## Protocol Section
### Identification Module
**NCT ID:** NCT02503579

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

**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

#### Organization Study ID Info
**ID:** 2015/0520
#### Organization
**Class:** OTHER
**Full Name:** University Ghent
### Status Module
#### Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Start Date
**Date:** 2015-08

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2015-07-21
**Type:** ESTIMATED
**Study First Submit Date:** 2015-05-29
**Study First Submit QC Date:** 2015-07-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University Hospital, Ghent

#### Lead Sponsor

**Class:** OTHER

**Name:** University Ghent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Executive Dysfunction

- Motor Activity

- Child

**Keywords:**

- Brain-derived neurotropic factor

- Executive function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 52

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: physical training

**Label:** physical training

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 1 training at the beginning of the study

1 training at the end of the study

**Label:** control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- physical training

**Description:** physical activity program, 30 minutes

**Name:** physical training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of serum Brain-derived neurotropic factor true blood samples.

**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.

**Description:** Measurement of serum Brain-derived neurotropic factor true blood samples.

**Measure:** 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.

#### Secondary Outcomes

**Description:** Questionnaire about daily physical activity.

**Measure:** Change of baseline after 9 weeks in Amount of daily physical activity (hours/week)

**Time Frame:** Baseline and change from baseline 9 weeks later.

**Description:** Physical fitness measurement with maximal endurance test on bicycle using Balke-protocol.

**Measure:** Change of baseline after 9 weeks in Maximal Oxygen Uptake during exertion test.

**Time Frame:** Baseline and change of baseline 9 week later.

**Description:** Physical fitness measurement with maximal endurance test on bicycle using Balke-protocol.

**Measure:** Change of baseline after 9 weeks in Maximal heart rate during exertion test.

**Time Frame:** Baseline and change of baseline 9 week later.

**Description:** EF measurement true computer tasks.

**Measure:** Change from Baseline after 9 weeks on Executive functioning test battery.

**Time Frame:** Baseline and change of baseline 9 weeks later.

**Description:** EF measurement true computer tasks.

**Measure:** 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.

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Maximum Age:** 10 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Revaki

**Name:** Hilde Van Waelvelde, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 35626772

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
