ExStroke Pilot Trial: Physical Exercise After Acute Ischaemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Difference in physical activity scale for the elderly
研究概览
简要总结
Summary
This study will look at physical exercise after acute ischaemic stroke. It is called the ExStroke Pilot Trial.
Physical activity is associated with a lower risk of first-time stroke. It remains unknown if physical activity also is associated with a lower risk of recurrent stroke. Patients with ischaemic stroke have a 30% to 40% risk of a recurrent stroke during a 5 year follow-up. The risk of acute myocardial infarction (MI) and death from vascular disease is approximately 15% each. The impact of lifestyle factors on risk for these events is insufficiently covered in the international scientific literature.
Purpose:
The purpose of the trial is to examine whether the level of physical activity increases in patients who have had an ischemic stroke, when they are informed about physical activity and instructed in a physical training program. The occurrence of new cerebro- and cardiovascular events in the patients will be registered. The patients are randomised to receive oral and written information by a physician and a physiotherapist about physical exercise; or to a control group with no instruction regarding physical exercise. Both groups will receive the best available therapy with regard to secondary stroke prevention and will be informed about lifestyle factors.
Irrespective of which group the patients are randomised to, all patients will receive the best possible established treatment with regard to prevention of thromboses; blood pressure control; lipid lowering agents, if necessary; and information about diet, tobacco smoking, and vitamin supplements.
Study Design:
The patients will be randomised centrally within 90 days after stroke onset, and they will be re-examined at 3, 6, 9, 12, 18, and 24 months. Inclusion criteria are patients with ischaemic stroke, aged 40 years or older. In the pilot trial a number of 300 included patients is wanted.
详细描述
Physical exercise after acute ischaemic stroke.
The ExStroke Pilot Trial.
A randomised clinical trial.
Investigation group
Principal investigator:
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
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 40 years or older.
- •Patients with a clinical diagnosis of stroke; symptoms lasting 24 hours or more.
- •Computed tomography (CT)-scan of the brain must either show a new infarct or be normal. Patients only with infarcts without clinical symptoms cannot be included.
- •Inclusion shall take place before day 90 after stroke onset.
- •Informed consent after verbal and written information.
- •The patient must be able to walk either unaided or with a cane or a walker.
排除标准
- •Patients who are unable to understand the information, or who cannot cooperate, are excluded.
- •Patients confined to a wheelchair or bed.
- •CT-scanning showing intracranial haemorrhage or focal pathology other than infarction, cerebral atrophy, or leucoaraiosis.
- •Modified Rankin score of 4 or 5 before the actual stroke.
- •Serious medical disease such as AIDS, metastatic cancer, or abnormalities that the investigator feels may compromise the patient's successful participation in the trial.
- •Earlier randomisation in this trial.
结局指标
主要结局
Difference in physical activity scale for the elderly
时间窗: 24 months
次要结局
- Occurrence of stroke, MI or death(24 months)
