New exercise method aims to boost strength in MS patients with severe disability
NCT ID NCT05433103
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a strength training program using blood flow restriction (BFR) in people with advanced multiple sclerosis (MS) who need help walking or use a wheelchair. BFR uses a device that partially blocks blood flow to the exercising limb, allowing low-intensity exercise to build muscle like high-intensity training. The goal is to improve strength, mobility, fatigue, and quality of life. The study enrolls 58 Veterans with MS.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed diagnosis of MS 2. Age 18-75 3. 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: 1. PDDS 8: Unable to sit in a wheelchair for more than one hour. 2. 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. 3. Moderate to Severe cognitive impairment as identified by the St. Louis University Mental Status Exam Score \<=20 4. History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia, clotting disorders 5. Systolic BP \>= 180 mmHg or Diastolic BP \>= 110 mmHg. 6. 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 7. Patient report of easy bruising 8. Severe lower extremity spasticity as defined as Modified Ashworth scale \>2. 9. Engaged in progressive resistance training program currently or in the previous 2 months prior to enrollment. 10. Use of blood flow restriction currently or in the previous 2 months prior to enrollment. 11. MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment. 12. Inability to tolerate pressure cuff during baseline assessment. 13. Unable to perform seated leg press exercise or no against gravity knee extension strength in at least one limb.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rocky Mountain Regional VA Medical Center, Aurora, CO
RECRUITINGAurora, Colorado, 80045-7211, United States
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Other studies related to the condition(s) this trial covers.
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