MyopiaNCT07121049
Influence of Strength Training on Myopia Care in Kindergarten Children
A study testing Strength training in people with Myopia and Physical Fitness, run by Hungkuang University.
Trial summary
With the advancement of technology and changes in lifestyle, the physical activity levels of modern children have gradually decreased. This affects their physical health, psychological development, and social skills, and may increase the risk of nearsightedness. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Physical Fitness, Muscle Strength
- What is being tested?
- Strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 19 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-7 who are going to be promoted from kindergarten to first grade
- Must be able to exercise
Who cannot join
- heart disease
- respiratory problems
- severe allergies
About this study
Official title: Study on the Influence of Muscle Strength and Physical Fitness Training on Myopia Health Care for Children in Kindergarten
With the advancement of technology and changes in lifestyle, the physical activity levels of modern children have gradually decreased. This affects their physical health, psychological development, and social skills, and may increase the risk of nearsightedness. Therefore, it is essential to implement muscle training and outdoor activities in schools, travel agencies, and kindergartens. This project aims to promote the comprehensive development of children through systematic muscle training and enhanced outdoor activities, integrating college students from early childhood education programs, travel agencies, and kindergartens to establish habits that prevent nearsightedness.
In the kindergarten setting, 60 children in the senior class will serve as the control group, while another 60 will be in the intervention group. The intervention group will participate in 10 weeks of muscle training and outdoor activities, including core exercises 3 times a week for 60 minutes each session from 4pm to 6pm. Additionally, there will be subsidized a total of 2 outdoor activities on weekends. This approach will not only improve the children's coordination and flexibility but also enhance their physical fitness. Regarding travel agencies, tailored outdoor activities specifically designed for young children can be created, such as ecological explorations and wilderness survival training, allowing children to enjoy the fun of movement and learning in a safe environment. Travel agencies should collaborate with educational institutions to provide professional guidance and safety assurances, giving parents peace of mind. For kindergartens, a comprehensive outdoor activity plan should be established, regularly organizing sports days and group competitions to encourage children to participate in team sports like soccer and relay races. This not only helps improve the children's muscle strength but also fosters their spirit of cooperation and social skills. Through these methods, we aim to effectively increase children's activity levels, promote their overall development, and reduce the risk of nearsightedness.
Read the detailed description
Body composition includes Metabolic age, body fat percentage, BMI, total body water (%), BMR (Basal Metabolic Rate), Visceral Fat, physique ratings, muscle quality, muscle mass. Body composition was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). Tanita Home Page. Available online: https://tanita.eu/understanding-your-measurements (accessed on 13 August 2022). The FSM is a standardized, norm-referenced test of functional strength for children aged 4-10 years (Smits-Engelsman, 2012).
The FSM consists of eight items that measure anaerobic muscular endurance (30-second sit-to-stand times, lateral up-and-down, box lift, and stair test) and muscular strength (overhand throw, underhand throw, chest throw, and standing long jump). For anaerobic muscular endurance items, the number of repetitions in a 30-second period is counted; for muscular strength items, the distance covered is measured in centimeters.
The Visual_Fatigue_Questionnaire is based on the subjective feelings of the subjects and contains 6 questions using a 5-point Likert scale. The subjects are required to circle the score that best describes their current state (1 represents not at all, 2 represents almost not, 3 represents average, 4 represents somewhat severe, and 5 represents very severe) among the following 6 questions.
- Conditions
- Myopia, Physical Fitness, Muscle Strength
- Being tested
- Strength training
- Keywords
- Kindergartens, Muscle training, Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
Through systematic muscle training and promotion of outdoor activities, the program integrates early childhood education college students with kindergartens to promote the all-round development of children and establish habits to prevent myopia.
| Study group | Role | What they receive |
|---|---|---|
| Strength training group | Experimental | The strength training group participated in 10 weeks of intervention, performing core muscle exercises three times a week between 4 and 6 p.m. Receives: Behavioral: Strength training |
| Placebo group | No intervention | Placebo group did not receive any intervention measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spherical Equivalent (SE)
Mean change in myopia severity. An Independent t-test was conducted to assess the difference in ΔSE (Spherical Equivalent) between the Intervention and Control groups.
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Secondary outcomes (7)
Change in Body Fat Percentage
Body Fat Percentage was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). Tanita Home Page. Available online: https://tanita.eu/understanding-your-measurements (accessed on 13 August 2022). A Paired t-test was used to evaluate within-group changes, while an Independent t-test examined the differences between the groups in ΔSE.
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Change in FSM Composite Score
Endurance is determined by the sum of repetitions from the four tests, while strength is measured by the mean distance achieved across the four tests.
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Change in Metabolic Age
Pearson Correlation was utilized to explore the association with ΔSE, while Partial Correlation was calculated while controlling for age. Metabolic age was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). Tanita Home Page. Available online: https://tanita.eu/understanding-your-measurements (accessed on 13 August 2022).
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Change in Visual Fatigue Score
Linear Regression analysis was employed, where the ΔScore was modeled as a function of the group and baseline score.
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Visceral Fat Responders
Proportion with ΔVisceral Fat ≤ -10%. A Chi-square test was implemented to determine the differences in responder rates between groups. Visceral Fat was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). Tanita Home Page. Available online: https://tanita.eu/understanding-your-measurements (accessed on 13 August 2022).
