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

NCT07593118 | Not Yet Recruiting

• 2 other identifiers: MR-33-26-0307392026-IRB-0154
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

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; Congenital Heart Disease; Accelerometer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline phase, 12-week intervention phase, and 2-week observation phase; total duration 15 to 17 weeks

Secondary Outcomes (15)

• Daily Step Count

  Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.

• Daily Sedentary Time

  Daily from baseline through the end of the 2-week observation phase, up to 17 weeks.

• Self-Reported Physical Activity

  Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks.

• 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

  Weekly from baseline through the end of the 2-week observation phase, up to 17 weeks

Other Outcomes (1)

• Social Validity

  At the end of the 2-week post-intervention observation phase.

Study Arms (1)

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.

Behavioral: Nintendo Switch-Based Exergame Physical Activity Promotion Intervention

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.

Exergame-Based Physical Activity Promotion Intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Children and Adolescents' Health and Diseases

Hangzhou, Zhejiang, 310052, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Jiajia Zhu, PhD

CONTACT

+8618701672976; 12318595@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse; Director, Department of Nursing

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

CN (1)