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.
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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS.
University of Colorado
Aurora, Colorado, United States
Change in Knee Extension Muscle Strength (More-involved Side)
Knee extension muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Hip Abduction Muscle Strength (More-involved Side)
Hip abduction muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Ankle Plantarflexion Muscle Strength (More-involved Side)
Ankle plantarflexion muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Knee Extension Muscle Strength (Less-involved Side)
Knee extension muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Hip Abduction Muscle Strength (Less-involved Side)
Hip abduction muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)
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Masking
NONE
Enrollment
16
Ankle plantarflexion muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in 30-second Sit-to-stand Completions
Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Berg Balance Scale
Functional mobility test measuring the participant's ability to balance in different postures. Scores on the Berg Balance Scale range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Timed 25-foot Walk
Functional mobility test measuring the time it takes a participant to walk 25 feet
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Activity Level
10-day average of activity level as measured by a wearable activity monitor
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in 12-Item MS Walking Scale
Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking)
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Modified Fatigue Impact Scale
Self-report questionnaire measuring fatigue caused by MS with scores ranging from 0 (no impact of fatigue in the past 4 weeks) to 84 (maximum impact of fatigue in the past 4 weeks)
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)
Change in MS Patient-Specific Function Scale
Self-report questionnaire measuring the ability of the participant to do three self-identified activities. Scores of each of the 3 activities range from 0 (unable to perform) to 10 (able to perform without difficulty). The score is the average of the 3 activities, with higher scores indicating better function.
Time frame: Measured at Baseline (Week 0) and Post Test (Week 9)