Project Get Fit With MS: Guidelines for Exercise Training and Fitness Outcomes in MS

Study Overview
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Brief Summary
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The purpose of this study is to test different types of exercise training for people with multiple sclerosis (MS). The exercise program is based on physical activity guidelines that have been developed specifically for people with MS. The investigators believe these guidelines will be effective for improving physical fitness and function in persons with mild-to-moderate MS.

Detailed Description
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Most adults with multiple sclerosis (MS) are physically inactive. One approach to address physical inactivity in this population has involved the provision of physical activity guidelines. Such physical activity guidelines are an important tool for exercise prescription, promotion, and monitoring, and recommend that people with MS participate in at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength training exercises for major muscle groups 2 times per week. The guidelines were developed from a systematic literature review and have yet to be tested for efficacy in improving fitness or other outcomes. This study will test that efficacy of aerobic and resistance training alone and in combination (based on the MS physical activity guidelines) for improving physical fitness and other outcomes (e.g., walking, thinking, MS symptoms) in persons with MS who have mild-to-moderate disability. Such an examination will be important to confirm the efficacy of the exercise prescription for people with MS and health-care providers. The investigators will further perform an exploratory analysis of blood biomarkers and eye imaging parameters to examine some of the mechanisms of exercise training effects in persons with MS.

Official Title
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Project GET FIT With MS: Guidelines for Exercise Training and Fitness Outcomes in MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Resistance exercise
* Behavioral: Stretching exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a definite diagnosis of MS self-reported Expanded Disability Status Scale (EDSS) score < 6.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 3.0 relapse free in past 30 days willing and able to visit the University of Illinois at Urbana-Champaign for on seven occasions (two testing visits; five training visits) and participate in a 6-month home-based exercise program non-exerciser asymptomatic and physician approval for undertaking exercise testing and training Exclusion Criteria: currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stretching exercise<br>The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week. | Behavioral: Stretching exercise<br>* The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week.<br>|
| Experimental: Resistance exercise<br>The resistance condition will consist of 1-3 sets, 10-15 repetitions of 12 exercises targeting lower body, upper body, and core muscle groups performed 2 days per week. | Behavioral: Resistance exercise<br>* strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness (aerobic and muscular) | Physical fitness determined by VO2 peak using a computer-driven cycle ergometer Muscular fitness determined by a seated dynamometer machine for leg strength and a hand dynamometer for upper body strength | 0 and 6 months | 
| Walking and physical function | A timed 25-Foot walk, a 6 -minute walk, walking on a GaitRite electronic walkway, 9-hole peg test and the use of a force platform will measure walking and physical function. | 0 and 6 months | 
| Cognition | The Brief International Cognitive Assessment for MS battery will be used. | 0 and 6 months | 
| Physical activity | an accelerometer along with the Godin Leisure Time Physical Activity Questionnaire and 7-day Physical Activity Recall Questionnaire will be used to measure physical activity. | 0 and 6 months | 
| Patient-rated outcomes | Self reporting questionnaires on fatigue, mobility, anxiety, depression, QoL, and social cognitive theory variable (e.g. Exercise Self-Efficacy Scale, Late-life function and disability scale) | 0 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | DXA scan | 0 and 6 months | 
| OCT Eye imaging |  | 0 and 6 months | 
| Cardiovascular function | ultrasonography techniques for arterial size, stiffness and blood pressure along with an ECG | 0 and 6 months | 
| Blood biomarkers | Circulating inflammatory markers, cytokines and growth factors | 0 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, exercise, home-based, training, fitness