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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02503579
Other study ID # 2015/0520
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date February 2016

Study information

Verified date December 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Nowadays children are getting more inactive and participate less in sports or daily physical activity. Previous studies have shown that a good physical fitness is associated with improved cognitive functions. While being physical active, physiological changes take places in the brain. Brain-derived neurotropic factor is one of the neurotropins that plays a crucial role in this process. Executive functions are cognitive processes that are responsible for organizing and controlling goal-directed actions. These functions are developing during childhood and play an important role in daily- and school functioning. 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 children. In a first trail the effect of physical fitness and physical training on executive functioning and levels of Brain-derived neurotropic factor will be studied. In a second trail the research question is expanded by investigating the same relations in children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder. Protocol trail 1: The included (typically developing) children will be randomized and stratified for level of physical fitness into 2 groups: the intervention group and the control group. The intervention group will receive physical activity training 2 times a week during 8 weeks. The control group will receive no additional training. At the beginning and the end of the training period both the intervention and control group will be tested for physical fitness and level of executive functioning. Protocol trail 2: Identical protocol to trail 1 except the participants will be children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder in stead of typically developing children.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 10 Years
Eligibility Trail 1 Inclusion Criteria: - typically developing children Exclusion Criteria: - children with: executive function-, neurological- or cognitive disorders Trail 2 Inclusion criteria: - typically developing children (control) - children with Developmental Coordination disorder, Attention deficit disorder or Autism Spectrum disorder Exclusion criteria: - Children with neurological- or cognitive disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
physical training
physical activity program, 30 minutes

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Ghent University Hospital, Ghent

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 Change of baseline after 9 weeks in Amount of daily physical activity (hours/week) Questionnaire about daily physical activity. Baseline and change from baseline 9 weeks later.
Secondary Change of baseline after 9 weeks in Maximal Oxygen Uptake during exertion test. Physical fitness measurement with maximal endurance test on bicycle using Balke-protocol. Baseline and change of baseline 9 week later.
Secondary Change of baseline after 9 weeks in Maximal heart rate during exertion test. Physical fitness measurement with maximal endurance test on bicycle using Balke-protocol. Baseline and change of baseline 9 week later.
Secondary Change from Baseline after 9 weeks on Executive functioning test battery. EF measurement true computer tasks. Baseline and change of baseline 9 weeks later.
Secondary Change from Baseline after acute physical activity on Executive functioning test battery. EF measurement true computer tasks. Baseline and change of baseline after 30 minutes of physical activity.
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