Status:
RECRUITING
Blood Flow Restriction And Veterans With MS
Lead Sponsor:
VA Office of Research and Development
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed Description
Multiple Sclerosis (MS) is a chronic neurological disorder affecting about 1 million Americans. Among the many MS symptoms, muscle weakness is among the most common, contributes to decreased mobility,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Patient report of easy bruising
- Severe lower extremity spasticity as defined as Modified Ashworth scale \>2.
- 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.
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05433103
Start Date
January 1 2023
End Date
December 31 2027
Last Update
March 14 2025
Active Locations (1)
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1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211