The Effect of Digital Therapy-Based Aerobic Exercise on Children With Neuroblastoma: Protocol for a Prospective Controlled Trial.
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BACKGROUND: Neuroblastoma, one of the most common extracranial solid tumors in children, often results in significant functional impairments, including muscle atrophy, reduced motor function, and sensory disturbances. While aerobic exercise has been shown to support functional recovery in patients with cancer, digital therapy-based aerobic exercise interventions have not yet been explored in pediatric neuroblastoma. OBJECTIVE: This study aims to develop and evaluate a digital intervention therapy to provide a safe, feasible, and tolerable home-based physical activity initiation protocol for children with neuroblastoma after chemoradiotherapy, with the main objectives of (1) breaking sedentary behavior habits and increasing daily energy expenditure, (2) gradually improving physical function (flexibility, basic muscle strength and muscle endurance, and balance ability), (3) establishing the habit of regular exercise and improving exercise self-efficacy, and (4) laying the foundation for a possible transition to more standard, albeit low-risk, aerobic exercise. METHODS: A total of 68 participants will be recruited and allocated to 2 groups matched in age and gender, with consideration given to the preferences of participants and their guardians. The control group will receive standard in-hospital medical treatment and health education, whereas the experimental group will receive a 6-month digital therapy-based aerobic exercise intervention in addition to standard care. Outcomes will be assessed at baseline and 3 and 6 months, with data collected for analysis. The primary outcomes are the 6-minute walk distance and the timed scores (in seconds) for the timed up and go and stair climb tests. The secondary outcomes include body composition, grip strength, and quality of life measured using the Pediatric Quality of Life Inventory version 4.0. RESULTS: Recruitment will be conducted from December 2025 to September 2026. We expect that the intervention group will show significantly greater improvements in physical function, physical activity levels, and fatigue management than the control group, demonstrating the effectiveness of digital therapy for rehabilitation training after radiotherapy and chemotherapy for neuroblastoma in children. CONCLUSIONS: We expect that the results of this study will provide evidence for rehabilitation after chemoradiotherapy in pediatric patients with neuroblastoma to improve physical function, physical activity levels, and fatigue management. In the future, expanding to multiple centers to conduct targeted surveys of different types of childhood cancers will help validate the effectiveness of digital therapy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72698.