Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
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Comparing the effect of intermittent blood flow restriction training and high-load resistance training in patients with patellofemoral pain: study protocol for a randomised trial.

BMJ Open 2023 October 22
BACKGROUND: Patellofemoral pain (PFP) syndrome is a common knee joint functional disorder. Blood flow restriction (BFR) training has shown promise in improving PFP; however, the effectiveness of intermittent BFR (iBFR) training remains uncertain. This study aims to compare the rehabilitative effects of iBFR combined with low-load resistance training and high-load resistance training in PFP patients and to assess the effectiveness of iBFR combined with low-load resistance training for improving PFP.

METHODS AND ANALYSIS: This randomised, patient-assessor blinded, controlled trial will include 42 eligible PFP patients randomly allocated to an intervention group (iBFR combined with low-load resistance training) or a control group (high-load resistance training) in a 1:1 ratio. Participants will receive interventions three times per week for 8 weeks and will be followed up for 24 weeks. The primary outcome measure is pain, and the secondary outcomes include self-reported function, quality of life, muscle strength and muscle thickness. Assessments will be conducted at baseline, 8 weeks and 24 weeks during follow-up. Intention-to-treat analysis will be performed.Collectively, we expect that the findings of this randomised clinical trial will contribute to understanding the potential benefits of iBFR training and provide insightful guidance for developing more effective treatment strategies for patients with PFP.

ETHICS AND DISSEMINATION: This study was approved by the Sports Science Experiment Ethics Committee of Beijing Sport University (2022274H). Written informed consent will be obtained from all participants. Trial results will be disseminated through peer-reviewed publications.

TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (ChiCTR2300068281).

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