The feasibility of an exercise intervention to improve sleep (time, quality and disturbance) in people with rheumatoid arthritis: a pilot RCT.

Current rheumatology guidelines recommend exercise as a key component in the management of people with RA, however, what is lacking is evidence on its impact on sleep. Objective is to assess the feasibility of a walking-based intervention on TST, sleep quality, and sleep disturbance and to generate potential effect size estimates for a main trial. Participants were recruited at weekly rheumatology clinics and through social media. Patients with RA were randomized to a walking-based intervention consisting of 28 sessions, spread over 8 weeks (2-5 times/week), with 1 per week being supervised by a physiotherapist, or to a control group who received verbal and written advice on the benefits of exercise. Primary outcomes were recruitment, retention, protocol adherence and participant experience. The study protocol was published and registered in ClinicalTrials.gov NCT03140995. One hundred and one (101) people were identified through clinics, 36 through social media. Of these, 24 met the eligibility criteria, with 20 randomized (18% recruitment; 100% female; mean age 57 (SD 7.3 years). Ten intervention participants (100%) and eight control participants (80%) completed final assessments, with both groups equivalent for all variables at baseline. Participants in the intervention group completed 87.5% of supervised sessions and 93% of unsupervised sessions. No serious adverse events were related to the intervention. Pittsburgh Sleep Quality Index global score showed a significant mean improvement between the exercise group-6.6 (SD 3.3) compared to the control group-0.25 (SD 1.1) (p = 0.012); Intervention was feasible, safe and highly acceptable to study participants, with those participants in the exercise group reporting improvements in sleep duration and sleep quality compared to the control group. Based on these findings, a fully powered randomized trial is recommended. Trial registration number: ClinicalTrials.gov Identifier: NCT03140995 (April 25th, 2017).

RCT Entities:   Population Interventions Outcomes