Feasibility and efficacy of a physical activity intervention for managing restless legs syndrome in multiple sclerosis: Results of a pilot randomized controlled trial.

Cederberg, Katie L J; Motl, Robert W

BACKGROUND This pilot randomized controlled trial examined the feasibility and efficacy of a physical activity behavior change intervention for improving restless legs syndrome (RLS) severity and secondary sleep outcomes among a sample of adults with multiple sclerosis (MS). METHODS Participants with MS(N=15) were randomly assigned into intervention(n=8) or waitlist control(n=7) conditions. The physical activity intervention was delivered over a 16-week period and outcomes were assessed at baseline and immediately following the 16-week period in both conditions. RESULTS There was a significant, positive effect of the intervention on overall RLS severity (p=.01;ηρ2=.43), severity during the night(p=.03,ηρ2=.35), severity during the day while resting(p=.01,ηρ2=.44), and severity during the day while active(p<.01,ηρ2=.61), and non-significant improvements in RLS severity while falling asleep (p=.33,ηρ2=.09). There were significant positive effects on sleep satisfaction(p<.01,ηρ2=.49) and non-significant improvements in self-reported global sleep quality(p=.35,ηρ2=.08). There was a significant intervention effect on self-reported time in bed(p=.03,ηρ2=.37) and total sleep time(p=.03,ηρ2=.36), and non-significant improvements in self-reported sleep latency (p=.08,ηρ2=.25), sleep efficiency(p=.27,ηρ2=.11), and daytime sleepiness (p=.52,ηρ2=.04;p=.35,ηρ2=.08;p=.51,ηρ2=.04). There was no significant effect of the intervention on device-measured sleep quality. CONCLUSIONS We provide preliminary evidence for the feasibility and efficacy of a physical activity intervention for reducing RLS severity and potentially improving self-reported sleep outcomes in adults with MS. CLINICALTRIALS. GOV IDENTIFICATION NUMBER NCT04061681.