NCT03894241

Brief Summary

Education and health are crucial topics for public policies as both largely determine the future wellbeing of the society. Currently, several studies recognize that physical activity (PA) benefits brain health in children. However, most of these studies have not been carried out in developing countries or lack the transference into the education field. The Cogni-Action Project is a crossover-randomized trial. The aim of the study is to determinate the acute effects of three different training sessions consisting in (i) "Moderate-Intensity Continuous Training" (MICT), (ii) "Cooperative High-Intensity Interval Training" (C-HIIT), and (iii) sedentary activity on spontaneous brain activity and neuroelectric indices of cognitive performance during a working memory and a reading task, as measured by electroencephalography (EEG) and eye-tracker. In an energy expenditure counterbalanced fashion, 32 adolescents will randomly undergo each training session , two weeks apart. The main strength of this project is that, to our knowledge, this is the first study analysing the potential influence of PA, sedentarism, and physical fitness on brain structure and function, cognitive performance, and academic achievement in Latin-America and, specifically, in Chile which has been catalogued with an important sociocultural gap. For this purpose, this study will use advanced technologies in neuroimaging (MRI), electrophysiology EEG, and eye-tracking , as well as objective and quality measurements of several physical and cognitive health outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

March 25, 2019

Last Update Submit

November 17, 2023

Conditions

Keywords

Sedentary lifestyleacademic performanceaerobic fitnesselectroencephalogram

Outcome Measures

Primary Outcomes (4)

  • Cognitive performance

    The Neurocognitive Performance test (NCPT, Lumos Labs, Inc.) is used to assess cognitive performance. It is a brief, repeatable, web-based platform of cognitive tasks intended to measure functioning across several cognitive domains including: working memory, visuospatial memory, psychomotor speed, fluid and logical reasoning, response inhibition, numerical calculation, and selective and divided attention. The NCPT has demonstrated adequate reliability and validity as a measure of cognitive performance, and in good concordance with pencil-paper assessments. Moreover, verb generation and working memory n-back tasks will be measured during the analysis with magnetic resonance in resting state. Also, reading and working memory n-back tasks will be measured during neuroelectric and eye-tracker measurements

    up to eight months

  • Brain structure and function

    Brain structural and functional information will be acquired using neuroimaging techniques. All images will be obtained with a 1.5 Tesla MRI scanner (AVANTO, Siemens Medical Systems, Erlangen, Germany).

    up to eight months

  • Neuroelectric measurement

    Electroencephalogram (EEG) measurement: A B-Alert X24 device for EEG (Advanced Brain Monitoring, California, United States) will be used, which consists of 24 active electrodes that minimize the noise of electrical devices outside the biological processes of interest, ensuring good signal quality.

    up to eight months

  • Eye-tracker measurement

    Eye-tracker: A Tobii Pro TX300 (Tobii, Stockholm, Sweden) will be used to track eye movements directly through a light sensitive camera near the infrared spectrum.

    up to eight months

Study Arms (3)

Sedentary condition

EXPERIMENTAL
Behavioral: physical activity

Moderate-intensity continuous training

EXPERIMENTAL
Behavioral: physical activity

Cooperative-high-intensity interval training

EXPERIMENTAL
Behavioral: physical activity

Interventions

Participants will assist to the three different sessions at the same weekday (e.g., Monday) and at the same daytime to avoid differences in preceding school activities or circadian rhythms. Participants will undergo a "Sedentary condition" (SC), sitting and watching a documentary on TV as has been used previously, and two different PA protocols consisting in "Moderate-Intensity Continuous Training" (MICT), i.e., continuous outdoor walking, and "Cooperative High-Intensity Interval Training" (C-HIIT), composed of a circuit training with a partner (physical education teacher)

Cooperative-high-intensity interval trainingModerate-intensity continuous trainingSedentary condition

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • boys aged 10-13 year-old
  • to have a score \>2 on a 5 point Tanner pubertal timing scale
  • normal vision
  • not being part of the government's educational integration program (i.e. psychological problems, attention deficit/hyperactivity disorder, depression, etc.)
  • not having any physical problem that is incompatible with intense PA
  • not being under psychoactive medications, and vii) to have approved guardians and children's informed consent.

You may not qualify if:

  • being part of the government's educational integration program (i.e. psychological problems, attention deficit/hyperactivity disorder, depression, etc.)
  • having any physical problem that is incompatible with intense PA
  • being under psychoactive medications, and vii) to have approved guardians and children's informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile

Valparaíso, Región de Valparaíso, Chile

Location

School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile

Valparaíso, Chile

Location

Related Publications (1)

  • Solis-Urra P, Olivares-Arancibia J, Suarez-Cadenas E, Sanchez-Martinez J, Rodriguez-Rodriguez F, Ortega FB, Esteban-Cornejo I, Cadenas-Sanchez C, Castro-Pinero J, Veloz A, Chabert S, Sadarangani KP, Zavala-Crichton JP, Migueles JH, Mora-Gonzalez J, Quiroz-Escobar M, Almonte-Espinoza D, Urzua A, Dragicevic CD, Astudillo A, Mendez-Gassibe E, Riquelme-Uribe D, Azagra MJ, Cristi-Montero C. Study protocol and rationale of the "Cogni-action project" a cross-sectional and randomized controlled trial about physical activity, brain health, cognition, and educational achievement in schoolchildren. BMC Pediatr. 2019 Jul 26;19(1):260. doi: 10.1186/s12887-019-1639-8.

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carlos Cristi-Montero, Ph.D.

    Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The Cogni-Action project presents a two-fold design with a cross-sectional investigation and a crossover-randomized trial. The aim of the first part is to establish the associations of physical activity (PA), sedentarism, and physical fitness with brain structure and function, cognitive performance and academic achievement in 797 Chilean schoolchildren. The aim of the second part is to determinate the acute effects of three different training sessions consisting in (i) "Moderate-Intensity Continuous Training" (MICT), (ii) "Cooperative High-Intensity Interval Training" (C-HIIT), and (iii) sedentary activity on spontaneous brain activity and neuroelectric indices of cognitive performance during a working memory and a reading task, as measured by electroencephalography (EEG) and eye-tracker. In an energy expenditure counterbalanced fashion, 32 adolescents will randomly undergo each training session, two weeks apart.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 28, 2019

Study Start

August 1, 2017

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations