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

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: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Acute Lymphoblastic Leukemia; Chronic Lung Disease; Heart Transplant
• Intervention / Treatment: Other: Physical activity

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: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Char Napurski, MPH, CCRP; Phone Number: 612-626-2140; Email: bake0257@umn.edu
• Study Contact Backup: Name: Pianosi Paolo, MD; Email: ppianosi@umn.edu

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Measure of Peak O2 intake during test exercise	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	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

Outcome Measure	Measure Description	Time Frame
The proportion of expiratory flow limitation (EFL)	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	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

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Pianosi Paolo, MD, Masonic Children's Hospital, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Quality of life; Fitness; Lung function
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Lung Diseases, Obstructive; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Behavior; Hemic and Lymphatic Diseases; Pulmonary Disease, Chronic Obstructive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID 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