NCT05433103Recruiting
Blood Flow Restriction And Veterans With MS
Low-Load Resistance Training With Blood Flow Restriction in People With Multiple Sclerosis and Advanced Disability: A Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
There currently is a lack of evidence to support exercise interventions in people with advanced disability due to MS (i.e., need assistance to walk or use a wheelchair). This project proposes to study a strength training program using blood flow restriction (BFR) in people with advanced disability due to MS. BFR uses a device that partially blocks blood flow to the exercising limb and causes a response in the muscle which can replicate the effects of high-intensity training using much lower intensities. This is ideal for people with MS who have advanced disability, as they often cannot tolerate higher intensity exercise due to severe weakness and fatigue. By studying BFR training in people with advanced disability due to MS, the investigators hope to help improve strength, mobility, fatigue, and quality of life in people with MS. This study will target enrollment of Veterans with MS, who tend to have more advanced disability than non-Veterans with MS.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 21 Jun 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Multiple sclerosis
- NCT number
- NCT05433103
What you commit to
- Study type: Interventional
- Planned participants: 58
- From 1 Jan 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- 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
Other
- 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.
- Systolic BP \>= 180 mmHg or Diastolic BP \>= 110 mmHg.
- Patient report of easy bruising
- Severe lower extremity spasticity as defined as Modified Ashworth scale \>2.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.