Injury PreventionNCT06049628
The Impact of FIFA 11+ on Isokinetic Muscle Strength and Balance
A study testing FIFA 11+ exercise program and routine program in people with Injury Prevention, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injury Prevention
- What is being tested?
- FIFA 11+ exercise program and routine program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ) 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
Who cannot join
- ) 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Injury Prevention
- Being tested
- FIFA 11+ exercise program, routine program
- Keywords
- adolescent, football, physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11+ exercise programBehavioural
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) .
routine programBehavioural
This program consists of jogging, and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| FIFA 11+ group | Experimental | The experimental group will apply FIFA 11+ training 3 times a week for 9 weeks. Receives: Behavioral: FIFA 11+ exercise program |
| control group | Active comparator | The control group members will be advised to continue their routine warm-up program 3 times a week for 9 weeks. Receives: Behavioral: routine program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic assessment
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.
Measured: Baseline
Isokinetic assessment
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
Measured: After the 9-week intervention
balance assessment
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.
Measured: Baseline
balance assessment
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.
Measured: After the 9-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Apr 2019
- Primary completion1 Apr 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- büşra aydın erkılıç, MSc, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049628
- Sponsor's protocol ID
- FIFA 11+
- Status last verified
- Jul 2023
- First submitted
- 15 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayala F, Pomares-Noguera C, Robles-Palazon FJ, Del Pilar Garcia-Vaquero M, Ruiz-Perez I, Hernandez-Sanchez S, De Ste Croix M. Training Effects of the FIFA 11+ and Harmoknee on Several Neuromuscular Parameters of Physical Performance Measures. Int J Sports Med. 2017 Apr;38(4):278-289. doi: 10.1055/s-0042-121260. Epub 2017 Feb 13.
PubMed 28192831
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of FIFA 11+ Exercise Program on Isokinetic Muscle Strength and Balance on Adolescent Amateur Soccer Players.
- ClinicalTrials.gov ID
- NCT06049628
- Acronym / sponsor ID
- FIFA 11+
- Conditions
- Injury Prevention
- Keywords
- adolescent, football, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIFA 11+ group | Experimental | Behavioral: FIFA 11+ exercise programThe experimental group will apply FIFA 11+ training 3 times a week for 9 weeks. |
| control group | Active comparator | Behavioral: routine programThe control group members will be advised to continue their routine warm-up program 3 times a week for 9 weeks. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ) 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
Key exclusion criteria (7 listed)
- ) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIFA 11+ exercise programFIFA 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) . | Behavioural | FIFA 11+ group |
| routine programThis program consists of jogging, and stretching exercises. | Behavioural | control group |
Primary outcome
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 28192831Ayala F, Pomares-Noguera C, Robles-Palazon FJ, Del Pilar Garcia-Vaquero M, Ruiz-Perez I, Hernandez-Sanchez S, De Ste Croix M. Training Effects of the FIFA 11+ and Harmoknee on Several Neuromuscular Parameters of Physical Performance Measures. Int J Sports Med. 2017 Apr;38(4):278-289. doi: 10.1055/s-0042-121260. Epub 2017 Feb 13.
Related trials for Injury Prevention
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Evaluating the Impacts of Informal Tick and Tickborne Disease Educational Tools on Children
Tick Bites
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
büşra aydın erkılıç, MSc principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA 11+ exercise program and routine program in people with Injury Prevention, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic assessment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.