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 the optimal dose 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 investigate which dose (15 vs. 2 x 30 minutes) of physical activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic stroke, gives patients the best improvement in neurological dysfunction.
- Physical activity 15 minutes/day Behavioral
Intervention Desc: weight-bearing treadmill, pulsereserve increase of 50 % ARM 1: Kind: Experimental Label: Low Dose Training Description: 15 minutes/day on a weight-bearing treadmill
- Physical activity, 2 x 30 minutes/day Behavioral
Intervention Desc: weight-bearing treadmill, pulsereserve increase of 50 % ARM 1: Kind: Experimental Label: High Dose Training Description: 2x 30 minutes/day on a weight-bearing treadmill
- Allocation: Randomized
- Masking: Double Blind (Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||disability||up to 5 days||No|
|Secondary||inflammation level||up to 5 days||No|
|Secondary||activity counts per day||up to 5 days||No|
|Primary||change in disability from baseline||up to 5 days||No|
|Secondary||change in inflammation level from baseline||up to 5 days||No|
|Secondary||changes and level of activity during up to 5 days of hospitalization||up to 5 days||No|
|Secondary||number of complications per patient||up to 30 days||No|