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

NCT05025774 | Recruiting

• 1 other identifier: PEDS-2021-29482
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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))

Conditions

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

Keywords

Quality of life; Lung function; Fitness; Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The proportion of expiratory flow limitation (EFL)

  3-4 hours during the onetime study visit day

• Association between cardiac function and patient reported outcomes of perceived fitness

  3-4 hours during the onetime study visit day

Study Arms (2)

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

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

Interventions

Physical activity OTHER

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

Case; Control

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Cases:
• Acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant
• 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
• years old
• Height: ≥ 48 inches
• Ambulatory without assistance
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample specimens will be saved for future use investigating biomarkers and/or Blood will be drawn from each participant and then separated and frozen as serum and mononuclear cells. Samples will be stored in the Department of Pediatrics freezers on the University of Minnesota Twin Cities campuses. All samples will be labeled with a unique participant ID number and no personal or identifiable data. Samples will be maintained for up to 5 years. Planned analysis include biomarker assessments. Samples will only be accessible to individuals listed on the IRB approval for this study.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pianosi Paolo, MD

  Masonic Children's Hospital, University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Char Napurski, MPH, CCRP

CONTACT

612-626-2140; bake0257@umn.edu

Pianosi Paolo, MD

CONTACT

ppianosi@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 27, 2021
• Study Start: March 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)