Back to resultsThe Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
Primary Purpose
Injury
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
"FIFA 11+"
no "FIFA 11+"
Sponsored by
About this trial
This is an interventional prevention trial for Injury focused on measuring injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
Eligibility Criteria
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
Sites / Locations
- Saarland University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
warm-up with 11+
control
Arm Description
The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries
the control group follows its regular training routine
Outcomes
Primary Outcome Measures
injury incidence
injury incidence (injuries per 1000h of soccer)
Secondary Outcome Measures
Full Information
NCT ID
NCT01993056
First Posted
November 19, 2013
Last Updated
November 22, 2013
Sponsor
Universität des Saarlandes
Collaborators
FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01993056
Brief Title
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes
Collaborators
FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury
Keywords
injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
warm-up with 11+
Arm Type
Experimental
Arm Description
The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
the control group follows its regular training routine
Intervention Type
Behavioral
Intervention Name(s)
"FIFA 11+"
Intervention Type
Behavioral
Intervention Name(s)
no "FIFA 11+"
Primary Outcome Measure Information:
Title
injury incidence
Description
injury incidence (injuries per 1000h of soccer)
Time Frame
August 2011 - June 2012
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hammes
Organizational Affiliation
Saarland University, Institute for Sports and Preventive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saarland University
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
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