Viewing Study NCT06496503



Ignite Creation Date: 2024-07-17 @ 11:07 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06496503
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-15
First Post: 2024-07-03

Brief Title: Effect of a School Intervention With Physical Activity on Executive Functions
Sponsor: State University of Londrina
Organization: State University of Londrina

Study Overview

Official Title: Effect of a School Intervention With Physical Activity on Executive Functions and Relationships With Cardiorespiratory Fitness and Motor Coordination Randomized Clinical Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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-Wilks 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 Mauchlys 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 P005
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None