Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
NCT ID: NCT05972876
Last Updated: 2025-02-04
Study Results
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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RECRUITING
NA
46 participants
INTERVENTIONAL
2024-04-17
2027-09-30
Brief Summary
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Objectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed.
Study design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing/able to participate.
Intervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.
Comparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.
Main study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Blood flow restriction training (BFRT)
Patients in the BFRT group will perform four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press, seated leg extension, deadlift and squat exercises with 30s inter-set rest periods throughout a 0-90° range of motion at 30% one-repetition maximum
Blood flow restriction training
BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
Resistance training (RT)
Patients in the resistance training group will perform 3x10 reps (30s inter-set rest) of unilateral leg press, seated leg extension, deadlift and squat exercises exercise throughout a 0-90° range of motion with incremental increase in external-load up to 70% of patients' one-repetition maximum
Resistance training
Resistance training will be performed without any blood flow restriction
Interventions
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Blood flow restriction training
BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
Resistance training
Resistance training will be performed without any blood flow restriction
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Zuyderland Medisch Centrum
OTHER
Responsible Party
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Principal Investigators
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Jasper Most
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medisch Centrum
Baris Koc, MD, PhDc
Role: STUDY_DIRECTOR
Zuyderland Medisch Centrum
Locations
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Zuyderland Medical Center
Sittard, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL83376.096.22
Identifier Type: -
Identifier Source: org_study_id
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