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NCT01038960 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

— ETHIC  

Official title:
Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01038960
Other study ID # ETHIC-SUS-AIL-09
Secondary ID 068.08
Status Completed
Phase Phase 3
First received December 22, 2009
Last updated August 24, 2016
Start date April 2008
Est. completion date December 2012

Study information
Verified date August 2016
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data ServicesNorway: Ethics CommitteeNorway: Ministry of Health and Care Services
Study type Interventional

Clinical Trial Summary

Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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,

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise training
3 months supervised interval training

Locations
Country Name City State
Norway Stavanger Health Research Stavanger

Sponsors (2)
Lead Sponsor Collaborator
Helse Stavanger HF Stavanger Health Research

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Therapy delivered from ICD, Anxiety score, functional status 3 months No
Secondary HRV, Endothelial function 3 months No
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