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Home Exercise Intervention in Persons With Multiple Sclerosis (HOMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bo Fernhall, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01824550
First received: April 1, 2013
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Multiple Sclerosis
Other: home-based exercise training condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exercise, Subclinical Atherosclerosis and Walking Mobility in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Disease state, and fatigue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This will be measured via questionnaires


Estimated Enrollment: 54
Study Start Date: August 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824550

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Bo Fernhall, PhD University of Illinois at Chicago
  More Information

Responsible Party: Bo Fernhall, Dean and Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01824550     History of Changes
Other Study ID Numbers: 2012-0836  RG 4702A1/2 
Study First Received: April 1, 2013
Last Updated: May 16, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 09, 2016