Experimental protocol of a randomized controlled clinical trial investigating exercise, subclinical atherosclerosis, and walking mobility in persons with multiple sclerosis

Contemp Clin Trials. 2015 Mar:41:280-6. doi: 10.1016/j.cct.2015.02.003. Epub 2015 Feb 14.

Abstract

Background: This randomized controlled trial (RCT) will investigate the effects of a home-based aerobic exercise training regimen (i.e., cycle ergometry) on subclinical atherosclerosis and walking mobility in persons with multiple sclerosis (MS) and minimal disability.

Methods/design: This RCT will recruit 54 men and women who have an Expanded Disability Status Scale characteristic of the 1st stage of MS (i.e., 0-4.0) to participate in a 3 month exercise or stretching intervention, with assessments of subclinical atherosclerosis and walking mobility conducted at baseline, week 6 (midpoint), and week 12 (conclusion) of the program. The exercise intervention will consist of 3 days/week of cycling, with a gradual increase of duration followed by an increase in intensity across the 3 month period. The attention-control condition will incorporate stretching activities and will require the same contact time commitment as the exercise condition. Both study groups will participate in weekly video chat sessions with study personnel in order to monitor and track program adherence. Primary outcomes will consist of assessments of vascular structure and function, as well as several walking tasks. Additional outcomes will include questionnaires, cardiorespiratory fitness assessment, and a 1-week free-living physical activity assessment.

Discussion: This investigation will increase understanding of the role of aerobic exercise as part of a treatment plan for managing subclinical atherosclerosis and improving walking mobility persons in the 1st stage of MS. Overall, this study design has the potential to lead to effective aerobic exercise intervention strategies for this population and improve program adherence.

Keywords: Aerobic exercise; Multiple sclerosis; Subclinical atherosclerosis; Walking mobility.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Arterial Pressure / physiology
  • Asymptomatic Diseases
  • Atherosclerosis / diagnostic imaging
  • Atherosclerosis / physiopathology
  • Atherosclerosis / therapy*
  • Carotid Intima-Media Thickness
  • Exercise
  • Exercise Therapy / methods*
  • Exercise Tolerance / physiology
  • Female
  • Humans
  • Male
  • Microvessels / physiopathology
  • Mobility Limitation*
  • Multiple Sclerosis, Relapsing-Remitting / rehabilitation*
  • Pulse Wave Analysis
  • Treatment Outcome
  • Vascular Stiffness / physiology