Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07142889

BFR Training for Post ACLR

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Denpasar, Bali, 80232, Indonesia

Location contact

I Putu Gde Surya Adhitya

CONTACT

[email protected]

+6288975003567

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Patella position

    Time frame: 8 weeks

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

  2. Muscle cross-sectional area

    Time frame: 8 weeks

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

  3. Vastus medial obliques fiber angle

    Time frame: 8 weeks

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

  4. Quadriceps strength

    Time frame: 8 weeks

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

  5. Dynamic balance

    Time frame: 8 weeks

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

  6. Leg function

    Time frame: 8 weeks

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

  7. Anterior knee pain

    Time frame: 8 weeks

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

Secondary outcomes

  1. Incidence of anterior cruciate ligament reinjury

    Time frame: 1 year

    Researchers will determine the incidence of anterior cruciate ligament reinjury with the physical examination of Lachman's test.

Study contacts

Contact information is provided by the study sponsor or research team.

I Putu Gde Surya Adhitya

CONTACT

[email protected]

+6288975003567

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.