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Executive Function DisorderNCT06510920

The Purpose of This Research is to Investigate the Effects of Aerobic Exercise on Executive Function in Obese Children

A study testing Aerobic exercise in people with Executive Function Disorder and Obesity, Childhood, run by Jing Xin at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to learn if aerobic exercise improves executive functioning in obese children. It will also understand the effects of aerobic exercise on executive functioning in obese children. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 8 to 10 yearsHealthy volunteers can take part
What is being tested?
Aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
1 Aug 2024to 30 Dec 2024
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

  • Age: Obese children aged 8-10 years.
  • The body weight was obese or above.
  • There was no history of other concomitant diseases related to obesity,Children with simple obesity.
  • Normal blood pressure.
  • The International Physical Activity Scale (IPAQ, Chinese version) measured participants 'physical activity in the past 7 days, with internal consistency reliability r = 0.927(Qiu NN, 2004).
  • The physical condition Safety questionnaire (PAR-Q) was used to ensure that the exercise in thistest could be completed safely(Appendix2).
  • Uncorrected or corrected visual acuity was normal.

Who cannot join

  • In the process of the experiment, it is necessary to participate in other forms of intervention experiments. If the members of the experimental group or the control group are engaged in regular exercise or planned training, they need to be excluded from the experiment.
  • If the members of the experimental group are absent from work for more than1 week, the samples will be deemed to fall off. If the members of the experimental group and the control group fail to participate in any of the data collection on time, they will be excluded.
  • Before and after the experiment, the members of the experimental group or the control group who limited their movement due to sprain and other reasons were excluded.They were randomly divided into experimental group and control group.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Jinan Tangye primary School

    Jinan, Shandong, 250100

    Xiangkun Yang, PHD, +86-15098729527, yangbanzhang@163.com

    Xin Jing, PHD

Other trials in China

About this study

Official title: Effects of Aerobic Exercise on Executive Function Among Obese Children

The goal of this clinical trial is to learn if aerobic exercise improves executive functioning in obese children. It will also understand the effects of aerobic exercise on executive functioning in obese children. The main questions it aims to answer are:

  1. What are the levels of executive functioning(inhibitory function, working memory, and cognitive flexibility) in normal-weight and obese children aged 8-10 years?
  2. What are the differences on executive function before and after aerobic exercise intervention among obese children?
  3. Do factors of health, gender and ages influence students' executive functioning (inhibitory function, working memory, and cognitive flexibility)? Researchers will compare the aerobic exercise intervention group with the no-aerobic exercise group in terms of executive function to see if and how much aerobic exercise has an effect on executive function.
Read more

Participants will:

(1) The aerobic exercise intervention group was given football and volleyball exercise intervention, and the control group was given routine school life for 3 months.

  1. Record the participants before and after the intervention level of executive function.
Read the detailed description

The purpose of this researchis to investigate the effects of aerobic exercise on executive function in obese children, with a focus on inhibition, working memory and cognitive flexibility. A confirmatory study was conducted to determine whether obese children have weaker executive function than normal-weight children. On the basis of existence, further studies are needed to investigate the effects of aerobic exercise on executive function in obese children.

General research objective:The aim of this study is to evaluate the effects of aerobic exercise on executive function among Obese children.Specific research objectives:1.Level:To determine the developmental level of executive function (inhibitory function, working memory, and cognitive flexibility) in normal weight and obese children aged 8-10 years.2.Effects:To investigate the effects of 12-week aerobic exercise intervention on executive function(inhibition, working memory, and cognitive flexibility) in obese children aged 8-10 years.3.Factors:To investigate whether health, gender, and age factors affect students\' executive functioning (inhibition, working memory, and cognitive flexibility).

Background: 1. Childhood obesity has become one of the most urgent public health problems in the world. The obesity rate for children and adolescents aged 6 to 17 years is close to 20%. 2. Obesity not only increases the prevalence of physical diseases in children, but also has a negative impact on the development of cognitive function in this age group. 3. A function is a higher level of cognitive function, is essential for individuals to directional control behavior. It includes inhibiting function, working memory and cognitive flexibility. Cognitive developmental delays in our country the third highest number of children in the world. 4. Physical exercise on the development of cognitive function in obese children with good effect. 5. National policy guidance and the attention to Chinese children\'s mental health and cognitive ability. 6. Childhood is the important period of executive function development. 7. The current domestic study of obese children explore more aerobic exercise influence on obese children body composition, but the study of obesity children\'s executive function is not perfect. As a result, more experiments are needed to verify these conclusions.

Significance: 1. Sample selection: Obese children are a special group at a critical age. Understanding of obese children and characteristics of executive function has important value. 2. The theoretical significance: the executive function still is a hot issue in the field of psychology in the world. Research results can provide a good reference for the obese child\'s follow-up study. 3. Practical significance: through scientific and reasonable means to improve the quality of life in obese children and to improve the executive function, reduce the cognitive and behavioral defects. The ultimate significance is to determine whether aerobic exercise can affects the obesity children\'s executive function, prove the effectiveness and scientific nature of aerobic exercise.

