- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503579
The Role of Brain-derived Neurotropic Factor in the Relationship Between Executive Function and Physical Training
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 Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Hilde Van Waelvelde, Professor, Revaki
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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