Home Exercise Intervention in Persons With Multiple Sclerosis (HOMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Illinois at Chicago
Sponsor:
Information provided by (Responsible Party):
Bo Fernhall, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01824550
First received: April 1, 2013
Last updated: June 1, 2014
Last verified: June 2014

April 1, 2013
June 1, 2014
August 2013
September 2015   (final data collection date for primary outcome measure)
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
Subclinical atherosclerosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01824550 on ClinicalTrials.gov Archive Site
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.
Mobility disability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Disease state, and fatigue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This will be measured via questionnaires
Explore the possible association between changes in subclinical atherosclerosis and changes in walking mobility following exercise training [ Time Frame: 3 months ] [ Designated as safety issue: No ]
 
Home Exercise Intervention in Persons With Multiple Sclerosis
Exercise, Subclinical Atherosclerosis and Walking Mobility in 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Multiple Sclerosis
Other: home-based exercise training condition
Home based endurance exercise training
  • Experimental: home-based exercise training condition
    Home based endurance exercise training
    Intervention: Other: home-based exercise training condition
  • No Intervention: attention control condition
    Attention control condition - home based flexibility training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
Not Provided
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Garett Griffith, M.S. 312-996-9594 gjgriff@uic.edu
United States
 
NCT01824550
2012-0836, RG 4702A1/2
Yes
Bo Fernhall, University of Illinois at Chicago
University of Illinois at Chicago
Not Provided
Principal Investigator: Bo Fernhall, PhD University of Illinois at Chicago
University of Illinois at Chicago
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP