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Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
58 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans with multiple sclerosis (MS) who have advanced disability. Participants will engage in a strength training program that uses a special device to improve muscle strength with lower intensity exercise.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with multiple sclerosis.
I am between 18 and 75 years old.
My MS disability level is 4 to 7.
You may not be able to join if
I cannot sit in a wheelchair for more than one hour.
My MS does not significantly impact my walking ability.
I have a history of blood clots or clotting disorders.
My blood pressure is too high.
I have severe cognitive impairment.
I experience severe lower leg muscle stiffness.
I have had a worsened condition or changes in medication recently.
I cannot perform the required leg exercises.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 res…
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.
Trial Locations
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Status
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,…
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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