Exercise with blood flow restriction for patients with complete ACL tears
Comparison of Conservative Treatment With Blood Flow Restriction With Standard Management in Total ACL Rupture. "Randomized Clinical Trial"
NA · European University Cyprus · NCT06727344
This study is testing if exercising with blood flow restriction can help people with complete ACL tears recover better than just standard treatment alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | European University Cyprus (other) |
| Locations | 2 sites (Nicosia and 1 other locations) |
| Trial ID | NCT06727344 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of exercise combined with blood flow restriction (BFR) in patients who have suffered a complete anterior cruciate ligament (ACL) rupture. Participants will be randomly assigned to either an intervention group that uses BFR during exercise or a control group that uses sham BFR, while both groups will follow a knee bracing protocol. The study aims to determine if BFR provides additional benefits over standard conservative treatment. Participants will engage in a structured exercise program over several weeks, with specific adjustments to their knee brace throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed complete ACL rupture who can adhere to the study protocol and communicate in Greek.
Not a fit: Patients with underlying health conditions such as heart disease, diabetes, or those who cannot use BFR due to skin issues or other contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and healing for patients with ACL injuries, potentially reducing the need for surgical intervention.
How similar studies have performed: While the use of blood flow restriction in rehabilitation is gaining interest, this specific approach in ACL injuries is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * MRI-confirmed complete rupture of ACL. Ability to communicate and read fluently in Greek and be willing to keep their leg immobilised for the required period based on the study protocol. Exclusion Criteria: * Heart disease, overweight, diabetes, pregnancy, thrombophilia, atrial fibrillation, heart failure, cancer, use of drugs that may increase blood clotting, use of hormones or contraceptives, any reason for not using BFR e.g., an open wound or serious skin problems and/or allergies to the cuff material.
Where this trial is running
Nicosia and 1 other locations
- European University Cyprus — Nicosia, Cyprus (RECRUITING)
- European University Cyprus — Nicosia, Cyprus (RECRUITING)
Study contacts
- Study coordinator: Alexis N Pitsillides, PhD candidate
- Email: alexpitsillides@gmail.com
- Phone: 0035799418065
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.
Conditions: ACL, ACL - Anterior Cruciate Ligament Rupture, BFR, Blood Flow Restriction, Brace, ACL rupture