Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177952
• Other study ID #: STUDY00003396: BFR MS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Flow Restriction
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Blood Flow Restriction
Resistance training with BFR
• Standard of Care
Resistance Training with no BFR

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	AdventHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Changes in Strength	determined via maximal voluntary contractions on the Biodex	Day 3, Week 4 and 8, Day 29