Home Exercise Intervention in Persons With Multiple Sclerosis (HOMS)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis|
- Subclinical atherosclerosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity
- Mobility disability [ Time Frame: 3 months ] [ Designated as safety issue: No ]This will be measured by the 6-min walk, 25 ft walk, the "Get-up-and-go" test and by gait characteristics.
- Disease state, and fatigue [ Time Frame: 3 months ] [ Designated as safety issue: No ]This will be measured via questionnaires
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: home-based exercise training condition
Home based endurance exercise training
Other: home-based exercise training condition
Home based endurance exercise training
No Intervention: attention control condition
Attention control condition - home based flexibility training
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824550
|Contact: Garett Griffith, M.S.||firstname.lastname@example.org|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Garett Griffith, M.S. 312-996-9594 email@example.com|
|Principal Investigator: Bo Fernhall, PhD|
|Principal Investigator:||Bo Fernhall, PhD||University of Illinois at Chicago|