Physical Activity Immediately After Acute Cerebral Ischemia
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|ClinicalTrials.gov Identifier: NCT01560520|
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : October 18, 2012
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.
|Condition or disease||Intervention/treatment|
|Ischemic Stroke Physical Activity||Behavioral: Physical activity|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much?|
|Study Start Date :||November 2011|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
Behavioral: Physical activity
Other Name: actical, Actical
- activity counts per day [ Time Frame: up to 7 days ]
- Inflammation level [ Time Frame: up to 7 days ]biomarker concentration
- Disability [ Time Frame: up to 7 days ]Scandinavian Stroke Scale score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale score (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560520
|Hillerød, Denmark, 3400|
|Principal Investigator:||Anna Maria Strømmen, MD||Neurologic Department|