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NCT Number: NCT05025774

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

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))

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Key information

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Other

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

Primary outcomes

  1. Measure of Peak O2 intake during test exercise

    Time frame: 3-4 hours during the onetime study visit day

    Maximal cardiopulmonary exercise testing (CPX) will be completed on cycle ergometer to determine peak oxygen uptake, a measure of cardiorespiratory fitness

  2. Measure of Cardiac output during test exercise

    Time frame: 3-4 hours during the onetime study visit day

    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

Secondary outcomes

  1. The proportion of expiratory flow limitation (EFL)

    Time frame: 3-4 hours during the onetime study visit day

    The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion

  2. Association between cardiac function and patient reported outcomes of perceived fitness

    Time frame: 3-4 hours during the onetime study visit day

    Logistic regression will be used to understand associations between cardiac function and patient reported outcomes of perceived fitness

Study contacts

Contact information is provided by the study sponsor or research team.

Char Napurski, MPH, CCRP

CONTACT

[email protected]

612-626-2140

Pianosi Paolo, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study 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)

Acronym: FLASHLITE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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