Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT06813950
Brief Summary:
Physical activity is essential for the health and well-being of children and adolescents. However, those living with cancer often experience reduced physical activity levels, which negatively impact their functional capacity and health-related quality of life (HRQoL). In Ecuador, data from the National Institute of Statistics and Census (2021) reveal that 20% of children engage in less than one hour of physical activity per week, highlighting the need for targeted interventions. While previous studies demonstrate that supervised exercise programs can improve physical and psychosocial health outcomes in pediatric oncology patients, no evidence exists from Ecuador to assess the effects of such programs.
This study will examine the impact of a structured physical activity program on the HRQoLof pediatric cancer patients in Quito, Ecuador. Using a case-control design, 90 participants will be randomized into two groups: an intervention group receiving a 10-week, supervised physical activity program and a control group with no exercise intervention and the programmed usual care as follow up if needed by the social worker. HRQoL surveys using a standardized instrument will be administered to all participants (those in the intervention group and those in the control group) at weeks 1, 12, and 24 to assess changes over time.
This research will address a critical public health gap by exploring how physical activity can mitigate the adverse effects of cancer treatment, improve physical and emotional health, and enhance the HRQoL in pediatric oncology patients. Findings will contribute valuable insights for integrating physical activity into pediatric oncology care in low- and middle-income countries.
Detailed Description:
This study is designed as a randomized controlled trial (RCT) to investigate the impact of a structured exercise program on the HRQoL of pediatric cancer patients. A total of 90 participants will be recruited and randomly assigned to either the intervention group or the control group.
The intervention group will participate in a 10-week structured physical activity program consisting of 120 minutes of supervised exercise per week, led by a team of physiotherapists and physical activity professionals. Meanwhile, the control group will not participate in any organized physical activity program but will continue with their usual activities.
Both groups will complete the Pediatric Quality of Life Inventory (PedsQL) surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24). These surveys are designed to assess changes in participants' HRQoL over time, providing comparative insights between the two groups.
Study:
NCT06813950
Study Brief:
Protocol Section:
NCT06813950