About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Completed knee dislocation or multiligament injury (PCL, MCL, LCL)
ACL Graft diameter < 8mm
Meniscal suture or meniscal root reattachment
Post-surgical immobilization
Trial design
Parallel
Treatments tested in this trial
Blood flow restriction training
Other interventionBFRT consists of a pressurized cuff that is applied to the proximal thigh in order to partially occlude blood flow while the patient exercises. It is believed that the accumulated effects of fatigue, mechanical tension, metabolic stress and reactive hyperaemia contribute to promoting adaptation of the quadriceps with minimal strain. Therefore, patients can train at reduced loads and may receive the same training benefits as if they were training with high loads.
Standard ACL rehabilitation
Other interventionA 14-16-week supervised accelerated early rehabilitation protocol was selected based on previous evidence.8 It is characterised by early unrestricted motion and weight-bearing, without the use of an immobilising brace and commencing early strength training.
Treatment groups
Trial outcomes
Primary outcomes
Quadriceps strength
Peak quadriceps strength
Quadriceps strength
Rate of torque
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