Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions
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: Cardiorespiratory exercise combined with patient education and individual follow-up sessions.
- Кому может быть актуально
- Состояния в реестре: Minor Stroke, Non-disabling Stroke, Transient Ischemic Attack. 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
- Дания
- 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
Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
Обзор
In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.
Подробное описание
Hypertension and physical inactivity are the most common risk factors for stroke. Patients with minor stroke or transient ischemic attack (TIA) have short-lasting symptoms, often with remission within hours or days. Though patients experience a quick remission, they have an increased risk of a recurrent stroke and progressive cognitive dysfunction. The patients are also likely to have other disposing risk factors such as diabetes, smoking, and hypercholesterolemia which may increase the risk of a recurrent stroke. Following hospital discharge, the patients are offered preventive medication, but no standardized rehabilitation or exercise. Previous studies have shown that physical exercise decreases cardiovascular risk factors for patients after stroke and increases physical function and quality of life.
The aim is to develop and evaluate a standardized exercise program (a stroke school) for patients with minor stroke or TIA. The intervention consist of 6 weeks of supervised aerobic exercise at the hospital combined with patient education including knowledge on stroke risk factors. Subsequently, 6 weeks of supervised aerobic exercise in their local municipality. After the 12 weeks of exercise, patients are offered individual, motivational follow-up sessions with the purpose to facilitate the patients to stay physically active in their everyday life.
This intervention will increase the patients´ knowledge regarding risk factors for stroke and cardiovascular disease, increase their cardiorespiratory fitness and facilitate the patients to be physical active and hopefully slow the progression of vascular disease.
Вмешательства
- Поведенческое Cardiorespiratory exercise combined with patient education and individual follow-up sessions
6 weeks of cardiorespiratory exercise combined with patient education at the hospital, followed by 6 weeks of cardiorespiratory exercise in the local municipality. Subsequently individual follow-up sessions with the aim to facilitate the patients to stay physically active in their everyday life
Первичные конечные точки
- Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months [Срок оценки: from baseline to 3 months (post-intervention)]
Вторичные конечные точки (12)
- Change in Physical Activity Scale [Срок оценки: from baseline to 3 months (post-intervention)]
- Change in Physical Activity Scale from baseline to 12-months post-stroke [Срок оценки: From baseline to 12-months post-stroke]
- Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke [Срок оценки: from baseline to 3 months (post-intervention)]
- Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke [Срок оценки: from baseline to 3 months (post-intervention)]
- Change in The WHO-5 Well-being index from baseline to 12-months post-stroke [Срок оценки: From baseline to 12-months post-stroke]
- Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke [Срок оценки: from baseline to 3 months (post-intervention)]
- Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke [Срок оценки: From baseline to 12-months post-stroke]
- Change in Anxiety and depression from baseline to 3 months post-stroke [Срок оценки: from baseline to 3 months (post-intervention)]
- Change in Anxiety and depression from baseline 12-months post-stroke [Срок оценки: From baseline 12-months post-stroke]
- Change in Fatigue Severity Scale from baseline to 3 months post-stroke [Срок оценки: from baseline to 3 months (post-intervention)]
- Change in Fatigue Severity Scale from baseline to 12-months post-stroke [Срок оценки: From baseline to 12-months post-stroke]
- Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke [Срок оценки: From baseline to 12-months post-stroke]
Критерии участия
Критерии включения
- Patients with a minor stroke or TIA without the need of rehabilitation after hospital discharge, but need physical activity in order to prevent cardiovascular diseases
- Patients spending ≤ 5 hour of leisure time on high-intensity physical activity on weekly basis within the last 3 months
- Able to speak and read Danish and to provide informed consent
- Individuals ≥ 18 years of age
Критерии исключения
- Previous large-artery stroke or hemorrhagic stroke
- Unstable cardiac condition, e.g. pacemaker
- Uncontrolled hypertension (patients not responding adequately to antihypertensive medication when applying treatment according to guidelines)
- Symptoms or comorbidities not allowing exercise on a stationary bicycle (e.g. claudication)
- Dyspnoea caused by heart or pulmonary disease (e.g. COPD)
- Aphasia, or dementia that interferer with understanding the protocol and/or physical examinations.
- Patients diagnosed with dementia at hospital admission (a score ≤23/30 on the Mini-Mental State Examination are not invited into the study)
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
- Профилактика
Центры проведения
Дания · 2 центра
- Herlev Hospital — Copenhagen
- Department of Neurology, Herlev-Gentofte Hospital — Herlev
Идентификаторы
NCT: NCT04945174 · H-20059985