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Open Access Highly Accessed Study protocol

COPE-ICD: A randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population

Selina K Berg12*, Jesper H Svendsen134, Ann-Dorthe Zwisler15, Birthe D Pedersen6, Pernille Preisler1, Lone Siersbæk-Hansen1, Mette B Hansen1, Rune H Nielsen1 and Preben U Pedersen2

Author Affiliations

1 Rigshospitalet, The Heart Center, University of Copenhagen, Copenhagen, Denmark

2 University of Aarhus, Institute of Public Health, Aarhus, Denmark

3 University of Copenhagen, Institute of Surgery and Medicine, Copenhagen, Denmark

4 The Danish National Research Foundation Center for Cardiac Arrhythmia (DARC), University of Copenhagen, Copenhagen, Denmark

5 University of Southern Denmark, Institute of Public Health, Denmark

6 University of Southern Denmark, Clinical Institute, Denmark

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BMC Cardiovascular Disorders 2011, 11:33  doi:10.1186/1471-2261-11-33

Published: 17 June 2011

Abstract

Background

Growing evidence exists that living with an ICD can lead to fear and avoidance behaviour including the avoidance of physical activity. It has been suggested that psychological stress can increase the risk of shock and predict death. Small studies have indicated a beneficial effect arising from exercise training and psychological intervention, therefore a large-scale rehabilitation programme was set up.

Methods/Design

A mixed methods embedded experimental design was chosen to include both quantitative and qualitative measures. A randomised clinical trial is its primary component. 196 patients (power-calculated) were block randomised to either a control group or intervention group at a single centre. The intervention consists of a 1-year psycho-educational component provided by two nurses and a 12-week exercise training component provided by two physiotherapists. Our hypothesis is that the COPE-ICD programme will reduce avoidance behaviour, sexual dysfunction and increase quality of life, increase physical capability, reduce the number of treatment-demanding arrhythmias, reduce mortality and acute re-hospitalisation, reduce sickness leading to absence from work and be cost-effective. A blinded investigator will perform all physical tests and data collection.

Discussion

Most participants are men (79%) with a mean age of 58 (range 20-85). Most ICD implantations are on primary prophylactic indication (66%). 44% is NYHA II. Mean walk capacity (6MWT) is 417 m. Mean perception of General Health (SF-36) is PCS 42.6 and MCS 47.1.

A large-scale ICD rehabilitation trial including psycho-educational intervention and exercise training has been initiated and will report findings starting in 2011.

Trial Registration

ClinicalTrials.gov: NCT00569478