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Developmental Coordination DisorderExLeBrainDCDNCT05936372

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

A study testing Acute intense aerobic exercise in people with Developmental Coordination Disorder, run by Institut Nacional d'Educacio Fisica de Catalunya at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 90 to 126 monthsHealthy volunteers can take part
Conditions the study is for
Developmental Coordination Disorder
What is being tested?
Acute intense aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesSpain
Study dates
5 Feb 2024to Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 90 to 126 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Albert Busquets Faciaben, PhD contact

+34934255445 ext. 213

albert.busquets@gencat.cat

Blai Ferrer Uris, PhD contact

+34934255445 ext. 213

bferrer@gencat.cat

Spain3 sites, 3 recruiting
  • Escola Bosc de Montjuïc

    Barcelona, 08038

    Marta, 934414224, a8003491@xtec.cat

    Recruiting
  • Escola Ramon Casas

    Barcelona, 08038

    Nuria Buyreu, 933315284, a8002976@xtec.cat

    Recruiting
  • Escola Seat

    Barcelona, 08038

    Júlia Beltran Arellano, 933329346, escolaseat@xtec.cat

    Recruiting

Other trials in Spain

About this study

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)

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.

Read more

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.

Being tested
Acute intense aerobic exercise
Keywords
Visuomotor adaptation, Attention, Physical exercise, Functional near-infrared spectroscopy (fNIRS), Cortical activation, Prefrontal cortex, Children
Medical subject headings
Motor Skills Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute intense aerobic exerciseBehavioural

    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.

Study groups in NCT05936372
Study groupRoleWhat they receive
EX-TDExperimentalTypical developed children that perform acute exercise prior to the learning task
Receives: Behavioral: Acute intense aerobic exercise
CON-TDNo interventionTypical developed children that not perform acute exercise prior to the learning task
EX-DCDExperimentalChildren with developmental coordination disorder (DCD) that perform acute exercise prior to the learning task
Receives: Behavioral: Acute intense aerobic exercise
CON-DCDNo interventionChildren with developmental coordination disorder (DCD) that not perform acute exercise prior to the learning task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0, 1, and 24 hours, and 7 days

  2. 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.

    Measured: 0, 1, and 24 hours, and 7 days

  3. 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).

    Measured: 0, 1, and 24 hours, and 7 days

  4. 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).

    Measured: 0, 1, and 24 hours, and 7 days

  5. 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).

    Measured: 0, 1, and 24 hours, and 7 days

  6. 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).

    Measured: 0, 1, and 24 hours, and 7 days

  7. 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).

    Measured: 0, 1, and 24 hours, and 7 days

Secondary outcomes (3)
  1. movement time

    Time spend moving the cursor from its initial position to its final position

    Measured: 0, 1, and 24 hours, and 7 days

  2. travel distance

    Displacement of the cursor from its initial position to its final position

    Measured: 0, 1, and 24 hours, and 7 days

  3. reaction time

    Reaction time will be defined as the time between target appearance and movement onset.

    Measured: 0, 1, and 24 hours, and 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start5 Feb 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936372
Sponsor's protocol ID
PID2020-120453RB-I00
Other IDs
PID2020-120453RB-I00
Acronym
ExLeBrainDCD
Status last verified
Feb 2024
First submitted
9 Jun 2023
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34482014
  • 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.

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

    PubMed 10933211
  • 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.

    PubMed 31590737
  • 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.

    PubMed 22191933
  • 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.

    PubMed 9084599
  • 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.

    PubMed 36114001
  • 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.

    PubMed 17553994
  • 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.

    PubMed 10933215
  • 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.

    PubMed 12867532
  • 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.

    PubMed 22171930
  • 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.

    PubMed 29523049
  • 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.

    PubMed 31555181
  • 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.

    PubMed 15585900
  • 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.

    PubMed 17011655

Questions about this trial

What is this clinical trial studying?

A study testing Acute intense aerobic exercise in people with Developmental Coordination Disorder, run by Institut Nacional d'Educacio Fisica de Catalunya at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Albert Busquets Faciaben, PhD (+34934255445 ext. 213, albert.busquets@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

initial directional error (time frame: 0, 1, and 24 hours, and 7 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936372, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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