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Not yet recruiting NCT07142889

BFR Training for Post ACLR

No phase Interventional Blood Flow Restriction Training Patella Position Muscle Morphology Anterior Cruciate Ligament Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low load-BFRt, Sham Low load-BFRt, High load-Eccentric training.
Who it may be relevant to
Registry conditions: Blood Flow Restriction Training, Patella Position, Muscle Morphology, Anterior Cruciate Ligament Reconstruction. Basic parameters: 15 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effectiveness of Blood Flow Restriction Training on Patellar Position, Muscle Morphology, and Lower Limb Function in Patients After Anterior Cruciate Ligament Reconstruction

Overview

This randomized clinical trial is designed to compare three different rehabilitation methods for patients who have undergone anterior cruciate ligament (ACL) reconstruction. The study aims to determine whether low-load blood flow restriction training (LL-BFRt) is more effective than high-load eccentric training (HL-Et) and a sham LL-BFRt in improving three key areas: patellar position, muscle morphology, and leg function. Study Design and Interventions Participants will be randomly assigned to one of the three intervention groups. All groups will perform eccentric exercises, including single leg squats, single leg deadlifts, lateral step downs, and single leg calf raises. The key differences lie in the load and the use of blood flow restriction: LL-BFRt Group: Participants will train at 30% of their repetition maximum (RM) while a cuff restricts blood flow to 70% of their artery occlusion pressure (AOP). HL-Et Group: Participants will train at a higher intensity, using 70% of their repetition maximum (RM), with no blood flow restriction. Sham LL-BFRt Group: Participants will perform the same exercises as the LL-BFRt group at 30% of their RM, but the cuff will not be inflated to a pressure that restricts blood flow. After the training period, the researchers will compare the outcomes across all three groups to see which method leads to the most significant improvements in patella position, muscle morphology, and leg function.

Interventions

  • Procedure Low load-BFRt
    The participants' two legs will be subjected to 70% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise.
  • Procedure Sham Low load-BFRt
    The participants' two legs will be subjected to 10% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise.
  • Procedure High load-Eccentric training
    The physical therapist will instruct the participants to complete eccentric exercises at a maximum of 70% repetitions, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise.

Primary outcome measures

  • Patella position [Time frame: 8 weeks]
  • Muscle cross-sectional area [Time frame: 8 weeks]
  • Vastus medial obliques fiber angle [Time frame: 8 weeks]
  • Quadriceps strength [Time frame: 8 weeks]
  • Dynamic balance [Time frame: 8 weeks]
  • Leg function [Time frame: 8 weeks]
  • Anterior knee pain [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Incidence of anterior cruciate ligament reinjury [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Ages 15-35 years old.
  • History of a unilateral ACL injury, underwent ACL reconstruction surgery more than 6 months ago, and completed rehabilitation with physiotherapy.
  • Adults participating in recreational or competitive sports at a minimum of level 3 on the Tegner Activity Scale.
  • No prior history of a grade 3 sprain/strain injury to other tissues in the knee and foot.
  • No recurring knee injuries after the ACL reconstruction surgery.
  • Willing to be a research subject from start to finish by signing an informed consent form.

Exclusion criteria

  • Hypertension, circulatory disorders, sickle cell anemia, obesity, diabetes, kidney disorders, venous thromboembolism, cancer, and tumors are contraindications for BFR application.
  • Experiencing a disability or being disabled.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherap — Denpasar

Identifiers

NCT: NCT07142889 · 1937/UN14.2.2.VII.14/LT/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