SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
Department of Neurology, Philipps-University Marburg
Marburg, Germany
RECRUITINGThe primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up.
Time frame: 18 months
Functional outcome
Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)
Time frame: 18 months
Cognitive deficits
Cognitive deficits in terms of vascular dementia as measured by the Structural Interview for diagnosis of Alzheimer dementia and multi-infarct dementia (SIDAM), the Vascular Dementia Assessment Scale cognitive subscale (VADAS-Cog), Stroop test and the Trail Makin Test
Time frame: 18 months
Post stroke depression
Post stroke depression as measured by Beck Depression Inventar (BDI II) and health-related quality of life (HrQoL) as measured by the EuroQol (EQ5D, visual analogue scale), Stroke Specific Quality of Life Scale, Stroke Impact Scale.
Time frame: 18 months
Severity of arterial hypertension, diabetes mellitus and hyperlipidemia
Time frame: 18 months
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