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

Sponsor
Aveiro University (Other)
Overall Status
Completed
CT.gov ID
NCT05334082
Collaborator
(none)
60
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2
3
20.1

Study Details

Study Description

Brief 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.

The investigators aim to test the effects of the FIFA 11 + program on physical performance and injury prevention in female futsal players.

Condition or Disease Intervention/Treatment Phase
  • Other: FIFA 11+
N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Experimental, randomized, controlled and multicenter studyExperimental, randomized, controlled and multicenter study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: FIFA 11+ Group

Teams will replace regular warm-up with the intervention protocol - FIFA11+ injury prevention program - during training sessions

Other: FIFA 11+
15 progressive exercise drills for training preparation (warm-up)
Other Names:
  • Injury prevention program
  • No Intervention: Control Group

    Teams will maintain regular warm-up during training sessions

    Outcome Measures

    Primary Outcome Measures

    1. Injuries sustained [6 months]

      injuries sustained during the study period

    2. Characteristics of the injury sustained [6 months]

      Trauma/overuse, body location, ligament/muscle injury

    3. Recovery time [6 months]

      days of recovery until return-to-play

    4. Training exposure [6 months]

      minutes of training

    5. Match exposure [6 months]

      minutes of match play

    6. Number of FIFA 11+ sessions [6 months]

      number of FIFA 11+ sessions attended during the study period

    Secondary Outcome Measures

    1. Speed [10 weeks]

      30m sprint (sec)

    2. Jump performance [10 weeks]

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

    3. Agility [10 weeks]

      T-Agility test (sec)

    4. Flexibility [10 weeks]

      sit-and-reach test (cm)

    5. Dynamic balance [10 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Escola Superior de Saúde da Universidade de Aveiro Aveiro Portugal 3810-193

    Sponsors and Collaborators

    • Aveiro University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MARIO ALEXANDRE GONÇALVES LOPES, Professor, Aveiro University
    ClinicalTrials.gov Identifier:
    NCT05334082
    Other Study ID Numbers:
    • FIFA11+FemaleFutsal
    First Posted:
    Apr 19, 2022
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MARIO ALEXANDRE GONÇALVES LOPES, Professor, Aveiro University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2022