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Behavioural Intervention

Blood Flow Restriction Exercise for Multiple Sclerosis (BRAVe-MS Trial)

N/A
Recruiting
Led By Mark M Manago, PT
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PDDS 5: Late cane
PDDS 6: Bilateral support
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline (week 0) and primary endpoint (week 11)
Awards & highlights

BRAVe-MS Trial Summary

This trial will study the effects of strength training using blood flow restriction in people with advanced disability due to MS. The goal is to help improve strength, mobility, fatigue, and quality of life.

Who is the study for?
This trial is for Veterans aged 18-75 with a confirmed MS diagnosis who need assistance to walk or use a wheelchair but can sit in one for over an hour. They should not have severe cognitive issues, recent blood clots, extremely high blood pressure, intense leg muscle stiffness, or be on certain MS treatments.Check my eligibility
What is being tested?
The study tests a strength training program using Blood Flow Restriction (BFR) designed for those with advanced disability from MS. BFR partially blocks blood flow during exercise, simulating high-intensity workouts at lower intensities which may improve strength and quality of life.See study design
What are the potential side effects?
Potential side effects might include discomfort from the pressure cuff used to restrict blood flow and possible bruising. Since it's low intensity exercise, other risks are likely minimal but could include typical exercise-related strain.

BRAVe-MS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need a cane to walk because of my condition.
Select...
I need help to walk.
Select...
I have been diagnosed with multiple sclerosis.
Select...
I am between 18 and 75 years old.
Select...
I need a cane to walk because of my condition.
Select...
I use a wheelchair or scooter for mobility.

BRAVe-MS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline (week 0) and primary endpoint (week 11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline (week 0) and primary endpoint (week 11) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quadriceps muscle strength
Secondary outcome measures
30-second sit to stand
Modified Fatigue Impact Scale
Muscle morphology
Other outcome measures
Activity Monitor Sedentary Time
Berg Balance Scale

BRAVe-MS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low-Load Exercise with Blood Flow RestrictionExperimental Treatment1 Intervention
The BFR intervention will combine low-load resistance training with between 60%-80% blood flow occlusion under the supervision of a licensed physical therapist.
Group II: Low-Load Exercise ControlActive Control1 Intervention
The control group with consist only of low-load resistance training under the supervision of a licensed physical therapist.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,394 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
1,140 Patients Enrolled for Multiple Sclerosis
Mark M Manago, PTPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO

Media Library

Low-Load Exercise with Blood Flow Restriction (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05433103 — N/A
Multiple Sclerosis Research Study Groups: Low-Load Exercise with Blood Flow Restriction, Low-Load Exercise Control
Multiple Sclerosis Clinical Trial 2023: Low-Load Exercise with Blood Flow Restriction Highlights & Side Effects. Trial Name: NCT05433103 — N/A
Low-Load Exercise with Blood Flow Restriction (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05433103 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to be a part of this clinical investigation?

"To be eligible for inclusion in this medical trial, participants should have been diagnosed with multiple sclerosis and must fall between the ages of 18-70. The goal is to recruit a total of 58 patients."

Answered by AI

Are there any vacancies left within this research trial?

"The clinicaltrials.gov website informs us that this study, originally posted on January 1st 2023 and last updated on November 3rd 2022, is not presently open for recruitment. However, 553 other medical trials are currently in the process of finding suitable patients."

Answered by AI

Are individuals over the age of 35 eligible to participate in this trial?

"The need for participants in this particular medical trial is limited to individuals aged 18 - 70. However, there are 44 trials available for minors and 394 clinical studies that cater specifically to patients 65 years old or older."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Blood Flow Restriction And Veterans With MS
2023. "Blood Flow Restriction And Veterans With MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05433103.
All > Multiple Sclerosis
~39 spots leftby Dec 2027
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