- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07645937
Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis (RRMS-BFR)
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.
Přehled studie
Postavení
Detailní popis
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:
- Low-load exercise with blood flow restriction (BFR).
- Low-load exercise with sham blood flow restriction.
- 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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hanifi BAL, pt
- Telefonní číslo: +905532139440
- E-mail: fzt.hanifibal@outlook.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Falešný srovnávač: 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.
|
|
Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Rectus Femoris Muscle Thickness
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: seçil özkurt, Dr., Istinye University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci nervového systému
- Autoimunitní onemocnění
- Onemocnění imunitního systému
- Demyelinizační autoimunitní onemocnění, CNS
- Autoimunitní onemocnění nervového systému
- Demyelinizační onemocnění
- Roztroušená skleróza
- Roztroušená skleróza, relapsující-remitující
- Terapeutika
- Modality fyzikální terapie
- Péče o pacienty
- Cvičební terapie
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Terapie omezením průtoku krve
Další identifikační čísla studie
- RRMS-BFR-RCT-2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Roztroušená skleróza (RS) - relaps-remitující
-
Uppsala UniversityAktivní, ne náborRoztroušená skleróza (relapsing remitování) | MS (roztroušená skleróza) | Roztroušená skleróza (RS) - relaps-remitujícíŠvédsko
Klinické studie na Blood Flow Restriction Training
-
Udayana UniversityDokončenoZdravé předměty | Sportovní úroveň 1Indonésie
-
The Hong Kong Polytechnic UniversityNáborChronická mrtviceHongkong