Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety (ETHIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038960
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : August 25, 2016
Stavanger Health Research
Information provided by (Responsible Party):
Helse Stavanger HF

December 22, 2009
December 24, 2009
August 25, 2016
April 2008
December 2012   (Final data collection date for primary outcome measure)
Therapy delivered from ICD, Anxiety score, functional status [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01038960 on Archive Site
HRV, Endothelial function [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety
Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study
Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.
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.
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ventricular Tachycardia
Behavioral: Exercise training
3 months supervised interval training
Other Name: ICD, exercise training
  • Experimental: Exercise training
    Intervention: Behavioral: Exercise training
  • No Intervention: Not training
    No organized training
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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,
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
068.08 ( Registry Identifier: Norwegian Social Science Data Services )
Not Provided
Plan to Share IPD: No
Helse Stavanger HF
Helse Stavanger HF
Stavanger Health Research
Principal Investigator: Alf Inge Larsen, MD, PhD University of Bergen
Helse Stavanger HF
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP