InjuriesNCT05334082
Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players
A study testing FIFA 11+ in people with Injuries and Flexibility, run by Aveiro University at 1 site in Portugal.
Trial summary
The FIFA 11 + is an injury prevention that has shown to improve physical performance and prevent injuries in male futsal players, however, this injury prevention program has not been tested in female futsal players. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injuries, Flexibility, Balance
- What is being tested?
- FIFA 11+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2021to 31 Jan 2022
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Futsal players enrolled in the Official Futsal Championship of the Portuguese Football Federation;
- Attendance of at least 50% of training sessions;
Who cannot join
- Clinical diagnosis of cancer, arthritis, heart disease, pulmonary disease, neurological disease.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde da Universidade de Aveiro
Aveiro, 3810-193
About this study
The FIFA 11 + is an injury prevention that has shown to improve physical performance and prevent injuries in male futsal players, however, this injury prevention program has not been tested in female futsal players.
The investigators aim to test the effects of the FIFA 11 + program on physical performance and injury prevention in female futsal players.
Read the detailed description
According to the FIFA Medical Assessment and Research Center (F-MARC), consistent implementation of the "11+" program can lead to a 30-50% reduction in injuries. As the practice of soccer implies risk of injury, as well as F-MARC, considers that during training you should also include exercises to reduce the risk of injury. This warm-up program is intended to replace the traditional pre-workout warm-up. According to F-MARC, the key elements in injury prevention programs for footballers are core strength, neuromuscular control and balance, eccentric hamstring training, plyometrics and agility. The FIFA 11 has shown to improve physical performance and prevent injuries in male futsal players, however, this injury prevention program has not been tested in female futsal players.
With an experimental, randomized, controlled and multicenter study, the investigators intend to verify if the FIFA "11+" reduces injuries and produces changes in proprioception, static and dynamic balance, muscle strength, plyometric and agility results different from traditional warm-up/training programs used in futsal in 10 weeks.
The study will be carried out during the 2021/22 season, in the first division of the senior female national championships with a sample of 60 athletes. It is intended to implement a rigorous methodological process that allows solving the methodological problems of previous studies. The investigators will also characterize the injury profile of female futsal players in Portugal.
The present study intends to include all injuries sustained by players throughout the abovementioned time period. Injuries will be categorized according to type, location, mechanism of injury (traumatic or overuse), whether the injury was a recurrence onset, severity and if it was during training or match. Injury definition and classification will be set in accordance to the consensus agreement of injury definitions: slight (0 days), minimal (1-3 days), mild (4-7 days), moderate (8-28 days), severe (>28 days) and career ending. Injury-related data will follow the Consensus statement on injury definitions.
Anthropometric data will include, sex, age, height; weight, body mass index (BMI).Technical data will include lower limb dominance; players' playing position (keeper, lastman, winger, pivot and wing-pivot) age of initiation of futsal practice.
All analyses will be conducted on SPSS version 24.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be tested with the Shapiro-Wilk test. Descriptive statistics will be used to calculate the mean and standard deviation (SD). Injury incidence rates (number of injuries/1000 player-hours) will be calculated for all selected groups.
Dispersion in these variables was expressed as typical deviation and/or maximum and minimum values. Normality was studied using the Kolmogorov-Smirnoff test. Qualitative variables were expressed as absolute frequency and percentage. Quantitative variables were contrasted using the Kruskal-Wallis test for independent samples. Qualitative variables were analyzed using contingency tables and their statistical significance using Pearson's 12 test. All hypothesis contrasts performed were bilateral, taking a value of p<0.05 as statistically significant.
- Conditions
- Injuries, Flexibility, Balance
- Being tested
- FIFA 11+
- Keywords
- Velocity, Epidemiology, Warm-up, Pliometric, Injury burden
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11+Other
Also called Injury prevention program
15 progressive exercise drills for training preparation (warm-up)
| Study group | Role | What they receive |
|---|---|---|
| FIFA 11+ Group | Experimental | Teams will replace regular warm-up with the intervention protocol - FIFA11+ injury prevention program - during training sessions Receives: Other: FIFA 11+ |
| Control Group | No intervention | Teams will maintain regular warm-up during training sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injuries sustained
injuries sustained during the study period
Measured: 6 months
Characteristics of the injury sustained
Trauma/overuse, body location, ligament/muscle injury
Measured: 6 months
Recovery time
days of recovery until return-to-play
Measured: 6 months
Training exposure
minutes of training
Measured: 6 months
Match exposure
minutes of match play
Measured: 6 months
Number of FIFA 11+ sessions
number of FIFA 11+ sessions attended during the study period
Measured: 6 months
Secondary outcomes (5)
Speed
30m sprint (sec)
Measured: 10 weeks
Jump performance
single and double leg hop test (distance jumped - cm)
Measured: 10 weeks
Agility
T-Agility test (sec)
Measured: 10 weeks
Flexibility
sit-and-reach test (cm)
Measured: 10 weeks
Dynamic balance
Y-balance test (%): lower lim reach distance (cm) normalized to the lenght of the lower limb (cm)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Nov 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies of the same condition, open and under way.
- 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
- Model description
- Experimental, randomized, controlled and multicenter study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO ALEXANDRE GONÇALVES LOPES, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334082
- Sponsor's protocol ID
- FIFA11+FemaleFutsal
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All collected IPD, all IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players
- ClinicalTrials.gov ID
- NCT05334082
- Acronym / sponsor ID
- FIFA11+FemaleFutsal
- Conditions
- Injuries, Flexibility, Balance
- Keywords
- Velocity, Epidemiology, Warm-up, Pliometric, Injury burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- 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.
The FIFA 11 + is an injury prevention that has shown to improve physical performance and prevent injuries in male futsal players, however, this injury prevention program has not been tested in female futsal players.
The investigators aim to test the effects of the FIFA 11 + program on physical performance and injury prevention in female futsal players.
Detailed description
According to the FIFA Medical Assessment and Research Center (F-MARC), consistent implementation of the "11+" program can lead to a 30-50% reduction in injuries. As the practice of soccer implies risk of injury, as well as F-MARC, considers that during training you should also include exercises to reduce the risk of injury. This warm-up program is intended to replace the traditional pre-workout warm-up. According to F-MARC, the key elements in injury prevention programs for footballers are core strength, neuromuscular control and balance, eccentric hamstring training, plyometrics and agility. The FIFA 11 has shown to improve physical performance and prevent injuries in male futsal players, however, this injury prevention program has not been tested in female futsal players.
With an experimental, randomized, controlled and multicenter study, the investigators intend to verify if the FIFA "11+" reduces injuries and produces changes in proprioception, static and dynamic balance, muscle strength, plyometric and agility results different from traditional warm-up/training programs used in futsal in 10 weeks.
The study will be carried out during the 2021/22 season, in the first division of the senior female national championships with a sample of 60 athletes. It is intended to implement a rigorous methodological process that allows solving the methodological problems of previous studies. The investigators will also characterize the injury profile of female futsal players in Portugal.
The present study intends to include all injuries sustained by players throughout the abovementioned time period. Injuries will be categorized according to type, location, mechanism of injury (traumatic or overuse), whether the injury was a recurrence onset, severity and if it was during training or match. Injury definition and classification will be set in accordance to the consensus agreement of injury definitions: slight (0 days), minimal (1-3 days), mild (4-7 days), moderate (8-28 days), severe (>28 days) and career ending. Injury-related data will follow the Consensus statement on injury definitions.
Anthropometric data will include, sex, age, height; weight, body mass index (BMI).Technical data will include lower limb dominance; players' playing position (keeper, lastman, winger, pivot and wing-pivot) age of initiation of futsal practice.
All analyses will be conducted on SPSS version 24.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be tested with the Shapiro-Wilk test. Descriptive statistics will be used to calculate the mean and standard deviation (SD). Injury incidence rates (number of injuries/1000 player-hours) will be calculated for all selected groups.
Dispersion in these variables was expressed as typical deviation and/or maximum and minimum values. Normality was studied using the Kolmogorov-Smirnoff test. Qualitative variables were expressed as absolute frequency and percentage. Quantitative variables were contrasted using the Kruskal-Wallis test for independent samples. Qualitative variables were analyzed using contingency tables and their statistical significance using Pearson's 12 test. All hypothesis contrasts performed were bilateral, taking a value of p<0.05 as statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental, randomized, controlled and multicenter study
| Arm | Type | Receives |
|---|---|---|
| FIFA 11+ Group | Experimental | Other: FIFA 11+Teams will replace regular warm-up with the intervention protocol - FIFA11+ injury prevention program - during training sessions |
| Control Group | No intervention | –Teams will maintain regular warm-up during training sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Futsal players enrolled in the Official Futsal Championship of the Portuguese Football Federation;
- Attendance of at least 50% of training sessions;
Key exclusion criteria (1 listed)
- Clinical diagnosis of cancer, arthritis, heart disease, pulmonary disease, neurological disease.
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+Also: Injury prevention program15 progressive exercise drills for training preparation (warm-up) | Other | FIFA 11+ Group |
Primary outcome
Injuries sustained
Time frame: 6 months
injuries sustained during the study period
Characteristics of the injury sustained
Time frame: 6 months
Trauma/overuse, body location, ligament/muscle injury
Recovery time
Time frame: 6 months
days of recovery until return-to-play
Training exposure
Time frame: 6 months
minutes of training
Match exposure
Time frame: 6 months
minutes of match play
Number of FIFA 11+ sessions
Time frame: 6 months
number of FIFA 11+ sessions attended during the study period
5 secondary outcomes
Speed
Time frame: 10 weeks
Jump performance
Time frame: 10 weeks
Agility
Time frame: 10 weeks
Flexibility
Time frame: 10 weeks
Dynamic balance
Time frame: 10 weeks
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 19 Apr 2022.
- Individual participant dataSharing planned: Undecided. All collected IPD, all IPD that underlie results in a publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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+ in people with Injuries and Flexibility, run by Aveiro University at 1 site in Portugal.
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 2 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 19 Apr 2022. 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 Portugal. 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?
Injuries sustained (time frame: 6 months). The study lists 6 primary outcomes in all. 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 19 Apr 2022.