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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01993056
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
Information provided by (Responsible Party):
Anne Krieg M.D., Saarland University

Brief 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.

Condition or disease Intervention/treatment Phase
Injury Behavioral: "FIFA 11+" Behavioral: no "FIFA 11+" Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: warm-up with 11+
The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries
Behavioral: "FIFA 11+"
Placebo Comparator: control
the control group follows its regular training routine
Behavioral: no "FIFA 11+"

Primary Outcome Measures :
  1. injury incidence [ Time Frame: August 2011 - June 2012 ]
    injury incidence (injuries per 1000h of soccer)

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01993056

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Saarland University
Saarbrücken, Saarland, Germany, 66111
Sponsors and Collaborators
Saarland University
FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
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Principal Investigator: Daniel Hammes Saarland University, Institute for Sports and Preventive Medicine
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Responsible Party: Anne Krieg M.D., Dr, Saarland University Identifier: NCT01993056    
Other Study ID Numbers: Saarland University 10/2011
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Anne Krieg M.D., Saarland University:
injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
Additional relevant MeSH terms:
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Wounds and Injuries