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临床试验/NCT06256068
NCT06256068尚未招募不适用

Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol

Medical University of Warsaw0 个研究点目标入组 300 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Physical activity level measured by the accelerometer

研究概览

简要总结

Cancer treatment in children is generally effective, but unfortunately, it often comes with side effects-unwanted negative impacts. Some medications used in cancer treatment, while beneficial in treating the disease, can have harmful effects on the heart and reduce a child's ability to tolerate physical activities such as climbing stairs, walking fast, running, or exercising. Physical activity is crucial for the proper growth and development of children, as well as for their future health as adults. The heart plays a vital role in pumping blood throughout the body, and its proper function is key to a person's ability to engage in physical activity.

The goal of this study is to understand the factors that influence physical activity levels in children who have undergone cancer treatment with methods that may be harmful to the heart. The researchers aim to investigate how these treatments affect the physical activity levels of these children.

The main questions the study seeks to answer are:

Do children who have undergone cancer treatment involving heart-toxic methods show lower levels of daily physical activity compared to children treated with non-toxic methods?

Is the level of physical activity influenced by heart-toxic treatment, or by other factors such as exercise capacity (measured through physical tests like treadmill or standing bike tests), quality of life, lifestyle, social and demographic factors, body type, or knowledge and motivation related to the positive effects of physical activity?

Participants will:

Complete a questionnaire

Perform an exercise test on a treadmill or standing bike to measure exercise capacity

Take part in the ALPHA physical fitness test, which includes simple exercises like jumping and running

Be measured for height and weight

Undergo a hand-grip test using a hand dynamometer

Wear an activity tracker for 14 days

Have an echocardiogram (ultrasound of the heart)

Researchers will compare 150 children treated with heart-toxic methods for cancer to 150 children treated with non-toxic methods. The children will be between 8 and 18 years old and will be 1 to 5 years post-cancer treatment.

The researchers hope that identifying the factors affecting physical activity levels in children treated with heart-toxic methods may improve cancer therapies for children, reduce side effects, and ultimately lead to increased physical activity. This would help promote better growth and overall health for these children in the future.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Physical activity level measured by the accelerometer

时间窗: 14 days measurement for 1 individual

The primary outcome of interest is the PA level measured by the accelerometer and the assessment of the World Health Organization (WHO) pediatric, age-adjusted PA achievement norms.

次要结局

  • Percentage of participants disqualified from CPET(Measured at the enrollment)
  • Exercise capacity measured in CPET(Measured at the enrollment)
  • Physical function in the ALPHA test battery(Measured at the enrollment)
  • Cardiac function(Measured at the enrollment)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Haponiuk-Skwarlińska

Principal investigator

Medical University of Warsaw

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