RECRUITING

Blood Flow Restriction And Veterans With MS

Conditions

Multiple Sclerosis Blood Flow Restriction Exercise Low-load resistance training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05433103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Mark M Manago, PT

CONTACT

(303) 399-8020

mark.manago@va.gov

Eliza A Biondi

CONTACT

(303) 724-9170

eliza.biondi@va.gov

Principal Investigator

Mark M Manago, PT

PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Locations (Sites)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Mark M Manago, PT, PRINCIPAL_INVESTIGATOR, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Multiple Sclerosis
Blood Flow Restriction
Exercise
Low-load resistance training

Additional Relevant MeSH Terms

Multiple Sclerosis