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The Role of Brain-derived Neurotropic Factor in the Relationship Between Executive Function and Physical Training

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ClinicalTrials.gov Identifier: NCT02503579
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : March 28, 2016
Sponsor:
Collaborator:
University Hospital, Ghent
Information provided by (Responsible Party):
Vakgroeprevaki, University Ghent

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.

Condition or disease Intervention/treatment Phase
Executive Dysfunction Motor Activity Child Behavioral: physical training Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: What's the Role of Brain-derived Neurotrophic Factor in the Relationship Between Executive Function and Physical Fitness/Training in Typically Developing Children? A Randomized Controlled Study
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: physical training
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
physical activity program, 30 minutes

No Intervention: control

1 training at the beginning of the study

1 training at the end of the study




Primary Outcome Measures :
  1. Change from baseline after 9 weeks in concentration of serum brain-derived neurotropic factor in blood sample. [ Time Frame: Baseline and change from baseline 9 weeks later. ]
    Measurement of serum Brain-derived neurotropic factor true blood samples.

  2. Change from Baseline after acute physical activity in concentration of serum brain-derived neurotropic factor in blood sample [ Time Frame: Baseline and change from baseline after 30 minutes of training. ]
    Measurement of serum Brain-derived neurotropic factor true blood samples.


Secondary Outcome Measures :
  1. Change of baseline after 9 weeks in Amount of daily physical activity (hours/week) [ Time Frame: Baseline and change from baseline 9 weeks later. ]
    Questionnaire about daily physical activity.

  2. Change of baseline after 9 weeks in Maximal Oxygen Uptake during exertion test. [ Time Frame: Baseline and change of baseline 9 week later. ]
    Physical fitness measurement with maximal endurance test on bicycle using Balke-protocol.

  3. Change of baseline after 9 weeks in Maximal heart rate during exertion test. [ Time Frame: Baseline and change of baseline 9 week later. ]
    Physical fitness measurement with maximal endurance test on bicycle using Balke-protocol.

  4. Change from Baseline after 9 weeks on Executive functioning test battery. [ Time Frame: Baseline and change of baseline 9 weeks later. ]
    EF measurement true computer tasks.

  5. Change from Baseline after acute physical activity on Executive functioning test battery. [ Time Frame: Baseline and change of baseline after 30 minutes of physical activity. ]
    EF measurement true computer tasks.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503579


Sponsors and Collaborators
University Ghent
University Hospital, Ghent
Investigators
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Principal Investigator: Hilde Van Waelvelde, Professor Revaki

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Responsible Party: Vakgroeprevaki, Kristof Van de Kerchove, MD, University Ghent
ClinicalTrials.gov Identifier: NCT02503579     History of Changes
Other Study ID Numbers: 2015/0520
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016

Keywords provided by Vakgroeprevaki, University Ghent:
Brain-derived neurotropic factor
Executive function