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
The correlation between muscle quality and spherical equivalent (SE)
Bivariate Correlation was analyzed with ΔSE, stratified by group. Muscle Quality was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). Tanita Home Page. Available online: https://tanita.eu/understanding-your-measurements (accessed on 13 August 2022).
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Hydration-Metabolism Interaction
A Two-way ANOVA was conducted to assess the effect on ΔSE, considering the interaction between group and hydration tertile.
Measured: From enrollment to the start of treatment, the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion19 Aug 2026 (estimated)
- Study completion19 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hungkuang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciao-Lin Ho, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121049
- Sponsor's protocol ID
- 11409
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Influence of Muscle Strength and Physical Fitness Training on Myopia Health Care for Children in Kindergarten
- ClinicalTrials.gov ID
- NCT07121049
- Acronym / sponsor ID
- 11409
- Conditions
- Myopia, Physical Fitness, Muscle Strength
- Keywords
- Kindergartens, Muscle training, Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hungkuang UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 19 Aug 2026 (estimated)
- Study completion
- 19 Aug 2026 (estimated)
- First posted
- 13 Aug 2025 (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.
With the advancement of technology and changes in lifestyle, the physical activity levels of modern children have gradually decreased. This affects their physical health, psychological development, and social skills, and may increase the risk of nearsightedness. Therefore, it is essential to implement muscle training and outdoor activities in schools, travel agencies, and kindergartens. This project aims to promote the comprehensive development of children through systematic muscle training and enhanced outdoor activities, integrating college students from early childhood education programs, travel agencies, and kindergartens to establish habits that prevent nearsightedness.
In the kindergarten setting, 60 children in the senior class will serve as the control group, while another 60 will be in the intervention group. The intervention group will participate in 10 weeks of muscle training and outdoor activities, including core exercises 3 times a week for 60 minutes each session from 4pm to 6pm. Additionally, there will be subsidized a total of 2 outdoor activities on weekends. This approach will not only improve the children's coordination and flexibility but also enhance their physical fitness. Regarding travel agencies, tailored outdoor activities specifically designed for young children can be created, such as ecological explorations and wilderness survival training, allowing children to enjoy the fun of movement and learning in a safe environment. Travel agencies should collaborate with educational institutions to provide professional guidance and safety assurances, giving parents peace of mind. For kindergartens, a comprehensive outdoor activity plan should be established, regularly organizing sports days and group competitions to encourage children to participate in team sports like soccer and relay races. This not only helps improve the children's muscle strength but also fosters their spirit of cooperation and social skills. Through these methods, we aim to effectively increase children's activity levels, promote their overall development, and reduce the risk of nearsightedness.
Detailed description
Body composition includes Metabolic age, body fat percentage, BMI, total body water (%), BMR (Basal Metabolic Rate), Visceral Fat, physique ratings, muscle quality, muscle mass. Body composition was examined by the TANITA RD-545 (Tanita Corporation, Tokyo-Japonya). Tanita Home Page. Available online: https://tanita.eu/understanding-your-measurements (accessed on 13 August 2022). The FSM is a standardized, norm-referenced test of functional strength for children aged 4-10 years (Smits-Engelsman, 2012).
The FSM consists of eight items that measure anaerobic muscular endurance (30-second sit-to-stand times, lateral up-and-down, box lift, and stair test) and muscular strength (overhand throw, underhand throw, chest throw, and standing long jump). For anaerobic muscular endurance items, the number of repetitions in a 30-second period is counted; for muscular strength items, the distance covered is measured in centimeters.
The Visual_Fatigue_Questionnaire is based on the subjective feelings of the subjects and contains 6 questions using a 5-point Likert scale. The subjects are required to circle the score that best describes their current state (1 represents not at all, 2 represents almost not, 3 represents average, 4 represents somewhat severe, and 5 represents very severe) among the following 6 questions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training group | Experimental | Behavioral: Strength trainingThe strength training group participated in 10 weeks of intervention, performing core muscle exercises three times a week between 4 and 6 p.m. |
| Placebo group | No intervention | –Placebo group did not receive any intervention measures. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 5-7 who are going to be promoted from kindergarten to first grade
- Must be able to exercise
Key exclusion criteria (3 listed)
- heart disease
- respiratory problems
- severe allergies
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 |
|---|---|---|
| Strength trainingThrough systematic muscle training and promotion of outdoor activities, the program integrates early childhood education college students with kindergartens to promote the all-round development of children and establish habits to prevent myopia. | Behavioural | Strength training group |
Primary outcome
Change in Spherical Equivalent (SE)
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Mean change in myopia severity. An Independent t-test was conducted to assess the difference in ΔSE (Spherical Equivalent) between the Intervention and Control groups.
7 secondary outcomes
Change in Body Fat Percentage
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Change in FSM Composite Score
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Change in Metabolic Age
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Change in Visual Fatigue Score
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Visceral Fat Responders
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
The correlation between muscle quality and spherical equivalent (SE)
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Hydration-Metabolism Interaction
Time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in people with Myopia and Physical Fitness, run by Hungkuang University.
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 2 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: opening soon, as of the sponsor's last update on 13 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 in Spherical Equivalent (SE) (time frame: From enrollment to the start of treatment, the end of treatment at 10 weeks). 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 13 Aug 2025.