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

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05025774
Collaborator
(none)
90
27

Study Details

Study Description

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))

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
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)
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Secondary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 25 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Masonic Cancer Center, University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT05025774
Other Study ID Numbers:
  • PEDS-2021-29482
First Posted:
Aug 27, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Masonic Cancer Center, University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022