Evaluating blood flow restriction training for ACL reconstruction recovery
MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study
This study is testing whether a new kind of light exercise with blood flow restriction can help people recover better after ACL surgery compared to traditional heavy lifting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 1 site (Sittard, Limburg) |
| Trial ID | NCT05972876 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of low-load blood flow restriction training (LL-BFRT) on the maturity of grafts used in anterior cruciate ligament (ACL) reconstruction compared to traditional heavy-load resistance training (HLRT). The study aims to assess various outcomes, including graft maturity as measured by MRI, donor-site morbidity, range of motion, knee stability, muscle strength, and overall patient satisfaction. Participants will be randomly assigned to either the LL-BFRT or HLRT group to determine the most effective rehabilitation approach. The trial is conducted at Zuyderland Medical Center, focusing on patients undergoing primary bone-patellar tendon-bone reconstruction.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18-64 who are scheduled for primary bone-patellar tendon-bone reconstruction.
Not a fit: Patients with conditions such as venous thromboembolism, sickle cell anemia, or those contraindicated for accelerated rehabilitation or MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance graft maturity and overall recovery for ACL reconstruction patients.
How similar studies have performed: While LL-BFRT is gaining popularity, this specific comparison with HLRT in ACL reconstruction is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sittard, Limburg
- Zuyderland Medical Center — Sittard, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jasper Most — Zuyderland Medisch Centrum
- Study coordinator: Jasper Most, PhD
- Email: j.most@zuyderland.nl
- Phone: 0031625159747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.