Effect of Blood Flow Restriction Rraining on Rehabilitation After Anterior Cruciate Ligament Reconstruction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital MAZ

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blood flow restriction training

    Other intervention

    BFRT 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 intervention

    A 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

60 Participants
are divided into 2 treatment groups
Group A: BFRT rehabilitation groupExperimental treatment 2 interventions
Group B: Standard rehabilitation groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quadriceps strength

Peak quadriceps strength

Time frame
From enrollment to the end of treatment at 14 weeks
2

Quadriceps strength

Rate of torque

Time frame
From enrollment to the end of treatment at 14 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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