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.
aged 8-18 years, with a confirmed diagnosis of congenital heart disease and a history of cardiac surgery or catheter-based intervention;
at least 3 months since the most recent surgery or intervention, with a clinically stable condition and no planned reintervention in the near future;
deemed by a pediatric cardiologist to be suitable for regular physical activity or low-to-moderate to moderate-to-vigorous physical activity;
presenting with insufficient physical activity and/or impaired exercise capacity, defined by at least one of the following: failure to meet the recommended physical activity level for children and adolescents (ie, an average of 60 minutes of moderate-to-vigorous physical activity per day), objectively impaired exercise capacity (eg, peak oxygen uptake <80% of predicted and/or anaerobic threshold <55% of predicted), or reduced exercise tolerance indicated by the 6-minute walk test, physical fitness assessment, or clinical exercise evaluation;
clear contraindications to exercise, such as uncontrolled arrhythmia, overt heart failure, severe pulmonary hypertension, or recent hemodynamic instability;
severe comorbidities that substantially interfere with exercise performance, such as serious neurological disorders, severe musculoskeletal disorders, or other conditions markedly limiting physical activity;
participation within the previous 3 months in another systematic intervention likely to substantially influence physical activity or exercise capacity;
any condition, as comprehensively judged by the research team, that may affect participant safety, intervention implementation, the quality of physical activity monitoring data, or completion of questionnaires or follow-up, including refusal to wear the monitoring device, refusal to complete follow-up, or evident risk of poor adherence.
Single group
Nintendo Switch-Based Exergame Physical Activity Promotion Intervention
BehavioralThe 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.
Daily Moderate-to-Vigorous Physical Activity (MVPA) Time
Daily moderate-to-vigorous physical activity (MVPA), expressed as minutes per day, will be objectively measured using an ActiGraph wGT3X-BT triaxial accelerometer worn on the dominant wrist during waking hours. Raw acceleration data will be collected at 30 Hz and processed into 5-second epochs. Non-wear time will be defined as at least 90 consecutive minutes of zero counts. A valid day will be defined as at least 10 hours of waking wear time. MVPA will be classified using wrist-based cut-points, with MVPA defined as at least 610 counts per 5 seconds.
Daily Step Count
Daily step count will be derived from ActiGraph wGT3X-BT accelerometer data and expressed as the total number of steps per valid day.
Daily Sedentary Time
Daily sedentary time will be derived from ActiGraph wGT3X-BT accelerometer data. Sedentary time will be calculated as the sum of all valid 5-second epochs classified as sedentary behavior using the wrist-based cut-point of less than 100 counts per 5 seconds, and expressed as minutes per valid day.
Self-Reported Physical Activity
Self-reported physical activity will be assessed using the Chinese version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The questionnaire assesses physical activity performed during the previous 7 days. Total physical activity volume will be calculated according to the IPAQ scoring protocol and expressed as metabolic equivalent minutes per week. MET-min/week will be calculated by multiplying the MET value assigned to each activity intensity by the reported minutes per day and days per week, and then summing across walking, moderate-intensity activity, and vigorous-intensity activity. The standard MET values are 3.3 for walking, 4.0 for moderate-intensity activity, and 8.0 for vigorous-intensity activity. The minimum possible value is 0 MET-min/week, and there is no fixed maximum value because the score depends on reported frequency and duration of physical activity. Higher values indicate greater self-reported physical activity volume.
Affective Attitude Toward Physical Activity
Affective attitude toward physical activity will be assessed using Multi-Process Action Control (M-PAC) framework-related affective attitude items. Participants will rate their anticipated emotional responses to physical activity using three 7-point rating items, such as whether physical activity is enjoyable or exciting. The total score will be calculated by summing the item scores. Scores range from 3 to 21, with higher scores indicating a more favorable affective attitude toward physical activity.
Social Validity
Social validity will be assessed using semi-structured interviews with participants and their caregivers after completion of the post-intervention observation phase. Interviews will explore perceptions of the intervention goals, procedures, outcomes, acceptability, feasibility, participation burden, family support, implementation barriers, perceived changes in physical activity or confidence, willingness to continue using exergames or other physical activity strategies, and suggestions for improvement.
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