- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Haroon Khan, MS. Sports Physical Therapy
- Número de teléfono: +923000526711
- Correo electrónico: haroonkhan2k00@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Hafsah Gul Khattak, DPT, MS-NMPT
- Número de teléfono: 923457170732
- Correo electrónico: hafsahgull_khattak@yahoo.com
Ubicaciones de estudio
-
-
-
Islamabad, Pakistán, 46000
- Reclutamiento
- Ibadat International University, Islamabad (Iiui)
-
Contacto:
- Hafsah Gul Khattak, DPT, MS-NMPT
- Número de teléfono: 923457170732
- Correo electrónico: hafsahgull_khattak@yahoo.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quadriceps Strength - Handheld Dynamometer
Periodo de tiempo: Baseline (Week 0) and Post-intervention (Week 8)
|
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.
|
Baseline (Week 0) and Post-intervention (Week 8)
|
|
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: Baseline (Week 0) and Post-intervention (Week 8)
|
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).
|
Baseline (Week 0) and Post-intervention (Week 8)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Outcomes - Kujala Anterior Knee Pain Scale (AKPS)
Periodo de tiempo: Baseline (Week 0) and Post-intervention (Week 8)
|
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).
|
Baseline (Week 0) and Post-intervention (Week 8)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hafsah Gul Khattak, DPT, MS-NMPT, Ibadat International University, Islamabad (Iiui)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIUI/RERC/ADT/2026/04/286
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .