NCT04086030

Blood Flow Restriction Following ACLR

Postoperative Blood Flow Restriction Training Following Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and improve strength after ACL reconstruction. It is hypothesized that BFR training will significantly reduce muscle loss and improve strength after ACL reconstruction. It is also hypothesized that BFR will result in improved patient reported outcomes and rates of return to sport.

Detailed description

Following anterior cruciate ligament (ACL) reconstruction, many patients experience weakness of the quadriceps (thigh muscles) and loss of muscle mass due to inactivity following surgery. Recent research has demonstrated that blood flow restriction (BFR) training can help reduce the loss of muscle mass and strength after surgery. Blood flow restriction training uses an inflatable cuff that prevents blood from flowing out of the leg while patients perform physical therapy exercises. This allows patients to use lighter weights while reducing muscle loss and building strength. This will be a prospective, randomized controlled trial of patients undergoing ACL reconstruction with bone-patellar tendon-bone (BTB) autograft. Half the subjects will be randomly assigned to the BFR group and half will undergo sham BFR therapy after surgery. Statistical Assumptions: To sufficiently power (80%) the investigation to detect a difference (alpha = 0.05) in quadriceps muscle strength (isokinetic contraction) following the completion of the BFR rehabilitation program, 19 subjects per group (38 total) would be required. However, accounting for a 20% attrition rate and an additional 20% potentially screened out at the time of surgery due to other pathology (i.e. repairable meniscus tears, cartilage defects, etc.) that alters the prescribed physical therapy protocol, this study will aim to recruit and enroll 54 subjects (27 per group). Following ACL reconstruction surgery, subjects will complete a standardized postoperative rehabilitation program with or without BFR. The rehabilitation program will be broken into 4 phases including (1) protection, range of motion, and proprioception; (2) strength and endurance; (3) power and agility; and (4) return to sport training. Physical therapy will occur 2 times per week for 20 weeks. Subjects will attend follow-up visits at 1, 3, 6, and 12 months. Physical exam and muscle mass measurements will be performed at all visits, while strength testing will be performed at 3, 6, and 12 months. The goal of this study is to determine the efficacy of BFR therapy in improving muscle strength and reducing loss of muscle mass following ACL reconstruction, in addition to determining the effect of BFR on patient reported outcomes and return to sport. It is anticipated that BFR will significantly reduce the loss of muscle mass and improve muscular strength compared to standard therapy. It is also expected that these subjects will have improved patient reported outcomes and greater rates of return to sport.

Conditions

• Anterior Cruciate Ligament Injuries
• ACL
• Physical Therapy

Interventions

Type	Name	Description
OTHER	Blood Flow Restriction Training	Patients will undergo standardized postoperative rehabilitation program including blood flow restriction training. Exercises will be performed with BFR at 80% LOP.
OTHER	Sham Blood Flow Restriction Training	Patients will undergo standardized postoperative rehabilitation program where exercises will be performed with sham BFR pressure of 20 mmHG.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2019-09-11
• Last updated: 2023-08-07