Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis: A Three-Arm Randomized Controlled Trial

Not yet recruitingNot a drug-phase studyRelapsing MSNCT07645937

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Blood Flow Restriction Training

Placebo

  • Sham Blood Flow Restriction

Given to everyone in the trial

  • Low-Load Exercise Program

What it measured

Main measures

  • Change in Rectus Femoris Muscle Thickness

    Baseline and Week 8

Who could take part

Relapsing MS · 18 to 65 · EDSS 2.5 to 3.5

Show the full criteria

Inclusion criteria

Inclusion Criteria:* Age 18-65 years * Diagnosis of relapsing-remitting multiple sclerosis according to revised McDonald criteria * EDSS score between 2.5 and 3.5 * Clinically stable disease * No relapse within the previous 3 months * No corticosteroid treatment within the previous 3 months * Ability to participate in exercise training * Written informed consent Exclusion Criteria:* Deep vein thrombosis or pulmonary embolism history * Peripheral vascular disease * Uncontrolled hypertension * Severe cardiovascular disease * Pregnancy * Recent lower extremity surgery or injury * Musculoskeletal or neurological conditions interfering with exercise participation * Contraindications to blood flow restriction training * Participation in another structured exercise trial during the study period

Exclusion criteria

Not separately supplied in the registry.

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

Contact details on the registry

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a chronic neurological disease associated with reduced muscle strength, impaired mobility, increased fatigue, and deterioration in muscle morphology. Rectus femoris muscle atrophy and reduced muscle quality have been linked to functional limitations and decreased mobility in individuals with MS. Blood flow restriction (BFR) training is a rehabilitation strategy that combines low-load exercise with partial vascular occlusion, enabling muscular adaptations comparable to those achieved with higher exercise loads. Although BFR has demonstrated promising results in several clinical populations, evidence regarding its effects on muscle morphology in individuals with relapsing-remitting multiple sclerosis (RRMS) remains limited. The purpose of this randomized controlled trial is to investigate the effects of low-load BFR exercise on rectus femoris muscle morphology in individuals with RRMS. Thirty participants with RRMS (EDSS 2.5-3.5) will be randomly assigned to one of three groups: a BFR exercise group, a sham-BFR exercise group, or an exercise-only control group. All participants will complete the same supervised exercise program twice weekly for eight weeks. The primary outcome will be rectus femoris muscle thickness assessed by ultrasonography. Secondary outcomes will include rectus femoris echo intensity, knee extensor muscle strength, Timed 25-Foot Walk performance, Nine-Hole Peg Test performance, Symbol Digit Modalities Test scores, and Modified Fatigue Impact Scale scores. This study aims to determine whether the addition of blood flow restriction to a standardized low-load exercise program results in superior morphological and functional adaptations compared with sham-BFR and exercise-only conditions in individuals with RRMS.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2026

    2. Main results due

      Mar 2027

    3. Finished

      Apr 2027

    Assembled by software from public sources.