Strength training using blood flow restriction for veterans with advanced multiple sclerosis

Low-Load Resistance Training With Blood Flow Restriction in People With Multiple Sclerosis and Advanced Disability: A Randomized Control Trial

This study tests if a special strength training program using blood flow restriction can help veterans with advanced multiple sclerosis improve their muscle strength, mobility, and overall quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: VA Office of Research and Development (Federal)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05433103 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a strength training program utilizing blood flow restriction (BFR) on veterans with advanced disability due to multiple sclerosis (MS). BFR involves partially blocking blood flow to the exercising limb, allowing low-load resistance training to mimic the benefits of high-intensity workouts, which is particularly beneficial for individuals with severe weakness and fatigue. The trial aims to evaluate improvements in muscle strength, mobility, fatigue, and overall quality of life for participants. By focusing on veterans, who often experience more severe symptoms, the study seeks to provide tailored exercise interventions for this population.

Who should consider this trial

Good fit: Ideal candidates for this study are veterans aged 18-75 with a confirmed diagnosis of multiple sclerosis and advanced disability (PDDS 4 to 7).

Not a fit: Patients with mild multiple sclerosis or those who do not require assistance for mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance strength, mobility, and quality of life for veterans suffering from advanced multiple sclerosis.

How similar studies have performed: Preliminary data suggests that blood flow restriction training has been safe and effective in similar populations, indicating potential for success in this study.

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.

Where this trial is running

Aurora, Colorado

• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Mark M Manago, PT — Rocky Mountain Regional VA Medical Center, Aurora, CO
• Study coordinator: Mark M Manago, PT

Conditions Multiple Sclerosis; Blood Flow Restriction; Exercise; Low-load resistance training