- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422771
Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
October 24, 2016 updated by: University of Manitoba
Effect of the Fédération Internationale de Football Association (FIFA) 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
In response to high injury rates in soccer, the Fédération Internationale de Football Association (FIFA) developed an injury prevention program called the "11+".
It is designed to replace a standard warm-up and takes about 20 minutes to complete.
The program has proven remarkably effective in decreasing the rate of injury in soccer players.
However, uptake of the 11+ has been less than desired.
Adoption of the program may be increased if additional benefits can be demonstrated and the program is introduced at a younger age.
The goals of this study are to (1)establish that young athletes can tolerate the program, and (2)measure the effects of the 11+ program on the physical performance of 10-12 year old girls.
Three teams will be randomly assigned to the intervention group and carry out the 11+ program for the duration of the indoor soccer season.
Another 3 teams will continue with their usual warm-up.
Pre- and post-intervention, balance, agility, core strength and movement control will be assessed in all athletes.
The investigators hypothesize that the athletes will tolerate the program well and that the intervention group will improve on the performance tests significantly more than the control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
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
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3E 0T6
- University of Manitoba
-
-
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
9 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Bonivital club level soccer athlete
Exclusion Criteria:
- any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Athletes in this group will continue with their usual warm-up for the duration of the indoor soccer season.
|
|
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Experimental: Intervention group
FIFA 11+ warm-up
|
A sequence of 15 exercises performed before soccer practices and games.
The exercises include strength, agility, balance and motor control components and take about 15-20 minutes to perform.
The intervention replaces any previous warm-up the athletes may have done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in single leg squat score at 6 months
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Landing Error Scoring System (LESS) score at 6 months
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne L Parsons, PhD, University of Manitoba
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
October 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
February 25, 2015
First Submitted That Met QC Criteria
April 20, 2015
First Posted (Estimate)
April 21, 2015
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Startup 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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