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NCT Number: NCT07311031

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

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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Key information

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation Blood Flow Restriction (BFR) Training Effects Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction training

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

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.

Primary outcomes

  1. Quadriceps strength

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

    Peak quadriceps strength

  2. Quadriceps strength

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

    Rate of torque

Study contacts

Contact information is provided by the study sponsor or research team.

Raul Zapata-Rodrigo, Orthopaedic Surgeon

CONTACT

[email protected]

+34620727950

Sponsors and collaborators

Lead sponsor

Hospital MAZ

Other

Registry information

Official study title

Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Knee Biomechanics and Rehabilitation After Anterior Cruciate Ligament Reconstruction in Active Workers

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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