Preventing Knee Injuries in Adolescent Female Football Players

Knee Injury Clinical Trial

Official title:

Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894595
• Other study ID #: M197-08
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: January 3, 2011
• Start date: August 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2010
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.

The investigators' hypotheses are:

1. a preventive training program reduces the incidence of ACL injury, and

2. a high match frequency and match play at senior level increase the risk of ACL injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4564
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Teams with female football players aged 13-17 years

Exclusion Criteria:

• Teams that did not reply to the invitation or declined participation

• Teams having less than two scheduled training sessions per week

• Teams already using the preventive program

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Knee Injuries
• Knee Injury

Intervention

Behavioral:
• Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.

Locations

Country	Name	City	State
Sweden	Department of Medical and Health Sciences, Linköping University	Linköping

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Folksam, Swedish Football Association, Swedish National Centre for Research in Sports

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of ACL injury		One competitive football season	No
Secondary	The incidence of any acute knee injury except contusion		One competitive football season	No