NCT03259932撤回不适用
Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Fatigue relief (assessed by the Fatigue Severity Scale)
研究概览
简要总结
After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18 years
- •National health insurance cover
- •1st minor ischaemic stroke (initial NIH score ≤ 4)
- •Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)
- •Patient living close to the participating centre (<50 km)
- •With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))
排除标准
- •haemorrhagic stroke
- •History of ischaemic or haemorrhagic stroke with clinical manifestations
- •History of TIA
- •Pre-existing dementia (defined according to DSM IV criteria)
- •Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible
- •Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)
- •Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion
- •Pre-stroke Rankin score ≥ 3
- •Pregnant patient
- •Patient under guardianship
结局指标
主要结局
Fatigue relief (assessed by the Fatigue Severity Scale)
时间窗: 4 months after the stroke
次要结局
未报告次要终点
研究者
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