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NCT Number: NCT01851655

Anterior Cruciate Ligament Reconstruction and Plyometric Exercise

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plyometric exercise

Behavioral

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).

Primary outcomes

  1. Change in International Knee Documentation Committee (IKDC) Subjective Form Score.

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    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).

  2. Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    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).

Secondary outcomes

  1. Change in Vertical Jump Height.

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    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).

  2. Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    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).

Other outcomes

  1. Change in Quadriceps Strength

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value)

  2. Change in Fear of Movement/Re-injury

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. 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).

  3. Change in Anterior Knee Laxity

    Time frame: Baseline (pre-intervention) to 9 weeks (post-intervention)

    Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • NFL Charities

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 10, 2013
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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