Actively Recruiting
MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone ACL Reconstruction: a Randomized Controlled Study
Led by Zuyderland Medisch Centrum · Updated on 2025-02-04
46
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of low-load blood flow restriction training (LL-BFRT) compared to heavy-load resistance training (HLRT) on graft maturity after anterior cruciate ligament (ACL) reconstruction using a bone-patellar tendon-bone graft. The study aims to understand whether LL-BFRT offers benefits or risks during rehabilitation by measuring MRI-based graft maturity as well as other factors like knee stability, range of motion, muscle strength, and patient satisfaction. Participants will be randomly assigned to one of two groups. The LL-BFRT group will perform biweekly strength training for 12 weeks starting two weeks after surgery, using a specialized tourniquet system to restrict blood flow during exercises such as leg press, leg extension, deadlift, and squats at 30% of their one-repetition maximum. The HLRT (resistance training) group will also train biweekly for 12 weeks, performing similar exercises but with heavier loads up to 70% of their one-repetition maximum without blood flow restriction. During the study, participants will be assessed at three and nine months after surgery with MRI scans to measure graft maturity and other evaluations including knee range of motion, stability, pain, function, muscle strength, and return to pre-injury sports level. Safety and feasibility of the rehabilitation methods will be monitored throughout. The total participation spans at least nine months to capture the main outcomes and recovery progress.
CONDITIONS
Brief Title
Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 64 years
- Undergoing primary bone-patellar tendon-bone ACL reconstruction at Zuyderland Medical Center
- Rehabilitation planned at Knie-Heup centrum Plus
- Able and willing to participate in the study
You will not qualify if you...
- History of venous thromboembolism
- Diagnosis of sickle cell anemia
- Severe hypertension
- Contraindication for accelerated rehabilitation
- Contraindication for MRI scan
- Not willing or unable to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months after surgery
Participants perform either blood flow restriction training or resistance training as part of their rehabilitation after ACL reconstruction.
Regular exercise sessions as part of rehabilitation; specific visit cadence not detailed
Duration - Assessments at 3 and 9 months after surgery
Participants undergo assessments to evaluate graft maturity, knee function, pain, strength, and return to sport.
2 visits (in-person) at 3 and 9 months post-surgery
Trial Site Locations
Total: 1 location
1
Zuyderland Medical Center
Sittard, Limburg, Netherlands, 6162 BG
Actively Recruiting
Research Team
J
Jasper Most, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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