NCT05936372

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

June 9, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

June 9, 2023

Last Update Submit

February 8, 2024

Conditions

Keywords

Visuomotor adaptationAttentionPhysical exerciseFunctional near-infrared spectroscopy (fNIRS)Cortical activationPrefrontal cortexChildren

Outcome Measures

Primary Outcomes (7)

  • initial directional error

    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

    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

    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

    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

    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

    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

    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 Outcomes (3)

  • movement time

    0, 1, and 24 hours, and 7 days

  • travel distance

    0, 1, and 24 hours, and 7 days

  • reaction time

    0, 1, and 24 hours, and 7 days

Study Arms (4)

EX-TD

EXPERIMENTAL

Typical developed children that perform acute exercise prior to the learning task

Behavioral: Acute intense aerobic exercise

CON-TD

NO INTERVENTION

Typical developed children that not perform acute exercise prior to the learning task

EX-DCD

EXPERIMENTAL

Children with developmental coordination disorder (DCD) that perform acute exercise prior to the learning task

Behavioral: Acute intense aerobic exercise

CON-DCD

NO INTERVENTION

Children with developmental coordination disorder (DCD) that not perform acute exercise prior to the learning task

Interventions

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.

EX-DCDEX-TD

Eligibility Criteria

Age90 Months - 126 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Escola Bosc de Montjuïc

Barcelona, 08038, Spain

RECRUITING

Escola Ramon Casas

Barcelona, 08038, Spain

RECRUITING

Escola Seat

Barcelona, 08038, Spain

RECRUITING

Related Publications (23)

  • Smits-Engelsman B, Verbecque E. Pediatric care for children with developmental coordination disorder, can we do better? Biomed J. 2022 Apr;45(2):250-264. doi: 10.1016/j.bj.2021.08.008. Epub 2021 Sep 2.

    PMID: 34482014BACKGROUND
  • Adams IL, Lust JM, Wilson PH, Steenbergen B. Compromised motor control in children with DCD: a deficit in the internal model?-A systematic review. Neurosci Biobehav Rev. 2014 Nov;47:225-44. doi: 10.1016/j.neubiorev.2014.08.011. Epub 2014 Sep 1.

    PMID: 25193246BACKGROUND
  • Fuster JM. Executive frontal functions. Exp Brain Res. 2000 Jul;133(1):66-70. doi: 10.1007/s002210000401.

    PMID: 10933211BACKGROUND
  • Fuster JM. The prefrontal cortex in the neurology clinic. Handb Clin Neurol. 2019;163:3-15. doi: 10.1016/B978-0-12-804281-6.00001-X.

    PMID: 31590737BACKGROUND
  • Goto K, Hoshi Y, Sata M, Kawahara M, Takahashi M, Murohashi H. Role of the prefrontal cortex in the cognitive control of reaching movements: near-infrared spectroscopy study. J Biomed Opt. 2011 Dec;16(12):127003. doi: 10.1117/1.3658757.

    PMID: 22191933BACKGROUND
  • Jueptner M, Stephan KM, Frith CD, Brooks DJ, Frackowiak RS, Passingham RE. Anatomy of motor learning. I. Frontal cortex and attention to action. J Neurophysiol. 1997 Mar;77(3):1313-24. doi: 10.1152/jn.1997.77.3.1313.

    PMID: 9084599BACKGROUND
  • Kumar N, Sidarta A, Smith C, Ostry DJ. Ventrolateral Prefrontal Cortex Contributes to Human Motor Learning. eNeuro. 2022 Sep 29;9(5):ENEURO.0269-22.2022. doi: 10.1523/ENEURO.0269-22.2022. Print 2022 Sep-Oct.

    PMID: 36114001BACKGROUND
  • Hampshire A, Duncan J, Owen AM. Selective tuning of the blood oxygenation level-dependent response during simple target detection dissociates human frontoparietal subregions. J Neurosci. 2007 Jun 6;27(23):6219-23. doi: 10.1523/JNEUROSCI.0851-07.2007.

    PMID: 17553994BACKGROUND
  • Passingham RE, Toni I, Rushworth MF. Specialisation within the prefrontal cortex: the ventral prefrontal cortex and associative learning. Exp Brain Res. 2000 Jul;133(1):103-13. doi: 10.1007/s002210000405.

    PMID: 10933215BACKGROUND
  • Bunge SA, Kahn I, Wallis JD, Miller EK, Wagner AD. Neural circuits subserving the retrieval and maintenance of abstract rules. J Neurophysiol. 2003 Nov;90(5):3419-28. doi: 10.1152/jn.00910.2002. Epub 2003 Jul 16.

