Rehabilitation, Quality of Life, and Exercise Tolerance in Patients With an ICD

This study is currently recruiting participants.

Verified by University Hospital Inselspital, Berne, April 2007

First Received: June 28, 2006 Last Updated: April 18, 2007 History of Changes

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00346112

Purpose

RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient rehabilitation therapy and psychological counselling including informative talks with conventional therapy, by a cardiologist or general practitioner after implantation of an internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three different strategies are compared. Study hypothesis: the rehabilitation programme will be beneficial in the management of any psychological problems possibly as a result from the intervention, and will help to overcome anxiety, and contribute to improved quality of life.

Condition	Intervention
Heart Patients After ICD Implantation	Procedure: psycho-educational

MedlinePlus related topics: Anxiety Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-Patients, RELAX-ICD Trial

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Anxiety and Depression

Study Start Date:	June 2006
Estimated Study Completion Date:	June 2009

Detailed Description:

University Hospital Inselspital Berne,Switzerland: Site Nr. 1 - Jean-Paul Schmid, MD, ... recruiting / Virga Jesseziekenhuis,Hasselt, Belgium: Site No. 2

Paul Dendale,MD,.... recruiting / Medical University of Gdansk, Poland, Site No. 3 - Dominika Zielinska,PhD,.... recruiting / Cliniques Universitaires Saint Luc, Brussel, Belgium: Site No. 4 - Christian Brohet,MD Prof.... recruiting / State Hospital for Cardiology, Balantonfüred, Hungary: Site No. 5 - Gabor Veress, MD Prof, ...recruiting

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

First ICD implant within past 12 weeks
Agrees to sign patient/partner informed consent

Exclusion Criteria:

Angina pectoris CCS III & IV
NYHA functional class IV
Inability to follow rehabilitation programme
Exercise limitations due to clinical condition
Symptomatic exercise-induced tachyarrhythmias
Any major non-cardiac condition that would adversely affect survival during study duration
Unable to comply to study procedures
Participates in a concurrent study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346112

Contacts

Contact: Jean-Paul Schmid, MD

0041-31-632 8972 ext 6047

jean-paul.schmid@insel.ch

Locations

Switzerland
University Hospital (Inselspital) Berne	Recruiting
Bern, Switzerland, 3010
Contact: Jean-Paul Schmid, MD 0041-31-632 89 72 jean-paul.schmid@insel.ch
Principal Investigator: Jean-Paul Schmid, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator:

Jean-Paul Schmid

Switzerland - University Hospital (Inselspital) Bern

More Information

No publications provided

Study ID Numbers:	P-KARE-01
Study First Received:	June 28, 2006
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00346112 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

ICD
distress
anxiety
quality-of-life

Study placed in the following topic categories:

Quality of Life

ClinicalTrials.gov processed this record on May 07, 2009