- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07585305
Comparative Effects of Blood Flow Restriction Resistance Training Versus Blood Flow Restriction Cycling on Pain, Quadriceps Strength, and Functional Outcomes in Athletes With Patellofemoral Pain (BFR-PFP-RCT)
Comparative Effects of Blood Flow Restriction Resistance Training Versus Blood Flow Restriction Cycling on Pain, Quadriceps Strength, and Functional Outcomes in Athletes With Patellofemoral Pain: A Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patellofemoral pain (PFP) is among the most prevalent musculoskeletal conditions in athletes, with reported prevalence of 30-40% in sports populations. High-load resistance training is the conventional rehabilitation approach but often exacerbates joint stress and reduces adherence. Blood flow restriction (BFR) training enables strength gains at low loads by applying a pneumatic cuff at 80% LOP on the proximal thigh.
This trial compares two BFR modalities:
- Group A (BFR-RT): Leg press and seated knee extension, 1x30 + 3x15 reps at 30% 1RM, 3x/week for 8 weeks.
- Group B (BFR-CYC): Stationary cycling at low resistance, 4x5-minute intervals at 70-80 RPM (RPE 11-13), 3x/week for 8 weeks.
All sessions are supervised one-on-one by a physiotherapist. Assessments are conducted at baseline and week 8. The study is single-blinded (outcome assessor blinded). Randomization via computer-generated sequence. Statistical analysis via SPSS v27 (paired t-test / Wilcoxon for within-group; independent t-test / Mann-Whitney for between-group, alpha=0.05).
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Haroon Khan, MS. Sports Physical Therapy
- Telefonnummer: +923000526711
- E-post: haroonkhan2k00@gmail.com
Studer Kontakt Backup
- Navn: Hafsah Gul Khattak, DPT, MS-NMPT
- Telefonnummer: 923457170732
- E-post: hafsahgull_khattak@yahoo.com
Studiesteder
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Islamabad, Pakistan, 46000
- Rekruttering
- Ibadat International University, Islamabad (Iiui)
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Ta kontakt med:
- Hafsah Gul Khattak, DPT, MS-NMPT
- Telefonnummer: 923457170732
- E-post: hafsahgull_khattak@yahoo.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Male and female athletes aged 18-40 years
- Clinically diagnosed with patellofemoral pain syndrome
- Anterior or retropatellar knee pain of at least 3 months duration
- Pain provoked by at least two functional activities (e.g., squatting, stair climbing, running, prolonged sitting)
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- History of knee surgery or significant knee trauma in the past 6 months
- Presence of ligament, meniscal, or cartilage injuries
- Neurological, vascular, or systemic inflammatory conditions
- Contraindications to BFR training (e.g., deep vein thrombosis, uncontrolled hypertension)
- Pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: BFR Resistance Training Group
Participants perform leg press and seated knee extension exercises at 30% of 1RM with a pneumatic cuff (12 cm wide, Delfi Medical) applied to the proximal thigh at 80% limb occlusion pressure (LOP).
Protocol: 1 set of 30 + 3 sets of 15 repetitions, with 60-second rest between sets (cuff deflated).
Frequency: 3 sessions/week for 8 weeks (24 sessions total).
1RM re-estimated every 2 weeks for progressive load adjustment.
Warm-up: 10 min low-resistance cycling (no BFR).
Cool-down: 5 min lower-limb stretching.
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Participants will undergo blood flow restriction (BFR) resistance training using a pneumatic cuff applied to the proximal thigh at 80% limb occlusion pressure.
Exercises include leg press and seated knee extension performed at 30% of one-repetition maximum (1RM).
Training will be conducted for 8 weeks, with supervised sessions 3 times per week.
Cuff pressure will be monitored and adjusted using BP cuff.
The aim is to improve quadriceps strength and reduce pain in patients with patellofemoral pain.
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Eksperimentell: BFR Cycling Group
Participants perform stationary cycling at low resistance targeting RPE 11-13, with a pneumatic cuff (12 cm wide, Delfi Medical) applied to the proximal thigh at 80% LOP.
Protocol: 4 x 5-minute cycling intervals at 70-80 RPM, with 1-minute rest between intervals (cuff deflated).
Frequency: 3 sessions/week for 8 weeks (24 sessions total).
Cadence increased by 5 RPM if RPE <11.
Warm-up: 10 min low-resistance cycling (no BFR).
Cool-down: 5 min lower-limb stretching.
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Participants will perform stationary cycling combined with blood flow restriction (BFR) applied to the proximal thigh at 80% limb occlusion pressure.
Cycling will be performed at low resistance with controlled cadence for 8 weeks, 3 sessions per week under physiotherapist supervision.
The protocol includes structured cycling intervals with rest periods and continuous monitoring of pain and perceived exertion.
The intervention aims to improve quadriceps strength, reduce pain, and enhance functional outcomes in patients with patellofemoral pain.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quadriceps Strength - Handheld Dynamometer
Tidsramme: Baseline (Week 0) and Post-intervention (Week 8)
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Isometric quadriceps muscle strength measured in Newtons using a calibrated handheld dynamometer (ICC > 0.90).
Measurement taken in a standardized seated position at 60° knee flexion.
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Baseline (Week 0) and Post-intervention (Week 8)
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Pain Intensity - Numeric Pain Rating Scale (NPRS)
Tidsramme: Baseline (Week 0) and Post-intervention (Week 8)
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Self-reported pain intensity rated on a 0-10 scale (0 = no pain, 10 = worst imaginable pain).
The NPRS has excellent test-retest reliability (ICC 0.95).
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Baseline (Week 0) and Post-intervention (Week 8)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Outcomes - Kujala Anterior Knee Pain Scale (AKPS)
Tidsramme: Baseline (Week 0) and Post-intervention (Week 8)
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13-item patient-reported outcome measure assessing functional limitations due to anterior knee pain.
Scored 0-100 (higher = better function).
High internal consistency (α = 0.83-0.91).
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Baseline (Week 0) and Post-intervention (Week 8)
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Hafsah Gul Khattak, DPT, MS-NMPT, Ibadat International University, Islamabad (Iiui)
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIUI/RERC/ADT/2026/04/286
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