Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
The main objective of this study is to evaluate the evolution of the sensitivity to insulin, a hormone that acts on sugar in the body, as well as other metabolic, motor and nutritional elements of children with cancer, according to the practice of intense physical activities or stretching. In view of the scientific work on this subject, it is expect to observe that the practice of intense physical activities will improve the results of the children in the metabolic, motor and nutritional evaluations, compared to the stretching program.
详细描述
The protocol consists of 6 months of intense physical activity and stretching programs for children with solid cancer or haematological disease, starting at diagnosis. Evaluations will be performed at the first, third and sixth month of the programs and then six and eighteen months after they are stopped. The physical activity sessions will take place in the hospital during hospitalizations or by videoconference when the children are at home. The sessions are adapted to the needs, desires and abilities of the children and will take place two to three times a week. They will be mediated by various activities such as soccer, rugby, darts, muscle strengthening. Inclusion lasts two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 5 and 18 years old;
- •have a solid cancer or hematological disease;
- •be treated for the first time in pediatric oncology and hematology department;
- •have an estimated life expectancy at diagnosis of more than 6 months.
排除标准
- •present a physical and/or psychological impossibility to follow an adapted physical activity program;
- •have a pre-existing heart disease that is not suitable for adapted physical activities;
- •have a known type 1 diabetes
- •have an obesity defined by a body mass index greater than or equal to the International Obesity Task Force 25 threshold
结局指标
主要结局
Insulin Sensitivity
时间窗: 6 months
Homeostasis Model Assessment of Insulin Resistance
次要结局
未报告次要终点