- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Haroon Khan, MS. Sports Physical Therapy
- Número de telefone: +923000526711
- E-mail: haroonkhan2k00@gmail.com
Estude backup de contato
- Nome: Hafsah Gul Khattak, DPT, MS-NMPT
- Número de telefone: 923457170732
- E-mail: hafsahgull_khattak@yahoo.com
Locais de estudo
-
-
-
Islamabad, Paquistão, 46000
- Recrutamento
- Ibadat International University, Islamabad (Iiui)
-
Contato:
- Hafsah Gul Khattak, DPT, MS-NMPT
- Número de telefone: 923457170732
- E-mail: hafsahgull_khattak@yahoo.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quadriceps Strength - Handheld Dynamometer
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Outcomes - Kujala Anterior Knee Pain Scale (AKPS)
Prazo: 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)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IIUI/RERC/ADT/2026/04/286
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .