Clinical trial NCT05936372: Effects of Acute Exercise on Motor Learning and Brain Activity in Children With DCD
Official title: Study Protocol to Examine the Effects of Acute Exercise on Motor Learning and Brain Activity in Children With Developmental Coordination Disorder (ExLe-Brain-DCD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: Visuomotor adaptation
Attention
Physical exercise
Functional near-infrared spectroscopy (fNIRS)
Cortical activation
Prefrontal cortex
Children
Lead sponsor: Institut Nacional d'Educacio Fisica de Catalunya
Sponsor class: OTHER
Collaborators: name: ICFO - The Institute of Photonic Sciences
name: Ministerio de Ciencia e Innovación, Spain
name: University of Stuttgart
name: The University of Texas at Arlington
First posted: 2023-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 90
Maximum age (years): 126
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: initial directional error
timeFrame: 0, 1, and 24 hours, and 7 days
measure: root mean square error
timeFrame: 0, 1, and 24 hours, and 7 days
measure: initial rate of learning
timeFrame: 0, 1, and 24 hours, and 7 days
measure: relative oxyhemoglobin concentration ([02Hb]) in the ventrolateral prefrontal cortex
timeFrame: 0, 1, and 24 hours, and 7 days
measure: relative oxyhemoglobin concentration ([02Hb]) in the dorsolateral prefrontal cortex
timeFrame: 0, 1, and 24 hours, and 7 days
measure: relative deoxyhemoglobin concentration ([HHb]) in the ventrolateral prefrontal cortex
timeFrame: 0, 1, and 24 hours, and 7 days
measure: relative deoxyhemoglobin concentration ([HHb]) in the dorsolateral prefrontal cortex
timeFrame: 0, 1, and 24 hours, and 7 days
Secondary outcomes:
measure: movement time
timeFrame: 0, 1, and 24 hours, and 7 days
measure: travel distance
timeFrame: 0, 1, and 24 hours, and 7 days
measure: reaction time
timeFrame: 0, 1, and 24 hours, and 7 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Escola Bosc de Montjuïc
city: Barcelona
country: Spain
facility: Escola Ramon Casas
city: Barcelona
country: Spain
facility: Escola Seat
Study officials:
affiliation: Institut Nacional d'Educació Física de Catalunya
name: Albert Busquets Faciaben, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Nacional d'Educació Física de Catalunya
name: Rosa M Angulo Barroso, PhD
role: PRINCIPAL_INVESTIGATOR
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