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Clinical Trials/NCT06496503
NCT06496503
Completed
Not Applicable

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

State University of Londrina1 site in 1 country100 target enrollmentSeptember 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Lifestyle
Sponsor
State University of Londrina
Enrollment
100
Locations
1
Primary Endpoint
Executive Functions
Status
Completed
Last Updated
11 months ago

Overview

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-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).

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2024
End Date
April 30, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
State University of Londrina
Responsible Party
Principal Investigator
Principal Investigator

Carla Cristiane Silva

Principal Investigator

State University of Londrina

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Cardiorespiratory fitness(Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.)

Study Sites (1)

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