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Open Access Study protocol

Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol

Matthew Plow1*, Marcia Finlayson2, Robert W Motl3 and Francois Bethoux4

Author Affiliations

1 Department of Biomedical Engineering, Department of Physical Medicine and Rehabilitation, Cleveland Clinic Lerner Research Institute, 9500 Euclid Ave, ND-20, Cleveland, OH, 44195, USA

2 School of Rehabilitation Therapy, Queen’s University, Louise D. Acton Building, 31 George Street, Kingston, Ontario, K7L 3N6, Canada

3 Department of Kinesiology and Community Health, University of Illinois Urbana-Champaign, 350 Freer Hall, 906 South Goodwin Avenue, Urbana, IL, 61801, USA

4 Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195, USA

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BMC Neurology 2012, 12:122  doi:10.1186/1471-2377-12-122

Published: 16 October 2012

Abstract

Background

Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels.

Methods/Design

A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1) a contact-control social support intervention, (2) a physical activity-only intervention, and (3) a physical activity plus fatigue management intervention. All interventions will last 12 weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ), and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e.g., self-efficacy).

Discussion

The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS.

Trial registration

NCT01572714