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CompletedNCT02422771Updated Oct 26, 2016

Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes

An interventional study of FIFA 11+ warm-up in Injury of Anterior Cruciate Ligament, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to female participants aged 9 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
9 Years to 11 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Injury of Anterior Cruciate Ligament
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 47 is close to the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 11 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Bonivital club level soccer athlete

Exclusion criteria

Exclusion Criteria:

  • any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • No intervention
    Control group

    Athletes in this group will continue with their usual warm-up for the duration of the indoor soccer season.

  • Experimental
    Intervention group

    FIFA 11+ warm-up

    Other: FIFA 11+ warm-up

Interventions

  • OtherFIFA 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.

06

What researchers measure

Primary outcomes

  1. Change in single leg squat score at 6 months

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Change in Landing Error Scoring System (LESS) score at 6 months

    Time frame: Baseline and 6 months

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Study locations

1 site
  • University of Manitoba
    Winnipeg, Manitoba R3E 0T6, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02422771
Lead sponsor
University of Manitoba
Responsible party
Sponsor
First posted
Apr 21, 2015
Start date
Oct 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Oct 26, 2016

Study contacts

Joanne L Parsons, PhD
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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