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综合心脏康复改善植入式心脏复律除颤器患者的预后。COPE-ICD随机临床试验的结果。

Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator. Findings from the COPE-ICD randomised clinical trial.

作者信息

Berg Selina Kikkenborg, Pedersen Preben U, Zwisler Ann-Dorthe, Winkel Per, Gluud Christian, Pedersen Birthe D, Svendsen Jesper H

机构信息

The Heart Centre Unit 2151, Rigshospitalet, Copenhagen University Hospital, Denmark

Centre of Clinical Guidelines - Clearinghouse, Faculty of Medicine and Technology, Aalborg University, Denmark.

出版信息

Eur J Cardiovasc Nurs. 2015 Feb;14(1):34-44. doi: 10.1177/1474515114521920. Epub 2014 Feb 5.

Abstract

AIMS

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.

CONCLUSION

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.

摘要

目的

这项随机临床试验的目的是评估在接受植入式心脏复律除颤器(ICD)治疗的患者中,包括运动训练和心理教育的综合心脏康复干预与“常规治疗”的效果对比。

方法

在本研究中,196例首次植入ICD的患者(平均年龄57.2岁(标准差(SD)=13.2);79%为男性)被随机(1:1)分为综合心脏康复组和“常规治疗”组。共有144名参与者完成了12个月的随访。干预措施包括为期12周的运动训练和为期1年的心理教育随访,重点关注与不良预后相关的可改变因素。使用了两个主要结局指标,即总体健康评分(简短健康调查问卷36项版(SF-36))和峰值摄氧量(VO₂)。事后分析包括SF-36和ICD治疗史。

结果

综合心脏康复组在运动训练后显著提高了VO₂摄取量,达到23.0(95%置信区间(CI)20.9-22.7)ml/min/kg,而对照组为20.8(95%CI 18.9-22.7)ml/min/kg(p=0.004(多重性p=0.015))。综合心脏康复显著改善了总体健康状况;在3个月时(平均62.8(95%CI 58.1-67.5)对64.4(95%CI:59.6-69.2))分;在6个月时(平均66.7(95%CI 61.5-72.0)对61.9(95%CI 56.1-67.7)分);以及12个月时(平均63.5(95%CI 57.7-69.3)对62.1(95%CI 56.2-68.0))分(p<0.05)。探索性分析显示两组之间存在显著差异,有利于干预组。在ICD治疗史上未见显著差异。

结论

结合运动训练和心理教育干预的综合心脏康复可改善VO₂摄取量和总体健康状况。此外,心理健康状况似乎也有所改善。在ICD电击次数或抗心动过速起搏治疗方面未发现显著差异。

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