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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05025774
Other study ID # PEDS-2021-29482
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date August 1, 2025

Study information

Verified date January 2024
Source Masonic Cancer Center, University of Minnesota
Contact Char Napurski, MPH, CCRP
Phone 612-626-2140
Email bake0257@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to more accurately assess cardiac function, ventilation and exercise capacity in a non-invasive fashion, and to better characterize exercise intolerance in the setting of three populations of individuals with chronic diseases of childhood (acute lymphoblastic leukemia (ALL), chronic lung disease (CLD) of prematurity, and post-heart transplant (HT))


Description:

Physical activity in childhood is an integral part of maintaining health and quality of life. Children who participate in routine physical activity are more likely to maintain a healthy body weight and are less likely to have heart disease, type 2 diabetes and high blood pressure as adults. Children with chronic disease are often limited from full participation in exercise for various reasons -perceived physical limitations, either from the patient and family or from their medical provider, or because of symptoms which cause exercise to feel uncomfortable. As the number of children living and aging with chronic disease continues to grow, the researchers are hoping to expand the current exercise testing capabilities for both clinical care and research in order to (i) provide data to permit formulation of evidence-based guidelines for exercise in chronic childhood disease; (ii) improve understanding of limitations to exercise in this growing population; (iii) learn long-term implications of chronic childhood disease as these individuals enter adulthood.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers
Gender All
Age group 8 Years to 25 Years
Eligibility Inclusion Criteria: - Cases: - Acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant - 8-25 years old - Height: = 48 inches - Ambulatory without assistance - English speaking - Normotensive (<95th percentile for age; okay if managed with antihypertensive medication) - SpO2 >92% - Not pregnant - ALL survivor specific: must have completed therapy = 3 months prior to study entry - Controls - 8-25 years old - Height: = 48 inches - Ambulatory without assistance - English speaking - No history of arrhythmia or known cardiac dysfunction at baseline - Normotensive (<95th percentile for age; okay if managed with antihypertensive medication) - SpO2 >95% - Not pregnant Exclusion Criteria: - Cases: - ALL specific: received cranial radiation, bone marrow transplant recipients - Investigator or patient's primary physician deems the patient unsuitable for the study - Controls: - History of malignancy, CLD or HT or any other diagnosis which may reduce cardiorespiratory function - Investigator deems the patient unsuitable for the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical activity
Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of Peak O2 intake during test exercise Maximal cardiopulmonary exercise testing (CPX) will be completed on cycle ergometer to determine peak oxygen uptake, a measure of cardiorespiratory fitness 3-4 hours during the onetime study visit day
Primary Measure of Cardiac output during test exercise Cardiac output is measured using C2H2 open-circuit breathing technique: a mass spectrometer medical gas analyzer will measure gas concentration continuously, yielding serial Stroke Volume measurements during incremental exercise. Cardiac output is the product of heart rate and stroke volume 3-4 hours during the onetime study visit day
Secondary The proportion of expiratory flow limitation (EFL) The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion 3-4 hours during the onetime study visit day
Secondary Association between cardiac function and patient reported outcomes of perceived fitness Logistic regression will be used to understand associations between cardiac function and patient reported outcomes of perceived fitness 3-4 hours during the onetime study visit day
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