Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
- Conditions
- Bone-Patellar Tendon-Bone GraftingAnterior Cruciate Ligament Reconstruction
- Interventions
- Behavioral: Resistance trainingBehavioral: Blood flow restriction training
- Registration Number
- NCT05972876
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.
- venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resistance training (RT) Resistance training 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 Blood flow restriction training (BFRT) Blood flow restriction training 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
- Primary Outcome Measures
Name Time Method Graft Maturity 3 and 9 months after surgery Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI)
- Secondary Outcome Measures
Name Time Method Range of motion 3 and 9 months after surgery Range of motion will be evaluated with the use of a goniometer.
Anterior knee pain 3 and 9 months after surgery anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain
patient confidence 3 and 9 months after surgery using the Anterior Cruciate Ligament Return To Sport after Injury scale, 0 to 100, 100 being the best outcome
Return to pre-injury level of sport 9 months after surgery Return to pre-injury level of sport and timing of return to sport will be evaluated by self-report
Knee stability 3 and 9 months after surgery With patients lying supine in 30° of flexion anterior tibial translation in mm will be measured with the use of a Rolimeter
Knee pain and function 3 and 9 months after surgery Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)
Knee function 3 and 9 months after surgery knee function (measured using the International Knee Documentation Committee, 0 to 100, 100 being the best outcome
hamstring strength 3 and 9 months after surgery Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO
isokinetic quadriceps strength 3 and 9 months after surgery Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO
Trial Locations
- Locations (1)
Zuyderland Medical Center
🇳🇱Sittard, Limburg, Netherlands