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NCT01993056 Clinical Trial

The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players

Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01993056
Other study ID # Saarland University 10/2011
Secondary ID
Status Completed
Phase N/A
First received November 19, 2013
Last updated November 22, 2013
Start date August 2011
Est. completion date June 2012

Study information
Verified date November 2013
Source Saarland University
Contact n/a
Is FDA regulated No
Health authority Germany: Ärztekammer des Saarlandes
Study type Interventional

Clinical Trial Summary

According to available data the injury rate in male veteran soccer is high. Interventions to prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and consists of several exercises with an overall-length of about 20 min. This study shall investigate the influence of 11+ on injury incidence and Functional Movement Screen (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a relationship between FMS-Score and injury incidence. For this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. Injuries are documented via questionnaires in accordance with the FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.

Recruitment information / eligibility
Status Completed
Enrollment 265
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 32 Years and older
Eligibility Inclusion Criteria:

- male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis

Exclusion Criteria:

- major time-loss injury, chronic inflammatory joint disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• "FIFA 11+"

• no "FIFA 11+"

Locations
Country Name City State
Germany Saarland University Saarbrücken Saarland

Sponsors (2)
Lead Sponsor Collaborator
Saarland University FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary injury incidence injury incidence (injuries per 1000h of soccer) August 2011 - June 2012 No
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