    PMID: 12867532BACKGROUND
  • Blank R, Smits-Engelsman B, Polatajko H, Wilson P; European Academy for Childhood Disability. European Academy for Childhood Disability (EACD): recommendations on the definition, diagnosis and intervention of developmental coordination disorder (long version). Dev Med Child Neurol. 2012 Jan;54(1):54-93. doi: 10.1111/j.1469-8749.2011.04171.x. No abstract available.

    PMID: 22171930BACKGROUND
  • Ferrer-Uris B, Busquets A, Angulo-Barroso R. Adaptation and Retention of a Perceptual-Motor Task in Children: Effects of a Single Bout of Intense Endurance Exercise. J Sport Exerc Psychol. 2018 Feb 1;40(1):1-9. doi: 10.1123/jsep.2017-0044. Epub 2018 Mar 9.

    PMID: 29523049BACKGROUND
  • Angulo-Barroso R, Ferrer-Uris B, Busquets A. Enhancing Children's Motor Memory Retention Through Acute Intense Exercise: Effects of Different Exercise Durations. Front Psychol. 2019 Aug 28;10:2000. doi: 10.3389/fpsyg.2019.02000. eCollection 2019.

    PMID: 31555181BACKGROUND
  • Kagerer FA, Bo J, Contreras-Vidal JL, Clark JE. Visuomotor adaptation in children with developmental coordination disorder. Motor Control. 2004 Oct;8(4):450-60. doi: 10.1123/mcj.8.4.450.

    PMID: 15585900BACKGROUND
  • Kagerer FA, Contreras-Vidal JL, Bo J, Clark JE. Abrupt, but not gradual visuomotor distortion facilitates adaptation in children with developmental coordination disorder. Hum Mov Sci. 2006 Oct;25(4-5):622-33. doi: 10.1016/j.humov.2006.06.003. Epub 2006 Oct 2.

    PMID: 17011655BACKGROUND
  • King BR, Kagerer FA, Harring JR, Contreras-Vidal JL, Clark JE. Multisensory adaptation of spatial-to-motor transformations in children with developmental coordination disorder. Exp Brain Res. 2011 Jul;212(2):257-65. doi: 10.1007/s00221-011-2722-z. Epub 2011 May 17.

    PMID: 21584627BACKGROUND
  • Lundbye-Jensen J, Skriver K, Nielsen JB, Roig M. Acute Exercise Improves Motor Memory Consolidation in Preadolescent Children. Front Hum Neurosci. 2017 Apr 20;11:182. doi: 10.3389/fnhum.2017.00182. eCollection 2017.

    PMID: 28473761BACKGROUND
  • Preston N, Magallon S, Hill LJ, Andrews E, Ahern SM, Mon-Williams M. A systematic review of high quality randomized controlled trials investigating motor skill programmes for children with developmental coordination disorder. Clin Rehabil. 2017 Jul;31(7):857-870. doi: 10.1177/0269215516661014. Epub 2016 Aug 1.

    PMID: 27481937BACKGROUND
  • Smits-Engelsman BC, Wilson PH, Westenberg Y, Duysens J. Fine motor deficiencies in children with developmental coordination disorder and learning disabilities: an underlying open-loop control deficit. Hum Mov Sci. 2003 Nov;22(4-5):495-513. doi: 10.1016/j.humov.2003.09.006.

    PMID: 14624830BACKGROUND
  • Wilmut K, Wann J. The use of predictive information is impaired in the actions of children and young adults with Developmental Coordination Disorder. Exp Brain Res. 2008 Dec;191(4):403-18. doi: 10.1007/s00221-008-1532-4. Epub 2008 Aug 16.

    PMID: 18709366BACKGROUND
  • Wilson PH, Maruff P, Lum J. Procedural learning in children with developmental coordination disorder. Hum Mov Sci. 2003 Nov;22(4-5):515-26. doi: 10.1016/j.humov.2003.09.007.

    PMID: 14624831BACKGROUND
  • Wilson PH, Ruddock S, Smits-Engelsman B, Polatajko H, Blank R. Understanding performance deficits in developmental coordination disorder: a meta-analysis of recent research. Dev Med Child Neurol. 2013 Mar;55(3):217-28. doi: 10.1111/j.1469-8749.2012.04436.x. Epub 2012 Oct 29.

    PMID: 23106668BACKGROUND
  • Zwicker JG, Missiuna C, Harris SR, Boyd LA. Developmental coordination disorder: a review and update. Eur J Paediatr Neurol. 2012 Nov;16(6):573-81. doi: 10.1016/j.ejpn.2012.05.005. Epub 2012 Jun 15.

    PMID: 22705270BACKGROUND

MeSH Terms

Conditions

Motor Skills DisordersMotor Activity

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Busquets Faciaben, PhD

CONTACT

Blai Ferrer Uris, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2023

First Posted

July 7, 2023

Study Start

February 5, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After finishing the study
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.

Locations