Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Training Study; Multiple Sclerosis; Blood Flow Restriction
• Interventions: Other: Standard of Care; Other: Blood Flow Restriction

• Registration Number: NCT05177952
• Lead Sponsor: University of Central Florida

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 Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-15
• Study Start: 2022-01-01
• Study First Posted: 2022-01-05
• Primary Completion: 2024-01-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	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.
Blood Flow Restriction	Blood Flow Restriction	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.

Primary Outcome Measures

Name	Time	Method
Change in Functional Outcomes- 6min walk	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	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	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	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	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 Outcome Measures

Name	Time	Method
Changes in Strength	Day 3, Week 4 and 8, Day 29	determined via maximal voluntary contractions on the Biodex

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States