Physical FitnessNCT07900399
Effects of the 11 for Health Program on Physical Fitness and Health-Related Outcomes in Schoolchildren
A study testing 11 for Health Program in people with Physical Fitness and Health, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of the 11 for Health program on physical fitness and health-related outcomes in fifth-grade students. The study will use a quasi-experimental pretest-posttest design with a control group. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Health, Body Composition
- What is being tested?
- 11 for Health Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students aged 10-12 years.
- Students enrolled in the participating fifth-grade classes at a public middle school.
Who cannot join
- Having a medical condition that could prevent safe participation in the exercise program or study assessments.
- Use of medications that may significantly affect physical performance or the study outcome measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tekirdag Namik Kemal University
Tekirdağ, Tekirdağ, 59000
Selim Esgiyayla, +90 5316187089, selimesgiyayla@gmail.com
About this study
Official title: Effects of School-Based Football Activities on Health Indicators and Physical Fitness in Middle School Children
This study aims to examine the effects of the 11 for Health program on physical fitness and health-related outcomes in fifth-grade students.
The study will use a quasi-experimental pretest-posttest design with a control group. Approximately 70 students from two fifth-grade classes at a public school in Türkiye will participate. One class will participate in the 11 for Health program. The other class will be the control group.
Read more
The intervention group will participate in the program twice a week for 11 weeks, with each session lasting 45 minutes. The program combines football-based physical activities with health education. The control group will not receive the program.
Students in both groups will undergo physical fitness and health assessments before and after the intervention. These assessments will include jumping performance, balance, change-of-direction performance, flexibility, body fat percentage, blood pressure, and resting heart rate. Researchers will compare changes in these measures between the two groups to evaluate the effects of the program.
Read the detailed description
The 11 for Health program will be implemented during school hours over 11 weeks, with two 45-minute sessions each week. Each week will include one "Play Football" session focusing on football-based physical activities, such as passing, dribbling, and shooting, and one "Play Fair" session integrating health education with physical activities. Health education topics will include personal hygiene, healthy eating, and avoiding harmful habits. Sessions will follow the 11 for Health instructor guide and will be delivered through interactive, age-appropriate activities. The control group will not receive the 11 for Health program during the study period.
Physical fitness and health-related outcomes will be assessed in both groups before and after the intervention using standardized testing procedures. Physical fitness assessments will include the T-Test to evaluate change-of-direction performance, the countermovement jump (CMJ) test to assess vertical jumping performance, and the single-leg balance test to evaluate postural control. The Sit-and-Reach Test will be used to assess flexibility. Jumping performance and balance will be assessed using force platforms.
Health-related assessments will include body fat percentage measured using bioelectrical impedance analysis. Systolic blood pressure, diastolic blood pressure, and resting heart rate will be measured using an automated blood pressure monitor.
- Conditions
- Physical Fitness, Health, Body Composition
- Being tested
- 11 for Health Program
- Keywords
- 11 for Health, Football, Physical Activity, School-based Intervention, Children, Physical Fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11 for Health ProgramOther
An 11-week school-based program consisting of two 45-minute sessions per week. The program combines football-based physical activities with health education.
| Study group | Role | What they receive |
|---|---|---|
| 11 for Health Intervention Group | Experimental | Students in this group will participate in the 11 for Health program twice a week for 11 weeks. Each session will last 45 minutes and will include football-based physical activities or health education activities. Receives: Other: 11 for Health Program |
| Control Group | No intervention | Students in this group will not receive the 11 for Health program during the study period and will continue their usual school activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Countermovement Jump Height
Countermovement jump (CMJ) height will be measured using VALD ForceDecks force platforms. Jump height will be calculated using the impulse-momentum method and reported in centimeters (cm). Higher values indicate greater jump height.
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Single-Leg Balance: Center of Pressure Mean Velocity
Single-leg balance will be assessed using VALD ForceDecks force platforms. Center of pressure (CoP) mean velocity will be recorded in millimeters per second (mm/s) during a 30-second single-leg standing test. Lower values indicate less postural sway.
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in T-Test Completion Time
Change-of-direction performance will be assessed using the T-Test. Participants will complete a standardized course involving forward, lateral, and backward movements. Completion time will be recorded in seconds using timing gates. Lower values indicate faster performance.
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Body Fat Percentage
Body fat percentage will be assessed using a bioelectrical impedance analysis (BIA) device. Results will be expressed as a percentage of total body mass.
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Secondary outcomes (4)
Change in Sit-and-Reach Test Performance
Flexibility will be assessed using the sit-and-reach test. Reach distance will be recorded in centimeters (cm).
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Systolic Blood Pressure
Systolic blood pressure will be measured using an automated blood pressure monitor and reported in millimeters of mercury (mmHg).
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured using an automated blood pressure monitor and reported in millimeters of mercury (mmHg).
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Resting Heart Rate
Resting heart rate will be measured using an automated blood pressure monitor and reported in beats per minute (bpm).
Measured: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical FitnessStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two existing fifth-grade classes will be assigned to the intervention and control groups without randomization. One class will receive the 11 for Health program, while the other will not receive the intervention during the study period. Both groups will undergo assessments before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, umut canlı, Namik Kemal University
- Investigators
- Umut CANLI, Professor, Study director, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900399
- Sponsor's protocol ID
- 2026.227.09.04
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations involving minors.
Publications
Skoradal MB, Purkhus E, Steinholm H, Olsen MH, Orntoft C, Larsen MN, Dvorak J, Mohr M, Krustrup P. "FIFA 11 for Health" for Europe in the Faroe Islands: Effects on health markers and physical fitness in 10- to 12-year-old schoolchildren. Scand J Med Sci Sports. 2018 Aug;28 Suppl 1:8-17. doi: 10.1111/sms.13209. Epub 2018 Jun 8.
PubMed 29882318Orntoft C, Fuller CW, Larsen MN, Bangsbo J, Dvorak J, Krustrup P. 'FIFA 11 for Health' for Europe. II: effect on health markers and physical fitness in Danish schoolchildren aged 10-12 years. Br J Sports Med. 2016 Nov;50(22):1394-1399. doi: 10.1136/bjsports-2016-096124. Epub 2016 Apr 29.
PubMed 27130927
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of School-Based Football Activities on Health Indicators and Physical Fitness in Middle School Children
- ClinicalTrials.gov ID
- NCT07900399
- Acronym / sponsor ID
- 2026.227.09.04
- Conditions
- Physical Fitness, Health, Body Composition
- Keywords
- 11 for Health, Football, Physical Activity, School-based Intervention, Children, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
This study aims to examine the effects of the 11 for Health program on physical fitness and health-related outcomes in fifth-grade students.
The study will use a quasi-experimental pretest-posttest design with a control group. Approximately 70 students from two fifth-grade classes at a public school in Türkiye will participate. One class will participate in the 11 for Health program. The other class will be the control group.
The intervention group will participate in the program twice a week for 11 weeks, with each session lasting 45 minutes. The program combines football-based physical activities with health education. The control group will not receive the program.
Students in both groups will undergo physical fitness and health assessments before and after the intervention. These assessments will include jumping performance, balance, change-of-direction performance, flexibility, body fat percentage, blood pressure, and resting heart rate. Researchers will compare changes in these measures between the two groups to evaluate the effects of the program.
Detailed description
The 11 for Health program will be implemented during school hours over 11 weeks, with two 45-minute sessions each week. Each week will include one "Play Football" session focusing on football-based physical activities, such as passing, dribbling, and shooting, and one "Play Fair" session integrating health education with physical activities. Health education topics will include personal hygiene, healthy eating, and avoiding harmful habits. Sessions will follow the 11 for Health instructor guide and will be delivered through interactive, age-appropriate activities. The control group will not receive the 11 for Health program during the study period.
Physical fitness and health-related outcomes will be assessed in both groups before and after the intervention using standardized testing procedures. Physical fitness assessments will include the T-Test to evaluate change-of-direction performance, the countermovement jump (CMJ) test to assess vertical jumping performance, and the single-leg balance test to evaluate postural control. The Sit-and-Reach Test will be used to assess flexibility. Jumping performance and balance will be assessed using force platforms.
Health-related assessments will include body fat percentage measured using bioelectrical impedance analysis. Systolic blood pressure, diastolic blood pressure, and resting heart rate will be measured using an automated blood pressure monitor.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two existing fifth-grade classes will be assigned to the intervention and control groups without randomization. One class will receive the 11 for Health program, while the other will not receive the intervention during the study period. Both groups will undergo assessments before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| 11 for Health Intervention Group | Experimental | Other: 11 for Health ProgramStudents in this group will participate in the 11 for Health program twice a week for 11 weeks. Each session will last 45 minutes and will include football-based physical activities or health education activities. |
| Control Group | No intervention | –Students in this group will not receive the 11 for Health program during the study period and will continue their usual school activities. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students aged 10-12 years.
- Students enrolled in the participating fifth-grade classes at a public middle school.
Key exclusion criteria (2 listed)
- Having a medical condition that could prevent safe participation in the exercise program or study assessments.
- Use of medications that may significantly affect physical performance or the study outcome measurements.
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 |
|---|---|---|
| 11 for Health ProgramAn 11-week school-based program consisting of two 45-minute sessions per week. The program combines football-based physical activities with health education. | Other | 11 for Health Intervention Group |
Primary outcome
Change in Countermovement Jump Height
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Countermovement jump (CMJ) height will be measured using VALD ForceDecks force platforms. Jump height will be calculated using the impulse-momentum method and reported in centimeters (cm). Higher values indicate greater jump height.
Change in Single-Leg Balance: Center of Pressure Mean Velocity
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Single-leg balance will be assessed using VALD ForceDecks force platforms. Center of pressure (CoP) mean velocity will be recorded in millimeters per second (mm/s) during a 30-second single-leg standing test. Lower values indicate less postural sway.
Change in T-Test Completion Time
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change-of-direction performance will be assessed using the T-Test. Participants will complete a standardized course involving forward, lateral, and backward movements. Completion time will be recorded in seconds using timing gates. Lower values indicate faster performance.
Change in Body Fat Percentage
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Body fat percentage will be assessed using a bioelectrical impedance analysis (BIA) device. Results will be expressed as a percentage of total body mass.
4 secondary outcomes
Change in Sit-and-Reach Test Performance
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Systolic Blood Pressure
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Diastolic Blood Pressure
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Resting Heart Rate
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 29882318Skoradal MB, Purkhus E, Steinholm H, Olsen MH, Orntoft C, Larsen MN, Dvorak J, Mohr M, Krustrup P. "FIFA 11 for Health" for Europe in the Faroe Islands: Effects on health markers and physical fitness in 10- to 12-year-old schoolchildren. Scand J Med Sci Sports. 2018 Aug;28 Suppl 1:8-17. doi: 10.1111/sms.13209. Epub 2018 Jun 8.
- Background: PubMed 27130927Orntoft C, Fuller CW, Larsen MN, Bangsbo J, Dvorak J, Krustrup P. 'FIFA 11 for Health' for Europe. II: effect on health markers and physical fitness in Danish schoolchildren aged 10-12 years. Br J Sports Med. 2016 Nov;50(22):1394-1399. doi: 10.1136/bjsports-2016-096124. Epub 2016 Apr 29.
- 11 for Health Program - Danish Football Association Instructor ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations involving minors.
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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.
Umut CANLI, Professor study director
Namik Kemal 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 11 for Health Program in people with Physical Fitness and Health, run by Namik Kemal 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selim Esgiyayla (+90 5316187089, selimesgiyayla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Countermovement Jump Height (time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after 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 NCT07900399, which also lists 2 linked publications.
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 28 Oct 2026.