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

Mayo Clinic

Status: Completed

Conditions: ACL Injury

Treatments: Behavioral: SHAM Exercise Blood Flow Restriction training; Behavioral: Exercise Blood Flow Restriction training

Study type: Interventional

Funder types: Other

Identifiers

NCT04302558

19-008473

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 13 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Blood Flow Restriction (BFR) group

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Blood Flow Restriction training

SHAM Blood Flow Restriction (BFR) group

Sham Comparator group

Description:

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

Treatment:

Behavioral: SHAM Exercise Blood Flow Restriction training