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

October 19, 2022 updated by: University of Colorado, Denver

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

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)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Knee extension muscle strength measured by hand-held dynamometry
Measured at Baseline (Week 0) and Post Test (Week 9)
Change in hip abduction muscle strength
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Hip abduction muscle strength measured by hand-held dynamometry
Measured at Baseline (Week 0) and Post Test (Week 9)
Change in ankle plantarflexion muscle strength
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Ankle plantarflexion muscle strength measured by hand-held dynamometry
Measured at Baseline (Week 0) and Post Test (Week 9)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 30-second sit-to-stand completions
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
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
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Functional mobility test measuring the participant's ability to balance in different postures. Scores 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
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
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
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
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 12-Item MS Walking Scale
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
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
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
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 MS Impact Scale-29
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Self-report questionnaire measuring the impact of MS on daily activity with scores ranging from 29 (MS has no impact on my daily life) to 145 (MS extremely impacts my daily life)
Measured at Baseline (Week 0) and Post Test (Week 9)
Change in MS Patient-Specific Function Scale
Time Frame: Measured at Baseline (Week 0) and Post Test (Week 9)
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)
Measured at Baseline (Week 0) and Post Test (Week 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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