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

This study is currently recruiting participants.
Verified August 2012 by Helse Stavanger HF
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
History of Changes
  Purpose

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


Condition Intervention Phase
Ventricular Tachycardia
 Behavioral: Exercise training
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Therapy delivered from ICD, Anxiety score, functional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HRV, Endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
training
 Behavioral: Exercise training
3 months supervised interval training
Other Name: ICD, exercise training
No Intervention: Not training
No organized training

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038960

Contacts
Contact: Alf Inge Larsen, MD, PhD +4751513201 laai@sus.no
Contact: Scott Munk, MD

Locations
Norway
Stavanger Health Research Recruiting
Stavanger, Norway
Contact: Torbjørn Aarsland, RN         torbjorn.aarsland@stahf.no    
Sub-Investigator: Kjetil Isaksen, MD            
Sponsors and Collaborators
Helse Stavanger HF
Stavanger Health Research
Investigators
Principal Investigator: Alf Inge Larsen, MD, PhD University of Bergen
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01038960     History of Changes
Other Study ID Numbers: ETHIC-SUS-AIL-09, 068.08
Study First Received: December 22, 2009
Last Updated: August 29, 2012
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Ethics Committee
Norway: Ministry of Health and Care Services

Keywords provided by Helse Stavanger HF:
ICD, training

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013