Recruiting

Observational Study

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT05025774

Conditions

Chronic Lung Disease

Chronic Obstructive Pulmonary Disease

Acute Lymphoblastic Leukemia

Heart Transplant

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Not accepted

Interventions

Physical activity

Study Details

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

Study ID

NCT05025774

Start date

Mar 14, 2025

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Case

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

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

Interventions

Physical activity

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

Primary outcome measure

  • Measure of Peak O2 intake during test exercise [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Char Napurski, MPH, CCRP

612-626-2140bake0257@umn.edu

Pianosi Paolo, MD

ppianosi@umn.edu

Locations

Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Lucie Turcotte, MD, MPH, MS

612-624-1818turc0023@umn.edu

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Quality of life
  • Lung function
  • Fitness
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2025-11-24.