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

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukemia; Chronic Lung Disease; Chronic Obstructive Pulmonary Disease; Heart Transplant
• Interventions: Other: Physical activity

• Registration Number: NCT05025774
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Study Start: 2025-06-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Physical activity	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
Case	Physical activity	Adolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant

Primary Outcome Measures

Name	Time	Method
Measure of Cardiac output during test exercise	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
Measure of Peak O2 intake during test exercise	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

Secondary Outcome Measures

Name	Time	Method
The proportion of expiratory flow limitation (EFL)	3-4 hours during the onetime study visit day	The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion
Association between cardiac function and patient reported outcomes of perceived fitness	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