Effects of Acute Exercise on Motor Learning and Brain Activity in Children With DCD (ExLeBrainDCD)

February 8, 2024 updated by: Albert Busquets Faciaben, Institut Nacional d'Educacio Fisica de Catalunya

Study Protocol to Examine the Effects of Acute Exercise on Motor Learning and Brain Activity in Children With Developmental Coordination Disorder (ExLe-Brain-DCD)

The aim of this study is to investigate the impact of an acute intense physical exercise bout on the learning ability of children with typical motor development (TD) and children with developmental coordination disorder (DCD). The effects will be studied during the learning and in the short- (1 hour), medium- (24 hours), and long-terms (7 days) after the initial learning. Participants will be divided into 4 groups: children with typical development who will exercise (EX-TD), children with developmental coordination disorder who will exercise (EX-DCD), children with typical development who will not exercise (CON-TD), and children with developmental coordination disorder who will not exercise (CON-DCD). Participants will be enrolled for 4 different sessions:

Session 1: First, participants will do a test to asses their cognitive ability and their height and weight will be measured. Then, participants will run a race test to assess their level of physical condition and to calculate high and moderate intensities of the exercise bout. The test will consist of running from one side to the other of a 20 m long track, while following the rhythm set by a sound.

Session 2: at least 48 hours after the first one, the participants will do an exercise bout running from side to side of a 20 m long track alternating high and moderate intensities during 13 min. The members of the control groups (CON-TD and CON-DCD) will not perform this exercise and, instead, will remain at rest for a time equivalent to the exercise of the other groups. On the other hand, participants will perform a learning task involving hand-eye coordination, in which participants will control the movements of a circle on a computer screen using a joystick. The objective of this task will be to move the circle to target points that will appear on the screen with the maximum accuracy and speed possible. Participants will be asked to practice this task for approximately 8 min. Then, after a 1-hour rest period, the participants will be asked to perform the learning task again (only 3.5 min) to check the level of retention of the initial learning. A headcap will be adjusted on the head of the participants during the motor task performance to measure the activity of the brain through infrared light.

Sessions 3 and 4: participants will complete two retention tests of the learning task (one in each session) 24 hours and 7 days after the second session, respectively. Participants will also wear the headcap for the brain activity measurements.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08038
        • Recruiting
        • Escola Bosc de Montjuïc
        • Contact:
      • Barcelona, Spain, 08038
        • Recruiting
        • Escola Ramon Casas
        • Contact:
      • Barcelona, Spain, 08038
        • Recruiting
        • Escola Seat
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Movement assessment battery for children - second edition (MABC-2) score: developmental coordination disorder (DCD) group score <15% and typically developed (TD) group score >25%
  • An average or better cognitive ability tested through the Test of Nonverbal Intelligence version 4 (TONI-4)
  • A parent-report history to confirm that, according to the child's pediatrician, motor difficulties showed by their child cannot be explained by any other neurological, developmental, and/or severe psychosocial problem. Comorbid attention deficit hyperactivity disorder, attention deficit disorder, and dyslexia will be acceptable in order to better represent the DCD population since data population-based studies suggest that almost 40% of the children with DCD have combined problems related to learning and/or attentional disorders.

Exclusion Criteria:

  • Participant health status do not allow hem/her to participate in physical activities (Physical Activity Readiness Questionnaire, PAR-Q)
  • Other comorbidities than attention deficit hyperactivity disorder, attention deficit disorder, and/or dyslexia
  • Reported neurological, developmental, and/or severe psychosocial problem that could explain the motor development problem
  • Participant that takes medication that could affect results
  • Uncorrected 20/20 vision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EX-TD
Typical developed children that perform acute exercise prior to the learning task
Behavioral: Acute intense aerobic exercise
The acute intense aerobic exercise bout (iE) will consist of a 13-minute 20-meter shuttle run. During this exercise bout two speeds, based on a percentage of the estimated maximal oxygen consumption (VO2max), will be combined: a fast-paced speed (fast: 85% of VO2max) and a slow-paced speed (slow: 60% VO2max). A total of 3 series of 3 min of the fast-paced speed will be carried interspersed with 2 series of 2 min of the slow-paced speed. Prior to the iE start, a warm-up protocol consisting of 2 min slow and 1 min fast will be done with the objective to familiarize participants with the iE speeds. A 5-minute rest period will be guaranteed before starting the iE. Transition time between iE and the rotational visuomotor adaptation task (rVMA) will be 4 min.
No Intervention: CON-TD
Typical developed children that not perform acute exercise prior to the learning task
Experimental: EX-DCD
Children with developmental coordination disorder (DCD) that perform acute exercise prior to the learning task
Behavioral: Acute intense aerobic exercise
The acute intense aerobic exercise bout (iE) will consist of a 13-minute 20-meter shuttle run. During this exercise bout two speeds, based on a percentage of the estimated maximal oxygen consumption (VO2max), will be combined: a fast-paced speed (fast: 85% of VO2max) and a slow-paced speed (slow: 60% VO2max). A total of 3 series of 3 min of the fast-paced speed will be carried interspersed with 2 series of 2 min of the slow-paced speed. Prior to the iE start, a warm-up protocol consisting of 2 min slow and 1 min fast will be done with the objective to familiarize participants with the iE speeds. A 5-minute rest period will be guaranteed before starting the iE. Transition time between iE and the rotational visuomotor adaptation task (rVMA) will be 4 min.
No Intervention: CON-DCD
Children with developmental coordination disorder (DCD) that not perform acute exercise prior to the learning task

