Recruiting

Blood Flow Restriction

Sponsor:

VA Office of Research and Development

Code:

NCT05433103

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low-Load Exercise with Blood Flow Restriction

Low-Load Exercise Control Group

Study Details

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 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.

Conditions

Multiple Sclerosis

Study ID

NCT05433103

Start date

Jan 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Low-Load Exercise with Blood Flow Restriction

The BFR intervention will combine low-load resistance training with between 60%-80% blood flow occlusion under the supervision of a licensed physical therapist.

active comparator: Low-Load Exercise Control

The control group with consist only of low-load resistance training under the supervision of a licensed physical therapist.

Interventions

Low-Load Exercise with Blood Flow Restriction

Participants in the BFR group will attend a 10-week, twice weekly intervention exercise session combining low-load resistance training with at least 60% blood flow occlusion. Standard education regarding the importance of exercise for people with MS will also be provided. All participants will also be asked to practice a home exercise program focusing on functional tasks one time a week.

Low-Load Exercise Control Group

Participants in the Control group will attend a 10-week, twice weekly intervention exercise session combining low-load resistance training. Standard education regarding the importance of exercise for people with MS will also be provided. All participants will also be asked to practice a home exercise program focusing on functional tasks one time a week.

Primary outcome measure

  • Quadriceps muscle strength [ Time Frame: Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11) ]

Central Contacts and Locations

Central contacts

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Principal Investigator:

Mark M Manago, PT

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Multiple Sclerosis
  • Blood Flow Restriction
  • Exercise
  • Low-load resistance training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-23.