NCT07121049

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

July 25, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2026

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

July 25, 2025

Last Update Submit

August 12, 2025

Conditions

Keywords

KindergartensMuscle trainingMyopia

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the start of treatment, the end of treatment at 10 weeks

Secondary Outcomes (7)

  • Change in Body Fat Percentage

    From enrollment to the start of treatment, the end of treatment at 10 weeks

  • Change in FSM Composite Score

    From enrollment to the start of treatment, the end of treatment at 10 weeks

  • Change in Metabolic Age

    From enrollment to the start of treatment, the end of treatment at 10 weeks

  • Change in Visual Fatigue Score

    From enrollment to the start of treatment, the end of treatment at 10 weeks

  • Visceral Fat Responders

    From enrollment to the start of treatment, the end of treatment at 10 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Strength training

Placebo group

NO INTERVENTION

Placebo group did not receive any intervention measures.

Interventions

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.

Strength training group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-7 who are going to be promoted from kindergarten to first grade
  • Must be able to exercise

You may not qualify if:

  • heart disease
  • respiratory problems
  • severe allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 13, 2025

Study Start

August 20, 2025

Primary Completion (Estimated)

August 19, 2026

Study Completion (Estimated)

August 19, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08