Back to resultsEffect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
Primary Purpose
Injury of Anterior Cruciate Ligament
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FIFA 11+ warm-up
Sponsored by
About this trial
This is an interventional prevention trial for Injury of Anterior Cruciate Ligament
Eligibility Criteria
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)
Sites / Locations
- University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Athletes in this group will continue with their usual warm-up for the duration of the indoor soccer season.
FIFA 11+ warm-up
Outcomes
Primary Outcome Measures
Change in single leg squat score at 6 months
Secondary Outcome Measures
Change in Landing Error Scoring System (LESS) score at 6 months
Full Information
NCT ID
NCT02422771
First Posted
February 25, 2015
Last Updated
October 24, 2016
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT02422771
Brief Title
Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
Official Title
Effect of the Fédération Internationale de Football Association (FIFA) 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Anterior Cruciate Ligament
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Athletes in this group will continue with their usual warm-up for the duration of the indoor soccer season.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
FIFA 11+ warm-up
Intervention Type
Other
Intervention Name(s)
FIFA 11+ warm-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in single leg squat score at 6 months
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Landing Error Scoring System (LESS) score at 6 months
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne L Parsons, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
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