- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07722975
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. juli 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 05450
- Social Security Hospital, Lahore
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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
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Eksperimentel: 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
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Manual Muscle Testing (MMT)
Tidsramme: baseline, 6 weeks (post intervention), 12 weeks (follow up)
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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
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baseline, 6 weeks (post intervention), 12 weeks (follow up)
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Numeric Pain Rating Scale (NPRS)
Tidsramme: baseline, 6 weeks (post intervention), 12 weeks( followup)
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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).
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baseline, 6 weeks (post intervention), 12 weeks( followup)
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Modified Borg Scale
Tidsramme: baseline, 6 weeks( post intervention), 12 weeks (follow up)
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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
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baseline, 6 weeks( post intervention), 12 weeks (follow up)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
- Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1.
- Sorensen B, Aagaard P, Hjortshoj MH, Hansen SK, Suetta C, Couppe C, Magnusson SP, Johannsen FE. Physiological and clinical effects of low-intensity blood-flow restricted resistance exercise compared to standard rehabilitation in adults with knee osteoarthritis-Protocol for a randomized controlled trial. PLoS One. 2023 Dec 14;18(12):e0295666. doi: 10.1371/journal.pone.0295666. eCollection 2023.
- Harper SA, Roberts LM, Layne AS, Jaeger BC, Gardner AK, Sibille KT, Wu SS, Vincent KR, Fillingim RB, Manini TM, Buford TW. Blood-Flow Restriction Resistance Exercise for Older Adults with Knee Osteoarthritis: A Pilot Randomized Clinical Trial. J Clin Med. 2019 Feb 21;8(2):265. doi: 10.3390/jcm8020265.
- Freitas EDS, Miller RM, Heishman AD, Aniceto RR, Silva JGC, Bemben MG. Perceptual responses to continuous versus intermittent blood flow restriction exercise: A randomized controlled trial. Physiol Behav. 2019 Dec 1;212:112717. doi: 10.1016/j.physbeh.2019.112717. Epub 2019 Oct 17.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2026
Primær færdiggørelse (Faktiske)
10. juli 2026
Studieafslutning (Faktiske)
20. juli 2026
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- UBAS/ERB/26/04/012
Plan for individuelle deltagerdata (IPD)
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