Executive DysfunctionNCT02503579
The Role of Brain-derived Neurotropic Factor in the Relationship Between Executive Function and Physical Training
A study testing physical training in people with Executive Dysfunction and Motor Activity, run by University Ghent.
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunction, Motor Activity, Child
- What is being tested?
- physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- typically developing children
- typically developing children (control)
- children with Developmental Coordination disorder, Attention deficit disorder or Autism Spectrum disorder
Who cannot join
- children with: executive function-, neurological- or cognitive disorders
- Trail 2
- Children with neurological- or cognitive disorders
About this study
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
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.
Read the 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.
- Conditions
- Executive Dysfunction, Motor Activity, Child
- Being tested
- physical training
- Keywords
- Brain-derived neurotropic factor, Executive function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingBehavioural
physical activity program, 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: physical training |
| control | No intervention | 1 training at the beginning of the study 1 training at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Questionnaire about daily physical activity.
Measured: Baseline and change from baseline 9 weeks later.
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.
Measured: Baseline and change of baseline 9 week later.
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.
Measured: Baseline and change of baseline 9 week later.
Change from Baseline after 9 weeks on Executive functioning test battery.
EF measurement true computer tasks.
Measured: Baseline and change of baseline 9 weeks later.
Change from Baseline after acute physical activity on Executive functioning test battery.
EF measurement true computer tasks.
Measured: Baseline and change of baseline after 30 minutes of physical activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Executive DysfunctionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Hilde Van Waelvelde, Professor, Principal investigator, Revaki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503579
- Sponsor's protocol ID
- 2015/0520
- Status last verified
- Dec 2023
- First submitted
- 29 May 2015
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35626772
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02503579
- Acronym / sponsor ID
- 2015/0520
- Conditions
- Executive Dysfunction, Motor Activity, Child
- Keywords
- Brain-derived neurotropic factor, Executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical training | Experimental | Behavioral: physical trainingParticipant 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. |
| control | No intervention | –1 training at the beginning of the study 1 training at the end of the study |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- typically developing children
- typically developing children (control)
- children with Developmental Coordination disorder, Attention deficit disorder or Autism Spectrum disorder
Key exclusion criteria (3 listed)
- children with: executive function-, neurological- or cognitive disorders
- Trail 2
- Children with neurological- or cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical trainingphysical activity program, 30 minutes | Behavioural | physical training |
Primary outcome
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.
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.
5 secondary outcomes
Change of baseline after 9 weeks in Amount of daily physical activity (hours/week)
Time frame: 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.
Change of baseline after 9 weeks in Maximal heart rate during exertion test.
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 35626772Latomme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde Van Waelvelde, Professor principal investigator
Revaki
Questions about this trial
What is this clinical trial studying?
A study testing physical training in people with Executive Dysfunction and Motor Activity, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.