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

Heart Patients After ICD Implantation Clinical Trial

Official title:

Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00346112
• Other study ID #: P-KARE-01
• Status: Terminated
• Phase: N/A
• First received: June 28, 2006
• Last updated: November 5, 2010
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2009
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Patients After ICD Implantation

Intervention

Procedure:
• psycho-educational

Locations

Country	Name	City	State
Switzerland	University Hospital (Inselspital) Berne	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and Depression