COPE-ICD: a randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population.
COPE-ICD: a randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population.
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DOI：
10.1186/1471-2261-11-33
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发表时间：
2011-06-17
影响因子：
2.1
通讯作者：
Pedersen PU
中科院分区：
文献类型：
--
作者：
Berg SK;Svendsen JH;Zwisler AD;Pedersen BD;Preisler P;Siersbæk-Hansen L;Hansen MB;Nielsen RH;Pedersen PU
越来越多的证据表明，与ICD一起生活可能导致恐惧和回避行为，包括避免身体活动。有人认为，心理压力可以增加休克的风险，并预测死亡。小型研究表明，运动训练和心理干预产生了有益的效果，因此建立了一个大规模的康复计划。选择了混合方法嵌入实验设计，包括定量和定性测量。随机临床试验是其主要组成部分。196例患者（把握度计算）在单中心被区组随机分配至对照组或干预组。干预措施包括由两名护士提供的为期1年的心理教育部分和由两名物理治疗师提供的为期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，性功能障碍和提高生活质量，提高体能，减少需要治疗的心律失常的数量，降低死亡率和急性再住院率，减少导致缺勤的疾病，并具有成本效益。设盲研究者将进行所有体格检查和数据收集。大多数参与者是男性（79%），平均年龄为58岁（范围20-85）。大多数ICD植入是针对主要预防性适应症（66%）。44%为NYHA II级。平均步行能力（6 MWT）为417米。一般健康状况（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在内的大规模ICD康复试验已经启动，并将于2011年开始报告结果。ClinicalTrials.gov：NCT00569478
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. 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
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影响因子：
1.6
作者：
FERRANS, CE;POWERS, MJ
通讯作者：
POWERS, MJ
影响因子：
37.8
作者：
GIBBONS, L;BLAIR, SN;COOPER, K
通讯作者：
COOPER, K
影响因子：
2
作者：
Kuhl, Emily A.;Sears, Samuel F.;Conti, Jamie B.
通讯作者：
Conti, Jamie B.
影响因子：
3.5
作者：
Kao, Chi-Wen;Friedmann, Erika;Thomas, Sue A.
通讯作者：
Thomas, Sue A.
DOI：
10.1097/hcr.0b013e31819276f7
发表时间：
2009-01-01
影响因子：
3.8
作者：
Fan, Sarah;Lyon, Caroline E.;Balady, Gary J.
通讯作者：
Balady, Gary J.