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

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Heart Patients After ICD Implantation

Treatments: Procedure: psycho-educational

Study type: Interventional

Funder types: Other

Identifiers

NCT00346112

P-KARE-01

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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