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

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ClinicalTrials.gov Identifier: NCT00346112
Recruitment Status : Terminated (insufficient recruitment)
First Posted : June 29, 2006
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Patients After ICD Implantation Procedure: psycho-educational Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial
Study Start Date : June 2006
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Anxiety and Depression


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

ClinicalTrials.gov Identifier: NCT00346112     History of Changes
Other Study ID Numbers: P-KARE-01
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

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