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
initial directional error
Time Frame: 0, 1, and 24 hours, and 7 days
Initial directional error (IDE) will be calculated as the absolute angular difference between the ideal trajectory, a linear vector from the center to the target, and the early real trajectory, defined by the linear vector from the center to the cursor position at the time of 80 ms after movement onset.
0, 1, and 24 hours, and 7 days
root mean square error
Time Frame: 0, 1, and 24 hours, and 7 days
Root mean square error (RMSE) will be calculated to represent the straightness of the movement between the ideal trajectory and the real joystick trajectory.
0, 1, and 24 hours, and 7 days
initial rate of learning
Time Frame: 0, 1, and 24 hours, and 7 days
The initial rate of learning (RL) will be computed as the first derivative of the first half of the function and evaluated at epoch 1 for both error variables initial directional error (RL-IDE) and root mean square error (RL-RMSE).
0, 1, and 24 hours, and 7 days
relative oxyhemoglobin concentration ([02Hb]) in the ventrolateral prefrontal cortex
Time Frame: 0, 1, and 24 hours, and 7 days
Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
0, 1, and 24 hours, and 7 days
relative oxyhemoglobin concentration ([02Hb]) in the dorsolateral prefrontal cortex
Time Frame: 0, 1, and 24 hours, and 7 days
Neural activation of each cortical area will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
0, 1, and 24 hours, and 7 days
relative deoxyhemoglobin concentration ([HHb]) in the ventrolateral prefrontal cortex
Time Frame: 0, 1, and 24 hours, and 7 days
Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).
0, 1, and 24 hours, and 7 days
relative deoxyhemoglobin concentration ([HHb]) in the dorsolateral prefrontal cortex
Time Frame: 0, 1, and 24 hours, and 7 days
Neural activation of each cortical area will be expressed as a relative decrease of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).
0, 1, and 24 hours, and 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
movement time
Time Frame: 0, 1, and 24 hours, and 7 days
Time spend moving the cursor from its initial position to its final position
0, 1, and 24 hours, and 7 days
travel distance
Time Frame: 0, 1, and 24 hours, and 7 days
Displacement of the cursor from its initial position to its final position
0, 1, and 24 hours, and 7 days
reaction time
Time Frame: 0, 1, and 24 hours, and 7 days
Reaction time will be defined as the time between target appearance and movement onset.
0, 1, and 24 hours, and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Nacional d'Educacio Fisica de Catalunya

Collaborators

The University of Texas at Arlington
University of Stuttgart
Ministerio de Ciencia e Innovación, Spain
ICFO - The Institute of Photonic Sciences

Investigators

  • Principal Investigator: Albert Busquets Faciaben, PhD, Institut Nacional d'Educació Física de Catalunya
  • Principal Investigator: Rosa M Angulo Barroso, PhD, Institut Nacional d'Educació Física de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID2020-120453RB-I00 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación de España)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only after finishing the study and with the express authorization of the Department of Education of the Generalitat of Catalonia, the data processed and anonymized will be stored in a specialized repository for research purposes. The data in this repository will be placed under the Creative Commons Attribution-Non Comercial-Share Alike (CC BY-NC-SA) license. They will only be used for scientific purposes and after requesting permission from the authors and under the same conditions that we have established. The following data will not be made publicly available:

  • Personal data and other data that can be tracked to participants identity.
  • Data that compromises the protection of a partner(s) intellectual property.
  • The level of data made available will also be considered, for example, pre-processed data will not be provided unless there is a clear reason for doing so.
  • Datasets which cannot be shared because of legal and contractual reasons.

IPD Sharing Time Frame

After finishing the study

IPD Sharing Access Criteria

Once processing, quality control, organisation, analysis, and publication are complete, the data will be made accessible by deposition in open access repositories (https://b2share.eudat.eu).

Members of the research team will form a data access committee. This committee will oversee that openly accessible data respect ethical and data security aspects, including intellectual property requirements. The possibilities of accessing the data in the specialized repository will always be decided in consultation with our collaborators and the Department of Education of the Generalitat de Catalunya.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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