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

April 18, 2022 updated by: MARIO ALEXANDRE GONÇALVES LOPES, Aveiro University

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aveiro, Portugal, 3810-193
        • Escola Superior de Saúde da Universidade de Aveiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIFA 11+ Group
Teams will replace regular warm-up with the intervention protocol - FIFA11+ injury prevention program - during training sessions
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injuries sustained
Time Frame: 6 months
injuries sustained during the study period
6 months
Characteristics of the injury sustained
Time Frame: 6 months
Trauma/overuse, body location, ligament/muscle injury
6 months
Recovery time
Time Frame: 6 months
days of recovery until return-to-play
6 months
Training exposure
Time Frame: 6 months
minutes of training
6 months
Match exposure
Time Frame: 6 months
minutes of match play
6 months
Number of FIFA 11+ sessions
Time Frame: 6 months
number of FIFA 11+ sessions attended during the study period
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed
Time Frame: 10 weeks
30m sprint (sec)
10 weeks
Jump performance
Time Frame: 10 weeks
single and double leg hop test (distance jumped - cm)
10 weeks
Agility
Time Frame: 10 weeks
T-Agility test (sec)
10 weeks
Flexibility
Time Frame: 10 weeks
sit-and-reach test (cm)
10 weeks
Dynamic balance
Time Frame: 10 weeks
Y-balance test (%): lower lim reach distance (cm) normalized to the lenght of the lower limb (cm)
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIFA11+FemaleFutsal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Injuries

Clinical Trials on FIFA 11+

3
Subscribe