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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Resistance training will target knee and hip extension, knee and hip flexion, and ankle plantarflexion 2x/week for 10 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests strength training with blood flow restriction (BFR), which uses a device to partly block blood flow to a limb during exercise. It is for adults with multiple sclerosis (MS) who need help walking or use a wheelchair, with a focus on enrolling Veterans. Researchers hope to improve strength, movement, tiredness, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of MS.
  • Be 18 to 75 years old.
  • Have a Patient Determined Disease Steps (PDDS) score of 4 to 7. This means you need support to walk, such as a cane or walker, or mainly use a wheelchair or scooter.

Who can't join

  • Have a PDDS score of 8 (cannot sit in a wheelchair for more than one hour) or 3 or lower (usually do not need help walking).
  • Have moderate to severe trouble with memory or thinking, with a score of 20 or lower on the St. Louis University Mental Status Exam.
  • Have a history of blood clots in deep veins or the lungs, poor blood flow in the limbs, or blood-clotting disorders; or report bruising easily.
  • Have blood pressure with a top number of 180 or higher or a bottom number of 110 or higher.
  • Have another health condition, pain, or ongoing treatment that greatly limits movement or makes the exercise program unsafe, as judged by a neurologist or physical therapist.
  • Have severe leg muscle stiffness (Modified Ashworth score above 2), cannot do a seated leg press, or have no strength to straighten at least one knee against gravity.
  • Are doing a strength program that gets harder over time or using BFR now, or did either in the past 2 months.
  • Had an MS flare-up or a change in medicine that slows MS in the past month, or cannot tolerate the pressure cuff at the first assessment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

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