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

Study Overview
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Brief Summary
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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))

Detailed Description
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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.

Official Title
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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)

Conditions
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Chronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia, Heart Transplant

Intervention / Treatment
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* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Adolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant | Other: Physical activity<br>* Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)<br>|
| Control<br>14-25 years old healthy individuals who are ambulatory without assistance. We may enroll younger subjects but we wish to subjects to match our patient population | Other: Physical activity<br>* Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fitness, Quality of life, Lung function, Exercise