Aim of this randomized controlled study is to test if intensive polyintervention therapy including life style modifications targeting at reduction of modifiable risk factors of stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients receiving standard care.
Stroke is the second most frequent cause of death and cognitive deficits including dementia occur frequently following a stroke. The frequency of cognitive disturbances has been reported up to 30% and thus occurs three times more frequent than recurrent stroke (10%). Major attempts have been made to prevent the occurrence of new strokes by means of effective strategies including preventive drugs. In contrast, hardly any studies have been performed addressing the prevention of deteriorating cognitive function following a stroke. In spite of this high prevalence therapeutic possibilities are extremely limited. It must be expected that cognitive deficits become even a more frequent disability following stroke. This is caused by the increased aging of the population leading to further increase of incidence, furthermore that more people survive their acute stroke due to increased possibilities of acute treatment, and that frequent risk factors (e.g. hypertension, diabetes) are increasingly controlled, thus leading to less severe strokes with less severe and permanent motor deficits, but an increase of potentially disabling cognitive disturbances. The aim of this randomized controlled study is to test an intensive multiple intervention therapy for the first time in stroke and to add life style modifications targeting modifiable risk factors for cognitive deterioration.
It is hypothesized that the risk of post-stroke cognitive decline can be significantly reduced compared to a control group with standard care when using polyintervention. These interventions will focus on nutrition, exercise, cognitive and social activity and monitoring and management of metabolic and vascular risk factors. Regular contacts with the subjects shall increase motivation and adherence to the study protocol.
- Motivation and lifestyle intervention Behavioral
Intervention Desc: Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity. ARM 1: Kind: Experimental Label: Motivation and lifestyle intervention Description: Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Number of persons having cognitively declined at 24 months||24 months after randomization||No|
|Primary||Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months||24 months after randomization||No|
|Secondary||Number of persons having cognitively declined 12 months after randomization||12 months after randomization||No|
|Secondary||Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months||12 months after randomization||No|
|Secondary||Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months||12 months after randomization||No|
|Secondary||Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months||24 months after randomization||No|
|Secondary||Change in cognitive abilities measured by composite scores for each of 5 cognitive domains||12 months after randomization||No|
|Secondary||Composite outcome for vascular events||24 months after randomization||Yes|
|Secondary||Neurological status on the National Institute of Health Stroke Scale (NIHSS) score||12 months after randomization||No|
|Secondary||Functional status on the modified Rankin Scale||12 months after randomization||No|
|Secondary||Activities of daily living on Barthel Index||12 months after randomization||No|
|Secondary||Quality of life on the EQ-5D||12 months after randomization||No|
|Secondary||Depression on the Center for Epidemiologic Studies Depression Scale (CESD)||12 months after randomization||No|
|Secondary||All cause mortality||24 months after randomization||Yes|
|Secondary||Neurological status on the National Institute of Health Stroke Scale (NIHSS)score||24 months after randomization||No|