Healthy ChildrenNCT05744323
Effects of Functional Training on Fundamental Motor Skills Among Children
A study testing Functional training in people with Healthy Children, run by Zhang Dong at 1 site in China.
Trial summary
The goal of this clinical trial is to examine the effects that functional training may have on the development of fundamental motor skills and to create a systematic functional training program suitable for healthy children aged 6-7 years. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Functional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Chinese Children in Taiyuan
- Primary school children are aged 6-7
- Including both gender boys and girls
Who cannot join
- Children cannot normally participate in regular physical education courses.
- The children have movement disorders.
- The children have physical or mental diseases.
- During the training period, the children have to do other sports training.
- The procedure for selecting samples will make use of stratified sampling in addition to a random number table.
Trial locations and contacts
1 site in 1 country.
China1 site
Wuyi Road Primary School, Taiyuan City, Shanxi Province, China
Taiyuan, Shanxi, 030012
About this study
Official title: Effects of Functional Training on Fundamental Motor Skills Among Chinese Children Aged 6-7 Years Old in Tai Yuan
The goal of this clinical trial is to examine the effects that functional training may have on the development of fundamental motor skills and to create a systematic functional training program suitable for healthy children aged 6-7 years.
The main question[s] it aims to answer are:
Read more
- [To examine the effects of functional training on FMS among children aged 6-7 years.]
- [To compare the effects of functional training on FMS between boys and girls]
This study will include an experimental group and a control group. The experimental group will engage in functional training, while the control group will follow the state-mandated physical education curriculum. Through experiments, we will investigate the effect of functional training on children's fundamental motor skills and assess whether the experimental group's intervention effect is superior to the control group. The samples in this study were normal Chinese children aged 6-7 years. There were 40 people in both the experimental and control groups, including 20 boys and 20 girls
Read the detailed description
Training intervention information This study will include an experimental group and a control group. The experimental group will engage in functional training, while the control group will follow the state-mandated physical education curriculum. Through experiments, we will investigate the effect of functional training on children's fundamental motor skills and assess whether the experimental group's intervention effect is superior to the control group. The samples in this study were normal Chinese children aged 6-7 years. There were 66 people in both the experimental group and control groups, including 35 boys and 35 girls.
Training Intervention Protocol for experiment group The selection of training items and content and the design of the training plan are based on the training content and principals involved in books such as the physical and motor function training for children, edited by Zhang Xiuli et al. (2018), the physical function training manual for adolescents and children edited by Wang Xiong (2019), and the functional training edited by Santana (2016). Furthermore, based on the literature review, the training frequency for the experiment was two (2) times a week, each lasting 45 minutes, including a 5-minute warm-up phase, a 35-minute main training phase, and a 5-minute relaxation phase, for a total training time of 12 weeks. The content was changed every two (2) weeks, and the intensity of the main phase of training ranged from 60% to 70%.
Training Intervention Protocol for control group The training content of the control group will be selected by the Compulsory Education Physical Education and Health Curriculum Standard in the year 2022. This standard follows the school's physical education teaching plan; the students in the control group will participate in the school's standard physical education curriculum. The specific content will be based on the actual physical education curriculum of the school. The training frequency for the control group was two times (2) a week, each lasting 45 minutes, and for a total training time of 12 weeks.
- Conditions
- Healthy Children
- Being tested
- Functional training
- Keywords
- functional training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional trainingOther
Physical and motor function training for children,may use BOSU balls, medicine balls, balance mats, fitness steps, and other training equipment to improve gradually
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will engage in functional training Receives: Other: Functional training |
| Control group | No intervention | the control group will follow the state-mandated physical education curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use the TGMD-2 scale to test locomotor skills
6 patterns tested within locomotor subtests. The scoring is based on points listed for each pattern. The total score is 24 points. The athletic performance will be criterion-based scores compared with norm-referenced standards.
Measured: baseline, pre-intervention/Change from baseline locomotor skills at 12 weeks.
Use the TGMD-2 scale to test object control skills
6 patterns tested within object control subtests. The scoring is based on points listed for each pattern. The total score is 24 points. The athletic performance will be criterion-based scores compared with norm-referenced standards.
Measured: baseline, pre-intervention/Change from baseline object control skills at 12 weeks.
