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

Danube University Krems

Status and phase

Completed

Phase 4

Conditions

Ischemic Stroke

Cognitive Decline

Dementia

Treatments

Behavioral: Motivation and lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01109836

LS 09-002 (Other Grant/Funding Number)

DUK-2010-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

202 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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