Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 5:09 AM
Study NCT ID:
NCT06256068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2024-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol
Sponsor:
Medical University of Warsaw
Organization:
Study Overview
Official Title:
Determinants of Physical Activity Level in Pediatric Oncological Patients Treated With Cardiotoxic Therapy - a Study Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: