The Cogni-Action Project: Physical Activity, Brain, and Cognition
Cogni-Action
Rationale, Design and Methods of a Study on Physical Activity, Sedentarism, Physical Fitness, and Brain , Cognitive Performance and Academic Achievement in School Children. The Cogni-Action Project
1 other identifier
interventional
32
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
Typical duration for not_applicable
2 active sites
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
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedNovember 21, 2023
November 1, 2023
2.2 years
March 25, 2019
November 17, 2023
Conditions
Keywords
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
EXPERIMENTALModerate-intensity continuous training
EXPERIMENTALCooperative-high-intensity interval training
EXPERIMENTALInterventions
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)
Eligibility Criteria
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
School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
Valparaíso, Chile
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.
PMID: 31349791DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Cristi-Montero, Ph.D.
Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- 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