Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation
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: standard care + moderate-intensity continuous exercise training, standard care + high-intensity interval training.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation. Базовые параметры: от 40 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
- Канада
- 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
Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation - a Multi-centre Randomized Controlled Trial
Обзор
The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.
Подробное описание
Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.
Вмешательства
- Поведенческое standard care + moderate-intensity continuous exercise training
Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks. - Поведенческое standard care + high-intensity interval training
Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.
Первичные конечные точки
- Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36). [Срок оценки: baseline to 12 weeks]
- Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET). [Срок оценки: baseline to 12 weeks]
Вторичные конечные точки (11)
- Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). [Срок оценки: baseline to 12 weeks]
- Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS). [Срок оценки: baseline to 12 weeks]
- Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale. [Срок оценки: baseline to 12 weeks]
- Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36). [Срок оценки: baseline to 12 weeks]
- Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET. [Срок оценки: baseline to 12 weeks]
- Changes in lower body muscular fitness measured by standard load tests. [Срок оценки: baseline to 12 weeks]
- Changes in volume and intensity of exercise measured directly by accelerometer. [Срок оценки: baseline to 12 weeks]
- Changes in volume and intensity of exercise measured by self-report (exercise logs). [Срок оценки: baseline to 12 weeks]
- Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary. [Срок оценки: baseline to 12 weeks]
- Changes in self reported sleep patterns measured by the 7-day sleep diary. [Срок оценки: baseline to 12 weeks]
- Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only). [Срок оценки: baseline to 12 weeks]
Критерии участия
Критерии включения
- persistent or permanent atrial fibrillation;
- rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
- able to perform a symptom-limited exercise test;
- at least 40 years of age (i.e. participants must be 40 years or older);
Критерии исключения
- currently participating in routine exercise training (more than two times per week);
- unstable angina;
- diagnosed severe mitral or aortic stenosis;
- diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
- pregnant, lactating or planning to become pregnant during the study period;
- unable to provide written, informed consent, or
- unwilling or unable to return for follow up at week 12.
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
- Двойное слепое
- Основная цель
- Другое
Центры проведения
Канада · 2 центра
- London Health Sciences Network — London
- University of Ottawa Heart Insititue — Ottawa
Идентификаторы
NCT: NCT03397602 · 0906