Physical Activity Immediately After Acute Cerebral Ischemia

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study

Conditions
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Acute Ischemic Stroke, Physical Activity, Accelerometer

Intervention / Treatment
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* Behavioral: physical activity 15 minutes/day
* Behavioral: physical activity, 2 x 30 minutes/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients admitted with acute ischemic stroke age > 18 years first stroke or only minor invalidity from previous strokes (mRS 0-2) truncal stability SSS < 58 Exclusion Criteria: 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 blood sampling generally not possible allergy due to accelerometer wear ulcers or other skin diseases in the area of accelerometer placement unstable cardiologic condition (AMI etc.) acute high and sustained resting systolic blood pressure where treatment is necessary acute heart rhythm disorder where treatment is necessary unable to cooperate significant orthopedic conditions (fractures etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Dose Training<br>15 minutes/day on a weight-bearing treadmill | Behavioral: physical activity 15 minutes/day<br>* weight-bearing treadmill, pulsereserve increase of 50 %<br>|
| Active Comparator: High Dose Training<br>2x 30 minutes/day on a weight-bearing treadmill | Behavioral: physical activity, 2 x 30 minutes/day<br>* weight-bearing treadmill, pulsereserve increase of 50 %<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in disability from baseline | Scandinavian Stroke Scale (SSS) | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in inflammation level from baseline | biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose | up to 5 days | 
| change in disability from baseline | National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS) | up to 5 days | 
| changes and level of activity during up to 5 days of hospitalization | activity counts per day measured by an accelerometer | up to 5 days | 
| number of complications per patient | all complications are counted from inclusion till day 30 in all patients | up to 30 days |