Идёт набор NCT05873543
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
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: smartphone-assisted hybrid cardiac rehabilitation (SHCR).
- Кому может быть актуально
- Состояния в реестре: Heart Failure. Базовые параметры: 18 лет — 80 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
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The aim of this randomized controlled trial is to compare the impact of a case manager-led smartphone-assisted hybrid cardiac rehabilitation program with usual care in patients with HF. Participants will undergo a 12-week program led by a case manager and assisted by a smartphone. The study aims to answer two main questions: 1. Is the novel cardiac rehabilitation model feasible for patients with HF? 2. Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?
Вмешательства
- Другое smartphone-assisted hybrid cardiac rehabilitation (SHCR)
The 12-week case manager-led SHCR program includes: * Customized exercise prescriptions following ACSM's heart failure guidelines. * A hybrid program combining in-person sessions, home self-exercise, and videoconferencing for exercise coaching(optional), supported by a smartphone app. * Case managers instruct patients on a communication app for weekly follow-ups, health education messages, exercise reminders, and progress tracking, including metrics like blood pressure, heart rate, weight, and
Первичные конечные точки
- Change of peak oxygen uptake [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Change of 6 minute walking test [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
Вторичные конечные точки (12)
- Adherence to prescribed exercise [Срок оценки: 12 weeks(post-intervention)]
- Evaluation of Quality of life [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Depression [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Anxiety [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Evaluation of physical activity [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Evaluation of grip strength [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Evaluation of frailty [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: Total cholesterol [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: LDL [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: HDL [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: Triglyceride [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
- Blood test: NT-proBNP [Срок оценки: at baseline, 12 weeks(post-intervention), and 6 months.]
Критерии участия
Критерии включения
- Patients with heart failure between the ages of 18 and 80 years old.
- NYHA (New York Heart Association) functional classification of 1 to 3.
- Patients must be in a stable condition and under outpatient follow-up.
Критерии исключения
- Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
- Patients who are unable to complete cardiopulmonary exercise testing.
- Patients who are unable to follow verbal instructions.
- Patients who are unable to walk independently or pedal a stationary bicycle.
- Patients who are unable to use communication app on a smartphone.
- Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation.
- Patients who do not provide consent to participate in the trial.
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
Тайвань · 1 центр
- Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital — Taipei
Идентификаторы
NCT: NCT05873543 · 202302009RINC