Congenital Heart DiseaseExPACE-CHDNCT07593118
Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease
A study testing Nintendo Switch-Based Exergame Physical Activity Promotion Intervention in people with Congenital Heart Disease and Physical Inactivity, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Physical Inactivity
- What is being tested?
- Nintendo Switch-Based Exergame Physical Activity Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Sep 2027
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
- having basic cognitive and communication abilities sufficient to understand instructions and complete questionnaires, trial sessions, and training tasks;
- willingness of both the child and the guardian to participate, with written informed consent obtained;
- availability of basic family conditions to support intervention delivery, including access to smart devices and/or game equipment, internet access, and at least one caregiver able to provide support.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Children and Adolescents' Health and Diseases
Hangzhou, Zhejiang, 310052
Jiajia Zhu, PhD, +86 18701672976, 12318595@zju.edu.cn
About this study
Official title: An Exergame-Based Physical Activity Promotion Intervention for Children and Adolescents With Congenital Heart Disease: A Multiple-Baseline Single-Case Experimental Design Study
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:
Read more
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.
Read the detailed description
Regular physical activity is important for physical function, exercise capacity, psychosocial development, quality of life, and long-term cardiovascular health in children and adolescents with congenital heart disease. However, this population may experience insufficient physical activity and increased sedentary behavior because of disease-related factors, parental concerns about exercise risk, long-term perceptions of exercise restriction, reduced physical fitness, and psychosocial barriers.
Exergames combine physical movement with interactive game-based tasks and may be suitable for children and adolescents because they are engaging, easy to access, and provide immediate feedback. Nintendo Switch motion-sensing games can incorporate activities such as jumping, striking, balance, coordination, and whole-body movement into game tasks. For clinically stable children and adolescents with congenital heart disease, exergames may offer a feasible approach to promoting moderate-intensity physical activity in home settings when appropriate safety screening and guidance are provided.
This study will evaluate an exergame-based physical activity promotion intervention combined with behavioral support strategies. The intervention is designed to promote physical activity through individualized exercise guidance, goal setting, self-monitoring, feedback reinforcement, caregiver support, and safety monitoring. The intervention will be delivered over 12 weeks and will be adjusted according to each participant's clinical condition, exercise tolerance, participation experience, and adherence.
A multiple-baseline single-case experimental design will be used because children and adolescents with congenital heart disease may differ substantially in diagnosis, post-treatment status, exercise capacity, family support, and behavioral response. Each participant will serve as his or her own control. Participants will be randomly assigned to one of three baseline lengths: 7 days, 14 days, or 21 days. This staggered introduction of the intervention is intended to help distinguish intervention-related changes from natural changes over time.
The study will follow an A-B-A' structure. Phase A is the baseline phase, during which no formal exergame intervention will be provided and physical activity will be monitored continuously. Phase B is the 12-week intervention phase, during which participants will receive the Nintendo Switch-based exergame physical activity promotion intervention with behavioral support. Phase A' is a 2-week observation phase, during which intensive intervention support will stop and physical activity monitoring will continue to assess maintenance of intervention effects.
Participants will complete six assessment visits or time points: screening and baseline assessment, end of baseline, week 4 of intervention, week 8 of intervention, week 12 of intervention, and the end of the 2-week observation phase. Physical activity will be monitored repeatedly from baseline through the observation phase. The primary outcome is daily moderate-to-vigorous physical activity in minutes per day, measured using an ActiGraph wGT3X-BT triaxial accelerometer. Secondary outcomes include daily step counts, energy expenditure, self-reported physical activity, behavioral change-related psychological factors, cardiopulmonary fitness, 6-minute walk distance, heart rate-related indicators, body composition, and health-related quality of life. Feasibility, acceptability, adherence, and adverse events will also be recorded.
Data will be analyzed at both the individual and aggregated levels. Individual-level analyses will include visual analysis of level, trend, variability or stability, immediacy of effect, overlap, and consistency of patterns across participants. Time-series or segmented regression methods may be used to estimate level and trend changes across phases. Aggregated analyses will use linear mixed-effects models, with hierarchical Bayesian models considered as supplementary analyses, to estimate overall intervention effects and individual differences.
This study will provide preliminary evidence on the feasibility, acceptability, safety, and potential effectiveness of an exergame-based physical activity promotion intervention for children and adolescents with congenital heart disease. The findings may inform the development and optimization of digital physical activity promotion and rehabilitation strategies for this population.
- Conditions
- Congenital Heart Disease, Physical Inactivity
- Being tested
- Nintendo Switch-Based Exergame Physical Activity Promotion Intervention
- Keywords
- Exergame, Physical Activity, Moderate-to-Vigorous Physical Activity, Children, Adolescents, Single-Case Experimental Design, Multiple-Baseline Design, Nintendo Switch, Congenital Heart Disease, Accelerometer
- Medical subject headings
- Heart Defects, Congenital, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Switch-Based Exergame Physical Activity Promotion InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Exergame-Based Physical Activity Promotion Intervention | Experimental | 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. Receives: Behavioral: Nintendo Switch-Based Exergame Physical Activity Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline phase, 12-week intervention phase, and 2-week observation phase; total duration 15 to 17 weeks
Secondary outcomes (15)
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.
Measured: Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
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.
Measured: Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
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.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
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.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Instrumental Attitude Toward Physical Activity
Instrumental attitude toward physical activity will be assessed using M-PAC framework-related instrumental attitude items. Participants will rate the perceived value or utility of physical activity using three 7-point rating items, such as whether physical activity is wise or beneficial. The total score will be calculated by summing the item scores. Scores range from 3 to 21, with higher scores indicating a more favorable instrumental attitude toward physical activity.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
Perceived Capability for Physical Activity
Perceived capability for physical activity will be assessed using M-PAC framework-related perceived capability items. Participants will rate their perceived ability to engage in physical activity using three 5-point Likert items. The total score will be calculated by summing the item scores. Scores range from 3 to 15, with higher scores indicating greater perceived capability for physical activity.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
Perceived Opportunity for Physical Activity
Perceived opportunity for physical activity will be assessed using M-PAC framework-related perceived opportunity items. Participants will rate their perceived environmental or contextual support for engaging in physical activity using three 5-point Likert items. The total score will be calculated by summing the item scores. Scores range from 3 to 15, with higher scores indicating greater perceived opportunity for physical activity.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Action Planning for Physical Activity
Action planning for physical activity will be assessed using M-PAC framework-related three items that evaluate the extent to which participants have made specific plans for engaging in physical activity. The total score will be calculated by summing the item scores. Scores range from 3 to 15, with higher scores indicating stronger action planning for physical activity.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Coping Planning for Physical Activity
Coping planning for physical activity will be assessed using using M-PAC framework-related three items that evaluate the extent to which participants have made plans to overcome anticipated barriers to physical activity. The total score will be calculated by summing the item scores. Scores range from 3 to 15, with higher scores indicating stronger coping planning for physical activity.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Physical Activity Habit Strength
Physical activity habit strength will be assessed using the Self-Report Behavioral Automaticity Index. This measure includes four items assessing the extent to which physical activity has become automatic or habitual. The total score will be calculated by summing the item scores. Scores range from 4 to 28, with higher scores indicating stronger physical activity habit strength.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Physical Activity Identity
Physical activity identity will be assessed using the role identity dimension of the Exercise Identity Scale. This measure includes four items assessing the extent to which participants identify themselves as physically active individuals. The total score will be calculated by summing the item scores. Scores range from 4 to 28, with higher scores indicating stronger physical activity identity.
Measured: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
peak oxygen uptake (VO₂peak)
peak oxygen uptake (VO₂peak) will be obtained from cardiopulmonary exercise testing (CEPT) when the participant is clinically eligible and able to complete the test. It will be expressed relative to body mass as mL/kg/min and used as an indicator of aerobic exercise capacity.
Measured: At baseline and immediately after the 12-week intervention
Six-Minute Walk Test Distance
Functional exercise tolerance will be assessed using the 6-minute walk test (6MWT). The test will be performed according to a standardized protocol on a flat, straight walking course. Participants will be instructed to walk as far as possible within 6 minutes, and the total distance walked will be recorded in meters. The 6MWT distance will be used as a measure of submaximal functional capacity and daily-life-relevant exercise tolerance.
Measured: At baseline and immediately after the 12-week intervention.
Body Mass Index (BMI)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared. Height and weight will be measured using standardized anthropometric procedures. Age- and sex-adjusted BMI percentiles or BMI z-scores may also be calculated according to appropriate growth reference standards.
Measured: At baseline and immediately after the 12-week intervention
Health-Related Quality of Life (HRQOL)
Health-Related Quality of Life (HRQOL) will be assessed using the Pediatric Quality of Life Inventory, including the PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 Cardiac Module. Items will be transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
Measured: At baseline and immediately after the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihua Zhu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593118
- Sponsor's protocol ID
- MR-33-26-030739
- Other IDs
- 2026-IRB-0154
- Acronym
- ExPACE-CHD
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be publicly shared because the study involves minors with congenital heart disease, a small sample size, and intensive longitudinal physical activity data, which may increase the risk of participant re-identification even after de-identification. Aggregate results will be reported in publications. Reasonable requests for additional information may be considered by the principal investigator and the ethics committee in accordance with institutional policies and participant privacy protections.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exergame-Based Physical Activity Promotion Intervention for Children and Adolescents With Congenital Heart Disease: A Multiple-Baseline Single-Case Experimental Design Study
- ClinicalTrials.gov ID
- NCT07593118
- Acronym / sponsor ID
- ExPACE-CHD / MR-33-26-030739
- Conditions
- Congenital Heart Disease, Physical Inactivity
- Keywords
- Exergame, Physical Activity, Moderate-to-Vigorous Physical Activity, Children, Adolescents, Single-Case Experimental Design, Multiple-Baseline Design, Nintendo Switch
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 May 2026 (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.
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.
Detailed description
Regular physical activity is important for physical function, exercise capacity, psychosocial development, quality of life, and long-term cardiovascular health in children and adolescents with congenital heart disease. However, this population may experience insufficient physical activity and increased sedentary behavior because of disease-related factors, parental concerns about exercise risk, long-term perceptions of exercise restriction, reduced physical fitness, and psychosocial barriers.
Exergames combine physical movement with interactive game-based tasks and may be suitable for children and adolescents because they are engaging, easy to access, and provide immediate feedback. Nintendo Switch motion-sensing games can incorporate activities such as jumping, striking, balance, coordination, and whole-body movement into game tasks. For clinically stable children and adolescents with congenital heart disease, exergames may offer a feasible approach to promoting moderate-intensity physical activity in home settings when appropriate safety screening and guidance are provided.
This study will evaluate an exergame-based physical activity promotion intervention combined with behavioral support strategies. The intervention is designed to promote physical activity through individualized exercise guidance, goal setting, self-monitoring, feedback reinforcement, caregiver support, and safety monitoring. The intervention will be delivered over 12 weeks and will be adjusted according to each participant's clinical condition, exercise tolerance, participation experience, and adherence.
A multiple-baseline single-case experimental design will be used because children and adolescents with congenital heart disease may differ substantially in diagnosis, post-treatment status, exercise capacity, family support, and behavioral response. Each participant will serve as his or her own control. Participants will be randomly assigned to one of three baseline lengths: 7 days, 14 days, or 21 days. This staggered introduction of the intervention is intended to help distinguish intervention-related changes from natural changes over time.
The study will follow an A-B-A' structure. Phase A is the baseline phase, during which no formal exergame intervention will be provided and physical activity will be monitored continuously. Phase B is the 12-week intervention phase, during which participants will receive the Nintendo Switch-based exergame physical activity promotion intervention with behavioral support. Phase A' is a 2-week observation phase, during which intensive intervention support will stop and physical activity monitoring will continue to assess maintenance of intervention effects.
Participants will complete six assessment visits or time points: screening and baseline assessment, end of baseline, week 4 of intervention, week 8 of intervention, week 12 of intervention, and the end of the 2-week observation phase. Physical activity will be monitored repeatedly from baseline through the observation phase. The primary outcome is daily moderate-to-vigorous physical activity in minutes per day, measured using an ActiGraph wGT3X-BT triaxial accelerometer. Secondary outcomes include daily step counts, energy expenditure, self-reported physical activity, behavioral change-related psychological factors, cardiopulmonary fitness, 6-minute walk distance, heart rate-related indicators, body composition, and health-related quality of life. Feasibility, acceptability, adherence, and adverse events will also be recorded.
Data will be analyzed at both the individual and aggregated levels. Individual-level analyses will include visual analysis of level, trend, variability or stability, immediacy of effect, overlap, and consistency of patterns across participants. Time-series or segmented regression methods may be used to estimate level and trend changes across phases. Aggregated analyses will use linear mixed-effects models, with hierarchical Bayesian models considered as supplementary analyses, to estimate overall intervention effects and individual differences.
This study will provide preliminary evidence on the feasibility, acceptability, safety, and potential effectiveness of an exergame-based physical activity promotion intervention for children and adolescents with congenital heart disease. The findings may inform the development and optimization of digital physical activity promotion and rehabilitation strategies for this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exergame-Based Physical Activity Promotion Intervention | Experimental | Behavioral: Nintendo Switch-Based Exergame Physical Activity Promotion InterventionParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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;
- having basic cognitive and communication abilities sufficient to understand instructions and complete questionnaires, trial sessions, and training tasks;
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Nintendo Switch-Based Exergame Physical Activity Promotion InterventionThe 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. | Behavioural | Exergame-Based Physical Activity Promotion Intervention |
Primary outcome
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
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.
15 secondary outcomes
Daily Step Count
Time frame: Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
Daily Sedentary Time
Time frame: Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
Self-Reported Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Affective Attitude Toward Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Instrumental Attitude Toward Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
Perceived Capability for Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
Perceived Opportunity for Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Action Planning for Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Coping Planning for Physical Activity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Physical Activity Habit Strength
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
Physical Activity Identity
Time frame: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
peak oxygen uptake (VO₂peak)
Time frame: At baseline and immediately after the 12-week intervention
Six-Minute Walk Test Distance
Time frame: At baseline and immediately after the 12-week intervention.
Body Mass Index (BMI)
Time frame: At baseline and immediately after the 12-week intervention
Health-Related Quality of Life (HRQOL)
Time frame: At baseline and immediately after the 12-week intervention.
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 18 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be publicly shared because the study involves minors with congenital heart disease, a small sample size, and intensive longitudinal physical activity data, which may increase the risk of participant re-identification even after de-identification. Aggregate results will be reported in publications. Reasonable requests for additional information may be considered by the principal investigator and the ethics committee in accordance with institutional policies and participant privacy protections.
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The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Switch-Based Exergame Physical Activity Promotion Intervention in people with Congenital Heart Disease and Physical Inactivity, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
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 7 inclusion and 4 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jiajia Zhu, PhD (+8618701672976, 12318595@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). 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 18 May 2026.