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

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07593118
Status
Not Yet Recruiting

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Conditions

  • Congenital Heart Disease
  • Physical Inactivity

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Nintendo Switch-Based Exergame Physical Activity Promotion Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
May 18, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exergame-Based Physical Activity Promotion Intervention
    Participants will receive an exergame-based physical activity promotion intervention using Nintendo Switch motion-sensing games. The study follows an A-B-A' structure. During the baseline phase, participants will be observed for 7, 14, or 21 days without the formal intervention. During the intervention phase, participants will receive a 12-week exergame-based physical activity program combined with behavioral support strategies, including individualized guidance, goal setting, self-monitoring, feedback, and caregiver support. During the 2-week observation phase, intensive intervention support will stop and physical activity monitoring will continue.

Primary Outcome Measure

Daily Moderate-to-Vigorous Physical Activity (MVPA) Time [ Time Frame: Baseline phase, 12-week intervention phase, and 2-week observation phase; total duration 15 to 17 weeks ]

Central Contacts

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