Berg Selina Kikkenborg, Pedersen Preben U, Zwisler Ann-Dorthe, Winkel Per, Gluud Christian, Pedersen Birthe D, Svendsen Jesper H
The Heart Centre Unit 2151, Rigshospitalet, Copenhagen University Hospital, Denmark
Centre of Clinical Guidelines - Clearinghouse, Faculty of Medicine and Technology, Aalborg University, Denmark.
Eur J Cardiovasc Nurs. 2015 Feb;14(1):34-44. doi: 10.1177/1474515114521920. Epub 2014 Feb 5.
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).
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.
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.
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.
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。
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。
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。