Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol
- Conditions
- Neoplasms
- Registration Number
- NCT06256068
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physical activity level measured by the accelerometer 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.
- Secondary Outcome Measures
Name Time Method Percentage of participants disqualified from CPET Measured at the enrollment Percentage of participants disqualified from CPET examination - secondary outcome is the assessment of the proportion of eligible pediatric oncology patients for CPET examination as well as the reasons and characteristics of the patients that were excluded from CPET examination,
Exercise capacity measured in CPET Measured at the enrollment Exercise capacity measured in CPET - maximal/peak oxygen consumption (VO2max/peak) below 47 mL/kg/min for boys and 42 mL/kg/min for girls will be defined as the EC alterations - secondary outcome is the maximal/peak oxygen consumption (VO2max/peak) measurement and defining the EC among the participants,
Physical function in the ALPHA test battery Measured at the enrollment Assessment of the fitness in the extended ALPHA (Assessing Levels of Physical Activity) health-related fitness test battery - defining the fitness level as low, moderate, or high (33, 34) - secondary outcome is the assessment of the physical fitness among the study group in the extended ALPHA test and defining its level,
Cardiac function Measured at the enrollment In cardiological assessment: global longitudinal strain (GLS), global radial strain (GRS), and global circumferential strain (GCS) below average for age, left ventricle diastolic diameter (LVDd) exceeding the normal limit, and ejection fraction (EF) 55% or less will be defined as the lowered systolic function, as well as in the comparison to the control groups - secondary outcome is the contractile function assessment of the heart among the study group and in comparison to the control group.