Home Exercise Intervention in Persons With Multiple Sclerosis (HOMS)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: home-based exercise training condition

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subclinical atherosclerosis	This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease state, and fatigue	This will be measured via questionnaires	3 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Bo Fernhall, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2012
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): September 7, 2018

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2012-0836; RG 4702A1/2 (Other Grant/Funding Number: NMSS)