes), which included information on RLS and other sleep disorders, RLS management including sleep hygiene practices, and complementary therapies. Feasibility and acceptability outcomes included program satisfaction and recruitment, retention, and adherence rates. In addition, participants were asked their preferences regarding three yoga class schedule scenarios for a future study. Attendance, yoga, and treatment logs were collected weekly. Program evaluation and yoga scheduling questionnaires were collected at week 12. Results: Forty-one adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or educational film (n = 22) program. Thirty participants (73%) completed the program. Yoga and education group participants attended an average of 13.0 ± 0.84 (81%) and 10.3 ± 0.3 classes (85%), respectively. Participants from both groups indicated satisfaction with the study. All yoga group respondents to the program evaluation reported they would likely (n = 6) or very likely (n = 7) continue yoga practice; 86.7% of education group respondents (13 of 15) indicated that they were likely (n = 7) or very likely (n = 6) to make lasting changes based on what they had learned. The preferred schedule for a future study was a 16-week study with once-weekly yoga classes. Conclusions: The findings of this study suggest that a larger RCT comparing yoga with an educational film group for the management of RLS is feasible. Trial registration: Clinicaltrials.gov: NCT03570515; 02/01/2017.