Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke (ASPIS)

• Number of persons having cognitively declined at 24 months [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  Cognitive decline is defined as a significant decline in the composite scores of at least 2 of 5 neuropsychologically tested domains (speed of mental processing, executive functions, working memory, memory, spatial constructive functions). The alpha level for the decision is 0.05.
  
  
• Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  Difference between the measures at baseline and at 24 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
  
  

• Number of persons having cognitively declined 12 months after randomization [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  Cognitive decline is defined as a significant decline in the composite scores of at least 2 of 5 neuropsychologically tested domains (speed of mental processing, executive functions, working memory, memory, spatial constructive functions). The alpha level for the decision is 0.05.
  
  
• Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
  
  
• Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  
• Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  
• Change in cognitive abilities measured by composite scores for each of 5 cognitive domains [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  For each of the five cognitive domains (executive functions, working memory, general memory, speed of cognitive processing, visual spatial ability) standardized composite scores are calculated from the differences between baseline and 12 months in individual neuropsychological test results.
  
  
• Composite outcome for vascular events [ Time Frame: 24 months after randomization ] [ Designated as safety issue: Yes ]
  vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death
  
  
• Neurological status on the National Institute of Health Stroke Scale (NIHSS) score [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  
• Functional status on the modified Rankin Scale [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  
• Activities of daily living on Barthel Index [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  
• Quality of life on the EQ-5D [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  
• Depression on the Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  
• All cause mortality [ Time Frame: 24 months after randomization ] [ Designated as safety issue: Yes ]
  
• Change in cognitive abilities measured by composite scores for each of 5 cognitive domains [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  For each of the five cognitive domains (executive functions, working memory, general memory, speed of cognitive processing, visual spatial ability) standardized composite scores are calculated from the differences between baseline and 24 months in individual neuropsychological test results.
  
  
• Neurological status on the National Institute of Health Stroke Scale (NIHSS)score [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  
• Functional status on the modified Rankin Scale [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  
• Activities of daily living on Barthel Index [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  
• Quality of life on the EQ-5D [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  
• Depression on the Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  

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.