Clinical trial NCT06939881: "11 For Health" in Türkiye; Effect on Physical Performance and Executive Function in 10-11-Year-Olds
Official title: "11 For Health" in Türkiye - Effects on Physical Performance and Executive Function in 10-11-Years-Old Schoolchildren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Executive Function (Cognition)
Physical Performance
Keywords: 11 for Health in Türkiye
executive function
schoolchildren
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2025-04-23
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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).

Detailed description: This study examined the impact of the school-based "11 for Health" program on the physical performance and executive function of 10-11-year-old Turkish schoolchildren. The program, developed by FIFA in collaboration with global health experts, integrates football-based physical activities with health education content. Given the growing concern over insufficient physical activity levels among children in Türkiye, the intervention sought to explore how structured school-based programs could enhance not only physical performance but also higher-order cognitive processes.

The rationale for the study stems from evidence indicating that physical activity is not only essential for maintaining cardiovascular and musculoskeletal health but also closely linked to cognitive functions such as attention, response inhibition, and planning. Executive functions are critical during late childhood as they influence academic performance, behavior regulation, and social competence.

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.

Participants were divided into a training group and a control group using convenience sampling. The training group received the intervention, while the control group continued their standard physical education curriculum. Pre- and post-intervention assessments were conducted over separate days to measure changes in physical and cognitive outcomes.

Physical performance was assessed using standardized protocols to evaluate balance (static, proprioceptive, dynamic), agility (pro-agility shuttle test), and vertical jump (countermovement jump). Executive function was measured using three computer-based tasks: the Go/No-Go test (response inhibition), the Tower of Hanoi (planning/problem-solving), and the Corsi Block Test (visuospatial working memory).

The study contributes to the growing literature on school-based physical activity interventions and their multifaceted impact on children's development, offering insights relevant to both educators and policymakers seeking to optimize school curricula for health and cognitive outcomes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Static Balance Performance (% Score)
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Dynamic Balance Performance - Left-Right and Front-Back (% Score)
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Proprioceptive Balance Performance (% Score)
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Countermovement Jump Performance (cm)
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Agility (seconds)
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Inhibitory Control (Number of correct responses and Reaction Time (ms))
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Planning and Problem-Solving Skills (Number of moves and seconds)
timeFrame: before and at the end of the 11-week intervention.
measure: Changes in Visuospatial Working Memory (correctly repeated number score)
timeFrame: before and at the end of the 11-week intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdag
country: Turkey
facility: Tekirdag Namik Kemal University, Sports Sciences Research and Development Centre, Tekirdag, Suleymanpasa 59030
state: Suleymanpasa
Study officials:
References:
citation: 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.
citation: 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.