Anterior Cruciate Ligament Reconstruction and Plyometric Exercise

NCT01851655 | Completed Results

• 1 other identifier: 156-2008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

rehabilitation; plyometric

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Vertical Jump Height.

  Baseline (pre-intervention) to 9 weeks (post-intervention)

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

  Baseline (pre-intervention) to 9 weeks (post-intervention)

Other Outcomes (3)

• Change in Quadriceps Strength

  Baseline (pre-intervention) to 9 weeks (post-intervention)

• Change in Fear of Movement/Re-injury

  Baseline (pre-intervention) to 9 weeks (post-intervention)

• Change in Anterior Knee Laxity

  Baseline (pre-intervention) to 9 weeks (post-intervention)

Study Arms (2)

Plyometric Exercise - High intensity

EXPERIMENTAL

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

Plyometric Exercise - Low intensity

ACTIVE COMPARATOR

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

Interventions

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).

Plyometric Exercise - High intensity; Plyometric Exercise - Low intensity

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• NFL Charities: collaborator

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

Related Publications (1)

• 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.

  PMID: 26797700 DERIVED

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Terese Chmielewski
• Organization: University of Florida

tchm@ufl.edu

352-273-6104

Study Officials

• Terese L Chmielewski, PT, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: May 10, 2013
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 18, 2014
• Results First Posted: September 18, 2014

Record last verified: 2014-09

Locations

US (1)