Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Effects of Intermittent Versus Continuous Blood Flow Restriction Training on Pain, Functional Ability, Muscle Strength and Exercise Perception Among Female Patients With Grade II Knee Osteoarthritis

20. července 2026 aktualizováno: Lahore University of Biological and Applied Sciences
This study holds significant clinical, academic, and practical importance in the field of musculoskeletal rehabilitation. Clinically, it addresses a critical need to identify an effective and tolerable strengthening strategy for females with early-stage knee osteoarthritis. By directly comparing intermittent and continuous BFR protocols, the findings will provide physiotherapists with evidence-based guidance for optimizing exercise prescription while minimizing discomfort and improving adherence.Academically, this research contributes to the limited body of literature comparing different BFR application strategies in knee osteoarthritis. The inclusion of exercise perception outcomes adds valuable insight into patient-centered rehabilitation, which is often underrepresented in clinical trials.From a practical and societal perspective, identifying a more tolerable BFR approach may enhance long-term exercise participation, delay disease progression, and reduce healthcare burden associated with knee osteoarthritis. The findings may also support the integration of low-load BFR training into rehabilitation programs in resource-limited clinical settings.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Knee osteoarthritis (KOA) is a chronic, progressive musculoskeletal disorder characterized by joint degeneration, pain, muscle weakness, and functional limitations, with a higher prevalence among middle-aged women. Quadriceps muscle weakness is a key clinical feature associated with reduced functional capacity and progression of the disease. Although high-load resistance training is considered effective for improving muscle strength, its application is often limited in symptomatic individuals due to increased joint loading and pain, thereby affecting adherence to rehabilitation programs.In recent years, low-load resistance training combined with Blood Flow Restriction (BFR) has gained attention as a viable alternative for enhancing muscle strength while minimizing mechanical stress on the joint. BFR training can be applied using continuous or intermittent protocols. Continuous BFR maintains cuff pressure throughout both exercise and rest periods, whereas intermittent BFR involves periodic deflation during rest intervals. These variations may influence physiological responses, fatigue levels, perceived exertion, and overall exercise tolerance, which are critical factors in clinical rehabilitation.This randomized controlled trial is designed to compare the effects of intermittent and continuous BFR training on pain, functional ability, muscle strength, and exercise perception in females with Grade II knee osteoarthritis. A total of 84 participants will be randomly allocated into two intervention groups and will undergo structured low-load resistance training in conjunction with standard physiotherapy care over a period of 8-12 weeks.Outcome measures will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks, including pain intensity (Numeric Pain Rating Scale), functional status (WOMAC Index), quadriceps muscle strength, and perceived exertion (Modified Borg Scale). The findings of this study are expected to provide evidence-based insights into the comparative effectiveness and tolerability of BFR application methods, thereby supporting optimized rehabilitation strategies and improving patient-centered outcomes in knee osteoarthritis management.

Typ studie

Intervenční

Zápis (Aktuální)

84

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Pákistán
    • Punjab Province
      • Lahore, Punjab Province, Pákistán, 05450
        • Social Security Hospital, Lahore

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Female patients aged 40-49 years.
  • Diagnosed with Grade II knee osteoarthritis (radiographically confirmed).
  • Moderate to severe pain (NPRS 4-7).
  • Ability to participate in exercise programs.

Exclusion Criteria:

  • Severe cardiovascular disease.
  • Uncontrolled hypertension.
  • Recent knee surgery or intra-articular injection.
  • Active cancer or metastatic disease

