Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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This research is being done to compare the current standard of care for strength training for patients with Multiple Sclerosis to lightweight resistance training with blood flow restriction.

Detailed Description
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The purpose of this study is to compare the effectiveness of the current Multiple Sclerosis standard of care exercise recommendations to low-load resistance training with blood flow restriction on functional outcomes, strength, muscle size, and neuromuscular control in Multiple Sclerosis patients. This study involves completing 2 training sessions per week for 12 weeks as well as pre- and post-training assessment visits for a total of 29 visits over 14 weeks. All visits will be on UCF's campus with a member of the research team.

Official Title
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The Chronic Effects of Low-Load Blood Flow Restriction or Standard of Care Resistance Exercise on Muscle and Neuromuscular Function in Patients With Multiple Sclerosis

Conditions
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Training Study, Multiple Sclerosis, Blood Flow Restriction

Intervention / Treatment
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* Other: Blood Flow Restriction
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females between the ages of 18 to 55 Diagnosed with Multiple Sclerosis Expanded Disability Status Score of 0 to 6.5 Able to walk 10 meters without assistance Are willing to come in for all 29 testing visits over 14 weeks Exclusion Criteria: No other known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease Multiple Sclerosis relapse in the past 30 days Are not currently undergoing a rehabilitation protocol Are not currently seeking medical care for a chronic condition that could limit exercise capacity other than multiple sclerosis Are not currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

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
Interventional Model Description: Randomized between group parallel
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Flow Restriction<br>The BFR group will complete 1 set of 30 (1 x 30) at 30% of their 1 repetition maximum for leg press, leg extension, leg curl, chest press, seated row, and shoulder press completed on exercise machines with 2 minutes between exercises. | Other: Blood Flow Restriction<br>* Resistance training with BFR<br>|
| Active Comparator: Standard of Care<br>The standard of care group will complete 1 set of 8-12 repetitions at 60-80% of their 1 repetition maximum for leg press, leg extension, leg curl, chest press, seated row, and shoulder press completed on exercise machines with 2 minutes between exercises. | Other: Standard of Care<br>* Resistance Training with no BFR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Outcomes- 10meter | determined via changes in 10 meter walk test, measured by how fast (in minutes and seconds) someone can walk 10 meters | Day 2, Week 4 and 8, Day 28 | 
| Change in Functional Outcomes- 6min walk | determined via changes in 6 minute walk test, measured by how far (in feet) someone can walk in 6 minutes | Day 2, Week 4 and 8, Day 28 | 
| Change in Functional Outcomes- CST | determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position | Day 2, Week 4 and 8, Day 28 | 
| Change in Functional Outcomes- 30CST | determined via changes in 30 second sit-to-stand, measured by how many times someone can stand from a seated position in 30 seconds | Day 2, Week 4 and 8, Day 28 | 
| Change in Functional Outcomes- MFIS | determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire | Day 2, Week 4 and 8, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Strength | determined via maximal voluntary contractions on the Biodex | Day 3, Week 4 and 8, Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Flow Restriction, Multiple Sclerosis, Exercise