BFR Training for Post ACLR

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorUdayana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Low load-BFRt

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Low load-BFRtExperimental treatment 1 intervention
Group B: Sham Low load-BFRtSham comparator 1 intervention
Group C: High load-Eccentric trainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patella position

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

Time frame
8 weeks
2

Muscle cross-sectional area

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

Time frame
8 weeks
3

Vastus medial obliques fiber angle

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

Time frame
8 weeks
4

Quadriceps strength

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

Time frame
8 weeks

Secondary outcomes

1

Incidence of anterior cruciate ligament reinjury

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

Time frame
1 year

Other outcomes

Sponsors and contacts

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