BFR in ACL Surgery

Study Overview
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Brief Summary
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This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects

Detailed Description
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This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn. Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR. Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.

Official Title
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Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Other: blood flow restriction
* Other: physical therapy standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, ages 18-34 years. Scheduled to undergo elective ACL surgery at UAMS. Capable of providing informed consent. Willing to exercise with BFR. COVID-19 negative or asymptomatic. Exclusion Criteria: Any surgical indication other than ACL repair. Body mass index >40. Pregnant female. Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests. Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest. Heart failure as evidenced by use of prescription diuretics. History of atrial fibrillation. Oxygen saturation <95% on room air at rest. Any other medical condition that would interfere with testing or increase one's risk of complications during exercise. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy. Compromised vascular circulation in the legs (e.g. peripheral vascular disease). History of deep vein thrombosis. Varicose veins in the legs. Known Sickle cell disease or trait. Unwilling to avoid using protein or amino-acid supplements during participation. Unwilling to avoid using BFR during prescribed post-operative physical therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical therapy with blood flow restriction<br> | Other: blood flow restriction<br>* Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.<br>|
| Other: physical therapy without blood flow restriction<br>Standard of care. | Other: physical therapy standard of care<br>* the current standard of care after surgery for ACL repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Voluntary Contraction | Max torque produced in newton meter per second during an isometric contraction | 16-weeks post-surgery |