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Идёт набор NCT06826534

At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure

Без фазы С лечением Cardiovascular Complication Chemotherapeutic Toxicity

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: Cardio-oncology rehabilitation.
Кому может быть актуально
Состояния в реестре: Cardiovascular Complication, Chemotherapeutic Toxicity. Базовые параметры: 0 лет — 21 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
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Обзор

The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are * To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors. * To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance. * To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications. * Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA. Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.

Вмешательства

  • Поведенческое Cardio-oncology rehabilitation
    Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week

Первичные конечные точки

  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Change in cardiac function after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Change in cardiac rhythm after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Change in cardiac stress after completion of a 6-month exercise intervention. [Срок оценки: Baseline to 6 months]
  • Average change in triglyceride level as measured from baseline to 6 months. [Срок оценки: Baseline to 6 months]
  • Average change in total cholesterol level as measured from baseline to 6 months. [Срок оценки: Baseline to 6 months]
  • Average change in high density lipoprotein level as measured from baseline to 6 months. [Срок оценки: Baseline to 6 months]
Вторичные конечные точки (3)
  • Average change in reported quality of life from baseline to 6 months [Срок оценки: Baseline to 6 months]
  • Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months [Срок оценки: Baseline to 6 months]
  • Average change in activity level from baseline to 6 months [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

  • Patients aged of 10-21 years at enrollment
  • Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
  • History of anthracycline exposure +/- radiation
  • Currently in remission, with at least 6 months off chemotherapy
  • Able to perform CPET
  • Baseline CPET with VO2 <80% (at start of study, or CPET at CHLA after January 2020)
  • Smartphone compatible with Fitbit (own or parent/legal guardian's)
  • Ability to complete and send diary and Fitbit information on a weekly basis
  • Ability to participate in monthly virtual check-in visits
  • Baseline activity prior to intervention <30min/day, 2x/week

Критерии исключения

  • Inability to obtain consent/assent
  • Unable to accurately perform quality of life survey independently
  • No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery
  • Contraindication to moderate activity (>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D)
  • Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
  • Unable to perform mild activity for at least 0.5h/day and at least 2x/week
  • Unable to come to hospital for study visits at 0 and 6 months
  • Unable to complete study-related surveys
  • Unable to complete and send diary and Fitbit information on a weekly basis
  • Unable to check-in monthly on virtual platform
  • On beta blockade
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT06826534 · CHLA-22-00323

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