Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

NCT05972876 | Recruiting

• 1 other identifier: NL83376.096.22
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction; Bone-Patellar Tendon-Bone Grafting

Keywords

Blood Flow Restriction Therapy

Outcome Measures

Primary Outcomes (1)

• Graft Maturity

  Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI)

  3 and 9 months after surgery

Secondary Outcomes (9)

• Range of motion

  3 and 9 months after surgery

• Knee stability

  3 and 9 months after surgery

• Anterior knee pain

  3 and 9 months after surgery

• Knee pain and function

  3 and 9 months after surgery

• Knee function

  3 and 9 months after surgery

Study Arms (2)

Blood flow restriction training (BFRT)

EXPERIMENTAL

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

Behavioral: Blood flow restriction training

Resistance training (RT)

ACTIVE COMPARATOR

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

Behavioral: Resistance training

Interventions

Blood flow restriction training BEHAVIORAL

BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure

Blood flow restriction training (BFRT)

Resistance training BEHAVIORAL

Resistance training will be performed without any blood flow restriction

Resistance training (RT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162 BG, Netherlands

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy; Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jasper Most

  Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

• Baris Koc, MD, PhDc

  Zuyderland Medisch Centrum

  STUDY DIRECTOR

Central Study Contacts

Jasper Most, PhD

CONTACT

0031625159747; j.most@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: April 17, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

NL (1)