Effect of a School Intervention With Physical Activity on Executive Functions

May 13, 2025 updated by: Carla Cristiane Silva, State University of Londrina

Effect of a School Intervention With Physical Activity on Executive Functions and Relationships With Cardiorespiratory Fitness and Motor Coordination: Randomized Clinical Trial

Previous studies have indicated the relationship between physical activity and cognitive performance, with movement being a promising tool for improving executive functions, especially during childhood, which is a period of intense brain development. Thus, the objective of this project is to verify a school physical activity intervention on executive functions and the relationships with cardiorespiratory fitness and motor coordination. This will be a randomized control trial in accordance with the Consort - Statement, including 118 children of both sexes; 60 in an experimental group and 58 in a control group. The children will follow their usual school routines, including Physical Education classes as part of the curriculum. The experimental group will also participate in an intervention for 12 weeks after school. The intervention will include three weekly physical exercise sessions, lasting between 50 and 60 minutes. The sessions will consist of activities involving games, sports, dance with a focus on aspects of motor coordination and cardiorespiratory fitness, as well as cognitive games. Assessments will be carried out at baseline, after 12 weeks of intervention and after the follow-up period. The students will undergo measurements of body mass and height, as well as nutritional classification using the body mass index (BMI). Following this, a general motor coordination test (KTK), a cardiorespiratory aptitude test (Léger), and tests to assess executive functions (Stroop and Corsi Block) will be applied. Data distribution will be verified using the Shapiro-Wilk's test. The comparisons between different moments (baseline, after 12 weeks, and at follow-up) will be performed using repeated measures ANOVA. Sphericity will be checked by Mauchly's test followed by the Greenhouse- Geisser correction when necessary. To identify differences, the Bonferroni correction will be applied. The significance level will be set at 5% (P<0.05).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During childhood, cognitive aspects of the prefrontal cortex are in the maturation phase. This process is associated with improvements in executive functions, in a continuous process, and although differentiated by its multiple aspects, it seems to correspond with the development peaks of the prefrontal cortex, which occur between 7 and 9 years of age. In addition to the biological alterations arising from the growth and development of the brain, physical activity performed regularly indicates a simple and effective way to improve the executive functions of children. Contreras-Osorio and colleagues stated that physical activity performed at moderate and vigorous intensities is positively related to working memory, reaction time, executive attention, cognitive flexibility, and planning in children and adolescents aged 10 to 12 years. Other authors highlight that activities involving cardiorespiratory fitness and motor coordination provide an increase in cognitive performance, with improvements in planning capacity, memory, self-control, and value judgment, among other fundamental components for social interaction and academic performance In a previous study, Visier-Alfonso and colleagues evaluated 186 school-age children aged 9 to 11 years and demonstrated positive effects on cardiorespiratory fitness, with increased physical activity, and positive changes in inhibitory control, working memory, and brain structure. Additionally, good levels of motor coordination are associated with complex movements and sport-specific skills, and are also essential for the development of higher levels of cognitive function. The relationships between motor skills and executive functions during childhood are based on coactivation events between the prefrontal cortex, the cerebellum, and the basal ganglia during different motor and cognitive tasks, especially when the task is complex, is a new task, or requires speed and concentration. This is because neural regions typically associated with cognitive operations can also be recruited during the performance of motor tasks.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • 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

  • Brazil
    • Paraná
      • Nova Fátima, Paraná, Brazil, 86310-000
        • School

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy

Neurotypical.

Exclusion Criteria:

Clinical or historical of cardiovascular disease

Hypertension

Insulin-dependent diabetes mellitus

Neurodiversity

Not be taking any drugs

Cannot participated in sports practices

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The children included in the experimental group will undergo 12 weeks of physical activity sessions, and it is mandatory that all children complete a minimum of two weekly sessions of physical activity for 50-60 minutes. The activities will consist of content such as motor and cognitive games, sports, dance, and gymnastics. The intensity of the sessions will be checked using accelerometry. The physical activity protocol is adapted from a previously described protocol (CMSP, 2021; Klem, Filha, Monteiro, 2017; Mazzoccante et al.; 2020; Paiano, 2019; Rodrigues, 2018; Rosini et al., 2014). Acceptance of the exercise program in the pediatric population has been previously observed in a pilot study.
Behavioral: Physical activity Protocol
The children included in the experimental group will undergo 12 weeks of physical activity sessions, and it is mandatory that all children complete a minimum of two weekly sessions of physical activity for 50-60 minutes. The activities will consist of content such as motor and cognitive games, sports, dance, and gymnastics. The intensity of the sessions will be checked using accelerometry. The physical activity protocol is adapted from a previously described protocol (CMSP, 2021; Klem, Filha, Monteiro, 2017; Mazzoccante et al.; 2020; Paiano, 2019; Rodrigues, 2018; Rosini et al., 2014). Acceptance of the exercise program in the pediatric population has been previously observed in a pilot study.
No Intervention: Control group
The children will follow their usual school routines, including Physical Education classes as part of the curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive Functions
Time Frame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
The executive functions will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention (follow-up period). Executive functions will be investigated in the domains of working memory, using the Corsi Block Test (Corsi, 1972; Kessels et al., 2000), and inhibitory control, investigated by the Stroop Test (Stroop, 1935; MacLeod, 1991). For both tests there will be familiarization and reproducibility of measurements for both the children and evaluator. The evaluation will be carried out by a single evaluator blind to group allocation.
Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.

The test will be conducted in the field with cones at a distance of 20 meters and a pre-recorded audio track to indicate the speed of each stage. The first stage starts at 8.5 km/h, with an increase of 0.5 km/h every minute, which indicates a change of stage. The test is considered to end when the child is unable to maintain the imposed speed or complete a stage with less than two errors (Léger et al., 1998).

The prescription of training will be dependent on the individual results for each child based on the last stage completed in the progressive test. At baseline, two field tests will be performed, the first one being a familiarization test and the second being considered as the value prior to the training. In addition, reproducibility of measurements will be tested to indicate the reliability of the results.
Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Coordination
Time Frame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
To evaluate general motor coordination, the Körperkoordinationstest Für Kinder (KTK) test will be applied (Kiphard; Schiling, 1974, apud Moreira et al., 2019; Nascimento et al., 2019). For all tests involving the KTK battery, there will be familiarization and reproducibility of measurements for both children and the evaluator. The evaluation will be carried out by a single evaluator blind to group allocation.
Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.

Collaborators and Investigators

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

Sponsor

State University of Londrina

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)

September 2, 2024

Primary Completion (Actual)

November 26, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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