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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07311031
Enrollment
60
Registered
2025-12-30
Start date
2025-12-20
Completion date
2027-09-01
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

KAATSU, Knee injury, ACL rehabilitation

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.

Interventions

OTHERBlood 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.

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.

Sponsors

Hospital MAZ
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quadriceps strengthFrom enrollment to the end of treatment at 14 weeksPeak quadriceps strength

Countries

Spain

Contacts

Primary ContactRaul Zapata-Rodrigo, Orthopaedic Surgeon
raulzapatarodrigo@gmail.com+34620727950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026