Home Exercise Intervention in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— HOMS  

Official title:

Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824550
• Other study ID #: 2012-0836
• Secondary ID: RG 4702A1/2
• Status: Completed
• Phase: N/A
• Start date: November 13, 2012
• Est. completion date: September 7, 2018

Study information

• Verified date: September 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 7, 2018
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• home-based exercise training condition
Home based endurance exercise training

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease state, and fatigue	This will be measured via questionnaires	3 months
Primary	Subclinical atherosclerosis	This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity	3 months
Secondary	Mobility disability	This will be measured by the 6-min walk, 25 ft walk, the "Get-up-and-go" test and by gait characteristics.	3 months