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Clinical Trials/NCT05177952
NCT05177952CompletedNot Applicable

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

University of Central Florida2 sites in 1 country20 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Change in Functional Outcomes- 6min walk

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Participants and Investigators will be aware of treatment groups

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Functional Outcomes- 6min walk

Time Frame: Day 2, Week 4 and 8, Day 28

determined via changes in 6 minute walk test, measured by how far (in feet) someone can walk in 6 minutes

Change in Functional Outcomes- MFIS

Time Frame: Day 2, Week 4 and 8, Day 28

determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire

Change in Functional Outcomes- 10meter

Time Frame: Day 2, Week 4 and 8, Day 28

determined via changes in 10 meter walk test, measured by how fast (in minutes and seconds) someone can walk 10 meters

Change in Functional Outcomes- CST

Time Frame: Day 2, Week 4 and 8, Day 28

determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position

Change in Functional Outcomes- 30CST

Time Frame: Day 2, Week 4 and 8, Day 28

determined via changes in 30 second sit-to-stand, measured by how many times someone can stand from a seated position in 30 seconds

Secondary Outcomes

  • Changes in Strength(Day 3, Week 4 and 8, Day 29)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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