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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346112

Enrollment

Unknown

Registered

2006-06-29

Start date

2006-06-30

Completion date

2009-12-31

Last updated

2010-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Patients After ICD Implantation

Keywords

ICD, distress, anxiety, quality-of-life

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

Interventions

PROCEDUREpsycho-educational

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Anxiety and Depression	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026