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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-05-04

Brief Summary

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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.

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Detailed Description

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Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Blood Flow Restriction (BFR) group

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.

Group Type EXPERIMENTAL

Exercise Blood Flow Restriction training

Intervention Type BEHAVIORAL

While exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow

SHAM Blood Flow Restriction (BFR) group

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

Group Type SHAM_COMPARATOR

SHAM Exercise Blood Flow Restriction training

Intervention Type BEHAVIORAL

While exercising Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow

Interventions

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Exercise Blood Flow Restriction training

While exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow

Intervention Type BEHAVIORAL

SHAM Exercise Blood Flow Restriction training

While exercising Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No