- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667219
Influencing Factors and Interventions of Physical Exercise Behaviour of 6-Year-Old Children in Guangdong, China
The goal of this clinical trial is to examine the relationship between children's physical exercise behavior and children's Fundamental Motor Skills (FMS) before and after changing the influencing factors of 6-year-old children's physical exercise behavior in Guangdong Province, China. The main question it aims to answer is:
Is there any change of the relationship (time, group, and interaction) between 6-year-old children's physical exercise behaviour and children's Fundamental Motor Skills (FMS) before and after the physical activity intervention of the influencing factors in Guangdong Province, China?
Participants will:
Intervention group, Length: 12 weeks, 40 minutes, twice a week. The intervention will be conducted using a relevant physical fitness training program.
Control group, Length: 12 weeks. Content: Physical exercise using kindergarten standards.
Researchers will compare the data before and after the intervention to know whether the Fundamental Motor Skills (FMS) of 6-year-old children have changed.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 511325
- Guangzhou Huali College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Preschool children aged 6 years old in Guangdong, China;
- Children who are of Chinese nationality;
- Male and female;
- Parents/guardians signed an informed consent form;
Exclusion Criteria:
- Have a mental illness with cognitive impairment problems;
- Children with speech or ear function impairment;
- Recent or imminent surgery (within 3 months), or medical co-morbidities;
- Parents/guardians did not sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group, a children's physical fitness training program
Length:12 weeks, 40 minutes one time, twice a week. Intervention content: The intervention will be conducted using a relevant physical fitness training program. |
54children who participated in after-school sports activities in Guangzhou Kindergarten (Guangzhou, China) were randomly selected as the experimental group. Intervention group Length:12 weeks, 40 minutes, twice a week. Intervention content: The intervention will be conducted using a relevant physical fitness training program , as follows: Week 1 / 4 first: Run quickly;Durian ball;Throw;Fast jogging (200 m) Week 1 / 4 second: Dodge run,Raise your legs high and go over the small hurdles; Durian ball (standing on one foot);standing long jump Week 2 / 5 first: Bow step transformation jump;Throw;Turn back 10 meters Week 2 / 5 second: Hop ;Stand on one foot with your eyes open Week 3 / 6 first:Skip over the small hurdles;Durian ball (standing on one foot);Throw; Fast jogging (200 m) Week 3 / 6 second:Jump on your feet and dodge running;Durian ball (squat);Jump support Weeks 7-12,Repeat the above content. FMS index was tested before the experiment, and once after the intervention. |
|
Experimental: control group, Physical exercise using kindergarten standards
Duration: 12 weeks.
Content: Physical exercise using kindergarten standards.
|
54 children who did not participate in after-school sports activities were selected as the control group. control group Duration: 12 weeks. Content: Physical exercise using kindergarten standards. FMS index was tested the same to intervention group before the test and FMS index was measured once again after 12 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in test values of 13 indicators of Fundmental Motor Skills in 6-year-old children at 12 weeks
Time Frame: 5 months
|
The FMS is measured with the tool TGMD-3. TGMD-3 is scored based on the completion quality of children. The unit of measurement is "scores". The 13-item test consists of two subscales: six locomotor skills (LM) (i.e., run, gallop, hop, slide, jump, and skip) and seven ball skills (BS), formerly known as object control skills (i.e., forehand strike, two-hand strike, overhand throw, underhand throw, dribble, catch, and kick). According to the TGMD-3, each skill has a set of performance criteria that is evaluated. In this case, raw scores for locomotor skills could range from 0 to 46. Similarly, ball skills could range from 0 to 54. The total score of all movements was 100 scores. The higher score represents a higher level of motor skill development, and the low score indicates a lack of some critical movement development. |
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USM/JEPeM/KK/23030260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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