[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05025774":3,"trial-entities:NCT05025774":113,"trial-summary:NCT05025774":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":28,"primary_purpose":15,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":80,"locations":83,"central_contacts":99,"overall_officials":107,"references":111,"see_also_links":112},"NCT05025774","PEDS-2021-29482","Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise","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)","RECRUITING","2026-12-01","2025-11","2025-11-24","2025-03-14","Masonic Cancer Center, University of Minnesota","OTHER",null,"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))","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.",[19,20,21,22],"Chronic Lung Disease","Chronic Obstructive Pulmonary Disease","Acute Lymphoblastic Leukemia","Heart Transplant",[24,25,26,27],"Quality of life","Lung function","Fitness","Exercise","OBSERVATIONAL",[],{"count":31,"type":32},90,"ESTIMATED",[34],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Physical activity","Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)",[38,39],"Case","Control",[41,45],{"measure":42,"description":43,"timeFrame":44},"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":46,"description":47,"timeFrame":44},"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",[49,52],{"measure":50,"description":51,"timeFrame":44},"The proportion of expiratory flow limitation (EFL)","The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion",{"measure":53,"description":54,"timeFrame":44},"Association between cardiac function and patient reported outcomes of perceived fitness","Logistic regression will be used to understand associations between cardiac function and patient reported outcomes of perceived fitness","ALL","8 Years","25 Years",{"inclusion":59,"exclusion":73,"raw_text":79},[60,61,62,63,64,65,66,67,68,69,70,62,63,64,65,71,66,72,68],"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 (\\\u003C95th 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","No history of arrhythmia or known cardiac dysfunction at baseline","SpO2 \\>95%",[60,74,75,76,77,78],"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","Inclusion Criteria:\n\n* Cases:\n\n  * Acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant\n  * 8-25 years old\n  * Height: ≥ 48 inches\n  * Ambulatory without assistance\n  * English speaking\n  * Normotensive (\\\u003C95th percentile for age; okay if managed with antihypertensive medication)\n  * SpO2 \\>92%\n  * Not pregnant\n  * ALL survivor specific: must have completed therapy ≥ 3 months prior to study entry\n* Controls\n\n  * 8-25 years old\n  * Height: ≥ 48 inches\n  * Ambulatory without assistance\n  * English speaking\n  * No history of arrhythmia or known cardiac dysfunction at baseline\n  * Normotensive (\\\u003C95th percentile for age; okay if managed with antihypertensive medication)\n  * SpO2 \\>95%\n  * Not pregnant\n\nExclusion Criteria:\n\n* Cases:\n\n  * ALL specific: received cranial radiation, bone marrow transplant recipients\n  * Investigator or patient's primary physician deems the patient unsuitable for the study\n* Controls:\n\n  * History of malignancy, CLD or HT or any other diagnosis which may reduce cardiorespiratory function\n  * Investigator deems the patient unsuitable for the study",[81,82],"CHILD","ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"Masonic Cancer Center","Minneapolis","Minnesota","55455","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Lucie Turcotte, MD, MPH, MS","CONTACT","612-624-1818","turc0023@umn.edu",{"lat":97,"lon":98},44.97997,-93.26384,[100,104],{"name":101,"role":93,"phone":102,"email":103},"Char Napurski, MPH, CCRP","612-626-2140","bake0257@umn.edu",{"name":105,"role":93,"email":106},"Pianosi Paolo, MD","ppianosi@umn.edu",[108],{"name":105,"affiliation":109,"role":110},"Masonic Children's Hospital, University of Minnesota","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":117},[21,115,116],"Chronic Lung Disorder","Heart Transplantation",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an observational study, meaning researchers will observe and collect information without providing specific treatments. It aims to enroll 90 participants.","completed","Fitness and Lung Function Study for Childhood Chronic Diseases","This study is looking at how exercise affects fitness and lung function in young people aged 8 to 25 who have survived acute lymphoblastic leukemia (ALL), live with chronic lung disease (CLD) from prematurity, or have had a heart transplant. Researchers want to better understand how these conditions impact exercise ability and heart and lung function. You would participate in a one-time study visit where your physical activity and exercise capacity will be measured. The study aims to gather information to help create better exercise guidelines for children with chronic diseases. The study is currently unclear on its recruitment status and plans to enroll 90 participants.","Measurements for primary endpoints are taken during the one-time study visit day.",106,"You would have a one-time study visit lasting 3-4 hours. During this visit, your physical activity will be reported, and your peak oxygen intake and cardiac output (how much blood your heart pumps) will be measured during exercise.","Not stated in the trial record.",[35],"v2"]