This prospective observational study assessed the safety of supervised exercise sessions in pediatric oncology patients across six centers over three years. A total of 74,083 sessions were analyzed, with 178 adverse events (AEs) documented, yielding an incidence of 1 AE per 416 sessions. The majority of AEs were low grade: 75% were grade 1, 23% grade 2, and only 2% grade 3. No life-threatening AEs were observed.
Of the 178 AEs, 85% (151/178) were judged as exercise-related, corresponding to an incidence of 204 per 100,000 exercise sessions. The most common AE types were pain (53%; n=94), nausea or vomiting (20%; n=35), and circulatory problems (17%; n=30). Triggers included physical (over)exertion (63%; n=112), medical treatments (44%; n=78), and fall-related incidents (23%; n=41).
Safety data indicate generally low-grade AEs, though systematic assessment of AEs remains limited. The study did not report serious adverse events or discontinuations. These findings support the tolerability of supervised exercise in pediatric oncology, but the authors note the need for prospective studies to refine evidence-based prevention strategies and test their effectiveness.
Clinically, this study provides reassurance that supervised exercise sessions are associated with a low rate of significant AEs. However, given the observational design and lack of a comparator, causal conclusions about safety cannot be drawn. Clinicians should continue to monitor patients during exercise and individualize prescriptions.
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IntroductionSupervised 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.MethodsA 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.ResultsIn 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%; n = 94), nausea or vomiting (20%; n = 35), and circulatory problems (17%; n = 30). Overall, AEs were primarily triggered by physical (over)exertion (63%; n = 112), medical treatments (44%; n = 78), and fall-related incidents (23%; n = 41). Based on these findings and existing guidelines, 11 recommendations for action to reduce AEs were developed, including a consensus-based risk assessment, multiprofessional collaboration, and continuous professional education of exercise experts providing the exercise sessions.ConclusionWe 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.