Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis (BFR-MS)

Feasibility of Low-load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis and Marked Mobility Restriction

The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Blood Flow Restriction Exercise

Detailed Description

The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.

Specific Aim 1: Determine the feasibility of BFR by assessing recruitment rate, retention, adherence, satisfaction, and safety.

Hypothesis: Feasibility will be demonstrated by: 1) enrolling 20 participants in 8 months, 2) retaining at least 16 (80%) participants, 3) 80% adherence to intervention, 4) 90% satisfaction with intervention, and 5) no serious adverse events related to the intervention.

Specific Aim 2: Determine changes in knee and hip extension, hip abduction, and ankle plantarflexion muscle strength after the 8-week intervention.

Hypothesis: Following intervention there will be clinically important within-group strength changes that correspond to established minimal detectable change values and which can be characterized as having at least a moderate effect size as defined by Cohen's d.

Exploratory Aim: Explore changes in functional mobility (30-Second Sit-to-Stand, Berg Balance Scale, Timed 25-Foot Walk. 10-day average activity level) and self-report measures (12-Item MS Walking Scale, Modified Fatigue Impact Scale, MS Impact Scale-29, and Patient-Specific Functional Scale) after the 8-week intervention.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ages 18-70
• Neurologist-confirmed diagnosis of multiple sclerosis

• Expanded Disability Status Scale (EDSS) 6.0 to 7.0

  • EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
  • EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting
  • EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day

Exclusion Criteria:

• EDSS 7.5 or greater: Restricted to wheelchair for all mobility, unable to walk more than a few steps, even with walking aid
• EDSS 5.5 or less: Able to walk more than 100 meters without walking aid or rest
• Unable to provide consent or follow simple directions
• Prior history of Deep Venous Thrombosis/ Pulmonary Embolism
• History of peripheral vascular disease, thrombophilia or other clotting disorders
• Patient report of easy bruising
• Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist of physical therapist
• Severe lower extremity spasticity as defined as Modified Ashworth scale > 2
• Currently undergoing supervised resistance training with a physical therapist or other exercise professional
• Use of Blood Flow Restriction currently or in the previous 3 months prior to enrollment
• MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment
• Inability to tolerate pressure cuff during baseline assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blood Flow Restriction Exercise; Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.

Other: Blood Flow Restriction Exercise; Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Extension Muscle Strength (More-involved Side)	Knee extension muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Hip Abduction Muscle Strength (More-involved Side)	Hip abduction muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Ankle Plantarflexion Muscle Strength (More-involved Side)	Ankle plantarflexion muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Knee Extension Muscle Strength (Less-involved Side)	Knee extension muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Hip Abduction Muscle Strength (Less-involved Side)	Hip abduction muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)	Ankle plantarflexion muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.	Measured at Baseline (Week 0) and Post Test (Week 9)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 12-Item MS Walking Scale	Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking)	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Modified Fatigue Impact Scale	Self-report questionnaire measuring fatigue caused by MS with scores ranging from 0 (no impact of fatigue in the past 4 weeks) to 84 (maximum impact of fatigue in the past 4 weeks)	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in 30-second Sit-to-stand Completions	Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Berg Balance Scale	Functional mobility test measuring the participant's ability to balance in different postures. Scores on the Berg Balance Scale range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently.	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Timed 25-foot Walk	Functional mobility test measuring the time it takes a participant to walk 25 feet	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Activity Level	10-day average of activity level as measured by a wearable activity monitor	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in MS Patient-Specific Function Scale	Self-report questionnaire measuring the ability of the participant to do three self-identified activities. Scores of each of the 3 activities range from 0 (unable to perform) to 10 (able to perform without difficulty). The score is the average of the 3 activities, with higher scores indicating better function.	Measured at Baseline (Week 0) and Post Test (Week 9)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Consortium of Multiple Sclerosis Centers
• Investigators: Principal Investigator: Mark M Manago, PT, DPT, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• Manago MM, Cohen ET, Cameron MH, Christiansen CL, Bade M. Reliability, Validity, and Responsiveness of the Patient-Specific Functional Scale for Measuring Mobility-Related Goals in People With Multiple Sclerosis. J Neurol Phys Ther. 2023 Jul 1;47(3):139-145. doi: 10.1097/NPT.0000000000000439. Epub 2023 Mar 7.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Resistance Training; Blood Flow Restriction
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: 20-0695; 205593 (Other Grant/Funding Number: Consortium of Multiple Sclerosis Centers)

Drug and device information, study documents

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