Use the Y-test to test balance skill
YBT requires children to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. The YBT composite score is calculated by summing the 3 reach directions and normalizing the results to the lower limb length. All measurement scores were taken from scales on standing boards to the nearest 0.5 cm. Distances can be read from the test equipment. Each test was repeated three times, and the maximum range in each direction was recorded.
Measured: baseline, pre-intervention/Change from baseline object balance skills at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- 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
- Model description
- The study will be conducted using a randomized controlled trial (RCT), and the study will be divided into three parts: pre-study baseline testing, intervention training and post-study testing. The entire experiment will be conducted in the first academic year of 2023.2-2023.4. A pilot study will be carried out first, followed by the actual research, in order to provide the framework and offer support for the full-scale experiment that will follow. The subjects involved in this study are 6-year-old and 7-year-old children, all students participating in the study will be divided into experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Dong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Dong, Universiti Putra Malaysia
- Investigators
- Kim Geok soh, Study director, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744323
- Sponsor's protocol ID
- CN20230101
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baron J, Bieniec A, Swinarew AS, Gabrys T, Stanula A. Effect of 12-Week Functional Training Intervention on the Speed of Young Footballers. Int J Environ Res Public Health. 2019 Dec 24;17(1):160. doi: 10.3390/ijerph17010160.
PubMed 31878326James, C. R. (2007). Functional Training for Athletes At All Levels.
Boyle, M. (2004). Functional training for sports. Human Kinetics Publishers.
Liebenson, C. (2014). Functional training handbook. Lippincott Williams & Wilkins.
Heggond, M. S., Suresh, M. M., & Sundar, K. (2020). Impact of functional training on selected motor fitness components of sprinters. Journal of Xi'an University of Architecture & Technology, 12, 649-654.
Kovac D, Krkeljas Z, Venter R. Effect of six-week traditional resistance and functional training on functional performance in female netball players. BMC Sports Sci Med Rehabil. 2022 Jan 15;14(1):10. doi: 10.1186/s13102-022-00402-8.
PubMed 35033152Radcliffe, J. C. (2007). Functional training for athletes at all levels: workouts for agility, speed and power. Simon and Schuster.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Training on Fundamental Motor Skills Among Chinese Children Aged 6-7 Years Old in Tai Yuan
- ClinicalTrials.gov ID
- NCT05744323
- Acronym / sponsor ID
- CN20230101
- Conditions
- Healthy Children
- Keywords
- functional training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhang DongUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- 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.
The goal of this clinical trial is to examine the effects that functional training may have on the development of fundamental motor skills and to create a systematic functional training program suitable for healthy children aged 6-7 years.
The main question[s] it aims to answer are:
- [To examine the effects of functional training on FMS among children aged 6-7 years.]
- [To compare the effects of functional training on FMS between boys and girls]
This study will include an experimental group and a control group. The experimental group will engage in functional training, while the control group will follow the state-mandated physical education curriculum. Through experiments, we will investigate the effect of functional training on children's fundamental motor skills and assess whether the experimental group's intervention effect is superior to the control group. The samples in this study were normal Chinese children aged 6-7 years. There were 40 people in both the experimental and control groups, including 20 boys and 20 girls
Detailed description
Training intervention information This study will include an experimental group and a control group. The experimental group will engage in functional training, while the control group will follow the state-mandated physical education curriculum. Through experiments, we will investigate the effect of functional training on children's fundamental motor skills and assess whether the experimental group's intervention effect is superior to the control group. The samples in this study were normal Chinese children aged 6-7 years. There were 66 people in both the experimental group and control groups, including 35 boys and 35 girls.
Training Intervention Protocol for experiment group The selection of training items and content and the design of the training plan are based on the training content and principals involved in books such as the physical and motor function training for children, edited by Zhang Xiuli et al. (2018), the physical function training manual for adolescents and children edited by Wang Xiong (2019), and the functional training edited by Santana (2016). Furthermore, based on the literature review, the training frequency for the experiment was two (2) times a week, each lasting 45 minutes, including a 5-minute warm-up phase, a 35-minute main training phase, and a 5-minute relaxation phase, for a total training time of 12 weeks. The content was changed every two (2) weeks, and the intensity of the main phase of training ranged from 60% to 70%.
