- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01038960
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety (ETHIC)
August 24, 2016 updated by: Helse Stavanger HF
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stavanger, Norway
- Stavanger Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise training
training
|
3 months supervised interval training
Other Names:
|
No Intervention: Not training
No organized training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Therapy delivered from ICD, Anxiety score, functional status
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HRV, Endothelial function
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alf Inge Larsen, MD, PhD, University of Bergen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
December 23, 2009
First Posted (Estimate)
December 24, 2009
Study Record Updates
Last Update Posted (Estimate)
August 25, 2016
Last Update Submitted That Met QC Criteria
August 24, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETHIC-SUS-AIL-09
- 068.08 (Registry Identifier: Norwegian Social Science Data Services)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventricular Tachycardia
-
University of PretoriaCompletedSupra-ventricular TachycardiaSouth Africa
-
Ottawa Heart Institute Research CorporationNot yet recruitingVentricular Fibrillation | Ventricular Tachycardia | Ventricular Arrhythmias | Recurrent Ventricular Tachycardia
-
Armgo Pharma, Inc.Food and Drug Administration (FDA)RecruitingCatecholaminergic Polymorphic Ventricular Tachycardia Type 1United States, Netherlands
-
University of Turin, ItalyAzienda Unità Sanitaria Locale Reggio Emilia; IRCCS Sacro Cuore Don Calabria... and other collaboratorsRecruitingRefractory Ventricular TachycardiaItaly
-
Thermedical, Inc.Not yet recruitingRefractory Ventricular TachycardiaUnited States, Canada
-
John SappCompleted
-
University of California, Los AngelesCompletedRefractory Ventricular TachycardiaUnited States
-
Hospital General Universitario Gregorio MarañonCompletedMonomorphic Ventricular TachycardiaSpain
-
Abbott Medical DevicesTerminatedMonomorphic Ventricular TachycardiaUnited States, United Kingdom, France, Australia, Italy
-
Abbott Medical DevicesWithdrawn
Clinical Trials on Exercise training
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Hacettepe UniversityCompleted
-
The Swedish School of Sport and Health SciencesSilicon Valley Exercise Analytics (svexa)RecruitingPhysical Performance | Maximal Oxygen ConsumptionSweden