- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993056
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
November 22, 2013 updated by: Anne Krieg M.D., Universität des Saarlandes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
265
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saarland
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Saarbrücken, Saarland, Germany, 66111
- Saarland University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
32 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: warm-up with 11+
The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries
|
|
PLACEBO_COMPARATOR: control
the control group follows its regular training routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
injury incidence
Time Frame: August 2011 - June 2012
|
injury incidence (injuries per 1000h of soccer)
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August 2011 - June 2012
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Hammes, Saarland University, Institute for Sports and Preventive Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 22, 2013
First Posted (ESTIMATE)
November 25, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 22, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Saarland University 10/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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