Ischemic StrokePhase 4ASPISNCT01109836
Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
A Phase 4 study testing Motivation and lifestyle intervention in people with Ischemic Stroke and Cognitive Decline, run by Danube University Krems at 5 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke, Cognitive Decline, Dementia
- What is being tested?
- Motivation and lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 5 sitesAustria
- Study dates
- Jun 2010to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Austria5 sites
Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig
Horn, 3580
Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer
Mauer bei Amstetten, 3362
Dept. Neurology, LK St.Pölten
Sankt Pölten, 3100
Dept of Neurology, Landesklinikum Donauregion Tulln
Tulln, A-3430
Dept of Neurology, Landesklinikum Wr. Neustadt
Wiener Neustadt, A-2700
About this study
Official title: ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
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.
Read the 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.
- Conditions
- Ischemic Stroke, Cognitive Decline, Dementia
- Being tested
- Motivation and lifestyle intervention
- Keywords
- prevention, cognitive decline, post-stroke dementia, life-style intervention, vascular risk factors, polyintervention, multifactorial treatment
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation and lifestyle interventionBehavioural
Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Motivation and lifestyle intervention | Experimental | Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity. Receives: Behavioral: Motivation and lifestyle intervention |
| Control | No intervention | Standard stroke care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 24 months after randomization
Secondary outcomes (18)
Number of persons having cognitively declined 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.
Measured: 12 months after randomization
Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months
Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
Measured: 12 months after randomization
Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months
Measured: 12 months after randomization
Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months
Measured: 24 months after randomization
Change in cognitive abilities measured by composite scores for each of 5 cognitive domains
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.
Measured: 12 months after randomization
Composite outcome for vascular events
vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death
Measured: 24 months after randomization
Neurological status on the National Institute of Health Stroke Scale (NIHSS) score
Measured: 12 months after randomization
Functional status on the modified Rankin Scale
Measured: 12 months after randomization
Activities of daily living on Barthel Index
Measured: 12 months after randomization
Quality of life on the EQ-5D
Measured: 12 months after randomization
Depression on the Center for Epidemiologic Studies Depression Scale (CESD)
Measured: 12 months after randomization
All cause mortality
Measured: 24 months after randomization
Change in cognitive abilities measured by composite scores for each of 5 cognitive domains
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.
Measured: 24 months after randomization
Neurological status on the National Institute of Health Stroke Scale (NIHSS)score
Measured: 24 months after randomization
Functional status on the modified Rankin Scale
Measured: 24 months after randomization
Activities of daily living on Barthel Index
Measured: 24 months after randomization
Quality of life on the EQ-5D
Measured: 24 months after randomization
Depression on the Center for Epidemiologic Studies Depression Scale (CESD)
Measured: 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danube University Krems
- Sponsor type
- University, hospital or other
- Collaborators
- NÖ Forschungs- und Bildungsges.m.b.H (NFB)
- Investigators
- Michael Brainin, Prof. MD, Principal investigator, Danube University Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109836
- Sponsor's protocol ID
- DUK-2010-001
- Other IDs
- LS 09-002
- Acronym
- ASPIS
- Status last verified
- Jun 2010
- First submitted
- 15 Apr 2010
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33278898Matz 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.
PubMed 26374482Brainin 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.
PubMed 24206541
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01109836
- Acronym / sponsor ID
- ASPIS / DUK-2010-001
- Conditions
- Ischemic Stroke, Cognitive Decline, Dementia
- Keywords
- prevention, cognitive decline, post-stroke dementia, life-style intervention, vascular risk factors, polyintervention, multifactorial treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Danube University KremsUniversity, hospital or other
- Collaborators
- NÖ Forschungs- und Bildungsges.m.b.H (NFB)
- Study start
- Jun 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivation and lifestyle intervention | Experimental | Behavioral: Motivation and lifestyle interventionIntensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity. |
| Control | No intervention | –Standard stroke care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivation and lifestyle interventionIntensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity. | Behavioural | Motivation and lifestyle intervention |
Primary outcome
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).
18 secondary outcomes
Number of persons having cognitively declined 12 months after randomization
Time frame: 12 months after randomization
Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months
Time frame: 12 months after randomization
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
Composite outcome for vascular events
Time frame: 24 months after randomization
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Derived from this study: PubMed 33278898Matz 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.
- Derived from this study: PubMed 26374482Matz 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.
- Derived from this study: PubMed 24206541Brainin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Brainin, Prof. MD principal investigator
Danube University Krems
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivation and lifestyle intervention in people with Ischemic Stroke and Cognitive Decline, run by Danube University Krems at 5 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of persons having cognitively declined at 24 months (time frame: 24 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109836, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.