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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

Must not have

History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia, clotting disorders

PDDS 3 or less: MS does not interfere with activities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline (week 0) and primary endpoint (week 11)

Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a cane to walk because of my condition.

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I need help to walk.

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I have been diagnosed with multiple sclerosis.

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I am between 18 and 75 years old.

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I need a cane to walk because of my condition.

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I use a wheelchair or scooter for mobility.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of blood clots or clotting disorders.

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My MS allows me to do daily activities without help.

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I have other health conditions or pain that affect my physical abilities.

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I cannot do a seated leg press or fully straighten my knee against gravity in at least one leg.

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I cannot sit in a wheelchair for more than an hour.

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My legs are very stiff, scoring over 2 on a spasticity scale.

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I bruise easily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline (week 0) and primary endpoint (week 11)

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

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.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,628 Previous Clinical Trials

3,325,921 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

~39 spots leftby Dec 2027

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