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

Primary Purpose

Injuries, Flexibility, Balance

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
FIFA 11+
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injuries focused on measuring Velocity, Epidemiology, Warm-up, Pliometric, Injury burden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Escola Superior de Saúde da Universidade de Aveiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FIFA 11+ Group

Control Group

Arm Description

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

Teams will maintain regular warm-up during training sessions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2022
Last Updated
April 18, 2022
Sponsor
Aveiro University
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1. Study Identification

Unique Protocol Identification Number
NCT05334082
Brief Title
Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players
Official Title
Effects of the FIFA 11+ on Physical Performance and Injury Prevention in Female Futsal Players
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Flexibility, Balance
Keywords
Velocity, Epidemiology, Warm-up, Pliometric, Injury burden

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, randomized, controlled and multicenter study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FIFA 11+ Group
Arm Type
Experimental
Arm Description
Teams will replace regular warm-up with the intervention protocol - FIFA11+ injury prevention program - during training sessions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Teams will maintain regular warm-up during training sessions
Intervention Type
Other
Intervention Name(s)
FIFA 11+
Other Intervention Name(s)
Injury prevention program
Intervention Description
15 progressive exercise drills for training preparation (warm-up)
Primary Outcome Measure Information:
Title
Injuries sustained
Description
injuries sustained during the study period
Time Frame
6 months
Title
Characteristics of the injury sustained
Description
Trauma/overuse, body location, ligament/muscle injury
Time Frame
6 months
Title
Recovery time
Description
days of recovery until return-to-play
Time Frame
6 months
Title
Training exposure
Description
minutes of training
Time Frame
6 months
Title
Match exposure
Description
minutes of match play
Time Frame
6 months
Title
Number of FIFA 11+ sessions
Description
number of FIFA 11+ sessions attended during the study period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Speed
Description
30m sprint (sec)
Time Frame
10 weeks
Title
Jump performance
Description
single and double leg hop test (distance jumped - cm)
Time Frame
10 weeks
Title
Agility
Description
T-Agility test (sec)
Time Frame
10 weeks
Title
Flexibility
Description
sit-and-reach test (cm)
Time Frame
10 weeks
Title
Dynamic balance
Description
Y-balance test (%): lower lim reach distance (cm) normalized to the lenght of the lower limb (cm)
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Escola Superior de Saúde da Universidade de Aveiro
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication.

Learn more about this trial

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

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