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

9 czerwca 2026 zaktualizowane przez: Hanifi Bal

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

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.

Przegląd badań

Szczegółowy opis

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system characterized by demyelination, axonal degeneration, and progressive functional impairment. Individuals with relapsing-remitting multiple sclerosis (RRMS) frequently experience reductions in lower-extremity muscle strength, impaired walking performance, fatigue, and decreased physical function. Among lower-extremity muscles, the rectus femoris (RF) plays a critical role in knee extension, gait performance, and functional mobility. Previous studies have demonstrated associations between RF muscle morphology, muscle performance, and mobility outcomes in individuals with MS.

Blood flow restriction (BFR) exercise involves the application of external pressure to the proximal portion of a limb during low-load exercise. By partially restricting arterial inflow and substantially reducing venous return, BFR creates a hypoxic and metabolically stressful environment within the exercising muscle. This physiological stimulus promotes early recruitment of fast-twitch motor units and may enhance anabolic signaling pathways despite the use of relatively low exercise loads. Consequently, BFR has emerged as a promising rehabilitation strategy for populations that may not tolerate high-intensity resistance training.

Although preliminary evidence suggests that BFR is feasible and safe in people with MS, existing studies have primarily focused on functional outcomes, and the effects of BFR on muscle morphology remain unclear. Furthermore, no randomized controlled trial has investigated rectus femoris muscle morphology as a primary outcome using a three-arm design incorporating both sham-BFR and exercise-only control conditions.

This study is designed as a prospective, parallel-group, three-arm randomized controlled trial. Thirty individuals with RRMS aged 18-65 years and an Expanded Disability Status Scale (EDSS) score between 2.5 and 3.5 will be recruited. Participants will be randomly allocated in a 1:1:1 ratio to one of three groups:

  1. Low-load exercise with blood flow restriction (BFR).
  2. Low-load exercise with sham blood flow restriction.
  3. Low-load exercise without blood flow restriction (control).

All groups will participate in an identical supervised exercise program twice weekly for eight weeks (16 sessions total). Exercise sessions will include a standardized warm-up period, quadriceps-focused strengthening exercises, cycling exercise, and cool-down/stretching activities. The only systematic difference between groups will be the cuff condition applied during the strengthening component.

In the BFR group, individualized arterial occlusion pressure (AOP) will be determined using a pneumatic cuff system, and exercise will be performed at 50-60% of AOP. In the sham-BFR group, cuffs will be applied in the same location but inflated to a pressure insufficient to produce meaningful vascular occlusion. The control group will perform the same exercise program without cuff application.

Outcome assessments will be conducted at baseline and after completion of the intervention. The primary outcome will be rectus femoris muscle thickness measured 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.

The study is expected to provide novel evidence regarding the effectiveness of low-load BFR exercise for improving muscle morphology and related functional outcomes in individuals with RRMS. In addition, the inclusion of a sham-BFR condition will allow differentiation between the physiological effects of blood flow restriction and potential placebo or expectancy effects associated with cuff application.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: BFR Exercise Group
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.
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.
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.
Pozorny komparator: Sham BFR Group
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.
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.
Low-load exercise performed with pneumatic cuffs applied to both proximal thighs but inflated to a pressure insufficient to produce meaningful vascular occlusion.
Aktywny komparator: Exercise Control Group
Participants will perform the same supervised low-load exercise program twice weekly for 8 weeks without blood flow restriction.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Rectus Femoris Muscle Thickness
Ramy czasowe: Baseline and Week 8
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Dyrektor Studium: seçil özkurt, Dr., Istinye University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be made publicly available because the informed consent obtained from participants does not include permission for public data sharing and institutional policies restrict release of participant-level data.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Blood Flow Restriction Training

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