Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment home-based exercise training condition
Sponsor University of Illinois at Chicago
Start date August 2013
End date October 2016
Trial size 54 participants
Trial identifier NCT01824550, 2012-0836, RG 4702A1/2

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Home based endurance exercise training
home-based exercise training condition
Home based endurance exercise training
(No Intervention)
Attention control condition - home based flexibility training

Primary Outcomes

Measure
Subclinical atherosclerosis
time frame: 3 months

Secondary Outcomes

Measure
Mobility disability
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis
Principal investigator Bo Fernhall, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.