Training Intervention Protocol for control group The training content of the control group will be selected by the Compulsory Education Physical Education and Health Curriculum Standard in the year 2022. This standard follows the school's physical education teaching plan; the students in the control group will participate in the school's standard physical education curriculum. The specific content will be based on the actual physical education curriculum of the school. The training frequency for the control group was two times (2) a week, each lasting 45 minutes, and for a total training time of 12 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be conducted using a randomized controlled trial (RCT), and the study will be divided into three parts: pre-study baseline testing, intervention training and post-study testing. The entire experiment will be conducted in the first academic year of 2023.2-2023.4. A pilot study will be carried out first, followed by the actual research, in order to provide the framework and offer support for the full-scale experiment that will follow. The subjects involved in this study are 6-year-old and 7-year-old children, all students participating in the study will be divided into experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Functional trainingThe experimental group will engage in functional training |
| Control group | No intervention | –the control group will follow the state-mandated physical education curriculum. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Chinese Children in Taiyuan
- Primary school children are aged 6-7
- Including both gender boys and girls
Key exclusion criteria (5 listed)
- Children cannot normally participate in regular physical education courses.
- The children have movement disorders.
- The children have physical or mental diseases.
- During the training period, the children have to do other sports training.
- The procedure for selecting samples will make use of stratified sampling in addition to a random number table.
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 |
|---|---|---|
| Functional trainingPhysical and motor function training for children,may use BOSU balls, medicine balls, balance mats, fitness steps, and other training equipment to improve gradually | Other | Experimental group |
Primary outcome
Use the TGMD-2 scale to test locomotor skills
Time frame: baseline, pre-intervention/Change from baseline locomotor skills at 12 weeks.
6 patterns tested within locomotor subtests. The scoring is based on points listed for each pattern. The total score is 24 points. The athletic performance will be criterion-based scores compared with norm-referenced standards.
Use the TGMD-2 scale to test object control skills
Time frame: baseline, pre-intervention/Change from baseline object control skills at 12 weeks.
6 patterns tested within object control subtests. The scoring is based on points listed for each pattern. The total score is 24 points. The athletic performance will be criterion-based scores compared with norm-referenced standards.
Use the Y-test to test balance skill
Time frame: baseline, pre-intervention/Change from baseline object balance skills at 12 weeks.
YBT requires children to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. The YBT composite score is calculated by summing the 3 reach directions and normalizing the results to the lower limb length. All measurement scores were taken from scales on standing boards to the nearest 0.5 cm. Distances can be read from the test equipment. Each test was repeated three times, and the maximum range in each direction was recorded.
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 1 Dec 2023.
- Background: PubMed 31878326Baron J, Bieniec A, Swinarew AS, Gabrys T, Stanula A. Effect of 12-Week Functional Training Intervention on the Speed of Young Footballers. Int J Environ Res Public Health. 2019 Dec 24;17(1):160. doi: 10.3390/ijerph17010160.
- BackgroundJames, C. R. (2007). Functional Training for Athletes At All Levels.
- BackgroundBoyle, M. (2004). Functional training for sports. Human Kinetics Publishers.
- BackgroundLiebenson, C. (2014). Functional training handbook. Lippincott Williams & Wilkins.
- Results publicationHeggond, M. S., Suresh, M. M., & Sundar, K. (2020). Impact of functional training on selected motor fitness components of sprinters. Journal of Xi'an University of Architecture & Technology, 12, 649-654.
- Results publication: PubMed 35033152Kovac D, Krkeljas Z, Venter R. Effect of six-week traditional resistance and functional training on functional performance in female netball players. BMC Sports Sci Med Rehabil. 2022 Jan 15;14(1):10. doi: 10.1186/s13102-022-00402-8.
- Results publicationRadcliffe, J. C. (2007). Functional training for athletes at all levels: workouts for agility, speed and power. Simon and Schuster.
- Individual participant dataSharing planned: No
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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.
Kim Geok soh study director
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional training in people with Healthy Children, run by Zhang Dong 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 3 inclusion and 5 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 1 Dec 2023. 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?
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?
Use the TGMD-2 scale to test locomotor skills (time frame: baseline, pre-intervention/Change from baseline locomotor skills at 12 weeks.). The study lists 3 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 NCT05744323, which also lists 7 linked publications.
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 1 Dec 2023.