Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis

NCT07645937 | Not Yet Recruiting

• 1 other identifier: RRMS-BFR-RCT-2026
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

Relapsing-Remitting Multiple Sclerosis; Blood Flow Restriction; BFR Training; Rectus Femoris; Muscle Morphology

Outcome Measures

Primary Outcomes (1)

• Change in Rectus Femoris Muscle Thickness

  Rectus femoris muscle thickness will be assessed using B-mode ultrasonography. Measurements will be obtained at baseline and after the 8-week intervention period. The primary outcome will be the change in rectus femoris muscle thickness from baseline to post-intervention.

  Baseline and Week 8

Study Arms (3)

BFR Exercise Group

EXPERIMENTAL

Participants will perform a supervised low-load exercise program twice weekly for 8 weeks combined with blood flow restriction applied to both proximal thighs at 50-60% of individually determined arterial occlusion pressure during the strengthening component of the intervention.

Device: Blood Flow Restriction Training; Behavioral: Low-Load Exercise Program

Sham BFR Group

SHAM COMPARATOR

Participants will perform the same supervised low-load exercise program twice weekly for 8 weeks. Pneumatic cuffs will be applied to both proximal thighs but inflated to a pressure insufficient to produce meaningful vascular occlusion.

Device: Sham Blood Flow Restriction; Behavioral: Low-Load Exercise Program

Exercise Control Group

ACTIVE COMPARATOR

Participants will perform the same supervised low-load exercise program twice weekly for 8 weeks without blood flow restriction.

Behavioral: Low-Load Exercise Program

Interventions

Sham Blood Flow Restriction DEVICE

Low-load exercise performed with pneumatic cuffs applied to both proximal thighs but inflated to a pressure insufficient to produce meaningful vascular occlusion.

Sham BFR Group

Blood Flow Restriction Training DEVICE

Low-load exercise performed with individualized blood flow restriction applied to both proximal thighs using pneumatic cuffs inflated to 50-60% of arterial occlusion pressure.

BFR Exercise Group

Low-Load Exercise Program BEHAVIORAL

Participants will perform a supervised low-load exercise program twice weekly for 8 weeks. The exercise program will include warm-up activities, quadriceps-focused strengthening exercises, cycling exercise, and cool-down activities. The same exercise program will be applied to all study groups.

BFR Exercise Group; Exercise Control Group; Sham BFR Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanifi Bal: lead
• Dicle University: collaborator

Related Publications (3)

• Langdon DW, Amato MP, Boringa J, Brochet B, Foley F, Fredrikson S, Hamalainen P, Hartung HP, Krupp L, Penner IK, Reder AT, Benedict RH. Recommendations for a Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). Mult Scler. 2012 Jun;18(6):891-8. doi: 10.1177/1352458511431076. Epub 2011 Dec 21.

  PMID: 22190573 BACKGROUND

• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

  PMID: 6685237 BACKGROUND

• Benedict RH, Amato MP, Boringa J, Brochet B, Foley F, Fredrikson S, Hamalainen P, Hartung H, Krupp L, Penner I, Reder AT, Langdon D. Brief International Cognitive Assessment for MS (BICAMS): international standards for validation. BMC Neurol. 2012 Jul 16;12:55. doi: 10.1186/1471-2377-12-55.

  PMID: 22799620 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• seçil özkurt, Dr.

  Istinye University

  STUDY DIRECTOR

Central Study Contacts

Hanifi BAL, pt

CONTACT

+905532139440; fzt.hanifibal@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by evaluators who are blinded to group allocation. Ultrasonographic and clinical outcome measurements will be conducted by assessors who are not informed of participants' intervention assignments. Participants and treating therapists will not be blinded because of the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ınvestigator

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) low-load exercise with blood flow restriction (BFR), (2) low-load exercise with sham blood flow restriction, or (3) low-load exercise without blood flow restriction (control). All groups will perform the same supervised exercise program twice weekly for 8 weeks. The only systematic difference between groups will be the cuff condition applied during the strengthening component of the intervention.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share