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Completed

NCT Number: NCT05334082

Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde da Universidade de Aveiro

Aveiro, 3810-193, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Futsal players enrolled in the Official Futsal Championship of the Portuguese Football Federation;
  • Attendance of at least 50% of training sessions;

Exclusion criteria

  • Clinical diagnosis of cancer, arthritis, heart disease, pulmonary disease, neurological disease.

Treatment and study plan

FIFA 11+

Other

15 progressive exercise drills for training preparation (warm-up)

Other names: Injury prevention program

Primary outcomes

  1. Injuries sustained

    Time frame: 6 months

    injuries sustained during the study period

  2. Characteristics of the injury sustained

    Time frame: 6 months

    Trauma/overuse, body location, ligament/muscle injury

  3. Recovery time

    Time frame: 6 months

    days of recovery until return-to-play

  4. Training exposure

    Time frame: 6 months

    minutes of training

  5. Match exposure

    Time frame: 6 months

    minutes of match play

  6. Number of FIFA 11+ sessions

    Time frame: 6 months

    number of FIFA 11+ sessions attended during the study period

Secondary outcomes

  1. Speed

    Time frame: 10 weeks

    30m sprint (sec)

  2. Jump performance

    Time frame: 10 weeks

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

  3. Agility

    Time frame: 10 weeks

    T-Agility test (sec)

  4. Flexibility

    Time frame: 10 weeks

    sit-and-reach test (cm)

  5. Dynamic balance

    Time frame: 10 weeks

    Y-balance test (%): lower lim reach distance (cm) normalized to the lenght of the lower limb (cm)

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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