Anterior Cruciate Ligament Reconstruction and Plyometric Exercise

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01851655

Enrollment

Registered

2013-05-10

Start date

2008-07-31

Completion date

2010-06-30

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

rehabilitation, plyometric

Brief summary

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

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.

Interventions

BEHAVIORALPlyometric 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 30 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in International Knee Documentation Committee (IKDC) Subjective Form Score.	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).
Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)	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

Measure	Time frame	Description
Change in Vertical Jump Height.	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).
Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.	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

Measure	Time frame	Description
Change in Fear of Movement/Re-injury	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).
Change in Anterior Knee Laxity	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).
Change in Quadriceps Strength	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)

Countries

United States

Participant flow

Pre-assignment details

25 subjects were consented to the study. One subject who was enrolled in the study was found to have insufficient quadriceps strength to participate in the study during baseline testing. She was withdrawn prior to randomization. 24 subjects were randomized to the study.

Participants by arm

Arm	Count
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). 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).	12
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) 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).	12
Total	24

Baseline characteristics

Characteristic	Plyometric Exercise - High Intensity	Plyometric Exercise - Low Intensity	Total
Age, Continuous	19.3 years STANDARD_DEVIATION 3.8	20.7 years STANDARD_DEVIATION 4.9	20.0 years STANDARD_DEVIATION 4.3
Sex: Female, Male Female	4 Participants	5 Participants	9 Participants
Sex: Female, Male Male	8 Participants	7 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 12	0 / 12
serious Total, serious adverse events	0 / 12	0 / 12

Outcome results

Primary

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).