NCT05334082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 22, 2022

Last Update Submit

April 18, 2022

Conditions

InjuriesFlexibilityBalance

Keywords

VelocityEpidemiologyWarm-upPliometricInjury burden

Outcome Measures

Primary Outcomes (6)

  • Injuries sustained

    injuries sustained during the study period

    6 months

  • Characteristics of the injury sustained

    Trauma/overuse, body location, ligament/muscle injury

    6 months

  • Recovery time

    days of recovery until return-to-play

    6 months

  • Training exposure

    minutes of training

    6 months

  • Match exposure

    minutes of match play

    6 months

  • Number of FIFA 11+ sessions

    number of FIFA 11+ sessions attended during the study period

    6 months

Secondary Outcomes (5)

  • Speed

    10 weeks

  • Jump performance

    10 weeks

  • Agility

    10 weeks

  • Flexibility

    10 weeks

  • Dynamic balance

    10 weeks

Study Arms (2)

FIFA 11+ Group

EXPERIMENTAL

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

Other: FIFA 11+

Control Group

NO INTERVENTION

Teams will maintain regular warm-up during training sessions

Interventions

FIFA 11+OTHER

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

Also known as: Injury prevention program
FIFA 11+ Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde da Universidade de Aveiro

Aveiro, 3810-193, Portugal

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Experimental, randomized, controlled and multicenter study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 19, 2022

Study Start

November 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

PT(1)