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

November 21, 2025 updated by: Masonic Cancer Center, University of Minnesota

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 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))

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Char Napurski, MPH, CCRP
  • Phone Number: 612-626-2140
  • Email: bake0257@umn.edu

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Masonic Cancer Center
        • Contact:
          • Lucie Turcotte, MD, MPH, MS
          • Phone Number: 612-624-1818
          • Email: turc0023@umn.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The case participants are the ALL survivors, CLD due to prematurity patients, and post-HT recipients. The control participants can be medical students, UMN staff's children, UMN/Fairview staff, medical residents and undergraduate or graduate students. The remaining controls will be from other UMMCH clinics with conditions unlikely to impact exercise capacity such as dermatology, orthopedics or sports medicine and the University Children's Clinic. Approval will be granted from the treating physician before approaching the control participants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Case
Adolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant
Other: Physical activity
Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)
Control
14-25 years old healthy individuals who are ambulatory without assistance. We may enroll younger subjects but we wish to subjects to match our patient population
Other: Physical activity
Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
3-4 hours during the onetime study visit day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of expiratory flow limitation (EFL)
Time Frame: 3-4 hours during the onetime study visit day
The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion
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
Logistic regression will be used to understand associations between cardiac function and patient reported outcomes of perceived fitness
3-4 hours during the onetime study visit day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Masonic Cancer Center, University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pianosi Paolo, MD, Masonic Children's Hospital, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEDS-2021-29482

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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