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| ID | Type | Description | Link |
|---|---|---|---|
| LS 09-002 | Other Grant/Funding Number | Life Science Krems |
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| Name | Class |
|---|---|
| NÖ Forschungs- und Bildungsges.m.b.H (NFB) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivation and lifestyle intervention | Experimental | Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity. |
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| Control | No Intervention | Standard stroke care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivation and lifestyle intervention | Behavioral | Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of persons having cognitively declined at 24 months | 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. | 24 months after randomization |
| Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months | Difference between the measures at baseline and at 24 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog). | 24 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of persons having cognitively declined 12 months after randomization | 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. | 12 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Brainin, Prof. MD | Danube University Krems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig | Horn | 3580 | Austria | |||
| Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278898 | Derived | Matz K, Tuomilehto J, Teuschl Y, Dachenhausen A, Brainin M. Comparison of oral glucose tolerance test and HbA1c in detection of disorders of glucose metabolism in patients with acute stroke. Cardiovasc Diabetol. 2020 Dec 5;19(1):204. doi: 10.1186/s12933-020-01182-6. | |
| 26374482 | Derived | Matz K, Teuschl Y, Firlinger B, Dachenhausen A, Keindl M, Seyfang L, Tuomilehto J, Brainin M; ASPIS Study Group. Multidomain Lifestyle Interventions for the Prevention of Cognitive Decline After Ischemic Stroke: Randomized Trial. Stroke. 2015 Oct;46(10):2874-80. doi: 10.1161/STROKEAHA.115.009992. Epub 2015 Sep 15. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months | Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog). | 12 months after randomization |
| Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months | 12 months after randomization |
| Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months | 24 months after randomization |
| Change in cognitive abilities measured by composite scores for each of 5 cognitive domains | 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. | 12 months after randomization |
| Composite outcome for vascular events | vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death | 24 months after randomization |
| Neurological status on the National Institute of Health Stroke Scale (NIHSS) score | 12 months after randomization |
| Functional status on the modified Rankin Scale | 12 months after randomization |
| Activities of daily living on Barthel Index | 12 months after randomization |
| Quality of life on the EQ-5D | 12 months after randomization |
| Depression on the Center for Epidemiologic Studies Depression Scale (CESD) | 12 months after randomization |
| All cause mortality | 24 months after randomization |
| Change in cognitive abilities measured by composite scores for each of 5 cognitive domains | 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. | 24 months after randomization |
| Neurological status on the National Institute of Health Stroke Scale (NIHSS)score | 24 months after randomization |
| Functional status on the modified Rankin Scale | 24 months after randomization |
| Activities of daily living on Barthel Index | 24 months after randomization |
| Quality of life on the EQ-5D | 24 months after randomization |
| Depression on the Center for Epidemiologic Studies Depression Scale (CESD) | 24 months after randomization |
| Mauer bei Amstetten |
| 3362 |
| Austria |
| Dept. Neurology, LK St.Pölten | Sankt Pölten | 3100 | Austria |
| Dept of Neurology, Landesklinikum Donauregion Tulln | Tulln | A-3430 | Austria |
| Dept of Neurology, Landesklinikum Wr. Neustadt | Wiener Neustadt | A-2700 | Austria |
| 24206541 | Derived | Brainin M, Matz K, Nemec M, Teuschl Y, Dachenhausen A, Asenbaum-Nan S, Bancher C, Kepplinger B, Oberndorfer S, Pinter M, Schnider P, Tuomilehto J; ASPIS Study Group. Prevention of poststroke cognitive decline: ASPIS--a multicenter, randomized, observer-blind, parallel group clinical trial to evaluate multiple lifestyle interventions--study design and baseline characteristics. Int J Stroke. 2015 Jun;10(4):627-35. doi: 10.1111/ijs.12188. Epub 2013 Nov 10. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |