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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Portugal

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.

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 groups in NCT05334082
Study groupRoleWhat they receive
FIFA 11+ GroupExperimentalTeams will replace regular warm-up with the intervention protocol - FIFA11+ injury prevention program - during training sessions
Receives: Other: FIFA 11+
Control GroupNo interventionTeams 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.

  1. Injuries sustained

    injuries sustained during the study period

    Measured: 6 months

  2. Characteristics of the injury sustained

    Trauma/overuse, body location, ligament/muscle injury

    Measured: 6 months

  3. Recovery time

    days of recovery until return-to-play

    Measured: 6 months

  4. Training exposure

    minutes of training

    Measured: 6 months

  5. Match exposure

    minutes of match play

    Measured: 6 months

  6. Number of FIFA 11+ sessions

    number of FIFA 11+ sessions attended during the study period

    Measured: 6 months

Secondary outcomes (5)
  1. Speed

    30m sprint (sec)

    Measured: 10 weeks

  2. Jump performance

    single and double leg hop test (distance jumped - cm)

    Measured: 10 weeks

  3. Agility

    T-Agility test (sec)

    Measured: 10 weeks

  4. Flexibility

    sit-and-reach test (cm)

    Measured: 10 weeks

  5. 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.

  1. First posted19 Apr 2022
  2. Study start1 Nov 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

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)
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.

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.

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