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Идёт набор NCT05025774

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

— Наблюдательное Chronic Lung Disease Chronic Obstructive Pulmonary Disease Acute Lymphoblastic Leukemia Heart Transplant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physical activity.
Кому может быть актуально
Состояния в реестре: Chronic Lung Disease, Chronic Obstructive Pulmonary Disease, Acute Lymphoblastic Leukemia, Heart Transplant. Базовые параметры: 8 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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))

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Measure of Peak O2 intake during test exercise [Срок оценки: 3-4 hours during the onetime study visit day]
  • Measure of Cardiac output during test exercise [Срок оценки: 3-4 hours during the onetime study visit day]
Вторичные конечные точки (2)
  • The proportion of expiratory flow limitation (EFL) [Срок оценки: 3-4 hours during the onetime study visit day]
  • Association between cardiac function and patient reported outcomes of perceived fitness [Срок оценки: 3-4 hours during the onetime study visit day]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Masonic Cancer Center — Minneapolis

Идентификаторы

NCT: NCT05025774 · PEDS-2021-29482

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