title: Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator. Findings from the COPE-ICD randomised clinical trial.
abstract: OBJECTIVE
  The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs 'treatment as usual' in patients treated with an implantable cardioverter defibrillator (ICD).
  
  
  METHODS
  In this study 196 patients with first time ICD implantation (mean age 57.2 (standard deviation (SD)=13.2); 79% men) were randomised (1:1) to comprehensive cardiac rehabilitation vs 'treatment as usual'. Altogether 144 participants completed the 12 month follow-up. The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes. Two primary outcomes, general health score (Short Form-36 (SF-36)) and peak oxygen uptake (VO₂), were used. Post-hoc analyses included SF-36 and ICD therapy history.
  
  
  RESULTS
  Comprehensive cardiac rehabilitation significantly increased VO2 uptake after exercise training to 23.0 (95% confidence interval (CI) 20.9-22.7) vs 20.8 (95% CI 18.9-22.7) ml/min/kg in the control group (p=0.004 (multiplicity p=0.015)). Comprehensive cardiac rehabilitation significantly increased general health; at three months (mean 62.8 (95% CI 58.1-67.5) vs 64.4 (95% CI: 59.6-69.2)) points; at six months (mean 66.7 (95% CI 61.5-72.0) vs 61.9 (95% CI 56.1-67.7) points); and 12 months (mean 63.5 (95% CI 57.7-69.3) vs 62.1 (95% CI 56.2-68.0)) points (p <0.05). Explorative analyses showed a significant difference between groups in favour of the intervention group. No significant difference was seen in ICD therapy history.
  
  
  CONCLUSIONS
  Comprehensive cardiac rehabilitation combining exercise training and a psycho-educational intervention improves VO₂-uptake and general health. Furthermore, mental health seems improved. No significant difference was found in the number of ICD shocks or anti-tachycardia pacing therapy.
authors: The Heart Centre Unit 2151, Rigshospitalet, Copenhagen University Hospital, Denmark selina@rh.dk.
authors: Selina Kikkenborg
authors: SK
authors: Berg
authors: Centre of Clinical Guidelines - Clearinghouse, Faculty of Medicine and Technology, Aalborg University, Denmark.
authors: Preben U
authors: PU
authors: Pedersen
authors: The Heart Centre Unit 2151, Rigshospitalet, Copenhagen University Hospital, Denmark.
authors: Ann-Dorthe
authors: AD
authors: Zwisler
authors: Centre for Clinical Intervention Research Unit 3344, Copenhagen University Hospital, Denmark.
authors: Per
authors: P
authors: Winkel
authors: Centre for Clinical Intervention Research Unit 3344, Copenhagen University Hospital, Denmark.
authors: Christian
authors: C
authors: Gluud
authors: Clinical Institute, University of Southern Denmark, Denmark.
authors: Birthe D
authors: BD
authors: Pedersen
authors: Danish National Research Foundation Centre for Cardiac Arrhythmia (DARC), University of Copenhagen, Denmark.
authors: Jesper H
authors: JH
authors: Svendsen
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000523:psychology / Q000534:rehabilitation* / Q000628:therapy*; D001521:Behavior Therapy / Q000379:methods*; D017147:Defibrillators, Implantable; D003718:Denmark; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011446:Prospective Studies; D011788:Quality of Life; D012046:Rehabilitation / Q000379:methods; D018570:Risk Assessment; D016896:Treatment Outcome
keywords: Arrhythmia; comprehensive cardiac rehabilitation; exercise training; implantable cardioverter defibrillators; psychoeducational intervention