- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433103
Blood Flow Restriction And Veterans With MS (BRAVe-MS)
Low-Load Resistance Training With Blood Flow Restriction in People With Multiple Sclerosis and Advanced Disability: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Multiple Sclerosis (MS) is a chronic neurological disorder affecting about 1 million Americans. Among the many MS symptoms, muscle weakness is among the most common, contributes to decreased mobility, and worsens as disability advances. While there is strong evidence that moderate-to-high intensity resistance training improves muscle strength in people with MS and low disability, there is little evidence evaluating resistance training in people with advanced disability due to MS (i.e., those who need assistance to walk or use a wheelchair). People with advanced disability due to MS require unique approaches to resistance training as they often cannot tolerate higher intensity exercise because of severe weakness and fatigue. Blood flow restriction (BFR) has the potential to address these issues. With BFR, resistance training at low intensities has been shown to be as effective as high intensity training without BFR at increasing muscle strength and hypertrophy in people with a variety of musculoskeletal conditions. The preliminary data supports the safety, feasibility, and tolerance of BFR resistance training in people with advanced disability due to MS. The objective of the currently proposed study is to evaluate the efficacy of low-load resistance training with BFR on muscle strength, mobility, and fatigue in people with advanced disability due to MS.
This proposed Phase II clinical trial will target enrollment of Veterans with MS, who would often have more severe symptoms, worse mobility, and more advanced disability compared to non-Veterans with MS. The study hopes to address a crucial gap that is highly relevant for Veterans with MS:
interventions to improve mobility and optimize function for those with advanced disability. Fifty-eight participants with MS and advanced disability will be randomized (1:1) to low-load resistance training with BFR (experimental) or without BFR (control). Resistance training will target knee and hip extension, knee and hip flexion, and ankle plantarflexion 2x/week for 10 weeks. A blinded assessor will collect outcomes at baseline, post- intervention (primary endpoint), and after 8 weeks of follow-up. The Study Aims are to determine between-group differences in 1) Muscle health: quadriceps strength (primary outcome) and muscle morphology (thickness and echogenicity); 2) Mobility: 30-Second Sit-to-Stand; and 3) Self-reported fatigue: Modified Fatigue Impact Scale. The investigators hypothesize that the experimental group will have significantly greater improvements in muscle strength and thickness, mobility, and self-reported fatigue compared to the control group. The long-term goal of this research is to develop clinically feasible exercise interventions for people with advanced disability due to MS that can improve participation, quality of life, and disability.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mark M Manago, PT
- Phone Number: (303) 399-8020
- Email: mark.manago@va.gov
Study Contact Backup
- Name: Eliza A Biondi
- Phone Number: (303) 724-9170
- Email: eliza.biondi@va.gov
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contact:
- Mark M Manago, PT
- Phone Number: 303-399-8020
- Email: mark.manago@va.gov
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Principal Investigator:
- Mark M Manago, PT
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Contact:
- Eliza A Biondi
- Phone Number: (303) 724-9170
- Email: eliza.biondi@va.gov
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed diagnosis of MS
- Age 18-75
Patient Determined Disease Steps (PDDS) 4 to 7
- PDDS 4: Early cane: I use a cane or a single crutch or some other form of support (such as touching a wall or leaning on someone's arm) for walking all the time or part of the time, especially when walking outside. I think I can walk 25 feet in 20 seconds without a cane or crutch. I always need some assistance (cane or crutch) if I want to walk as far as three blocks.
- PDDS 5: Late cane: To be able to walk 25 feet, I have to have a cane, crutch, or someone to hold onto. I can get around the house or other buildings by holding onto furniture or touching the walls for support. I may use a scooter or wheelchair if I want to go greater distances.
- PDDS 6: Bilateral support: To be able to walk as far as 25 feet I must have two canes or crutches or a walker. I may use a scooter or wheelchair for longer distances.
- PDDS 7: Wheelchair/scooter: My main form of mobility is a wheelchair. I may be able to stand and/or take one or two steps, but I can't walk 25 feet, even with crutches or a walker.
Exclusion Criteria:
- PDDS 8: Unable to sit in a wheelchair for more than one hour.
- PDDS 3 or less: MS does not interfere with my activities, especially my walking. I can work a full day, but athletic or physically demanding activities are more difficult than they used to be. I usually don't need a can or other assistance to walk, but I might need some assistance during an attack.
- Moderate to Severe cognitive impairment as identified by the St. Louis University Mental Status Exam Score <=20
- History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia, clotting disorders
- Systolic BP >= 180 mmHg or Diastolic BP >= 110 mmHg.
- 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 or physical therapist
- Patient report of easy bruising
- Severe lower extremity spasticity as defined as Modified Ashworth scale >2.
- Engaged in progressive resistance training program currently or in the previous 2 months prior to enrollment.
- Use of blood flow restriction currently or in the previous 2 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.
- Unable to perform seated leg press exercise or no against gravity knee extension strength in at least one limb.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-Load Exercise with Blood Flow Restriction
The BFR intervention will combine low-load resistance training with between 60%-80% blood flow occlusion under the supervision of a licensed physical therapist.
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Participants in the BFR group will attend a 10-week, twice weekly intervention exercise session combining low-load resistance training with at least 60% blood flow occlusion.
Standard education regarding the importance of exercise for people with MS will also be provided.
All participants will also be asked to practice a home exercise program focusing on functional tasks one time a week.
Other Names:
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Active Comparator: Low-Load Exercise Control
The control group with consist only of low-load resistance training under the supervision of a licensed physical therapist.
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Participants in the Control group will attend a 10-week, twice weekly intervention exercise session combining low-load resistance training.
Standard education regarding the importance of exercise for people with MS will also be provided.
All participants will also be asked to practice a home exercise program focusing on functional tasks one time a week.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quadriceps muscle strength
Time Frame: Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11)
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Quadriceps muscle strength measured using dynamometry.
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Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle morphology
Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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Muscle morphology is measured using ultrasonography to determine thickness and echogenicity.
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Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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30-second sit to stand
Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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The number of times the participant can transition from sitting to standing in 30 seconds.
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Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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Modified Fatigue Impact Scale
Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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A 21-item questionnaire describing how fatigue may affect a person.
Scores range from 0 to 84 with higher scores indicating more fatigue.
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Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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A test administered by a trained professional consisting of 14 predetermined tasks, each of which are scored on a scale from 0 to 4. Total scores range from 0 to 56 with higher scores indicating better balance.
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Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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Activity Monitor Sedentary Time
Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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Sedentary time is measured using an ActivPal device and is defined as time spent sitting, lying, or sleeping.
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Change between Baseline (Week 0) and Primary Endpoint (Week 11)
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Collaborators and Investigators
Investigators
- Principal Investigator: Mark M Manago, PT, Rocky Mountain Regional VA Medical Center, Aurora, CO
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F4242-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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