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

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ClinicalTrials.gov Identifier: NCT01109836
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : January 13, 2015
Sponsor:
Collaborator:
NÖ Forschungs- und Bildungsges.m.b.H (NFB)
Information provided by:
Danube University Krems

Tracking Information
First Submitted Date  ICMJE April 15, 2010
First Posted Date  ICMJE April 23, 2010
Last Update Posted Date January 13, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Number of persons having cognitively declined at 24 months [ Time Frame: 24 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.
  • Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months [ Time Frame: 24 months after randomization ]
    Difference between the measures at baseline and at 24 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01109836 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Number of persons having cognitively declined 12 months after randomization [ Time Frame: 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.
  • Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months [ Time Frame: 12 months after randomization ]
    Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
  • 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 ]
  • Change in cognitive abilities measured by composite scores for each of 5 cognitive domains [ Time Frame: 12 months after randomization ]
    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.
  • Composite outcome for vascular events [ Time Frame: 24 months after randomization ]
    vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death
  • Neurological status on the National Institute of Health Stroke Scale (NIHSS) score [ Time Frame: 12 months after randomization ]
  • Functional status on the modified Rankin Scale [ Time Frame: 12 months after randomization ]
  • Activities of daily living on Barthel Index [ Time Frame: 12 months after randomization ]
  • Quality of life on the EQ-5D [ Time Frame: 12 months after randomization ]
  • Depression on the Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 12 months after randomization ]
  • All cause mortality [ Time Frame: 24 months after randomization ]
  • Change in cognitive abilities measured by composite scores for each of 5 cognitive domains [ Time Frame: 24 months after randomization ]
    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.
  • Neurological status on the National Institute of Health Stroke Scale (NIHSS)score [ Time Frame: 24 months after randomization ]
  • Functional status on the modified Rankin Scale [ Time Frame: 24 months after randomization ]
  • Activities of daily living on Barthel Index [ Time Frame: 24 months after randomization ]
  • Quality of life on the EQ-5D [ Time Frame: 24 months after randomization ]
  • Depression on the Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 24 months after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Official Title  ICMJE ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
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.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Ischemic Stroke
  • Cognitive Decline
  • Dementia
Intervention  ICMJE Behavioral: Motivation and lifestyle intervention
Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
Study Arms
  • Experimental: Motivation and lifestyle intervention
    Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
    Intervention: Behavioral: Motivation and lifestyle intervention
  • No Intervention: Control
    Standard stroke care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2015)
202
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2010)
200
Actual Study Completion Date November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01109836
Other Study ID Numbers  ICMJE DUK-2010-001
LS 09-002 ( Other Grant/Funding Number: Life Science Krems )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prim. Univ. Prof. Dr. Michael Brainin, Danube University Krems
Study Sponsor  ICMJE Danube University Krems
Collaborators  ICMJE NÖ Forschungs- und Bildungsges.m.b.H (NFB)
Investigators  ICMJE
Principal Investigator: Michael Brainin, Prof. MD Danube University Krems
PRS Account Danube University Krems
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP