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

December 12, 2023 updated by: University Ghent

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
physical activity program, 30 minutes
No Intervention: control

1 training at the beginning of the study

1 training at the end of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Baseline and change from baseline after 30 minutes of training.
Measurement of serum Brain-derived neurotropic factor true blood samples.
Baseline and change from baseline after 30 minutes of training.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and change from baseline 9 weeks later.
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.
Baseline and change of baseline 9 week later.
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.
Baseline and change of baseline 9 week later.
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.
Baseline and change of baseline 9 weeks later.
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.
Baseline and change of baseline after 30 minutes of physical activity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hilde Van Waelvelde, Professor, Revaki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimated)

July 21, 2015

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/0520

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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