The Effectiveness of Blood Flow Restriction Training on Patellar Position, Muscle Morphology, and Lower Limb Function in Patients After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patella position
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patella position
时间窗: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the patella position.
Muscle cross-sectional area
时间窗: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and hamstring muscles.
Vastus medial obliques fiber angle
时间窗: 8 weeks
Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.
Quadriceps strength
时间窗: 8 weeks
Using a hand-held dynamometer, researchers will determine the isometric quadriceps muscle.
Dynamic balance
时间窗: 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.
Leg function
时间窗: 8 weeks
Using KOOS questionnaires will determine the subjective score of the patient's leg function.
Anterior knee pain
时间窗: 8 weeks
Using the Kujala questionnaire will determine the subjective score of the patient's knee pain levels.
次要结局
- Incidence of anterior cruciate ligament reinjury(1 year)
研究者
I Putu Gde Surya Adhitya
Principal Investigator
Udayana University