Injury of Anterior Cruciate LigamentNCT02422771
Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
A study testing FIFA 11+ warm-up in people with Injury of Anterior Cruciate Ligament, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 9 to 11 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injury of Anterior Cruciate Ligament
- What is being tested?
- FIFA 11+ warm-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Bonivital club level soccer athlete
Who cannot join
- any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Injury of Anterior Cruciate Ligament
- Being tested
- FIFA 11+ warm-up
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11+ warm-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Athletes in this group will continue with their usual warm-up for the duration of the indoor soccer season. |
| Intervention group | Experimental | FIFA 11+ warm-up Receives: Other: FIFA 11+ warm-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in single leg squat score at 6 months
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in Landing Error Scoring System (LESS) score at 6 months
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne L Parsons, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422771
- Sponsor's protocol ID
- Startup 1
- Status last verified
- Dec 2015
- First submitted
- 25 Feb 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Fédération Internationale de Football Association (FIFA) 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
- ClinicalTrials.gov ID
- NCT02422771
- Acronym / sponsor ID
- Startup 1
- Conditions
- Injury of Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Athletes in this group will continue with their usual warm-up for the duration of the indoor soccer season. |
| Intervention group | Experimental | Other: FIFA 11+ warm-upFIFA 11+ warm-up |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Bonivital club level soccer athlete
Key exclusion criteria (1 listed)
- any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIFA 11+ warm-upA 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. | Other | Intervention group |
Primary outcome
Change in single leg squat score at 6 months
Time frame: Baseline and 6 months
1 secondary outcome
Change in Landing Error Scoring System (LESS) score at 6 months
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne L Parsons, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA 11+ warm-up in people with Injury of Anterior Cruciate Ligament, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in single leg squat score at 6 months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.