Preliminary Results or Evidence:The conceptual framework of this study is in the theoretical framework and formed on the basis of previous research achievements, in order to solve the research questions of this study. This conceptual framework takes aerobic exercise as the independent variable and executive function as the dependent variable. Executive function includes three aspects: inhibition function, working memory function, and cognitive flexibility. Based on the theoretical basis of \"Development and Practice of Physical Activity Program to Enhance Children\'s Executive Function\" written by Chen Aiguo et al, this study investigated the effects of aerobic exercise on executive function of children aged 8 to 10 years old. This model was chosen because it was found to be very useful as a conceptual framework for predicting the effects of executive function during aerobic exercise. Therefore, it is believed that the framework model will provide a good basis for the current research.

Research Design \& Methods:

Experiment 1:The levels of executive functioning among normal-weight and obese children.Executive function will be tested in obese children compared with normal-weight children. To explore the executive function of children aged 8-10 years with different body mass index (BMI). The subjects will be divided into obese group and normal weight group, and the executive function tasks of obese and normal weight children will be tested. Flanker task paradigm ,N-Back task paradigm and more-odd shifting task paradigm will be used to test the executive function, and the differences between working memory ,inhibitory control function and cognitive flexibility in different groups will be investigated. Behavioral tasks will be tested in quiet office conditions, and all three tasks will be tested using the computer program.To measure the levels of executive functioning(inhibitory function, working memory, and cognitive flexibility) in normal-weight and obese children aged 8-10 years.

experiment 2:Effects of aerobic exercise on executive function among obese children.To investigate the effects of 12-week aerobic exercise intervention on executive function (inhibitory function, working memory, and cognitive flexibility)among obese children aged 8-10 years.The participants will be divided into obese exercise group and obese control group, and the behavioral paradigm of executive function will be tested before the intervention to obtain the pre-test data. Then, the obese exercise group will be given aerobic exercise intervention for 12 weeks, and the posttest data will be collected after 12 weeks. Executive function will be tested using Flanker, N-Back and more-odd shifting task paradigms to examine the relationship between the effects of a 12-week aerobic exercise intervention on working memory , inhibitory control and Flexibility of cognition in the exercise group. The aerobic exercise intervention will be conducted in designated areas of the school playground, and the behavioral task will be tested using the computer program in quiet office conditions.

Experimental Equipment: Decathlon heart rate, height, body weight tester, equipped with E - Prime computer software Research environment: 1: aerobic exercise: Primary school playground. 2. Executive function test: Quiet computer room For the purpose of gathering data in this study, this study is delimited on the subject of the public primary schools in Jinan City. After review and discussion by expert members of the expert panel, this study determined that three computer programs that measure executive function(inhibition, working memory, and cognitive flexibility).The Intervention days regarding aerobic exercise .The present study was limited to executive function testing in children aged 8-10 years (3rd and 5th grade in Chinese primary schools) from selected primary schools where the aerobic exercise intervention was implemented and where multi-functional computer classrooms with measurable executive function were available .

Being tested
Aerobic exercise
Keywords
Executive function, Obese Children, Aerobic Exercise, Mental health
Medical subject headings
Pediatric Obesity, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exerciseBehavioural

    The mixed design scheme of football and volleyball sports technology and competition will be adopted.aerobic exercise intensity will be moderate-intensity aerobic exercise load , and the intervention time was 12 weeks, 60 minutes each time, twice a week. The main preparation activities were jogging and special preparation activities (10 minutes), and the main part was technical teaching combined with competition (60 minutes).The end part is mostly jogging and stretching (10 minutes). Two subjects in each group were selected to wear Decathlon Bluetooth heart rate band, and the exercise intensity was controlled by detecting the heart rate of the subjects.

Study groups in NCT06510920
Study groupRoleWhat they receive
Obese children aerobic exercise intervention groupExperimentalAerobic exercise intervention on children obesity in the experimental group, the form of aerobic exercise for football and volleyball training, strength control in moderate intensity, time 1 hour, twice a week.
Receives: Behavioral: Aerobic exercise
Obese children of control groupNo interventionControl group in obese children will be conducted in normal school physical education, in addition to no other exercise intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-test: executive function in normal weight children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    Measured: Baseline and week 1

  2. Pre-test: executive function in obese children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    Measured: Baseline and week 1

  3. After 12 weeks of executive function level of obese children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    Measured: week 12

  4. After 12 weeks in the control group executive function level of obese children

    Three computer programs will be used to measure executive function:1.Flanker task paradigm to measure inhibition. This test computer recorded reaction durations in milliseconds, and the test score will be calculated as the average reaction durations of the conflict and non-conflict scenarios minus.2.N-Back task paradigm to measure working memory. This test computer records the reaction time in milliseconds, and the test score is the average reaction time.3.More-odd shifting task paradigm to measure cognitive flexibility. This test computer records the reaction time in milliseconds, and the test score is the subtraction of the average reaction time of the switching condition and the non-switching condition. For each of the three tests, the computer returns Units on a Scale 0 to 1 (0= error, 1= correct) to calculate the correct rate.

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510920
Sponsor's protocol ID
- JKEUPM-2024-232
Status last verified
Jul 2024
First submitted
27 Jun 2024
Last updated
19 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise in people with Executive Function Disorder and Obesity, Childhood, run by Jing Xin at 1 site in China.

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 7 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Jing, PHD (+86-15820095961, jingxin125678@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-test: executive function in normal weight children (time frame: Baseline and week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Jul 2024.

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