The Impact of FIFA 11+ on Isokinetic Muscle Strength and Balance

September 15, 2023 updated by: Yeditepe University

The Impact of FIFA 11+ Exercise Program on Isokinetic Muscle Strength and Balance on Adolescent Amateur Soccer Players.

FIFA 11+ program; It consists of simple, easily remembered, and time-consuming, sport-specific exercises underlying fair play. Although the FIFA 11+ program is a well-established warm-up protocol for injury prevention among football players, the performance improvement aspect of the program is not often discussed in the literature. The study's objective is to investigate the efficacy of the FIFA 11+ program on sports performance parameters such as dynamic balance, isokinetic muscle strength performance in adolescent amateur male football players.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was planned in a randomized controlled experimental type. The footballers of a team from an amateur league will be included in the research. All participants will be tested at baseline and 9 weeks after baseline. The participants will be submitted to the following testing procedures: dynamic balance (Star Excursion Balance Test), muscle strength assessment (Isokinetic assessment). After the baseline measurements will be completed, the control group members will be advised to continue their regular warm-up program. This program consists of jogging and stretching exercises. The experimental group will complete the FIFA 11+ training, which consisted of six different types of running exercises; six exercises with three levels of increasing difficulty to improve the participants' strength, agility, core stability, eccentric control, etc.; and advanced running exercises, such as running across the pitch, bounding, planting, cutting. The FIFA 11+ will be applied to the experimental group 3 times a week for 9 weeks. The control group's warm-up duration will be matched to the experimental group's duration (20-25 min). This routine workout will perform 3 times a week for 9 weeks. At the end of 9 weeks, the evaluations will be repeated (Star Excursion Balance Test, Isokinetic assessment).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey, 34755
        • Yeditepe University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ) To accept being a case study member
  • ) Being in the 15-18 age range
  • ) To be a soccer player in amateur league clubs with experience for at least one year
  • ) Having no systemic diseases
  • ) Having the necessary mental and physical activity level to be able to take and complete the tests

Exclusion Criteria:

  • ) Refusing to be a member of a case study
  • ) Having visual impairment and perceptual disorder at a severe level
  • ) Having pain that prevents testing
  • ) Having diseases with neurological dysfunction
  • ) Footballers who stop playing active football during the study period and disrupt the training program by not participating in 3 exercises in a row
  • ) Having an injury in the research process
  • ) Having an injury in the last six months before the research

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FIFA 11+ group
The experimental group will apply FIFA 11+ training 3 times a week for 9 weeks.
Behavioral: FIFA 11+ exercise program
FIFA 11+ program; It consists of simple, easily remembered, and time-consuming, sport-specific exercises underlying fair play. The F 11+ consisted of 3 parts: the first part consisted of running exercises (part 1); the second part included six exercises, which were made up of three levels of difficulty and aimed at enhancing balance, strength, muscle control, and core stability (part 2). The final and the third part covered advanced running exercises (part 3) .
Active Comparator: control group
The control group members will be advised to continue their routine warm-up program 3 times a week for 9 weeks.
Behavioral: routine program
This program consists of jogging, and stretching exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isokinetic assessment
Time Frame: Baseline
When assessing the football players in terms of strengths, frequently use isokinetic systems . Computer aided muscle-testing dynamometers are utilized for measuring muscle force and this provides us with an assessment of muscles and group of muscle in an isokinetic manner. Isokinetic muscle testing is conducted with a stable speed of angular motion yet variable resistance.
Baseline
Isokinetic assessment
Time Frame: After the 9-week intervention
When assessing the football players in terms of strengths, frequently use isokinetic systems . Computer aided muscle-testing dynamometers are utilized for measuring muscle force and this provides us with an assessment of muscles and group of muscle in an isokinetic manner. Isokinetic muscle testing is conducted with a stable speed of angular motion yet variable resistance
After the 9-week intervention
balance assessment
Time Frame: Baseline
Dynamic postural control will be measured with the Star Excursion Balance Test (SEBT), which will be applied with a system of 8 lines. The foot will be placed in the center of the testing system to be bisected equally in the medial-lateral anteroposterior planes. SEBT is made up of 8 directions: anterior, anterolateral, lateral, posterolateral, posterior, posteromedial, medial, and anteromedial.
Baseline
balance assessment
Time Frame: After the 9-week intervention
Dynamic postural control will be measured with the Star Excursion Balance Test (SEBT), which will be applied with a system of 8 lines. The foot will be placed in the center of the testing system to be bisected equally in the medial-lateral anteroposterior planes. SEBT is made up of 8 directions: anterior, anterolateral, lateral, posterolateral, posterior, posteromedial, medial, and anteromedial.
After the 9-week intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yeditepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: büşra aydın erkılıç, MSc, Yeditepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FIFA 11+

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.

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