Anterior Cruciate Ligament Reconstruction and Plyometric Exercise

September 17, 2014 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. time from injury to ACL reconstruction is no greater than 6 months,
  2. pre-injury activity level includes participation in high-demand activities, and
  3. 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:

  1. bilateral knee injury,
  2. prior knee ligament injury and/or surgery,
  3. concomitant other ligamentous injury > Grade I,
  4. meniscal repair performed in conjunction with ACL reconstruction,
  5. cartilage repair procedure performed in conjunction with ACL reconstruction,
  6. complications during surgery requiring protocol modification, and
  7. renal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Plyometric Exercise - High intensity
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
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).
ACTIVE_COMPARATOR: Plyometric Exercise - Low intensity
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (pre-intervention) to 9 weeks (post-intervention)
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).
Baseline (pre-intervention) to 9 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (pre-intervention) to 9 weeks (post-intervention)
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).
Baseline (pre-intervention) to 9 weeks (post-intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (pre-intervention) to 9 weeks (post-intervention)
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).
Baseline (pre-intervention) to 9 weeks (post-intervention)
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).
Baseline (pre-intervention) to 9 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

NFL Charities

Investigators

  • Principal Investigator: Terese L Chmielewski, PT, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

April 25, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (ESTIMATE)

May 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 156-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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