Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke Cognitive Decline Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Motivation and lifestyle intervention

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

Group Type EXPERIMENTAL

Motivation and lifestyle intervention

Intervention Type BEHAVIORAL

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

Control

Standard stroke care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivation and lifestyle intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No