Clinical trial NCT06496503: Effect of a School Intervention With Physical Activity on Executive Functions
Official title: Effect of a School Intervention With Physical Activity on Executive Functions and Relationships With Cardiorespiratory Fitness and Motor Coordination: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Keywords: cognitive function
child
physical activity
schoolchildren
Lead sponsor: State University of Londrina
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be performed carefully following the recommendations proposed by the Cochrane Collaboration. The process will consist of two stages, firstly, the generation of numbers using a random number table, and secondly, allocation concealment, using opaque, sealed envelopes. After signing the consent form, an envelope will be opened for each child and they will be instructed as to which group they have been allocated, the experimental or control.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Executive Functions
timeFrame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
Other outcomes:
measure: Motor Coordination
timeFrame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
Locations:
city: Nova Fátima
country: Brazil
facility: School
state: Paraná
Study officials:
References:
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