- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aveiro, Portugal, 3810-193
- Escola Superior de Saúde da Universidade de Aveiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIFA11+FemaleFutsal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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