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

NCT ID: NCT05025774

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2026-12-01

Brief Summary

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.

Conditions

Chronic Lung Disease; Chronic Obstructive Pulmonary Disease; Acute Lymphoblastic Leukemia; Heart Transplant

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case

Adolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant

Physical activity

Intervention Type: OTHER

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

Physical activity

Intervention Type: OTHER

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

Interventions

Physical activity

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pianosi Paolo, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Children's Hospital, University of Minnesota

Locations

Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Char Napurski, MPH, CCRP

Role: CONTACT

bake0257@umn.edu

612-626-2140

Pianosi Paolo, MD

Role: CONTACT

ppianosi@umn.edu

Facility Contacts

Lucie Turcotte, MD, MPH, MS

Role: primary

turc0023@umn.edu

612-624-1818

Other Identifiers

PEDS-2021-29482

Identifier Type: -

Identifier Source: org_study_id