Blood Flow Restriction And Veterans With MS (NCT05433103) | Clinical Trial Compass
RecruitingNot Applicable
Blood Flow Restriction And Veterans With MS
United States58 participantsStarted 2023-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Confirmed diagnosis of MS
✓. Age 18-75
✓. Patient Determined Disease Steps (PDDS) 4 to 7
Exclusion criteria
✕. 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.
✕. 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
✕. Systolic BP \>= 180 mmHg or Diastolic BP \>= 110 mmHg.
✕. 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
What they're measuring
1
Quadriceps muscle strength
Timeframe: Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11)