NCT01109836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 13, 2015

Status Verified

June 1, 2010

Enrollment Period

4.4 years

First QC Date

April 15, 2010

Last Update Submit

January 12, 2015

Conditions

Ischemic StrokeCognitive DeclineDementia

Keywords

preventioncognitive declinepost-stroke dementialife-style interventionvascular risk factorspolyinterventionmultifactorial treatment

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    24 months after randomization

Secondary Outcomes (18)

  • Number of persons having cognitively declined 12 months after randomization

    12 months after randomization

  • Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months

    12 months after randomization

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

    12 months after randomization

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

    24 months after randomization

  • Change in cognitive abilities measured by composite scores for each of 5 cognitive domains

    12 months after randomization

  • +13 more secondary outcomes

Study Arms (2)

Motivation and lifestyle intervention

EXPERIMENTAL

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

Behavioral: Motivation and lifestyle intervention

Control

NO INTERVENTION

Standard stroke care

Interventions

Motivation and lifestyle interventionBEHAVIORAL

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

Motivation and lifestyle intervention

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig

Horn, 3580, Austria

Location

Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer

Mauer bei Amstetten, 3362, Austria

Location

Dept. Neurology, LK St.Pölten

Sankt Pölten, 3100, Austria

Location

Dept of Neurology, Landesklinikum Donauregion Tulln

Tulln, A-3430, Austria

Location

Dept of Neurology, Landesklinikum Wr. Neustadt

Wiener Neustadt, A-2700, Austria

Location

Related Publications (3)

  • 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.

    PMID: 33278898DERIVED

  • 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.

    PMID: 26374482DERIVED

  • 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.

    PMID: 24206541DERIVED

MeSH Terms

Conditions

Ischemic StrokeCognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Michael Brainin, Prof. MD

    Danube University Krems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 23, 2010

Study Start

June 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 13, 2015

Record last verified: 2010-06

Locations

AU(5)