Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease (ExPACE-CHD)
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:
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jiajia Zhu, PhD
- Telefonní číslo: +8618701672976
- E-mail: 12318595@zju.edu.cn
Studijní místa
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310052
- Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Children and Adolescents' Health and Diseases
-
Kontakt:
- Jiajia Zhu, PhD
- Telefonní číslo: +86 18701672976
- E-mail: 12318595@zju.edu.cn
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Daily Moderate-to-Vigorous Physical Activity (MVPA) Time
Časové okno: 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.
|
Baseline phase, 12-week intervention phase, and 2-week observation phase; total duration 15 to 17 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Daily Step Count
Časové okno: Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
Daily step count will be derived from ActiGraph wGT3X-BT accelerometer data and expressed as the total number of steps per valid day.
|
Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Daily Sedentary Time
Časové okno: Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Self-Reported Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Affective Attitude Toward Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Instrumental Attitude Toward Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
|
|
Perceived Capability for Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks
|
|
Perceived Opportunity for Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Action Planning for Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Coping Planning for Physical Activity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Physical Activity Habit Strength
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
Physical Activity Identity
Časové okno: Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
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.
|
Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.
|
|
peak oxygen uptake (VO₂peak)
Časové okno: At baseline and immediately after the 12-week intervention
|
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.
|
At baseline and immediately after the 12-week intervention
|
|
Six-Minute Walk Test Distance
Časové okno: At baseline and immediately after the 12-week intervention.
|
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.
|
At baseline and immediately after the 12-week intervention.
|
|
Body Mass Index (BMI)
Časové okno: At baseline and immediately after the 12-week intervention
|
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.
|
At baseline and immediately after the 12-week intervention
|
|
Health-Related Quality of Life (HRQOL)
Časové okno: At baseline and immediately after the 12-week intervention.
|
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.
|
At baseline and immediately after the 12-week intervention.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Social Validity
Časové okno: At the end of the 2-week post-intervention observation phase.
|
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.
|
At the end of the 2-week post-intervention observation phase.
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MR-33-26-030739
- 2026-IRB-0154 (Jiný identifikátor: Children's Hospital, Zhejiang University School of Medicine)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Vrozená srdeční choroba
-
Region SkaneZápis na pozvánkuSrdeční selhání New York Heart Association (NYHA) třída II | Srdeční selhání New York Heart Association (NYHA) třída IIIŠvédsko
-
Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus Copernicus... a další spolupracovníciUkončenoSrdeční selhání, systolické | Srdeční Selhání Se Sníženou Ejekční frakcí | Srdeční selhání New York Heart Association Třída IV | Srdeční selhání New York Heart Association Třída IIIPolsko
-
Novartis PharmaceuticalsDokončenoPacienti, kteří úspěšně dokončili 12měsíční léčebné období základní studie (de Novo Heart Recipients), kteří měli zájem o léčbu EC-MPS
-
University of WashingtonAmerican Heart AssociationDokončenoSrdeční selhání, městnavé | Mitochondriální alterace | Srdeční selhání New York Heart Association Třída IVSpojené státy
-
Portuguese Association of Interventional CardiologyMedtronicNáborTěžká symptomatická aortální stenóza (definována jako třída New York Heart Association (NYHA) ≥ II)Portugalsko
-
QLT Inc.DokončenoLCA (Leber Congenital Amaurosis) | RP (Retinitis Pigmentosa)Spojené státy, Kanada, Německo, Holandsko, Spojené království
-
QLT Inc.DokončenoLCA (Leber Congenital Amaurosis) | RP (Retinitis Pigmentosa)Kanada, Spojené státy, Německo, Holandsko, Spojené království