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The Cogni-Action Project: Physical Activity, Brain, and Cognition (Cogni-Action)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894241
Recruitment Status : Unknown
Verified March 2019 by Carlos Cristi Montero, Pontificia Universidad Catolica de Valparaiso.
Recruitment status was:  Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Cristi Montero, Pontificia Universidad Catolica de Valparaiso

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.


Condition or disease Intervention/treatment Phase
Cognitive Function 1, Social Behavioral: physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sedentary condition Behavioral: physical activity
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)

Experimental: Moderate-intensity continuous training Behavioral: physical activity
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)

Experimental: Cooperative-high-intensity interval training Behavioral: physical activity
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)




Primary Outcome Measures :
  1. Cognitive performance [ Time Frame: up to eight months ]
    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

  2. Brain structure and function [ Time Frame: up to eight months ]
    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).

  3. Neuroelectric measurement [ Time Frame: up to eight months ]
    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.

  4. Eye-tracker measurement [ Time Frame: up to eight months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894241


Locations
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Chile
School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
Valparaíso, Valparaiso, Chile
School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
Valparaíso, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Valparaiso
Investigators
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Principal Investigator: Carlos Cristi-Montero, Ph.D. Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlos Cristi Montero, Professor, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile, Pontificia Universidad Catolica de Valparaiso
ClinicalTrials.gov Identifier: NCT03894241    
Other Study ID Numbers: CONICYT/FONDECYT 2016/11160703
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Cristi Montero, Pontificia Universidad Catolica de Valparaiso:
Sedentary lifestyle
academic performance
aerobic fitness
electroencephalogram