Skip to main content
OpenTrials
Completed

NCT Number: NCT01824550

Home Exercise Intervention in Persons With Multiple Sclerosis

The objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in persons with Multiple Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both subclinical atherosclerosis and mobility disability.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

This study will use a two-arm randomized control trial (RCT) design to examine the effect of a home-based exercise training program versus a minimal exercise, attention control condition on markers of subclinical atherosclerosis and mobility disability in persons with MS. The primary outcomes will be subclinical atherosclerosis including measures of arterial structure and function and measures of mobility disability including the six-minute walk and timed 25-foot walk, GaitRite walking assessment and one week of accelerometry data.

Fifty-four persons with MS who have an Expanded Disability Status Score (EDSS) score between 0 and 4.0 will be randomized into either the home-based exercise training condition or the attention control condition. Participation in this study will include a 3-month exercise program to be completed at home. In addition, participants will need to come to University of Illinois at Chicago (UIC) three times to undergo testing. Each visit will take about 3-4 hours to complete. Testing that will take place during these three visits include blood pressure measurement, six vascular (artery) measurements, heart measurements, short walking tests, peak aerobic capacity test, blood draw, five quality of Life questionnaires and two cognitive function tests.

The home-based exercise regimen will include cycle ergometry as an aerobic mode of training 3 times per week with a gradual progression of duration and intensity across a 12-week period. Exercise prescription will be based on the peak aerobic capacity cycling test conducted during the first visit. The attention control will involve stretching using the same frequency and duration across a 12-week period with exercises recommended by the National Multiple Sclerosis Society (NMSS). Both arms will receive weekly internet "coaching" sessions via video chatting.

Subclinical atherosclerosis and mobility disability data will be collected before, after 6 weeks of training and immediately after the 12-week intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • physically inactive
  • BMI<40
  • 1st stage of MS (i.e., defined as EDSS score of 0 - 4.0)
  • independently ambulatory (walking without an assistive device such as a cane or orthotic)
  • relapse free in the past 30 days
  • confirmed diagnosis of MS
  • asymptomatic (i.e., no underlying clinically diagnosed cardiovascular disease)
  • be on a stable disease modifying therapy
  • physician approval for undertaking exercise testing and training

Treatment and study plan

home-based exercise training condition

Other

Home based endurance exercise training

Primary outcomes

  1. Subclinical atherosclerosis

    Time frame: 3 months

    This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity

Secondary outcomes

  1. Mobility disability

    Time frame: 3 months

    This will be measured by the 6-min walk, 25 ft walk, the "Get-up-and-go" test and by gait characteristics.

Other outcomes

  1. Disease state, and fatigue

    Time frame: 3 months

    This will be measured via questionnaires

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis

Acronym: HOMS

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Apr 4, 2013
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.