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

NCT05025774 · Masonic Cancer Center, University of Minnesota

Recruiting

In plain English

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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)

About this study

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.

Eligibility criteria

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

Enrollment target: 90 participants

Age groups: child, adult

Timeline

Starts: 2025-03-14

Estimated completion: 2026-12-01

Last updated: 2025-11-24

Interventions

Other: Physical activity

Primary outcomes

• Measure of Peak O2 intake during test exercise (3-4 hours during the onetime study visit day)
• Measure of Cardiac output during test exercise (3-4 hours during the onetime study visit day)

Sponsor

Masonic Cancer Center, University of Minnesota · other

Contacts & investigators

ContactChar Napurski, MPH, CCRP · contact · bake0257@umn.edu · 612-626-2140

ContactPianosi Paolo, MD · contact · ppianosi@umn.edu

InvestigatorPianosi Paolo, MD · principal_investigator, Masonic Children's Hospital, University of Minnesota

All locations (1)

Masonic Cancer CenterRecruiting

Minneapolis, Minnesota, United States

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