Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke

Danube University Krems202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

202

Conditions

Ischemic Stroke Cognitive Decline Dementia

Interventions

Motivation and lifestyle interventionBEHAVIORAL

Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic ischemic stroke with clinical syndrome of stroke and a corresponding ischemic lesion. * MRI or CT results compatible with clinical diagnosis of acute ischemic stroke * NIH Stroke Scale Score on admission 1 to 14, both inclusive * Modified Rankin Scale before stroke 0 to 2, inclusive * Randomization within 3 months after stroke onset (goal: 80% within 3 weeks) * Sufficient communication possible * Informed consent given by the patient and/or the patient's legally acceptable representative Exclusion Criteria: * Substantial cognitive decline (Mini Mental State Examination (MMSE) score \> 24) or pre-existing dementia or Parkinson disease * Persistent disturbed level of consciousness * Persistent aphasia * Pre-existing significant psychiatric diseases (i.e. Schizophrenia, Major Depression, Bipolar Disorders, all according to DSMIV); Patients with minor Depression (DSM IV) can be included * Severe sensory impairment making neuropsychological testing impossible * Severe comorbidity (e.g. unstable or severe cardiovascular or pulmonal disease, neoplasm, severe liver or renal insufficiency and symptomatic stenosis of the ipsilateral carotid artery, cancer…) * Unreliability for follow up * Unwillingness or inability to participate or to sign the informed consent

Locations (5)

Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig

Horn, Austria

Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer

Mauer bei Amstetten, Austria

Dept. Neurology, LK St.Pölten

Sankt Pölten, Austria

Dept of Neurology, Landesklinikum Donauregion Tulln

Tulln, Austria

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 24 months after randomization

Secondary Outcomes

Number of persons having cognitively declined 12 months after randomization

Time frame: 12 months after randomization

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).

Time frame: 12 months after randomization

Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months

Time frame: 12 months after randomization

Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months

Time frame: 24 months after randomization

Data from ClinicalTrials.gov

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