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植入式心脏复律除颤器患者的幻影电击:一项随机康复试验(COPE-ICD)的结果。

Phantom shocks in patients with implantable cardioverter defibrillator: results from a randomized rehabilitation trial (COPE-ICD).

机构信息

The Heart Centre, Rigshospitalet, University of Copenhagen, Unit 2152, Blegdamsvej 9, Copenhagen 2100, Denmark.

出版信息

Europace. 2013 Oct;15(10):1463-7. doi: 10.1093/europace/eut087. Epub 2013 Apr 18.

Abstract

AIMS

The aim of this trial was to assess a combined rehabilitation intervention including an exercise training component and a psycho-educational component in patients treated with implantable cardioverter defibrillator (ICD). The hypothesis was that the intervention would reduce the occurrence of phantom shocks.

METHODS AND RESULTS

The design was secondary explorative analyses of data from a randomized controlled trial. One hundred and ninety-six patients with first-time ICD implantation (79% male, mean age 58 years) were randomized (1 : 1) to either combined rehabilitation or a control group receiving 'treatment as usual'. A total of 144 participants completed the 12-month follow-up. Intervention consisted of 12 weeks of exercise training and 1 year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes, e.g. phantom shocks. Outcome measures were ancillary questions regarding the experience of phantom shocks, date, time, and place. Twelve patients (9.4%) experienced a phantom shock, 7 in the intervention group and 5 in the control group (NS). Neither age, sex, quality of life nor perceived health at baseline was significantly related to the probability of occurrence of phantom shock.

CONCLUSION

Phantom shocks were experienced by about one in ten ICD patients, with no interventional effect found and no significant difference found regarding receiving an actual shock therapy among phantom shock patients. :

TRIAL REGISTRATION

ClinicalTrials.gov (ID: NCT00569478).

摘要

目的

本试验旨在评估包括运动训练和心理教育成分的综合康复干预措施对植入式心脏复律除颤器(ICD)治疗患者的疗效。假设该干预措施将降低幻影电击的发生。

方法和结果

本设计为一项随机对照试验的二次探索性分析。196 名首次接受 ICD 植入的患者(79%为男性,平均年龄 58 岁)被随机分为综合康复组(1:1)或接受“常规治疗”的对照组。共有 144 名参与者完成了 12 个月的随访。干预措施包括 12 周的运动训练和 1 年的心理教育随访,重点关注与不良结局相关的可改变因素,如幻影电击。结局指标是关于幻影电击体验的辅助问题,包括日期、时间和地点。12 名患者(9.4%)经历了幻影电击,其中 7 名在干预组,5 名在对照组(无统计学差异)。年龄、性别、生活质量或基线时的健康感知均与幻影电击发生的概率无显著相关性。

结论

约十分之一的 ICD 患者经历了幻影电击,干预组和对照组在接受实际电击治疗方面没有发现显著差异。

试验注册

ClinicalTrials.gov(编号:NCT00569478)。

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