NCT02503579

Brief Summary

This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in the relationship between physical fitness/activity and executive functions in typically developing children and children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

May 29, 2015

Last Update Submit

December 12, 2023

Conditions

Executive DysfunctionMotor ActivityChild

Keywords

Brain-derived neurotropic factorExecutive function

Outcome Measures

Primary Outcomes (2)

  • Change from baseline after 9 weeks in concentration of serum brain-derived neurotropic factor in blood sample.

    Measurement of serum Brain-derived neurotropic factor true blood samples.

    Baseline and change from baseline 9 weeks later.

  • Change from Baseline after acute physical activity in concentration of serum brain-derived neurotropic factor in blood sample

    Measurement of serum Brain-derived neurotropic factor true blood samples.

    Baseline and change from baseline after 30 minutes of training.

Secondary Outcomes (5)

  • Change of baseline after 9 weeks in Amount of daily physical activity (hours/week)

    Baseline and change from baseline 9 weeks later.

  • Change of baseline after 9 weeks in Maximal Oxygen Uptake during exertion test.

    Baseline and change of baseline 9 week later.

  • Change of baseline after 9 weeks in Maximal heart rate during exertion test.

    Baseline and change of baseline 9 week later.

  • Change from Baseline after 9 weeks on Executive functioning test battery.

    Baseline and change of baseline 9 weeks later.

  • Change from Baseline after acute physical activity on Executive functioning test battery.

    Baseline and change of baseline after 30 minutes of physical activity.

Study Arms (2)

physical training

EXPERIMENTAL

Participant receive a submaximal (60% -75% maximal oxygen uptake) physical activity training of 30 minutes during 8 weeks, 2 times a week. Individual heart rates will be monitored during the training.

Behavioral: physical training

control

NO INTERVENTION

1 training at the beginning of the study 1 training at the end of the study

Interventions

physical trainingBEHAVIORAL

physical activity program, 30 minutes

physical training

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • typically developing children

You may not qualify if:

  • children with: executive function-, neurological- or cognitive disorders
  • Trail 2
  • typically developing children (control)
  • children with Developmental Coordination disorder, Attention deficit disorder or Autism Spectrum disorder
  • Children with neurological- or cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Latomme J, Calders P, Van Waelvelde H, Marien T, De Craemer M. The Role of Brain-Derived Neurotrophic Factor (BDNF) in the Relation between Physical Activity and Executive Functioning in Children. Children (Basel). 2022 Apr 22;9(5):596. doi: 10.3390/children9050596.

    PMID: 35626772DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hilde Van Waelvelde, Professor

    Revaki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

July 21, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

December 18, 2023

Record last verified: 2023-12