Hot Water Immersion After Myocardial Infarction
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: Thermotherapy.
- Кому может быть актуально
- Состояния в реестре: Cardiac Disease, Cardiac Rehabilitation. Базовые параметры: от 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
- Швеция
- 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
Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study
Обзор
Myocardial infarction (MI) is a leading cause of death in developed countries, including Sweden. Standard treatment for patients after MI includes exercise-based cardiac rehabilitation which contributes to improved cardiovascular function and reduces the risk of hospital readmissions, new cardiovascular events and mortality. Thermotherapy may also have beneficial effects on cardiovascular disease by a reduction in inflammatory status and improved metabolism and vascular function. Given the well-documented effects of exercise training on cardiac rehabilitation and recent evidence that thermotherapy may improve cardiovascular function, we wish to investigate the effect of exercise combined with hot water immersion (HWI) in cardiac rehabilitation post-MI. This is a single-centre, randomized controlled clinical trial in patients with recent MI. Our aim is to investigate whether exercise training combined with HWI improves inflammatory and metabolic status, cardiovascular function as well as psychological well-being, compared with exercise training alone. Patients will be randomized 1:1 to an 8 week intervention with exercise training 2 times per week followed by 15 minutes of hot water immersion, or to a control group with exercise training alone. The primary endpoint is changes in the inflammatory marker interleukin (IL-) 6 between groups at 8 weeks. Secondary endpoints include other biomarkers of inflammation, metabolism, effects on cardiovascular function and psychological benefits. Secondary prevention after MI has improved during the last decades but readmissions and death following acute MI remain large health challenges. If HWI in addition to standard cardiac rehabilitation can lower inflammation more than standard therapy alone, and improve metabolic, cardiovascular and psychological status, it could be a cost-effective and safe complementary strategy for secondary prevention after MI, particularly for those with limited exercise capability.
Вмешательства
- Другое Thermotherapy
Hot baths directly after an exercise session
Первичные конечные точки
- Concentrations of interleukin 6 (IL-6) in blood [Срок оценки: 8 weeks (aiming at 16 bath (or control) sessions during the intervention period]
Вторичные конечные точки (6)
- Concentrations of other biomarkers of inflammation in blood [Срок оценки: 8 weeks]
- Concentrations of biomarkers of metabolism in blood [Срок оценки: 8 weeks]
- Change in percent in endothelial flow-mediated dilatation (FMD) [Срок оценки: 8 weeks]
- Change in sympathetic/parasympathetic activity [Срок оценки: 8 weeks]
- Change in score of participants´ subjectively reported psychological well-being [Срок оценки: 8 weeks]
- Change in diastolic and systolic blood pressure (mm(Hg) [Срок оценки: 8 weeks]
Критерии участия
Критерии включения
- Patients with a diagnosis of ST-elevation myocardial infarction (STEMI) or non-STEMI
- Concomitant participation in standard care exercise-based cardiac rehabilitation
- Male or female patients ≥ 18 years
- Written informed consent
Критерии исключения
- Regularly performing hot water immersion, sauna or other types of thermotherapy
- Not willing to perform hot water immersion regularly
- Febrile illness or acute, ongoing infection
- <18 years of age
- Inability to provide informed consent
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
- Лечение
Центры проведения
Швеция · 1 центр
- Örebro University hospital — Örebro
Идентификаторы
NCT: NCT05725655 · 279938