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RCT of PEP Program to Reduce ACL Injuries in Female Collegiate Soccer Players

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ClinicalTrials.gov Identifier: NCT00140270
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : September 1, 2005
Sponsor:
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women’s soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Behavioral: PEP program Phase 2

Detailed Description:
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women’s soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.

Study Type : Interventional  (Clinical Trial)
Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Effectiveness of a Neuromuscular and Proprioceptive Training Program to Reduce Ligamentous Knee Injuries Among Female Collegiate Soccer Players.
Study Start Date : August 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Ligamentous knee and ankle injuries;
  2. specific interest is the ACL


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female soccer athlete on participating Division I women's soccer team

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140270


Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Julie Gilchrist, MD Centers for Disease Control and Prevention

Additional Information:
ClinicalTrials.gov Identifier: NCT00140270     History of Changes
Other Study ID Numbers: CDC-NCIPC-3185
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: September 1, 2005
Last Verified: August 2005

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries