Effect of a School Intervention With Physical Activity on Executive Functions
NCT Number: NCT06496503
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Lifestyle
Interventions: BEHAVIORAL: Physical activity Protocol
Sponsor: State University of Londrina
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-02
Completion Date: 2025-03-31
Locations: School, Nova Fátima, Paraná, 86310-000, Brazil

Summary:
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).

Primary Outcome Measures: Executive Functions, 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: Cardiorespiratory fitness, 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: Motor Coordination, 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.