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临床试验/NCT01560520
NCT01560520已完成不适用

Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much?

Hillerod Hospital, Denmark1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
activity counts per day

研究概览

简要总结

Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.

Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.

Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.

Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.

Clarification of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.

The purpose of the project is to describe the amount and pattern of physical activity in stroke patients in the first week after admission. The investigators hypothesis is that patients are inactive for most of the time during hospitalization, activity being correlated with severity of stroke, but not with age, BMI and sex.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients admitted with acute ischemic stroke
  • age > 18 years

排除标准

  • symptoms attributable to other diseases than ischemic stroke
  • debut of symptoms > 48 h prior to admission
  • consent not given < 24 h of admission
  • pregnancy or lactation
  • isolation
  • bloodsampling generally not possible
  • allergy due to accelerometer wear
  • ulcers or other skin diseases in the area of accelerometer placement

结局指标

主要结局

activity counts per day

时间窗: up to 7 days

次要结局

  • Inflammation level(up to 7 days)
  • Disability(up to 7 days)

研究者

发起方
Hillerod Hospital, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Maria Strømmen

clinical assistant

Hillerod Hospital, Denmark

研究点 (1)

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