Low Load Resistance Training Using Blood Flow Restriction for People W

Feasibility of Low-load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis and Marked Mobility Restriction

CompletedNot a drug-phase studyMS (type not specified)NCT04633759

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Blood Flow Restriction Exercise

Results by group

Change in Knee Extension Muscle Strength (More-involved Side)

Measured at Baseline (Week 0) and Post Test (Week 9)

GroupValueIntervalNumber analysed
Blood Flow Restriction Exercise0.11 kg0.02–0.2114

Change in Hip Abduction Muscle Strength (More-involved Side)

Measured at Baseline (Week 0) and Post Test (Week 9)

GroupValueIntervalNumber analysed
Blood Flow Restriction Exercise0.05 kg0–0.114

Change in Ankle Plantarflexion Muscle Strength (More-involved Side)

Measured at Baseline (Week 0) and Post Test (Week 9)

GroupValueIntervalNumber analysed
Blood Flow Restriction Exercise0.16 kg0.03–0.2914

Change in Knee Extension Muscle Strength (Less-involved Side)

Measured at Baseline (Week 0) and Post Test (Week 9)

GroupValueIntervalNumber analysed
Blood Flow Restriction Exercise0.11 kg0.03–0.1914

Change in Hip Abduction Muscle Strength (Less-involved Side)

Measured at Baseline (Week 0) and Post Test (Week 9)

GroupValueIntervalNumber analysed
Blood Flow Restriction Exercise0.05 kg0.02–0.0914

Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)

Measured at Baseline (Week 0) and Post Test (Week 9)

GroupValueIntervalNumber analysed
Blood Flow Restriction Exercise0.14 kg0.04–0.2514

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Blood Flow Restriction Exercise140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in Knee Extension Muscle Strength (More-involved Side)

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Physical function

  • Change in Hip Abduction Muscle Strength (More-involved Side)

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Physical function

  • Change in Ankle Plantarflexion Muscle Strength (More-involved Side)

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Physical function

  • Change in Knee Extension Muscle Strength (Less-involved Side)

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Physical function

  • Change in Hip Abduction Muscle Strength (Less-involved Side)

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Physical function

  • Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Physical function

Other measures (7)

  • Change in 30-second Sit-to-stand Completions

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Walking and mobility

  • Change in Berg Balance Scale

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Walking and mobility

  • Change in Timed 25-foot Walk

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Disability progressionWalking and mobility

  • Change in Activity Level

    Measured at Baseline (Week 0) and Post Test (Week 9)

  • Change in 12-Item MS Walking Scale

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Walking and mobility

  • Change in Modified Fatigue Impact Scale

    Measured at Baseline (Week 0) and Post Test (Week 9)

    Fatigue

  • Change in MS Patient-Specific Function Scale

    Measured at Baseline (Week 0) and Post Test (Week 9)

Who could take part

MS (type not specified) · 18 to 70 · EDSS 6.0 to 7.0

Show the full criteria

Inclusion criteria

* Adults ages 18-70 * Neurologist-confirmed diagnosis of multiple sclerosis * Expanded Disability Status Scale (EDSS) 6.0 to 7.0 * EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting * EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting * EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day

Exclusion criteria

* EDSS 7.5 or greater: Restricted to wheelchair for all mobility, unable to walk more than a few steps, even with walking aid * EDSS 5.5 or less: Able to walk more than 100 meters without walking aid or rest * Unable to provide consent or follow simple directions * Prior history of Deep Venous Thrombosis/ Pulmonary Embolism * History of peripheral vascular disease, thrombophilia or other clotting disorders * Patient report of easy bruising * Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist of physical therapist * Severe lower extremity spasticity as defined as Modified Ashworth scale > 2 * Currently undergoing supervised resistance training with a physical therapist or other exercise professional * Use of Blood Flow Restriction currently or in the previous 3 months prior to enrollment * MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment * Inability to tolerate pressure cuff during baseline assessment

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2021

    2. Main results due

      Oct 2022

    3. Finished

      Oct 2022

    4. Results posted

      Jun 2026

    Assembled by software from public sources.