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Open Access Highly Accessed Study protocol

The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial

Nancy E Mayo1*, Mark Bayley2, Pierre Duquette3, Yves Lapierre4, Ross Anderson5 and Susan Bartlett1

Author Affiliations

1 Division of Clinical Epidemiology, Royal Victoria Hospital, McGill University Health Centre, Montreal, QC H3A 1A1, Canada

2 UHN - Toronto Rehabilitation Institute, University Centre, 550 University Avenue, Toronto, ON M5G 2A2, Canada

3 Centre hospitalier de l’Université de Montréal, 1560 Sherbrooke Street E, Montreal, Quebec H2L 4M1, Canada

4 Montreal Neurological Institute and Hospital, 3801 University Street, Montreal, Quebec H3A 2B4, Canada

5 Department of Kinesiology and Physical Education, Faculty of Education, McGill University, Montreal, QC H2W 1S4, Canada

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BMC Neurology 2013, 13:69  doi:10.1186/1471-2377-13-69

Published: 28 June 2013

Abstract

Background

Despite the commonly known benefits of exercise and physical activity evidence shows that persons Multiple Sclerosis (MS) are relatively inactive yet physical activity may be even more important in a population facing functional deterioration. No exercise is effective if it is not done and people with MS face unique barriers to exercise engagement which need to be overcome. We have developed and pilot tested a Multiple Sclerosis Tailored Exercise Program (MSTEP) and it is ready to be tested against general guidelines for superiority and ultimately for its impact on MS relevant outcomes. The primary research question is to what extent does an MS Tailored Exercise Program (MSTEP) result in greater improvements in exercise capacity and related outcomes over a one year period in comparison to a program based on general guidelines for exercise among people with MS who are sedentary and wish to engage in exercise as part of MS self-management.

Methods/Design

The proposed study is an assessor-blind, parallel-group, randomized controlled trial (RCT). The duration of the intervention will be one year with follow-up to year two. The targeted outcomes are exercise capacity, functional ambulation, strength, and components of quality of life including frequency and intensity of fatigue symptoms, mood, global physical function, health perception, and objective measures of activity level. Logistic regression will be used to test the main hypothesis related to the superiority of the MSTEP program based on a greater proportion of people making a clinically relevant gain in exercise capacity at 1 year and at 2 years, using an intention-to-treat approach. Sample size will be 240 (120 per group).

Discussion

The MS community is clearly looking for interventions to help alleviate the disabling sequelae of MS and promote health. Exercise is a well-known intervention which has known benefits to all, yet few exercise regularly. For people with MS, the role of exercise in MS management needs to be rigorously assessed to inform people as to how best to use exercise to reduce disability and promote health.

Trial registration

Clinical Trials.gov: NCT01611987