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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Helse Stavanger HF.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stavanger Health Research
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01038960
First received: December 22, 2009
Last updated: August 29, 2012
Last verified: August 2012

December 22, 2009
August 29, 2012
April 2008
December 2012   (final data collection date for primary outcome measure)
Therapy delivered from ICD, Anxiety score, functional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01038960 on ClinicalTrials.gov Archive Site
HRV, Endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventricular Tachycardia
Behavioral: Exercise training
3 months supervised interval training
Other Name: ICD, exercise training
  • Experimental: Exercise training
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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,
Both
18 Years to 80 Years
No
Contact: Alf Inge Larsen, MD, PhD +4751513201 laai@sus.no
Contact: Scott Munk, MD
Norway
 
NCT01038960
ETHIC-SUS-AIL-09, 068.08
Yes
Helse Stavanger HF
Helse Stavanger HF
Stavanger Health Research
Principal Investigator: Alf Inge Larsen, MD, PhD University of Bergen
Helse Stavanger HF
August 2012

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