Rigshospitalet, The Heart Center, University of Copenhagen, Copenhagen, Denmark.
BMC Cardiovasc Disord. 2011 Jun 17;11:33. doi: 10.1186/1471-2261-11-33.
Growing evidence exists that living with an ICD can lead to fear and avoidance behaviour including the avoidance of physical activity. It has been suggested that psychological stress can increase the risk of shock and predict death. Small studies have indicated a beneficial effect arising from exercise training and psychological intervention, therefore a large-scale rehabilitation programme was set up.
METHODS/DESIGN: A mixed methods embedded experimental design was chosen to include both quantitative and qualitative measures. A randomised clinical trial is its primary component. 196 patients (power-calculated) were block randomised to either a control group or intervention group at a single centre. The intervention consists of a 1-year psycho-educational component provided by two nurses and a 12-week exercise training component provided by two physiotherapists. Our hypothesis is that the COPE-ICD programme will reduce avoidance behaviour, sexual dysfunction and increase quality of life, increase physical capability, reduce the number of treatment-demanding arrhythmias, reduce mortality and acute re-hospitalisation, reduce sickness leading to absence from work and be cost-effective. A blinded investigator will perform all physical tests and data collection.
Most participants are men (79%) with a mean age of 58 (range 20-85). Most ICD implantations are on primary prophylactic indication (66%). 44% is NYHA II. Mean walk capacity (6MWT) is 417 m. Mean perception of General Health (SF-36) is PCS 42.6 and MCS 47.1.A large-scale ICD rehabilitation trial including psycho-educational intervention and exercise training has been initiated and will report findings starting in 2011.
ClinicalTrials.gov: NCT00569478.
越来越多的证据表明，植入 ICD 后可能会导致恐惧和回避行为，包括避免身体活动。有研究表明，心理压力会增加电击风险，并预测死亡。一些小型研究表明，运动训练和心理干预会产生有益效果，因此开展了一项大型康复计划。
方法/设计：选择混合方法嵌入式实验设计，包括定量和定性测量。主要部分是一项随机临床试验。在一个中心，将 196 名患者（根据计算得出的样本量）按块随机分为对照组或干预组。干预措施包括由两名护士提供为期一年的心理教育部分和由两名物理治疗师提供为期 12 周的运动训练部分。我们的假设是，COPE-ICD 计划将减少回避行为、性功能障碍并提高生活质量，提高身体能力，减少需要治疗的心律失常次数，降低死亡率和急性再入院率，减少因病缺勤和降低成本效益。一名盲法调查员将进行所有的体能测试和数据收集。
大多数参与者为男性（79%），平均年龄为 58 岁（范围 20-85 岁）。大多数 ICD 植入是出于初级预防指征（66%）。44%的患者为纽约心脏协会心功能分级（NYHA）Ⅱ级。平均步行能力（6MWT）为 417 米。一般健康感知（SF-36）的平均感知为 PCS 42.6 和 MCS 47.1。一项包括心理教育干预和运动训练的大型 ICD 康复试验已经启动，将从 2011 年开始报告结果。
ClinicalTrials.gov：NCT00569478。
