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Recruiting NCT05025774

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

— Observational Chronic Lung Disease Chronic Obstructive Pulmonary Disease Acute Lymphoblastic Leukemia Heart Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical activity.
Who it may be relevant to
Registry conditions: Chronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia, Heart Transplant. Basic parameters: 8 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

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

Primary outcome measures

  • Measure of Peak O2 intake during test exercise [Time frame: 3-4 hours during the onetime study visit day]
  • Measure of Cardiac output during test exercise [Time frame: 3-4 hours during the onetime study visit day]
Secondary outcome measures (2)
  • The proportion of expiratory flow limitation (EFL) [Time frame: 3-4 hours during the onetime study visit day]
  • Association between cardiac function and patient reported outcomes of perceived fitness [Time frame: 3-4 hours during the onetime study visit day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Masonic Cancer Center — Minneapolis

Identifiers

NCT: NCT05025774 · PEDS-2021-29482

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