Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction

Not Applicable

• Conditions: Stroke; Obesity
• Interventions: Other: Weight reduction program; Other: Lecture on healthy nutrition

• Registration Number: NCT01721538
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Study First Posted: 2012-11-04
• Last Update Posted: 2012-11-04
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.:

  • AV-Block ≥ 2nd degree
  • Heart insufficiency (NYHA > 2)
  • Pericarditis, pericardial effusion
  • Severe kidney insufficiency (Creatinine > 3 mg/dl; Urea > 150 mg/dl)
  • Hepatic insufficiency (GOT > 3 x ULN; GPT > 3 x ULN)
  • Severe psychiatric disease within the last six months (psychosis, suicide attempts)
  • Chronic alcohol addiction or drug addiction
  • HIV- or hepatitis infection
  • Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program)

• Cognitive impairment with MMSE < 20

• Depression with BDI > 20

• Patients who are unable to give consent to study participation (MMSE < 20, aphasia)

• Recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program

• Simultaneous participation in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapy arm	Weight reduction program	Non-drug therapeutic weight reduction program (15 weeks)
Control arm	Lecture on healthy nutrition	Lecture on healthy nutrition (1 hour)

Primary Outcome Measures

Name	Time	Method
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.	18 months

Secondary Outcome Measures

Name	Time	Method
Functional outcome	18 months	Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)
Cognitive deficits	18 months	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
Post stroke depression	18 months	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.
Severity of arterial hypertension, diabetes mellitus and hyperlipidemia	18 months

Trial Locations

Locations (1)

Department of Neurology, Philipps-University Marburg; 🇩🇪 Marburg, Germany