BFR Training for Post ACLR

Udayana University

Status: Not yet enrolling

Conditions: Blood Flow Restriction Training; Muscle Morphology; Anterior Cruciate Ligament Reconstruction; Leg Function; Patella Position

Treatments: Procedure: Sham Low load-BFRt; Procedure: High load-Eccentric training; Procedure: Low load-BFRt

Study type: Interventional

Funder types: Other

Identifiers

NCT07142889

1937/UN14.2.2.VII.14/LT/2025

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Low load-BFRt

Experimental group

Description:

70% of the arterial occlusion pressure and 30% of the maximum repetition rate

Treatment:

Procedure: Low load-BFRt

Sham Low load-BFRt

Sham Comparator group

Description:

10% of the arterial occlusion pressure and 30% of the maximum repetition rate

Treatment:

Procedure: Sham Low load-BFRt

High load-Eccentric training

Active Comparator group

Description:

70% of the maximum repetition rate

Treatment:

Procedure: High load-Eccentric training