Clinical trial Recruiting at 1 site Observational Ages 8 to 25

Exercise, lung, and heart fitness in young survivors of heart transplant, childhood leukemia, and premature lung disease

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)

Run by Masonic Cancer Center, University of Minnesota · NCT05025774 · Data updated 2026-11-12

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.

More Acute Lymphoblastic Leukemia trials

Quick facts

Study typeObservational
Ages8 Years to 25 Years
SexAll
Enrollment90 (estimated)
SponsorMasonic Cancer Center, University of Minnesota
Academic / other
Drugs / interventionsradiation
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedMarch 14, 2025
Main results expectedNovember 1, 2026
Study endsDecember 1, 2026
Registry record updatedNovember 24, 2025
Trial IDNCT05025774 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.