BFR Training for Post ACLR

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Patella position [Срок оценки: 8 weeks]
• Muscle cross-sectional area [Срок оценки: 8 weeks]
• Vastus medial obliques fiber angle [Срок оценки: 8 weeks]
• Quadriceps strength [Срок оценки: 8 weeks]
• Dynamic balance [Срок оценки: 8 weeks]
• Leg function [Срок оценки: 8 weeks]
• Anterior knee pain [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Incidence of anterior cruciate ligament reinjury [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherap — Denpasar

Идентификаторы

NCT: NCT07142889 · 1937/UN14.2.2.VII.14/LT/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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