Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Philipps University Marburg Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The 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.
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Dr. Yaroslav Winter
Neurologist and Research Fellow
Philipps University Marburg Medical Center
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of ischemic stroke
- •Age: 20 - 85 years
- •BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm
- •Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12)
- •Patient must be capable of understanding informed consent
- •Written informed consent for participation in the study
Exclusion Criteria
- •Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion)
- •Speech disturbance (aphasia or sever dysarthria)
- •Dimming of consciousness
- •Stroke due to arterial dissection or coagulation disorder
- •Drug-related weight changes during previous 3 months
- •Changes in appetite influencing medication listed in appendix during previous 3 months
- •Bariatric surgery in the past
- •Diabetes mellitus with a history of severe ketoacidosis
- •Pregnancy or nursing
- •Severe co-morbid disorders, e.g.:
Outcomes
Primary Outcomes
The 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
Secondary Outcomes
- Functional outcome(18 months)
- Cognitive deficits(18 months)
- Post stroke depression(18 months)
- Severity of arterial hypertension, diabetes mellitus and hyperlipidemia(18 months)