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Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease

NCT07593118 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-05-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether a Nintendo Switch-based exergame physical activity program can help children and adolescents with congenital heart disease increase their physical activity. It will also learn about the safety, acceptability, and feasibility of this program. The study will include children and adolescents aged 8 to 18 years who have congenital heart disease, have received surgical or interventional treatment, and are clinically stable.

The main questions it aims to answer are:

Does the exergame-based program increase the amount of time participants spend in moderate-to-vigorous physical activity each day? Is the exergame-based program safe, acceptable, and feasible for children and adolescents with congenital heart disease?

All participants will receive the same exergame-based physical activity program. Researchers will use different baseline observation periods to help understand whether changes in physical activity happen after the program starts.

Participants will:

Wear an activity monitor to measure daily physical activity. Complete a baseline observation period lasting 7, 14, or 21 days. Take part in a 12-week Nintendo Switch-based exergame physical activity program with guidance, goal setting, self-monitoring, feedback, and caregiver support.

Complete a 2-week observation period after the program to see whether physical activity changes are maintained.

Complete study assessments at screening, the end of baseline, week 4, week 8, week 12, and the end of the observation period.

Researchers will also collect information on step counts, energy expenditure, self-reported physical activity, exercise capacity, quality of life, adherence, acceptability, and adverse events.

Conditions

Interventions

BEHAVIORAL

Nintendo Switch-Based Exergame Physical Activity Promotion Intervention

The intervention is a 12-week physical activity promotion program based on Nintendo Switch motion-sensing exergames for children and adolescents with congenital heart disease. Participants will be guided to complete game-based physical activity tasks involving whole-body movement, balance, coordination, and moderate-intensity activity. The program combines exergame play with behavioral support strategies, including individualized exercise guidance, goal setting, self-monitoring, feedback, caregiver support, adherence monitoring, and safety education. The intervention will be adjusted according to each participant's clinical condition, exercise tolerance, participation experience, and adherence. Physical activity and adverse events will be monitored throughout the study.

Sponsors & Collaborators

  • The Children's Hospital of Zhejiang University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-31
Completion
2027-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593118 on ClinicalTrials.gov