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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038960
First Posted: December 24, 2009
Last Update Posted: August 25, 2016
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.
Collaborator:
Stavanger Health Research
Information provided by (Responsible Party):
Helse Stavanger HF
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Therapy delivered from ICD, Anxiety score, functional status [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • HRV, Endothelial function [ Time Frame: 3 months ]

Enrollment: 40
Study Start Date: April 2008
Study Completion Date: December 2012
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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038960


Locations
Norway
Stavanger Health Research
Stavanger, Norway
Sponsors and Collaborators
Helse Stavanger HF
Stavanger Health Research
Investigators
Principal Investigator: Alf Inge Larsen, MD, PhD University of Bergen
  More Information

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01038960     History of Changes
Other Study ID Numbers: ETHIC-SUS-AIL-09
068.08 ( Registry Identifier: Norwegian Social Science Data Services )
First Submitted: December 22, 2009
First Posted: December 24, 2009
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Helse Stavanger HF:
ICD, training

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