CompletedNot Applicable

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

United States16 participantsStarted 2021-02-19

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 prof…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Knee Extension Muscle Strength (More-involved Side)

Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)

Change in Hip Abduction Muscle Strength (More-involved Side)

Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)

Change in Ankle Plantarflexion Muscle Strength (More-involved Side)

Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)

Change in Knee Extension Muscle Strength (Less-involved Side)

Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)

Change in Hip Abduction Muscle Strength (Less-involved Side)

Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)

Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)

Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)

Trial details

NCT IDNCT04633759

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-05

Results submitted2022-12-20

View on ClinicalTrials.gov More Multiple Sclerosis trials