Blood Flow Restriction And Veterans With MS

NCT05433103 | Recruiting

• 1 other identifier: F4242-W
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quadriceps muscle strength

  Quadriceps muscle strength measured using dynamometry.

  Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11)

Secondary Outcomes (3)

• Muscle morphology

  Change between Baseline (Week 0) and Primary Endpoint (Week 11)

• 30-second sit to stand

  Change between Baseline (Week 0) and Primary Endpoint (Week 11)

• Modified Fatigue Impact Scale

  Change between Baseline (Week 0) and Primary Endpoint (Week 11)

Other Outcomes (2)

• Berg Balance Scale

  Change between Baseline (Week 0) and Primary Endpoint (Week 11)

• Activity Monitor Sedentary Time

  Change between Baseline (Week 0) and Primary Endpoint (Week 11)

Study Arms (2)

Low-Load Exercise with Blood Flow Restriction

EXPERIMENTAL

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

Other: Low-Load Exercise with Blood Flow Restriction

Low-Load Exercise Control

ACTIVE COMPARATOR

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

Other: Low-Load Exercise Control Group

Interventions

Low-Load Exercise with Blood Flow Restriction OTHER

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.

Also known as: BFR

Low-Load Exercise with Blood Flow Restriction

Low-Load Exercise Control Group OTHER

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.

Also known as: Control

Low-Load Exercise Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Mark M Manago, PT

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark M Manago, PT

CONTACT

(303) 399-8020; mark.manago@va.gov

Eliza A Biondi

CONTACT

(303) 724-9170; eliza.biondi@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Outcomes Assessor will be blinded to group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized control trial with two groups.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)