Blood Flow Restriction And Veterans With MS (BRAVe-MS)
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|ClinicalTrials.gov Identifier: NCT05433103|
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : January 19, 2023
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Low-Load Exercise with Blood Flow Restriction Other: Low-Load Exercise Control Group||Not Applicable|
Multiple Sclerosis (MS) is a chronic neurological disorder affecting about 1 million Americans. Among the many MS symptoms, muscle weakness is among the most common, contributes to decreased mobility, and worsens as disability advances. While there is strong evidence that moderate-to-high intensity resistance training improves muscle strength in people with MS and low disability, there is little evidence evaluating resistance training in people with advanced disability due to MS (i.e., those who need assistance to walk or use a wheelchair). People with advanced disability due to MS require unique approaches to resistance training as they often cannot tolerate higher intensity exercise because of severe weakness and fatigue. Blood flow restriction (BFR) has the potential to address these issues. With BFR, resistance training at low intensities has been shown to be as effective as high intensity training without BFR at increasing muscle strength and hypertrophy in people with a variety of musculoskeletal conditions. The preliminary data supports the safety, feasibility, and tolerance of BFR resistance training in people with advanced disability due to MS. The objective of the currently proposed study is to evaluate the efficacy of low-load resistance training with BFR on muscle strength, mobility, and fatigue in people with advanced disability due to MS.
This proposed Phase II clinical trial will target enrollment of Veterans with MS, who would often have more severe symptoms, worse mobility, and more advanced disability compared to non-Veterans with MS. The study hopes to address a crucial gap that is highly relevant for Veterans with MS:
interventions to improve mobility and optimize function for those with advanced disability. Fifty-eight participants with MS and advanced disability will be randomized (1:1) to low-load resistance training with BFR (experimental) or without BFR (control). Resistance training will target knee and hip extension, knee and hip flexion, and ankle plantarflexion 2x/week for 10 weeks. A blinded assessor will collect outcomes at baseline, post- intervention (primary endpoint), and after 8 weeks of follow-up. The Study Aims are to determine between-group differences in 1) Muscle health: quadriceps strength (primary outcome) and muscle morphology (thickness and echogenicity); 2) Mobility: 30-Second Sit-to-Stand; and 3) Self-reported fatigue: Modified Fatigue Impact Scale. The investigators hypothesize that the experimental group will have significantly greater improvements in muscle strength and thickness, mobility, and self-reported fatigue compared to the control group. The long-term goal of this research is to develop clinically feasible exercise interventions for people with advanced disability due to MS that can improve participation, quality of life, and disability.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized control trial with two groups.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Investigator and Outcomes Assessor will be blinded to group allocation|
|Primary Purpose:||Supportive Care|
|Official Title:||Low-Load Resistance Training With Blood Flow Restriction in People With Multiple Sclerosis and Advanced Disability: A Randomized Control Trial|
|Actual Study Start Date :||January 1, 2023|
|Estimated Primary Completion Date :||December 31, 2027|
|Estimated Study Completion Date :||December 31, 2027|
Experimental: Low-Load Exercise with Blood Flow Restriction
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
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.
Other Name: BFR
Active Comparator: Low-Load Exercise Control
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
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.
Other Name: Control
- Quadriceps muscle strength [ Time Frame: Change in muscle strength between Baseline (Week 0) and Primary Endpoint (Week 11) ]Quadriceps muscle strength measured using dynamometry.
- Muscle morphology [ Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11) ]Muscle morphology is measured using ultrasonography to determine thickness and echogenicity.
- 30-second sit to stand [ Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11) ]The number of times the participant can transition from sitting to standing in 30 seconds.
- Modified Fatigue Impact Scale [ Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11) ]A 21-item questionnaire describing how fatigue may affect a person. Scores range from 0 to 84 with higher scores indicating more fatigue.
- Berg Balance Scale [ Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11) ]A test administered by a trained professional consisting of 14 predetermined tasks, each of which are scored on a scale from 0 to 4. Total scores range from 0 to 56 with higher scores indicating better balance.
- Activity Monitor Sedentary Time [ Time Frame: Change between Baseline (Week 0) and Primary Endpoint (Week 11) ]Sedentary time is measured using an ActivPal device and is defined as time spent sitting, lying, or sleeping.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05433103
|Contact: Mark M Manago, PT||(303) firstname.lastname@example.org|
|Contact: Emily R Hager, BS MS||(303) email@example.com|
|United States, Colorado|
|Rocky Mountain Regional VA Medical Center, Aurora, CO||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Mark M Manago, PT 303-399-8020 firstname.lastname@example.org|
|Contact: Emily R Hager, BS MS (303) 724-6035 email@example.com|
|Principal Investigator: Mark M Manago, PT|
|Principal Investigator:||Mark M Manago, PT||Rocky Mountain Regional VA Medical Center, Aurora, CO|