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intermittent blood flow
Participants will perform low-load resistance exercises at 20-30% of one-repetition maximum (1RM) combined with intermittent BFR application. Cuff pressure will be applied during exercise sets and released during rest intervals. Each session will include a 10-minute warm-up , followed by a 30-minute structured exercise program and a 15-minute cool-down. Sessions will be conducted 2-3 times per week for a duration of 8-12 weeks, with progressive overload applied as tolerated.
Jiný: Intermittent blood flow training (iBFR)
Hamstrings stretching, 3 repetitions of 30 s, Bridge with isometric contraction of the transversus abdominis-CORE training, 3 repetitions of 30 s, Hip abduction with weights , 3 sets of 10 repetitions, Calm exercises with an elastic band, 3 sets of 10 repetitions, Calf raises with weights , 3 sets of 10 repetitions, Sensori-motor training at mini-trampoline, 3 repetitions of 30 s, Leg press, 0-60°, 4 sets of 10 repetitions, Seated knee extension , 90-0° of knee flexion, 4 sets of 10 repetitions. In the iBFR group, the cuff is deflated during each set's rest period and is quickly reinflated to the target pressure 20-30 s into the rest, ensuring the entire rest period does not exceed 45 s . Intensity: 20- 30% of 1RM with BFR cuffs, Frequency: 3 sessions per week for 12 weeks. Each session comprises a 10-min warm up with static cycling, a 30-min exercise program, and a 15-min cool down. BFR cuff from Hhccteo company will be used. pressure:130-150 mmHg, cuff width 5-7cm
Experimentální: Continuous blood flow training
Participants will perform the same low-load resistance exercise protocol (20-30% 1RM) with continuous BFR application. Cuff pressure will be maintained throughout both exercise and rest periods. Exercise selection, session structure (warm-up, training, cool-down), frequency (2-3 sessions/week), and duration (8-12 weeks) will be identical to Group A to ensure comparability between groups
Jiný: Continuous blood flow training (cBFR)
Hamstrings stretching, 3 repetitions of 30 s, Bridge with isometric contraction of the transversus abdominis-CORE training, 3 repetitions of 30 s, Hip abduction with weights (side lying), 3 sets of 10 repetitions, Calm exercises (side lying) with an elastic band, 3 sets of 10 repetitions, Calf raises with weights (standing), 3 sets of 10 repetitions, Sensori motor training (standing) at mini-trampoline, 3 repetitions of 30 s, Leg press (machine), 0-60°, 4 sets of 10 repetitions, Seated knee extension, 90-0° of knee flexion, 4 sets of 10 repetitions. In the cBFR group, the Intensity of excersise will be 20-30% of 1RM with BFR cuffs ,Frequency: 3 sessions per week for 12 weeks. Each session comprises a 10-min warmup with static cycling, a 30-min exercise program, and a 15-min cool down. BFR cuff from Hhccteo company will be used. The parameters will be pressure: 130-150 mmHg, cuff width 5-7 cm. Progressive overload will be applied by gradually increasing repetitions or load as tolerated

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Manual Muscle Testing (MMT)
Časové okno: baseline, 6 weeks (post intervention), 12 weeks (follow up)
Quadriceps strength will be assessed using standardized isometric testing procedure. It grades muscle strength on a 0-5 scale based on the ability to move a joint against gravity and external resistance. A grade of 0 indicates no visible or palpable muscle contraction, while 1 (Trace) represents a slight contraction without actual movement. Grade 2 (Poor) describes the ability to move the joint through its full range only when gravity is eliminated, whereas Grade 3 (Fair) allows movement through the full range against gravity but without resistance. Grade 4 (Good) indicates movement against moderate resistance, and Grade 5 (Normal) reflects full range of motion against maximal resistance, representing normal muscle strength
baseline, 6 weeks (post intervention), 12 weeks (follow up)
Numeric Pain Rating Scale (NPRS)
Časové okno: baseline, 6 weeks (post intervention), 12 weeks( followup)
The NPRS is a10-point scale (0-10) used to quantify pain intensity. Pain severity will be interpreted as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
baseline, 6 weeks (post intervention), 12 weeks( followup)
Modified Borg Scale
Časové okno: baseline, 6 weeks( post intervention), 12 weeks (follow up)
It is used to assess ratings of exercise-related perceived exertion. The scale ranges from (0 to 10), where 0 means no breathlessness at all and 10 means maximium breathlessness. According to this, 0-2 for Minimal exertion, 3-4 for Moderate (often target for rehab), 5-6 for Hard and 7-10 is for Very hard to maximal
baseline, 6 weeks( post intervention), 12 weeks (follow up)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Lahore University of Biological and Applied Sciences

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. května 2026

Primární dokončení (Aktuální)

10. července 2026

Dokončení studie (Aktuální)

20. července 2026

Termíny zápisu do studia

První předloženo

20. července 2026

První předloženo, které splnilo kritéria kontroly kvality

20. července 2026

První zveřejněno (Aktuální)

23. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • UBAS/ERB/26/04/012

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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 Intermittent blood flow training (iBFR)

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Israel

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit