Home Exercise Intervention in Persons With Multiple Sclerosis (HOMS)
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|ClinicalTrials.gov Identifier: NCT01824550|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2013
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: home-based exercise training condition||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||November 2018|
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
- 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
- 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.
- Disease state, and fatigue [ Time Frame: 3 months ]This will be measured via questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824550
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Bo Fernhall, PhD||University of Illinois at Chicago|