BFR Training for Post ACLR

NCT ID: NCT07142889

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low load-BFRt

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

Group Type: EXPERIMENTAL

Low load-BFRt

Intervention Type: PROCEDURE

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.

Sham Low load-BFRt

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

Group Type: SHAM_COMPARATOR

Sham Low load-BFRt

Intervention Type: PROCEDURE

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.

High load-Eccentric training

70% of the maximum repetition rate

Group Type: ACTIVE_COMPARATOR

High load-Eccentric training

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

I Putu Gde Surya Adhitya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar

Denpasar, Bali, Indonesia

Countries

Indonesia

Central Contacts

I Putu Gde Surya Adhitya

Role: CONTACT

surya_adhitya@unud.ac.id

+6288975003567

Facility Contacts

I Putu Gde Surya Adhitya

Role: primary

surya_adhitya@unud.ac.id

+6288975003567

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id