Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

NCT ID: NCT05177952

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-05-31

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.

Conditions

Training Study; Multiple Sclerosis; Blood Flow Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction

Intervention Type: OTHER

Resistance training with BFR

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Resistance Training with no BFR

Interventions

Blood Flow Restriction

Resistance training with BFR

Intervention Type: OTHER

Standard of Care

Resistance Training with no BFR

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AdventHealth

OTHER

Sponsor Role: collaborator

University of Central Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ethan Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

University of Central Florida

Orlando, Florida, United States

Countries

United States

Other Identifiers

STUDY00003396: BFR MS

Identifier Type: -

Identifier Source: org_study_id