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

• ClinicalTrials.gov Identifier: NCT04633759
• Recruitment Status: Completed
• First Posted: November 18, 2020
• Last Update Posted: October 20, 2022
• Sponsor: University of Colorado, Denver
• Collaborator: Consortium of Multiple Sclerosis Centers
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Other: Blood Flow Restriction Exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Low-load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis and Marked Mobility Restriction
• Actual Study Start Date: February 19, 2021
• Actual Primary Completion Date: October 5, 2022
• Actual Study Completion Date: October 5, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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

Secondary Outcome Measures :

1. 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
2. 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.
3. 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
4. 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
5. 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)
6. 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)
7. 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)
8. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Consortium of Multiple Sclerosis Centers

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT04633759
• Other Study ID Numbers: 20-0695; 205593 ( Other Grant/Funding Number: Consortium of Multiple Sclerosis Centers )
• First Posted: November 18, 2020
• Last Update Posted: October 20, 2022
• Last Verified: October 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:

Multiple Sclerosis; Blood Flow Restriction; Resistance Training

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases