Back to resultsExercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety (ETHIC)
Primary Purpose
Ventricular Tachycardia
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring ICD, training
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD
Exclusion Criteria:
- Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,
Sites / Locations
- Stavanger Health Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise training
Not training
Arm Description
training
No organized training
Outcomes
Primary Outcome Measures
Therapy delivered from ICD, Anxiety score, functional status
Secondary Outcome Measures
HRV, Endothelial function
Full Information
NCT ID
NCT01038960
First Posted
December 22, 2009
Last Updated
August 24, 2016
Sponsor
Helse Stavanger HF
Collaborators
Stavanger Health Research
1. Study Identification
Unique Protocol Identification Number
NCT01038960
Brief Title
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety
Acronym
ETHIC
Official Title
Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
Stavanger Health Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.
Detailed Description
ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
ICD, training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Description
training
Arm Title
Not training
Arm Type
No Intervention
Arm Description
No organized training
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Other Intervention Name(s)
ICD, exercise training
Intervention Description
3 months supervised interval training
Primary Outcome Measure Information:
Title
Therapy delivered from ICD, Anxiety score, functional status
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HRV, Endothelial function
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD
Exclusion Criteria:
Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alf Inge Larsen, MD, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger Health Research
City
Stavanger
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety
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