Physical Activity Clinical Trial
Official title:
Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much?
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients admitted with acute ischemic stroke - age > 18 years 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 - bloodsampling generally not possible - allergy due to accelerometer wear - ulcers or other skin diseases in the area of accelerometer placement |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Hillerød Hospital | Hillerød |
Lead Sponsor | Collaborator |
---|---|
Hillerod Hospital, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | activity counts per day | up to 7 days | No | |
Secondary | Inflammation level | biomarker concentration | up to 7 days | No |
Secondary | Disability | 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) | up to 7 days | No |
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