Incidence, characteristics and suggestions for prevention of adverse events in supervised pediatric oncology exercise sessions.

Introduction: Supervised exercise sessions in pediatric oncology offer numerous benefits, including mitigated treatment-related symptoms and improved physical and psychological outcomes. However, systematic assessment of adverse events (AEs) remains limited which restricts implementation and optimization of exercise safety in this vulnerable population. We aimed to prospectively assess AEs during exercise sessions, describe their characteristics and provide recommendations for action to reduce AEs. Methods: A prospective observational study was conducted at six pediatric oncology centers over three years to systematically record AEs and related information occurring during usual care exercise sessions from acute cancer treatment to post-treatment phase. An AE was defined as any adverse event temporally associated with an exercise session, regardless of whether it was causally related to the exercise itself. Each AE was categorized and graded according to the Common Terminology Criteria for AEs, and additional contextual information was documented in a centralized database. Based on the findings, AE characteristics were analyzed and a multidisciplinary consensus process was used to develop recommendations. Results: In total, 178 (75% grade 1; 23% grade 2; 2% grade 3) AEs were documented across 74,083 supervised exercise sessions, corresponding to 1 AE per 416 sessions. No life-threatening AEs were observed. Of the 178 AEs, 85% (151/178) were judged as exercise-related, resulting in an incidence of 204 per 100,000 exercise sessions (0.2%). Most common AE types were pain (53%; Conclusion: We found an overall low incidence of AEs during supervised exercise sessions in pediatric oncology, of generally low grade. The study highlights the need for prospective studies to refine evidence-based prevention strategies, test their effectiveness and implement them.