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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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

Conditions

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Heart Patients After ICD Implantation

Keywords

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ICD distress anxiety quality-of-life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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psycho-educational

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Paul Schmid

Role: PRINCIPAL_INVESTIGATOR

Switzerland - University Hospital (Inselspital) Bern

Locations

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University Hospital (Inselspital) Berne

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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P-KARE-01

Identifier Type: -

Identifier Source: org_study_id