Clinical trial NCT05025774: Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Lung Disease
Chronic Obstructive Pulmonary Disease
Acute Lymphoblastic Leukemia
Heart Transplant
Keywords: Quality of life
Lung function
Fitness
Exercise
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Measure of Peak O2 intake during test exercise
timeFrame: 3-4 hours during the onetime study visit day
measure: Measure of Cardiac output during test exercise
timeFrame: 3-4 hours during the onetime study visit day
Secondary outcomes:
measure: The proportion of expiratory flow limitation (EFL)
timeFrame: 3-4 hours during the onetime study visit day
measure: Association between cardiac function and patient reported outcomes of perceived fitness
timeFrame: 3-4 hours during the onetime study visit day
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Children's Hospital, University of Minnesota
name: Pianosi Paolo, MD
role: PRINCIPAL_INVESTIGATOR
References: