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

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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05025774
Acronym
FLASHLITE
Enrollment
90
Registered
2021-08-27
Start date
2025-03-14
Completion date
2026-12-01
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Quality of life, Lung function, Fitness, Exercise

Brief 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))

Detailed 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.

Interventions

OTHERPhysical activity

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

Sponsors

Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 25 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of Peak O2 intake during test exercise3-4 hours during the onetime study visit dayMaximal cardiopulmonary exercise testing (CPX) will be completed on cycle ergometer to determine peak oxygen uptake, a measure of cardiorespiratory fitness
Measure of Cardiac output during test exercise3-4 hours during the onetime study visit dayCardiac 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

Secondary

MeasureTime frameDescription
The proportion of expiratory flow limitation (EFL)3-4 hours during the onetime study visit dayThe proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion
Association between cardiac function and patient reported outcomes of perceived fitness3-4 hours during the onetime study visit dayLogistic regression will be used to understand associations between cardiac function and patient reported outcomes of perceived fitness

Countries

United States

Contacts

Primary ContactChar Napurski, MPH, CCRP
bake0257@umn.edu612-626-2140
Backup ContactPianosi Paolo, MD
ppianosi@umn.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026