Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction (TimeToMature)

Z

Zuyderland Medisch Centrum

Status

Not yet enrolling

Conditions

Bone-Patellar Tendon-Bone Grafting
Anterior Cruciate Ligament Reconstruction

Treatments

Behavioral: Blood flow restriction training
Behavioral: Resistance training

Study type

Interventional

Funder types

Other

Identifiers

NCT05972876
NL83376.096.22

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.

Exclusion criteria

  • venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Blood flow restriction training (BFRT)
Experimental group
Description:
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
Treatment:
Behavioral: Blood flow restriction training
Resistance training (RT)
Active Comparator group
Description:
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
Treatment:
Behavioral: Resistance training

Trial contacts and locations

1

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Central trial contact

Jasper Most, PhD

Data sourced from clinicaltrials.gov

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