Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise

Chronic Obstructive Pulmonary Disease Clinical Trial

— FLASHLITE  

Official title:

Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant Bronchopulmonary Dysplasia (BPD, Also Known as Chronic Lung Disease of Prematurity) Through Exercise (FLASHLITE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05025774
• Other study ID #: PEDS-2021-29482
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 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
• 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
• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Chronic Lung Disease
• Chronic Obstructive Pulmonary Disease
• Heart Transplant
• Leukemia
• Lung Diseases
• Lung Diseases, Obstructive
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Pulmonary Disease, Chronic Obstructive

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