Chronic Lung DiseaseFLASHLITENCT05025774
Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
An observational study of Chronic Lung Disease and Chronic Obstructive Pulmonary Disease, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Chronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia
- What is being tested?
- Physical activity
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pianosi Paolo, MD contact
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center
Minneapolis, Minnesota, 55455
Lucie Turcotte, MD, MPH, MS, 612-624-1818, turc0023@umn.edu
About this study
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)
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))
Read the 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.
- Conditions
- Chronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia, Heart Transplant
- Being tested
- Physical activity
- Keywords
- Quality of life, Lung function, Fitness, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)
| Study group | Role | What they receive |
|---|---|---|
| Case | Adolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant Receives: Other: Physical activity | |
| 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 Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-4 hours during the onetime study visit day
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
Measured: 3-4 hours during the onetime study visit day
Secondary outcomes (2)
The proportion of expiratory flow limitation (EFL)
The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion
Measured: 3-4 hours during the onetime study visit day
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
Measured: 3-4 hours during the onetime study visit day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start14 Mar 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pianosi Paolo, MD, Principal investigator, Masonic Children's Hospital, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025774
- Sponsor's protocol ID
- PEDS-2021-29482
- Acronym
- FLASHLITE
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05025774
- Acronym / sponsor ID
- FLASHLITE / PEDS-2021-29482
- Conditions
- Chronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia, Heart Transplant
- Keywords
- Quality of life, Lung function, Fitness, Exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Physical activityAdolescent or young adult acute lymphoblastic leukemia survivor, OR living with chronic lung disease of prematurity, OR living with heart transplant |
| Control | – | Other: Physical activity14-25 years old healthy individuals who are ambulatory without assistance. We may enroll younger subjects but we wish to subjects to match our patient population |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (19 listed)
- Cases:
- Controls
Key exclusion criteria (6 listed)
- Cases:
- Controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityParticipant Reported Physical Activity and Outcomes (completed via REDCap or on paper) | Other | Case, Control |
Primary outcome
Measure of Peak O2 intake during test exercise
Time frame: 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
Measure of Cardiac output during test exercise
Time frame: 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
2 secondary outcomes
The proportion of expiratory flow limitation (EFL)
Time frame: 3-4 hours during the onetime study visit day
Association between cardiac function and patient reported outcomes of perceived fitness
Time frame: 3-4 hours during the onetime study visit day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pianosi Paolo, MD contact
Pianosi Paolo, MD principal investigator
Masonic Children's Hospital, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Disease and Chronic Obstructive Pulmonary Disease, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Char Napurski, MPH, CCRP (612-626-2140, bake0257@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Peak O2 intake during test exercise (time frame: 3-4 hours during the onetime study visit day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.