Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Blood Flow Restriction; Training Study
• Intervention / Treatment: Other: Blood Flow Restriction; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Blood Flow Restriction; Resistance training with BFR
Active Comparator: 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.	Other: Standard of Care; Resistance Training with no BFR

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: AdventHealth
• Investigators: Principal Investigator: Ethan Hill, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Exercise; Blood Flow Restriction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: STUDY00003396: BFR MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No