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

This study has been terminated.
(insufficient recruitment)
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00346112
First received: June 28, 2006
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial

Resource links provided by NLM:

U.S. FDA Resources

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: December 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

Locations
Switzerland
University Hospital (Inselspital) Berne
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Jean-Paul Schmid Switzerland - University Hospital (Inselspital) Bern
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346112     History of Changes
Other Study ID Numbers: P-KARE-01
Study First Received: June 28, 2006
Last Updated: November 5, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
ICD
distress
anxiety
quality-of-life

ClinicalTrials.gov processed this record on May 21, 2013