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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014