Changing physical activity behavior for people with multiple sclerosis: protocol of a randomized controlled feasibility trial (iStep-MS)

Introduction: Although physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behavior. Behavior change interventions may assist people with MS to increase physical activity and reduce sedentary behavior. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims to determine the safety, feasibility and acceptability of a behavior change intervention to increase physical activity and reduce sedentary behavior among people with MS.

Methods and Analysis: Sixty people with MS will be randomized (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behavior (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the program and semistructured interviews exploring participants’ and therapists’ experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use.

Ethics and Dissemination: Research ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists.