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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Exercise
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Blood Flow Restriction, Resistance Training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood Flow Restriction Exercise

Arm Description

Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.

Outcomes

Primary Outcome Measures

Change in knee extension muscle strength
Knee extension muscle strength measured by hand-held dynamometry
Change in hip abduction muscle strength
Hip abduction muscle strength measured by hand-held dynamometry
Change in ankle plantarflexion muscle strength
Ankle plantarflexion muscle strength measured by hand-held dynamometry

Secondary Outcome Measures

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
Change in Berg Balance Scale
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.
Change in timed 25-foot walk
Functional mobility test measuring the time it takes a participant to walk 25 feet
Change in activity level
10-day average of activity level as measured by a wearable activity monitor
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)
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)
Change in MS Impact Scale-29
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)
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)

Full Information

First Posted
November 12, 2020
Last Updated
October 19, 2022
Sponsor
University of Colorado, Denver
Collaborators
Consortium of Multiple Sclerosis Centers
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1. Study Identification

Unique Protocol Identification Number
NCT04633759
Brief Title
Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis
Acronym
BFR-MS
Official Title
Feasibility of Low-load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis and Marked Mobility Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Consortium of Multiple Sclerosis Centers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Blood Flow Restriction, Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction Exercise
Arm Type
Experimental
Arm Description
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in knee extension muscle strength
Description
Knee extension muscle strength measured by hand-held dynamometry
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in hip abduction muscle strength
Description
Hip abduction muscle strength measured by hand-held dynamometry
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in ankle plantarflexion muscle strength
Description
Ankle plantarflexion muscle strength measured by hand-held dynamometry
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Secondary Outcome Measure Information:
Title
Change in 30-second sit-to-stand completions
Description
Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in Berg Balance Scale
Description
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.
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in timed 25-foot walk
Description
Functional mobility test measuring the time it takes a participant to walk 25 feet
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in activity level
Description
10-day average of activity level as measured by a wearable activity monitor
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in 12-Item MS Walking Scale
Description
Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking)
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in Modified Fatigue Impact Scale
Description
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)
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in MS Impact Scale-29
Description
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)
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)
Title
Change in MS Patient-Specific Function Scale
Description
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)
Time Frame
Measured at Baseline (Week 0) and Post Test (Week 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis

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