Clinical trial NCT01109836: Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Official title: ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Cognitive Decline
Dementia
Keywords: prevention
cognitive decline
post-stroke dementia
life-style intervention
vascular risk factors
polyintervention
multifactorial treatment
Lead sponsor: Danube University Krems
Sponsor class: OTHER
Collaborators: name: NÖ Forschungs- und Bildungsges.m.b.H (NFB)
First posted: 2010-04-23
Enrollment: 202
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of persons having cognitively declined at 24 months
timeFrame: 24 months after randomization
measure: Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months
timeFrame: 24 months after randomization
Secondary outcomes:
measure: Number of persons having cognitively declined 12 months after randomization
timeFrame: 12 months after randomization
measure: Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months
timeFrame: 12 months after randomization
measure: Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months
timeFrame: 12 months after randomization
measure: Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months
timeFrame: 24 months after randomization
measure: Change in cognitive abilities measured by composite scores for each of 5 cognitive domains
timeFrame: 12 months after randomization
measure: Composite outcome for vascular events
timeFrame: 24 months after randomization
measure: Neurological status on the National Institute of Health Stroke Scale (NIHSS) score
timeFrame: 12 months after randomization
measure: Functional status on the modified Rankin Scale
timeFrame: 12 months after randomization
measure: Activities of daily living on Barthel Index
timeFrame: 12 months after randomization
measure: Quality of life on the EQ-5D
timeFrame: 12 months after randomization
measure: Depression on the Center for Epidemiologic Studies Depression Scale (CESD)
timeFrame: 12 months after randomization
measure: All cause mortality
timeFrame: 24 months after randomization
measure: Change in cognitive abilities measured by composite scores for each of 5 cognitive domains
timeFrame: 24 months after randomization
measure: Neurological status on the National Institute of Health Stroke Scale (NIHSS)score
timeFrame: 24 months after randomization
measure: Functional status on the modified Rankin Scale
timeFrame: 24 months after randomization
measure: Activities of daily living on Barthel Index
timeFrame: 24 months after randomization
measure: Quality of life on the EQ-5D
timeFrame: 24 months after randomization
measure: Depression on the Center for Epidemiologic Studies Depression Scale (CESD)
timeFrame: 24 months after randomization
Other outcomes:
Locations:
city: Horn
country: Austria
facility: Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig
city: Mauer bei Amstetten
country: Austria
facility: Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer
city: St. Pölten
country: Austria
facility: Dept. Neurology, LK St.Pölten
city: Tulln
country: Austria
facility: Dept of Neurology, Landesklinikum Donauregion Tulln
city: Wr. Neustadt
country: Austria
facility: Dept of Neurology, Landesklinikum Wr. Neustadt
Study officials:
affiliation: Danube University Krems
name: Michael Brainin, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.