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

摘要: Growing evidence exists that living with an ICD can lead to fear and avoidance behaviour including the of physical activity. It has been suggested psychological stress increase risk shock predict death. Small studies have indicated a beneficial effect arising from exercise training intervention, therefore large-scale rehabilitation programme was set up. A mixed methods embedded experimental design chosen include both quantitative qualitative measures. randomised clinical trial is its primary component. 196 patients (power-calculated) were block either control group or intervention at single centre. The consists 1-year psycho-educational component provided by two nurses 12-week physiotherapists. Our hypothesis COPE-ICD will reduce behaviour, sexual dysfunction quality life, capability, number treatment-demanding arrhythmias, mortality acute re-hospitalisation, sickness leading absence work be cost-effective. blinded investigator perform all tests data collection. Most participants are men (79%) mean age 58 (range 20-85). implantations on prophylactic indication (66%). 44% NYHA II. Mean walk capacity (6MWT) 417 m. perception General Health (SF-36) PCS 42.6 MCS 47.1. initiated report findings starting in 2011. ClinicalTrials.gov: NCT00569478