Clinical trial NCT01851655: Anterior Cruciate Ligament Reconstruction and Plyometric Exercise
Official title: The Effect of Plyometric Exercise Intensity on Function & Articular Cartilage Metabolism After ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: rehabilitation
plyometric
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: NFL Charities
First posted: 2013-05-10
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in International Knee Documentation Committee (IKDC) Subjective Form Score.
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
measure: Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
Secondary outcomes:
measure: Change in Vertical Jump Height.
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
measure: Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
Other outcomes:
measure: Change in Quadriceps Strength
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
measure: Change in Fear of Movement/Re-injury
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
measure: Change in Anterior Knee Laxity
timeFrame: Baseline (pre-intervention) to 9 weeks (post-intervention)
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Terese L Chmielewski, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chmielewski TL, George SZ, Tillman SM, Moser MW, Lentz TA, Indelicato PA, Trumble TN, Shuster JJ, Cicuttini FM, Leeuwenburgh C. Low- Versus High-Intensity Plyometric Exercise During Rehabilitation After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Mar;44(3):609-17. doi: 10.1177/0363546515620583. Epub 2016 Jan 21.