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

Study Overview
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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.

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

Conditions
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ACL Injury

Intervention / Treatment
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* Behavioral: Exercise Blood Flow Restriction training
* Behavioral: SHAM Exercise Blood Flow Restriction training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Flow Restriction (BFR) group<br>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. | Behavioral: Exercise Blood Flow Restriction training<br>* 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<br>|
| Sham Comparator: SHAM Blood Flow Restriction (BFR) group<br>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 | Behavioral: SHAM Exercise Blood Flow Restriction training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength | 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 | 2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative |