NCT06939881

Brief Summary

The goal of this study was to evaluate whether the school-based "11 for Health" program could improve physical performance and executive function among 10-11-year-old Turkish schoolchildren. The main questions it aimed to answer were: Does the program enhance physical performance, including agility, balance, and vertical jump? Does it improve executive function skills such as response inhibition, problem solving, and working memory? Researchers compared students who participated in the 11-week "11 for Health" intervention to those who continued their regular school curriculum. Participants: A total of 56 children (28 girls and 28 boys) from 5th grade participated. The training group attended two 45-minute "11 for Health" sessions per week for 11 weeks. Both groups were assessed before and after the intervention on physical performance (e.g., balance, agility, countermovement jump) and executive function (Go/No-Go, Tower of Hanoi, and Corsi Block tests).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

18 days

First QC Date

April 11, 2025

Last Update Submit

April 18, 2025

Conditions

Keywords

11 for Health in Türkiyeexecutive functionschoolchildren

Outcome Measures

Primary Outcomes (8)

  • Changes in Static Balance Performance (% Score)

    Static balance was measured using the Sensbalance MiniBoard device. Participants were asked to stand still on the platform for approximately 30 seconds. The device calculated the participant's ability to maintain posture without significant sway.

    before and at the end of the 11-week intervention.

  • Changes in Dynamic Balance Performance - Left-Right and Front-Back (% Score)

    Dynamic balance was evaluated using the Sensbalance MiniBoard through controlled weight shifting in mediolateral and anteroposterior directions.

    before and at the end of the 11-week intervention.

  • Changes in Proprioceptive Balance Performance (% Score)

    Proprioceptive balance was assessed via subtle postural adjustments on the Sensbalance MiniBoard. Scores were automatically generated based on sway control.

    before and at the end of the 11-week intervention.

  • Changes in Countermovement Jump Performance (cm)

    Vertical jump height was measured using an accelerometer-based system (IVMES, Ankara, Turkey) during countermovement jump (CMJ) trials. Unit of Measurement: Centimeter (cm) - Highest jump height

    before and at the end of the 11-week intervention.

  • Changes in Agility (seconds)

    Assessed via the Pro-Agility Test (20-yard shuttle run) using photocell timing gates. The total time to complete the right-left-center shuttle sequence was recorded. Unit of Measurement: Seconds (s) - Time to complete the test

    before and at the end of the 11-week intervention.

  • Changes in Inhibitory Control (Number of correct responses and Reaction Time (ms))

    Inhibitory control was assessed using a computer-based Go/No-Go task, which measured participants' ability to suppress automatic motor responses. The task included 200 trials: 100 Go (letter X) and 100 No-Go (letter O) stimuli. Participants were instructed to press a button as quickly as possible for Go stimuli and withhold responses for No-Go stimuli. Key outcome variables included: Accuracy of correct responses to Go stimuli (AC-Go) Accuracy of correct inhibitions to No-Go stimuli (AC-NoGo) Mean reaction time for correct Go responses (Go RT) Unit of Measurement: Number of correct responses and reaction time in milliseconds (ms)

    before and at the end of the 11-week intervention.

  • Changes in Planning and Problem-Solving Skills (Number of moves and seconds)

    Description: Executive function was assessed using a computer-based Tower of Hanoi task, designed to evaluate planning, problem-solving, and rule-based learning. Participants moved three disks across three pegs while following predefined rules to match a target configuration. Four outcome variables were recorded: Total number of moves Total time to solution (seconds) Average time per move (seconds) Latency to first move (planning time in seconds) Unit of Measurement: Number of moves and seconds (s)

    before and at the end of the 11-week intervention.

  • Changes in Visuospatial Working Memory (correctly repeated number score)

    Description: The Corsi Block Test was used to evaluate visual working memory and attention. In this computerized task, participants were asked to reproduce increasingly complex sequences of illuminated blocks. The task terminated when the participant failed to correctly repeat sequences of a given length twice in a row. Unit of Measurement: Span score (maximum sequence length correctly repeated)

    before and at the end of the 11-week intervention.

Study Arms (2)

"11 for Health" program

EXPERIMENTAL

"11 for Health" program training group

Other: "11 for Health" training group

control group

NO INTERVENTION

Control Group; The control group continued with their regular school curriculum, which included two 45-minute physical education classes per week, and did not receive any additional intervention.

Interventions

The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, implemented during school hours. Each week included one session focused on football-related physical activities (e.g., passing, dribbling, shooting) and another on health education topics (e.g., hygiene, nutrition, mental well-being), both delivered in an engaging and inclusive format. The program emphasized social interaction, autonomy-supportive teaching, and real-life applicability through take-home tasks.

"11 for Health" program

Eligibility Criteria

Age10 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Typically developing children
  • Aged between 10 and 11 years
  • Enrolled in the 5th grade of primary school
  • Not currently taking any medication
  • Provided informed consent from both the child and their parent/guardian

You may not qualify if:

  • Having any diagnosed cardiovascular, neurological, orthopedic, or psychiatric condition
  • Taking regular medication
  • Outside the age range of 10-11 years
  • Presence of any developmental disorder or learning disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namik Kemal University, Sports Sciences Research and Development Centre, Tekirdag, Suleymanpasa 59030

Tekirdağ, Suleymanpasa, 59030, Turkey (Türkiye)

Location

Related Publications (2)

  • Lind RR, Geertsen SS, Orntoft C, Madsen M, Larsen MN, Dvorak J, Ritz C, Krustrup P. Improved cognitive performance in preadolescent Danish children after the school-based physical activity programme "FIFA 11 for Health" for Europe - A cluster-randomised controlled trial. Eur J Sport Sci. 2018 Feb;18(1):130-139. doi: 10.1080/17461391.2017.1394369. Epub 2017 Nov 21.

    PMID: 29161988BACKGROUND
  • Madsen M, Elbe AM, Madsen EE, Ermidis G, Ryom K, Wikman JM, Rasmussen Lind R, Larsen MN, Krustrup P. The "11 for Health in Denmark" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT. Scand J Med Sci Sports. 2020 Sep;30(9):1787-1795. doi: 10.1111/sms.13704. Epub 2020 May 27.

    PMID: 32353906BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study sample was determined and divided into groups using the convenience sampling method. This non-random sampling approach involves selecting participants based on the researcher's judgment, allowing for practical, fast, and cost-effective data collection. At this stage, two 5th-grade classes from the same school that met the inclusion criteria and agreed to participate were selected. One class was assigned as the control group (CG; n=29) and the other as the training group (TG; n=27).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 23, 2025

Study Start

February 5, 2024

Primary Completion

February 23, 2024

Study Completion

June 14, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Measurements: Data obtained from physical fitness parameters (e.g., static, dynamic and proprioceptive balance, agility, countermovement jump) and executive function assessments (e.g., Go/No-Go, Tower of Hanoi, and Corsi Block tests) will be shared. Data Anonymization: All shared data will be fully anonymized to ensure participant confidentiality. Personal identifiers such as names, birth dates, and school affiliations will be removed. Data will be reviewed and aggregated where necessary to prevent the possibility of participant re-identification. Data Format: The data will be provided in standardized file formats such as CSV or Excel (.xlsx) to support compatibility and ease of use in secondary analyses. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 1 year after publication with no end date.
Access Criteria
Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.

Locations