Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction

Not Applicable

Completed

• Conditions: ACL Injury
• Interventions: Behavioral: Exercise Blood Flow Restriction training; Behavioral: SHAM Exercise Blood Flow Restriction training

• Registration Number: NCT04302558
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-08
• Study First Posted: 2020-03-10
• Study Start: 2020-12-18
• Primary Completion: 2022-05-04
• Study Completion: 2022-05-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Subjects must be between 13 and 40 years old
• Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
• Subjects must be able to understand study procedures and comply with them for the entire duration of the study
• Subjects must have normal contralateral limb strength

Exclusion Criteria

• Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
• Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
• Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
• Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Flow Restriction (BFR) group	Exercise Blood Flow Restriction training	Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while the blood flow to the leg is reduced by a blood flow restriction cuff.
SHAM Blood Flow Restriction (BFR) group	SHAM Exercise Blood Flow Restriction training	Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while a blood flow restriction cuff is applied but inflation pressure will be limited

Primary Outcome Measures

Name	Time	Method
Change in muscle diameter (hypertrophy)	2 weeks pre-operative, 8-10 days post-operative	Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris

Secondary Outcome Measures

Name	Time	Method
Change in muscle strength	2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative	Muscle strength will be measured in subjects as the percent strength of the injured leg compared to the non-injured leg based on handheld dynamometer and the number of leg presses performed at the 1-rep maximum

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States