Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Knee Biomechanics and Rehabilitation After Anterior Cruciate Ligament Reconstruction in Active Workers
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
- 1
- 主要终点
- Quadriceps strength
研究概览
简要总结
Importance: Following anterior cruciate ligament reconstruction (ACLR), patients often experience quadriceps muscle weakness and atrophy, frequently leading to long-term complications. A promising rehabilitation program based on blood flow restriction training (BFRT) seems to be particularly valuable for patients who may be unable to train with heavy loads due recent surgery. Previous studies have demonstrated that BFRT promotes strength gains and muscle mass increases, with adaptations comparable to traditional high-intensity training, despite using low-load resistance exercises.
Objective: to evaluate the effect of blood flow restriction training on quadriceps strength and knee biomechanics in a 4-month rehabilitation program of patients who have had an ACL reconstruction.
Design: The study will be a two-arm superiority randomized controlled clinical trial.
Setting: The trial will be conducted at a work-related injuries specialised hospital, MAZ Hospital, Zaragoza, Spain.
Participants: Participants will be active workers who have suffered an acute ACL tear and they have undergone ACL reconstruction (n=60).
Intervention: Patients will recieve a 14-16-week supervised accelerated early rehabilitation protocol; one group will complete it applying blood flow restriction training and the other will not.
Main Outcome and Measure: The primary outcomes will be peak quadriceps strength and rate of torque development measured both isometrically and isokinetcally with a Isokinetic Dynamometer CON-TREX MG.
Limitations: Potential limitations include patients and physiotherapists are not blinded.
Conclusions: The focus of the research will examine the impact of blood flow restriction rehabilitation on patients who have undergone ACLR.
Relevance: The study has potential to restore quadriceps strength to a greater extent than standard rehabilitation protocol. Moreover, patients will spend less time in the rehabilitation process to return to work compared to standard care.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (18-65 years of age); must be skeletally mature with closed physes
- •Worker active
- •Diagnosis of acute (<8 weeks), unilateral ACL tear with planned surgery confirmed via clinical examination and MRI
- •No previous ACL injury or reconstruction on the involved limb
- •Planned graft: autologous ipsilateral hamstring graft for ACL reconstruction
- •Planned fixation: suspensory cortical femoral device and tibial interference screw
排除标准
- •Completed knee dislocation or multiligament injury (PCL, MCL, LCL)
- •ACL Graft diameter < 8mm
- •Meniscal suture or meniscal root reattachment
- •Post-surgical immobilization
- •Any current or previous conditions or surgeries that might affect gait
- •Spinal fusion
- •Any implanted medical device or other contraindications for MRI
- •History of deep vein thrombosis and/or varicose veins or familiy history of deep vein thrombosis
- •Taking anti-coagulant drugs for any blood, cardiac or congenital disease that may cause coagulation disorders
- •Taking bone and muscle metabolism-modulation drugs or muscle supplements (e.g., creatine, amino acids, whey protein,…)
- •Recent inflammation, bleeding disorders, active bleeding, or infection within the lower limbs
- •Diabetic or have uncontrolled hypertension
- •Diminished capacity to provide informed consent
- •Unfeasible to attend regular physical therapy and study visits
结局指标
主要结局
Quadriceps strength
时间窗: From enrollment to the end of treatment at 14 weeks
Peak quadriceps strength
次要结局
未报告次要终点
研究者
Raul Zapata Rodrigo
Orthopaedic Surgeon
Hospital MAZ