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

Not Applicable

Terminated

• Conditions: Heart Patients After ICD Implantation

• Registration Number: NCT00346112
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-28
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-29
• Study Completion: 2009-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety and Depression

Trial Locations

Locations (1)

University Hospital (Inselspital) Berne; 🇨🇭 Bern, Switzerland