Trial Outcomes & Findings for Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis (NCT NCT04633759)
NCT ID: NCT04633759
Last Updated: 2026-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Measured at Baseline (Week 0) and Post Test (Week 9)
Results posted on
2026-06-09
Participant Flow
Participant recruitment occurred in collaboration with the UCHealth Movement Disorders Clinic.
Participants were pre-screened over the telephone prior to baseline testing. Enrollment occurred upon signing of the consent form at the beginning of the baseline testing session. Participants were then fully screened to determine final inclusion status prior to beginning intervention.
Participant milestones
| Measure |
Blood Flow Restriction Exercise
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 6.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=20 Participants
|
|
Expanded Disability Status Scale
|
6.5 units on a scale
STANDARD_DEVIATION 0.4 • n=20 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Knee Extension Muscle Strength (More-involved Side)
|
0.11 kg
Interval 0.02 to 0.21
|
PRIMARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Hip Abduction Muscle Strength (More-involved Side)
|
0.05 kg
Interval 0.0 to 0.1
|
PRIMARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Ankle Plantarflexion Muscle Strength (More-involved Side)
|
0.16 kg
Interval 0.03 to 0.29
|
PRIMARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Knee Extension Muscle Strength (Less-involved Side)
|
0.11 kg
Interval 0.03 to 0.19
|
PRIMARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Hip Abduction Muscle Strength (Less-involved Side)
|
0.05 kg
Interval 0.02 to 0.09
|
PRIMARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)
|
0.14 kg
Interval 0.04 to 0.25
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in 30-second Sit-to-stand Completions
|
1.9 Sit-to-stand completions
Interval 1.0 to 2.8
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Berg Balance Scale
|
5.2 score on a scale
Interval 3.2 to 7.4
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)Functional mobility test measuring the time it takes a participant to walk 25 feet
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Timed 25-foot Walk
|
-3.3 seconds
Interval -7.9 to 1.3
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)10-day average of activity level as measured by a wearable activity monitor
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Activity Level
|
333 Steps
Interval -191.0 to 857.0
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking)
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in 12-Item MS Walking Scale
|
-8.8 score on a scale
Interval -11.5 to 4.4
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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)
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in Modified Fatigue Impact Scale
|
-8.8 score on a scale
Interval -16.5 to -1.1
|
SECONDARY outcome
Timeframe: Measured at Baseline (Week 0) and Post Test (Week 9)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.
Outcome measures
| Measure |
Blood Flow Restriction Exercise
n=14 Participants
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
Change in MS Patient-Specific Function Scale
|
2.8 score on a scale
Interval 1.9 to 3.8
|
Adverse Events
Blood Flow Restriction Exercise
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blood Flow Restriction Exercise
n=14 participants at risk
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
Blood Flow Restriction Exercise: 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.
|
|---|---|
|
General disorders
Edema Limbs
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected across the 10 weeks of study participation.
|
|
General disorders
Fall
|
42.9%
6/14 • Number of events 7 • Adverse Event data was collected across the 10 weeks of study participation.
|
|
General disorders
Muscle Strain
|
14.3%
2/14 • Number of events 2 • Adverse Event data was collected across the 10 weeks of study participation.
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected across the 10 weeks of study participation.
|
|
Infections and infestations
COVID-19
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected across the 10 weeks of study participation.
|
|
Cardiac disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected across the 10 weeks of study participation.
|
Additional Information
Mark Manago
University of Colorado Denver, Anschutz Medical Campus
Phone: 303-724-9101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place