Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis (BFR-MS)

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: Blood Flow Restriction Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04633759

205593 (Other Grant/Funding Number)

20-0695

Details and patient eligibility

About

The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.

Full description

Specific Aim 1: Determine the feasibility of BFR by assessing recruitment rate, retention, adherence, satisfaction, and safety.

Hypothesis: Feasibility will be demonstrated by: 1) enrolling 20 participants in 8 months, 2) retaining at least 16 (80%) participants, 3) 80% adherence to intervention, 4) 90% satisfaction with intervention, and 5) no serious adverse events related to the intervention.

Specific Aim 2: Determine changes in knee and hip extension, hip abduction, and ankle plantarflexion muscle strength after the 8-week intervention.

Hypothesis: Following intervention there will be clinically important within-group strength changes that correspond to established minimal detectable change values and which can be characterized as having at least a moderate effect size as defined by Cohen's d.

Exploratory Aim: Explore changes in functional mobility (30-Second Sit-to-Stand, Berg Balance Scale, Timed 25-Foot Walk. 10-day average activity level) and self-report measures (12-Item MS Walking Scale, Modified Fatigue Impact Scale, MS Impact Scale-29, and Patient-Specific Functional Scale) after the 8-week intervention.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults ages 18-70
Neurologist-confirmed diagnosis of multiple sclerosis
Expanded Disability Status Scale (EDSS) 6.0 to 7.0
- EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
- EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting
- EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day

Exclusion criteria

EDSS 7.5 or greater: Restricted to wheelchair for all mobility, unable to walk more than a few steps, even with walking aid
EDSS 5.5 or less: Able to walk more than 100 meters without walking aid or rest
Unable to provide consent or follow simple directions
Prior history of Deep Venous Thrombosis/ Pulmonary Embolism
History of peripheral vascular disease, thrombophilia or other clotting disorders
Patient report of easy bruising
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 of physical therapist
Severe lower extremity spasticity as defined as Modified Ashworth scale > 2
Currently undergoing supervised resistance training with a physical therapist or other exercise professional
Use of Blood Flow Restriction currently or in the previous 3 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