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

NCT05025774 — Recruiting, 90 participants, Masonic Cancer Center, University of Minnesota

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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)

RegistryNCT05025774, acronym FLASHLITE
StatusRecruiting
Study typeObservational
Enrollment90 (Estimated)
SponsorMasonic Cancer Center, University of Minnesota (Other)
ConditionsChronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia, Heart Transplant
InterventionsPhysical activity (Other)
Datesstart 2025-03-14, primary completion 2026-11-01 (estimated), completion 2026-12-01 (estimated), first posted 2021-08-27, last updated 2025-11-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Lung Disease All trials for Chronic Obstructive Pulmonary Disease All trials of Physical activity

-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))

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
CaseOther: Physical activityAdolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant
ControlOther: Physical activity14-25 years old healthy individuals who are ambulatory without assistance. We may enroll younger subjects but we wish to subjects to match our patient population
  • Physical activity (Other): Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)

+Outcome measures

Primary outcomes

  • Measure of Peak O2 intake during test exercise [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
  • Measure of Cardiac output during test exercise [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

  • The proportion of expiratory flow limitation (EFL) [3-4 hours during the onetime study visit day]: The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion
  • Association between cardiac function and patient reported outcomes of perceived fitness [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

+Eligibility

Sex: All, ages: 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

+Locations (1)

FacilityCityCountryStatus
Masonic Cancer CenterMinneapolis, MinnesotaUnited StatesRecruiting

+Investigators

  • Pianosi Paolo, MD, Principal investigator, Masonic Children's Hospital, University of Minnesota