Multiple SclerosisBFR-MSNCT04633759
Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis
A study testing Blood Flow Restriction Exercise in people with Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood Flow Restriction Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 5 Oct 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood Flow Restriction Exercise
- Keywords
- Multiple Sclerosis, Blood Flow Restriction, Resistance Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Exercise | Experimental | Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks. Receives: Other: Blood Flow Restriction Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: Measured at Baseline (Week 0) and Post Test (Week 9)
Secondary outcomes (7)
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: 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: 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: 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: Measured at Baseline (Week 0) and Post Test (Week 9)
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: 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: 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: Measured at Baseline (Week 0) and Post Test (Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start19 Feb 2021
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers
- Responsible party
- Sponsor
- Investigators
- Mark M Manago, PT, DPT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633759
- Sponsor's protocol ID
- 20-0695
- Other IDs
- 205593
- Acronym
- BFR-MS
- Status last verified
- May 2026
- First submitted
- 12 Nov 2020
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36897202