Effect of a School Intervention With Physical Activity on Executive Functions

NCT06496503 | Completed DMC

• 1 other identifier: UEL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Lifestyle

Keywords

cognitive function; child; physical activity; schoolchildren

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cardiorespiratory fitness

  Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.

Other Outcomes (1)

• Motor Coordination

  Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The children will follow their usual school routines, including Physical Education classes as part of the curriculum

Interventions

Physical activity Protocol BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy
• Neurotypical.

You may not qualify if:

• Clinical or historical of cardiovascular disease
• Hypertension
• Insulin-dependent diabetes mellitus
• Neurodiversity
• Not be taking any drugs
• Cannot participated in sports practices

Sponsors & Collaborators

• State University of Londrina: lead

Study Sites (1)

School

Nova Fátima, Paraná, 86310-000, Brazil

Location

Related Publications (20)

• Contreras-Osorio F, Guzman-Guzman IP, Cerda-Vega E, Chirosa-Rios L, Ramirez-Campillo R, Campos-Jara C. Effects of the Type of Sports Practice on the Executive Functions of Schoolchildren. Int J Environ Res Public Health. 2022 Mar 24;19(7):3886. doi: 10.3390/ijerph19073886.

  PMID: 35409571 BACKGROUND

• Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.

  PMID: 21299297 BACKGROUND

• de Greeff JW, Bosker RJ, Oosterlaan J, Visscher C, Hartman E. Effects of physical activity on executive functions, attention and academic performance in preadolescent children: a meta-analysis. J Sci Med Sport. 2018 May;21(5):501-507. doi: 10.1016/j.jsams.2017.09.595. Epub 2017 Oct 10.

  PMID: 29054748 BACKGROUND

• Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

  PMID: 23020641 BACKGROUND

• Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.

  PMID: 21852486 BACKGROUND

• Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008 Dec;26(14):1557-65. doi: 10.1080/02640410802334196.

  PMID: 18949660 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Fuster JM. The prefrontal cortex--an update: time is of the essence. Neuron. 2001 May;30(2):319-33. doi: 10.1016/s0896-6273(01)00285-9. No abstract available.

  PMID: 11394996 BACKGROUND

• Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.

  PMID: 11296689 BACKGROUND

• Leger LA, Mercier D, Gadoury C, Lambert J. The multistage 20 metre shuttle run test for aerobic fitness. J Sports Sci. 1988 Summer;6(2):93-101. doi: 10.1080/02640418808729800.

  PMID: 3184250 BACKGROUND

• MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.

  PMID: 2034749 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.

  PMID: 20332511 BACKGROUND

• Moreira JPA, Lopes MC, Miranda-Junior MV, Valentini NC, Lage GM, Albuquerque MR. Korperkoordinationstest Fur Kinder (KTK) for Brazilian Children and Adolescents: Factor Analysis, Invariance and Factor Score. Front Psychol. 2019 Nov 19;10:2524. doi: 10.3389/fpsyg.2019.02524. eCollection 2019.

  PMID: 31803092 BACKGROUND

• Nascimento WMD, Henrique NR, Marques MDS. KTK MOTOR TEST: REVIEW OF THE MAIN INFLUENCING VARIABLES. Rev Paul Pediatr. 2019 Jun 19;37(3):372-381. doi: 10.1590/1984-0462/;2019;37;3;00013. eCollection 2019.

  PMID: 31241688 BACKGROUND

• Serrien DJ, Ivry RB, Swinnen SP. The missing link between action and cognition. Prog Neurobiol. 2007 Jun;82(2):95-107. doi: 10.1016/j.pneurobio.2007.02.003. Epub 2007 Feb 23.

  PMID: 17399884 BACKGROUND

• Rigoli D, Piek JP, Kane R, Oosterlaan J. Motor coordination, working memory, and academic achievement in a normative adolescent sample: testing a mediation model. Arch Clin Neuropsychol. 2012 Nov;27(7):766-80. doi: 10.1093/arclin/acs061. Epub 2012 Jul 9.

  PMID: 22777140 BACKGROUND

• Roebers CM, Kauer M. Motor and cognitive control in a normative sample of 7-year-olds. Dev Sci. 2009 Jan;12(1):175-81. doi: 10.1111/j.1467-7687.2008.00755.x.

  PMID: 19120425 BACKGROUND

• van der Fels IM, Te Wierike SC, Hartman E, Elferink-Gemser MT, Smith J, Visscher C. The relationship between motor skills and cognitive skills in 4-16 year old typically developing children: A systematic review. J Sci Med Sport. 2015 Nov;18(6):697-703. doi: 10.1016/j.jsams.2014.09.007. Epub 2014 Sep 21.

  PMID: 25311901 BACKGROUND

• Visier-Alfonso ME, Alvarez-Bueno C, Sanchez-Lopez M, Cavero-Redondo I, Martinez-Hortelano JA, Nieto-Lopez M, Martinez-Vizcaino V. Fitness and executive function as mediators between physical activity and academic achievement. J Sports Sci. 2021 Jul;39(14):1576-1584. doi: 10.1080/02640414.2021.1886665. Epub 2021 Feb 21.

  PMID: 33612080 BACKGROUND

• Wassenberg R, Feron FJ, Kessels AG, Hendriksen JG, Kalff AC, Kroes M, Hurks PP, Beeren M, Jolles J, Vles JS. Relation between cognitive and motor performance in 5- to 6-year-old children: results from a large-scale cross-sectional study. Child Dev. 2005 Sep-Oct;76(5):1092-103. doi: 10.1111/j.1467-8624.2005.00899.x.

  PMID: 16150004 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The team of evaluators, teachers, and researchers who process the results will be completely independent. At all stages of the study (baseline until follow-up) the same outcome assessors will be recruited. None of the individuals, researchers, or evaluators involved will have knowledge as to group allocation. The professional responsible for the physical activities will be hired for this purpose and not belong to the project research team.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: September 2, 2024
• Primary Completion: November 26, 2024
• Study Completion: April 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)