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Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction (SCENARIO)

Primary Purpose

Stroke, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Weight reduction program
Lecture on healthy nutrition
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, prevention, obesity, weight reduction

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Philipps-University MarburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Therapy arm

Control arm

Arm Description

Non-drug therapeutic weight reduction program (15 weeks)

Lecture on healthy nutrition (1 hour)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional outcome
Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)
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
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.
Severity of arterial hypertension, diabetes mellitus and hyperlipidemia

Full Information

First Posted
November 1, 2012
Last Updated
November 2, 2012
Sponsor
Philipps University Marburg Medical Center
Collaborators
Von Behring-Röntgen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01721538
Brief Title
Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction
Acronym
SCENARIO
Official Title
Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Von Behring-Röntgen Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Obesity
Keywords
stroke, prevention, obesity, weight reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapy arm
Arm Type
Experimental
Arm Description
Non-drug therapeutic weight reduction program (15 weeks)
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Lecture on healthy nutrition (1 hour)
Intervention Type
Other
Intervention Name(s)
Weight reduction program
Intervention Type
Other
Intervention Name(s)
Lecture on healthy nutrition
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Functional outcome
Description
Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)
Time Frame
18 months
Title
Cognitive deficits
Description
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
Title
Post stroke depression
Description
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
Title
Severity of arterial hypertension, diabetes mellitus and hyperlipidemia
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaroslav Winter, MD
Phone
00496421-5865200
Email
wintery@med.uni-marburg.de
Facility Information:
Facility Name
Department of Neurology, Philipps-University Marburg
City
Marburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winter Yaroslav, MD
Phone
004964215865200
Email
wintery@med.uni-marburg.de
First Name & Middle Initial & Last Name & Degree
Yaroslav Winter, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18703800
Citation
Winter Y, Rohrmann S, Linseisen J, Lanczik O, Ringleb PA, Hebebrand J, Back T. Contribution of obesity and abdominal fat mass to risk of stroke and transient ischemic attacks. Stroke. 2008 Dec;39(12):3145-51. doi: 10.1161/STROKEAHA.108.523001. Epub 2008 Aug 14.
Results Reference
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Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction

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