Exercise, lung, and heart fitness in young survivors of heart transplant, childhood leukemia, and premature lung disease
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)
This project tests non-invasive exercise and breathing tests to see how well 8–25-year-olds who survived childhood leukemia, were born with chronic lung disease of prematurity, or had a heart transplant tolerate and perform during physical activity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 8 Years to 25 Years |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05025774 on ClinicalTrials.gov |
What this trial studies
This observational project uses standardized, non-invasive exercise testing and respiratory measurements to document cardiac function, ventilation, and exercise capacity in three groups aged 8–25: acute lymphoblastic leukemia survivors, individuals with chronic lung disease of prematurity, and heart transplant recipients. Participants complete supervised exercise protocols with concurrent heart and breathing measurements, and results are compared with healthy age-matched controls. The goal is to characterize exercise intolerance, identify physiologic limitations, and expand testing capabilities for clinical care and research. Findings are intended to inform evidence-based exercise guidance and improve understanding of long-term implications as these individuals age.
Who should consider this trial
Good fit: Ideal candidates are ambulatory, English-speaking 8–25-year-olds at least 48 inches tall who are survivors of ALL (off therapy ≥3 months), have chronic lung disease of prematurity, or have received a heart transplant, and meet study oxygen saturation and blood pressure criteria.
Not a fit: Patients who are pregnant, unable to ambulate, have significant baseline cardiac dysfunction or arrhythmia, have oxygen saturation below the study cutoffs, or — for ALL — received cranial radiation or a bone marrow transplant are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this work could lead to clearer, personalized exercise guidance that improves safety, fitness, and long-term quality of life for these survivors.
How similar studies have performed: Non-invasive cardiopulmonary exercise testing has been used previously to characterize fitness in each population, but applying a single standardized protocol across these three groups to guide pediatric exercise recommendations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Pianosi Paolo, MD — Masonic Children's Hospital, University of Minnesota
- Study coordinator: Char Napurski, MPH, CCRP
- Email: bake0257@umn.edu
- Phone: 612-626-2140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.