JMIR Publications

ABSTRACT

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 cancer patients, digital therapy-based aerobic exercise interventions have not yet been explored in pediatric neuroblastoma.

Objective:

This study presents a protocol for a non-randomized controlled trial designed to investigate the effects of a 24-week digital therapeutics-based aerobic exercise intervention on motor function, body composition, muscular strength, and quality of life in children with neuroblastoma through a comparative analysis with conventional rehabilitation therapy. The primary objectives are to validate whether the digital intervention demonstrates superiority or equivalence to standard care and to propose optimized protocols, thereby providing theoretical support for the clinical implementation and broader dissemination of digital rehabilitation therapies.

Methods:

The final sample will comprise 68 children with neuroblastoma, which will be recruited and allocated into two groups, matched for 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, while the experimental group will undergo a 6-month digital therapy-based aerobic exercise intervention in addition to standard care. Outcomes will be assessed at baseline, 3 months, and 6 months, with data collected for analysis. The primary outcome is the six-minute walking distance (6MWD), and secondary outcomes include body composition, grip strength, and quality of life, measured using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).

Results:

The recruitment of this trial is scheduled to begin in spring 2026. We will begin data analysis once data collection is complete, which is planned to occur in fall 2026.

Conclusions:

This non-randomized controlled trial is designed to access the effect of digital therapy-based aerobic exercise on children with neuroblastoma. Primary endpoints include cardiopulmonary fitness, muscular strength, body composition, and quality of life improvements. Digital therapy-based aerobic exercise is is a 24-week, innovative approach to health management that combines digital technology with scientifically guided aerobic exercise programs to prevent, manage or treat specific health problems. This study aims to provide an evidence-based support for clinical implementation of digital exercise interventions in pediatric oncology. Clinical Trial: The study has been registered with the China Clinical Trial Registry (registration number: ChiCTR2300074139).