Меню
Идёт набор NCT07572435

Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease

Без фазы С лечением Complex Congenital Heart Disease

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: Community-Based Remote Cardiac Rehabilitation Program, standard of care.
Кому может быть актуально
Состояния в реестре: Complex Congenital Heart Disease. Базовые параметры: 8 лет — 18 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Preliminary Efficacy of a Community-Based Remote Cardiac Rehabilitation Program on Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease: A Single Blind, Randomized Controlled Trial

Обзор

This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.

Вмешательства

  • Поведенческое Community-Based Remote Cardiac Rehabilitation Program
    The program consists of supervised remote exercise via ZOOM once a week (approx. 60 minutes, including warm-up, aerobic, resistance, respiratory, and cool-down exercises) and self-directed exercise 3 to 7 times a week. Biological signals (ECG, heart rate, SpO2) are monitored using wearable devices (mobiCARE, pulse oximeter, and smartwatch). A respiratory muscle training device (POWERbreathe) is also utilized.
  • Поведенческое standard of care
    Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.

Первичные конечные точки

  • Change in Maximal Oxygen Consumption (VO2 max) [Срок оценки: Baseline (Week 0), 12 weeks]
Вторичные конечные точки (12)
  • Change in Pediatric Quality of Life Inventory (PedsQL) Total Score [Срок оценки: Baseline (Week 0), 12 weeks, 24 weeks]
  • Cardiac Rehabilitation Program Attendance Rate [Срок оценки: 12 weeks, 24 weeks]
  • Drop-out Rate [Срок оценки: 12 weeks, 24 weeks]
  • Change in Physical Activity Level [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Global Physical Activity Questionnaire (GPAQ) Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Parent Proxy-Report Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Resilience Scale for Youth (RS-Y) Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Child Behavior Checklist (CBCL) Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score [Срок оценки: Baseline, 12 weeks, 24 weeks]
  • Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score [Срок оценки: Baseline, 12 weeks, 24 weeks]

Критерии участия

Критерии включения

  • Aged 8 to 18 years.
  • Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.
  • At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.
  • Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.
  • Participant or guardian has agreed to participate and signed the written informed consent form.
  • Confirmed to have decreased physical activity level and physical well-being through assessments (Must meet both):
  • KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below.
  • Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.

Критерии исключения

  • Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.
  • Neurological or musculoskeletal disorders that make independent exercise impossible.
  • Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.
  • Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's Depression Inventory 2: Self-Report \[K-CDI-2:SR\] and Revised Children's Manifest Anxiety Scale, Second Edition \[RCMAS-2\]).
  • Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).
  • Currently wearing an artificial pacemaker.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT07572435 · 2511-022-1690

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