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

NCT07311031 | Not Yet Recruiting

• 1 other identifier: MAZ Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

KAATSU; Knee injury; ACL rehabilitation

Outcome Measures

Primary Outcomes (2)

• Quadriceps strength

  Peak quadriceps strength

  From enrollment to the end of treatment at 14 weeks

• Quadriceps strength

  Rate of torque

  From enrollment to the end of treatment at 14 weeks

Study Arms (2)

BFRT rehabilitation group

EXPERIMENTAL

Receive standard ACL physical therapy plus blood flow restriction training

Other: Blood flow restriction training; Other: Standard ACL rehabilitation

Standard rehabilitation group

ACTIVE COMPARATOR

Receive standard ACL physical therapy

Other: Standard ACL rehabilitation

Interventions

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.

BFRT rehabilitation group

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.

BFRT rehabilitation group; Standard rehabilitation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital MAZ: lead

Study Sites (1)

MAZ Hospital

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (5)

• Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.

  PMID: 30951598 BACKGROUND

• Gopinatth V, Garcia JR, Reid IK, Knapik DM, Verma NN, Chahla J. Blood Flow Restriction Enhances Recovery After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2025 Apr;41(4):1048-1060. doi: 10.1016/j.arthro.2024.05.032. Epub 2024 Jun 16.

  PMID: 38889851 BACKGROUND

• Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.

  PMID: 39350350 BACKGROUND

• Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705.

  PMID: 24088967 BACKGROUND

• Matar HE, Platt SR, Bloch BV, James PJ, Cameron HU. A Systematic Review of Randomized Controlled Trials in Anterior Cruciate Ligament Reconstruction: Standard Techniques Are Comparable (299 Trials With 25,816 Patients). Arthrosc Sports Med Rehabil. 2021 May 14;3(4):e1211-e1226. doi: 10.1016/j.asmr.2021.03.017. eCollection 2021 Aug.

  PMID: 34430902 BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jose Antonio Casajus Mallen, University professor

  Universidad de Zaragoza

  STUDY CHAIR

Central Study Contacts

Raul Zapata-Rodrigo, Orthopaedic Surgeon

CONTACT

+34620727950; raulzapatarodrigo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (1)