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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02422771
Other study ID # Startup 1
Secondary ID
Status Completed
Phase N/A
First received February 25, 2015
Last updated October 24, 2016
Start date October 2015
Est. completion date March 2016

Study information

Verified date December 2015
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 9 Years to 11 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Canada University of Manitoba Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in single leg squat score at 6 months Baseline and 6 months No
Secondary Change in Landing Error Scoring System (LESS) score at 6 months Baseline and 6 months No
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