Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Change from baseline oxidative metabolism at 12 weeks
研究概览
简要总结
In the early years of life and during adolescence, physical activity is crucial for good development of motor skills. It is even more so for those children and young people who are forced to undergo anti-cancer therapies and therefore undergo long periods of hospitalization (often bedridden) and prolonged periods of physical inactivity.
The research project "Sport Therapy" was born with the aim of demonstrating that, through targeted physical activity administered by the sports physician in collaboration with the pediatrician hematologist, it is possible to facilitate the full recovery of these patients, avoiding the high risk of chronic diseases related to a sedentary lifestyle and allowing them to better reintegrate, once healed, in their community of origin (school, sport and social relations).
The research project "Sport Therapy" was born within the Maria Letizia Verga Center at the Pediatric Clinic of the University of Milan Bicocca, at the Foundation for the Mother and Her Child, San Gerardo Hospital in Monza. Every year, around 80 children and adolescents with leukemia, lymphoma or blood disorders leading to bone marrow transplantation are treated here.
详细描述
State of the art. Today, thanks to the progress made in the early diagnosis and treatment of cancer, there are more than 300 thousand young patients in Europe who have been cured of pediatric cancer, and by 2020 there will be almost half a million . For these children and young people, having the opportunity to perform targeted physical activity during treatment plays a key role in preventing diseases due to physical inactivity, which are one of the worst and most widespread consequences for healed patients.
Children and adolescents suffering from cancer of the blood, because of the therapies to which they are subjected, suffer a progressive reduction in respiratory and cardiac capacity, as well as muscle strength. Targeted physical exercise is a possible therapeutic approach to solving their significant problems of reduced ability to perform exercise. It is possible to administer this type of therapy thanks to the synergy created by the collaboration between pediatricians, hematologists, and sports physicians.
Why is this research important? For at least three reasons:
- the results of the "Sport Therapy" research project will launch precision training as one of the therapeutic weapons available to combat the consequences of hematological diseases in childhood;
- by increasing the physical capacity of children and adolescents with malignant hemopathies during the phases of cancer treatment, the investigators will reduce the heavy legacy left by treatment, thus bridging the gap regarding their disadvantage towards healthy peers and ensuring their full reintegration into their communities (school, sport, social relations);
- a standardization of the methodology for using precision exercise in hospitalized children and adolescents will facilitate the monitoring of the progress of these type of interventions at the international level and the data from the "Sport Therapy" project will allow governments and concerned bodies not to further postpone the establishment of strategies necessary to improve the health and welfare of people cured of cancer diseases.
Innovative aspects of research. At the end of the research project "Sport Therapy":
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with malignant hemopathies attending the Maria Letizia Verga Center
排除标准
- •Children under 2 years
研究组 & 干预措施
Children with malignant hemopathies
Children with malignant hemopathies attending a precision exercise training
干预措施: Sport Therapy (Other)
Healthy children
Healthy children
结局指标
主要结局
Change from baseline oxidative metabolism at 12 weeks
时间窗: 12 weeks
Maximal O2 uptake and skeletal muscle O2 extraction
Change from baseline strength of upper and lower limbs (1RM) at 12 weeks
时间窗: 12 weeks
1 repetition maximal
Change from baseline balance at 12 weeks
时间窗: 12 weeks
Stabilometry
Change from baseline Quality of Life questionnaire at 12 weeks
时间窗: 12 weeks
The PedsQL Measurement Model is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales (physical, emotional, social, school) and 3 Summary Scores (physical health, psycho-social health and total). Each item has a score between 0 and 4, so the scale score is between 0-100. Higher scores indicate a better QoL.
次要结局
- Change from baseline 6 minute walking test at 12 weeks(12 weeks)
- Change from baseline Time up and down stairs test at 12 weeks(12 weeks)
- Change from baseline Satisfaction at 12 weeks(12 weeks)
- Change from baseline MOON test at 12 weeks(12 weeks)
- Change from baseline yo yo test at 12 weeks(12 weeks)