Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Exercise
12 weeks of supervised cardiorespiratory exercise twice a week (6 weeks at the hospital and 6 weeks in the local municipality) combined with patient education and individual follow-up sessions
干预措施: Cardiorespiratory exercise combined with patient education and individual follow-up sessions (Behavioral)
Usual care
The usual care group is encouraged to perform home-based aerobic exercise on their own
结局指标
主要结局
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
时间窗: from baseline to 3 months (post-intervention)
A sub-maximal exercise test on a stationary bicycle where the workload increases by 15 Watts (W) every minute and each minute the patient recites a standardized text passage. When the patient is no longer able to speak comfortably the test terminates. The higher score the better cardiorespiratory fitness
次要结局
- Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in The WHO-5 Well-being index from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in Physical Activity Scale(from baseline to 3 months (post-intervention))
- Change in Physical Activity Scale from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Anxiety and depression from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Anxiety and depression from baseline 12-months post-stroke(From baseline 12-months post-stroke)
- Change in Fatigue Severity Scale from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Fatigue Severity Scale from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke(From baseline to 12-months post-stroke)
- Change in The Multidimensional Fatigue Inventory from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in blood pressure from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in blood pressure from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in body mass index from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in body mass index from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in Modified rankin scale from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Modified rankin scale from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in Cathepsin B from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in Cathepsin B from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)
- Change in the Stages of exercise behavior change from baseline to 3 months post-stroke(from baseline to 3 months (post-intervention))
- Change in the Stages of exercise behavior change from baseline to 12-months post-stroke(From baseline to 12-months post-stroke)