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Clinical Trials/NCT05025774
NCT05025774
Recruiting
Not Applicable

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)

Masonic Cancer Center, University of Minnesota1 site in 1 country90 target enrollmentMarch 14, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Lung Disease
Sponsor
Masonic Cancer Center, University of Minnesota
Enrollment
90
Locations
1
Primary Endpoint
Measure of Cardiac output during test exercise
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2025
End Date
December 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • 8-25 years old

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • The proportion of expiratory flow limitation (EFL)(3-4 hours during the onetime study visit day)
  • Association between cardiac function and patient reported outcomes of perceived fitness(3-4 hours during the onetime study visit day)

Study Sites (1)

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