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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2027-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction Rehabilitation Blood Flow Restriction (BFR) Training Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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BFRT rehabilitation group

Receive standard ACL physical therapy plus blood flow restriction training

Group Type EXPERIMENTAL

Blood flow restriction training

Intervention Type OTHER

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

Intervention Type OTHER

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.

Standard rehabilitation group

Receive standard ACL physical therapy

Group Type ACTIVE_COMPARATOR

Standard ACL rehabilitation

Intervention Type OTHER

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.

Interventions

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Blood flow restriction training

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.

Intervention Type OTHER

Standard ACL rehabilitation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Pregnant
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No