A sham-treatment-controlled, randomized single-blinded study on the influence of 6 weeks of prehabilitation training under local muscular hypoxia ("Blood Flow Restriction Training") prior to arthroscopic anterior cruciate ligament replacement on knee joint function, morphology and strength.

A sham-treatment-controlled, randomized single-blinded study on the influence of 6 weeks of prehabilitation training under local muscular hypoxia ("Blood Flow Restriction Training") prior to arthroscopic anterior cruciate ligament replacement on knee joint function, morphology and strength. - BFR-Prehab

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033583

Enrollment

Registered

2024-03-19

Start date

2024-04-20

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

S83.5

Interventions

Group 1: Intervention group: training under local, muscular hypoxia ("Blood Flow Restriction Training", "BFR training")

Trainingsprotocol: 6 weeks á 3x/week , 6 sets at 40RM (Repetition Maximum), Reperfusion after set 2 and set 4. Group 2: Sham-Controlgroup

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: - BMI: male 20-30, female 19-30 - Tegner score 4-9 Irritation-free knee joint: - Pain: VAS [1-10]: 5cm) - Heat: temperature [°] < 2 - Function: 10 squats without additional load - Unilateral ACL rupture including concomitant injuries requiring treatment (e.g. partial meniscus resection), from which no changed follow-up treatment is derived

Exclusion criteria

Exclusion criteria: Cardiovascular diseases: - Coronary heart disease - Existing or increased risk of venous thromboembolism - Increased risk of hemorrhagic stroke - Increased risk of exercise-induced rhabdomyolysis - Increased risk of atrial fibrillation or heart failure - Previous use of medications known to increase the risk of blood clotting - Induration/Marfan syndrome - Vascular endothelial dysfunction - Previous hemophilia - Cardiopulmonary diseases - Silent myocardial ischemia - Left ventricular dysfunction - Iatrogenic changes in the arterial/venous vessels of the lower extremities - Inserted stents, bypasses - sickle cell anemia Other exclusion criteria: - Pregnancy - Oncological history - Acute or chronic infections - Inability to undergo surgery - Open wounds or infections of the extremities to be trained - Acute compartment syndrome - Acute need for surgery (e.g. incarceration of the meniscus) and significant changes to the post-treatment protocol (e.g. suturing of the meniscus)

Design outcomes

Primary

Measure	Time frame
Torque (force) of the knee joint flexors and extensors at 180°/s isokinetic angular velocity [Nm/Kg] 12 weeks after anterior cruciate ligament replacement	—

Secondary

Measure	Time frame
- Knee injury and Osteoarthritis Outcome Score (KOOS) - Short Form 12 Health Questionnaire (SF12) - Return to Sport after anterior cruciate ligament injury score (ACL-RSI) - Numerical Rating Scale Pain (NRS) - Questionnaire: Patient satisfaction and postoperative analgesia requirements (BFR-COMP) - Muscle thickness for Vastus medialis obliquus (VMO), and Vastus medialis (VM) and vastus lateralis (VLO) in pre- and postoperative ultrasound examination	—

Measure

Time frame

- Knee injury and Osteoarthritis Outcome Score (KOOS) - Short Form 12 Health Questionnaire (SF12) - Return to Sport after anterior cruciate ligament injury score (ACL-RSI) - Numerical Rating Scale Pain (NRS) - Questionnaire: Patient satisfaction and postoperative analgesia requirements (BFR-COMP) - Muscle thickness for Vastus medialis obliquus (VMO), and Vastus medialis (VM) and vastus lateralis (VLO) in pre- and postoperative ultrasound examination

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026