BFR Training for Post ACLR

NCT07142889 | Not Yet Recruiting

• 1 other identifier: 1937/UN14.2.2.VII.14/LT/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Patella position

  Using a musculoskeletal ultrasonography, researchers will determine the patella position.

  8 weeks

• Muscle cross-sectional area

  Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and hamstring muscles.

  8 weeks

• Vastus medial obliques fiber angle

  Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.

  8 weeks

• Quadriceps strength

  Using a hand-held dynamometer, researchers will determine the isometric quadriceps muscle.

  8 weeks

• Dynamic balance

  Using a modified star excursion balance test, researchers will determine the distance of three positions of legs reaching, including forward, posteromedial, and posterolateral.

  8 weeks

• Leg function

  Using KOOS questionnaires will determine the subjective score of the patient's leg function.

  8 weeks

• Anterior knee pain

  Using the Kujala questionnaire will determine the subjective score of the patient's knee pain levels.

  8 weeks

Secondary Outcomes (1)

• Incidence of anterior cruciate ligament reinjury

  1 year

Study Arms (3)

Low load-BFRt

EXPERIMENTAL

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

Procedure: Low load-BFRt

Sham Low load-BFRt

SHAM COMPARATOR

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

Procedure: Sham Low load-BFRt

High load-Eccentric training

ACTIVE COMPARATOR

70% of the maximum repetition rate

Procedure: High load-Eccentric training

Interventions

Low load-BFRt 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.

Low load-BFRt

Sham Low load-BFRt 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.

Sham Low load-BFRt

High load-Eccentric training 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.

High load-Eccentric training

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

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

Denpasar, Bali, 80232, Indonesia

Location

Central Study Contacts

I Putu Gde Surya Adhitya

CONTACT

+6288975003567; surya_adhitya@unud.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion: November 20, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)