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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-25
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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))

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

ALL specific: received cranial radiation, bone marrow transplant recipients

Investigator or patient's primary physician deems the patient unsuitable for the study

History of malignancy, CLD or HT or any other diagnosis which may reduce cardiorespiratory function

Investigator deems the patient unsuitable for the study

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Physical activity

    Other intervention

    Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Case1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3-4 hours during the onetime study visit day
2

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

Time frame
3-4 hours during the onetime study visit day

Secondary outcomes

1

The proportion of expiratory flow limitation (EFL)

The proportion of expiratory flow limitation (EFL) during exercise while tracking dyspnea and perceived exertion

Time frame
3-4 hours during the onetime study visit day
2

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

Time frame
3-4 hours during the onetime study visit day

Other outcomes

Sponsors and contacts

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