Anterior Cruciate Ligament Reconstruction and Plyometric Exercise

Study Overview
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Brief Summary
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This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or high-intensity plyometric exercise. The objective of the study was to determine the effect of plyometric exercise intensity on knee function and knee cartilage in patients with ACL reconstruction.

Detailed Description
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As part of the study, investigators will insure patients meet the criteria for advanced rehabilitation based on knee motion, pain levels and quadriceps strength. Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of 2 testing sessions and an 8 week intervention (2 visits per week) at the UF&Shands Orthopaedics and Sports Medicine Institute. The testing sessions will include clinical measures of knee impairments, questionnaires, biomechanical analysis and functional performance testing.

Official Title
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The Effect of Plyometric Exercise Intensity on Function & Articular Cartilage Metabolism After ACL Reconstruction

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Behavioral: Plyometric Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: time from injury to ACL reconstruction is no greater than 6 months, pre-injury activity level includes participation in high-demand activities, and meet the criteria for advanced rehabilitation including full active knee extension, active knee flexion within 5 degrees of the contralateral side, pain rating no greater or equal to 1/10 with activities of daily living, and involved side knee extensor strength at least 60% of the contralateral side. Exclusion Criteria: bilateral knee injury, prior knee ligament injury and/or surgery, concomitant other ligamentous injury > Grade I, meniscal repair performed in conjunction with ACL reconstruction, cartilage repair procedure performed in conjunction with ACL reconstruction, complications during surgery requiring protocol modification, and renal disease.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 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: Plyometric Exercise - High intensity<br>The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort). | Behavioral: Plyometric Exercise<br>* Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each).<br>|
| Active Comparator: Plyometric Exercise - Low intensity<br>A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort) | Behavioral: Plyometric Exercise<br>* Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Knee Documentation Committee (IKDC) Subjective Form Score. | The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score). | Baseline (pre-intervention) to 9 weeks (post-intervention) | 
| Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value). | Baseline (pre-intervention) to 9 weeks (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vertical Jump Height. | Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value). | Baseline (pre-intervention) to 9 weeks (post-intervention) | 
| Change in the Ratio of Urinary CTXII to Serum CPII Concentrations. | CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value). | Baseline (pre-intervention) to 9 weeks (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, plyometric