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Home Exercise Intervention in Persons With Multiple Sclerosis (HOMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
home-based exercise training condition
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

home-based exercise training condition

attention control condition

Arm Description

Home based endurance exercise training

Attention control condition - home based flexibility training

Outcomes

Primary Outcome Measures

Subclinical atherosclerosis
This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity

Secondary Outcome Measures

Mobility disability
This will be measured by the 6-min walk, 25 ft walk, the "Get-up-and-go" test and by gait characteristics.

Full Information

First Posted
April 1, 2013
Last Updated
September 24, 2019
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01824550
Brief Title
Home Exercise Intervention in Persons With Multiple Sclerosis
Acronym
HOMS
Official Title
Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 13, 2012 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
September 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
home-based exercise training condition
Arm Type
Experimental
Arm Description
Home based endurance exercise training
Arm Title
attention control condition
Arm Type
No Intervention
Arm Description
Attention control condition - home based flexibility training
Intervention Type
Other
Intervention Name(s)
home-based exercise training condition
Intervention Description
Home based endurance exercise training
Primary Outcome Measure Information:
Title
Subclinical atherosclerosis
Description
This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mobility disability
Description
This will be measured by the 6-min walk, 25 ft walk, the "Get-up-and-go" test and by gait characteristics.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Disease state, and fatigue
Description
This will be measured via questionnaires
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Fernhall, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Home Exercise Intervention in Persons With Multiple Sclerosis

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