Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.
Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.
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DOI：
10.1186/1745-6215-14-104
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发表时间：
2013-04-22
期刊：
影响因子：
2.5
通讯作者：
Zwisler AD
中科院分区：
文献类型：
--
作者：
Sibilitz KL;Berg SK;Hansen TB;Risom SS;Rasmussen TB;Hassager C;Køber L;Steinbrüchel D;Gluud C;Winkel P;Thygesen LC;Hansen JL;Schmid JP;Conraads V;Brocki BC;Zwisler AD
心脏瓣膜疾病很常见，在西方世界的患病率估计为2.5%。由于人口老龄化，这一数字正在上升。一旦出现症状，心脏瓣膜疾病可能是致命的，并严重影响日常生活和生活质量。手术治疗，无论是瓣膜置换术还是修复，仍然是治疗的选择。然而，手术后，向日常生活的过渡可能会成为身体、精神和社会的挑战。我们假设全面的心脏康复计划可以改善身体能力和自我评估的心理健康，并减少心脏瓣膜手术后的住院和医疗费用。一项随机临床试验，CopenHeartVR，旨在调查心脏瓣膜手术后心脏康复加常规护理是否优于常规治疗。试验将随机分配210例患者，1:1干预对照组，采用中心随机化，盲法结局评估和统计分析。干预包括12周的体育锻炼和包括5次咨询的心理教育干预。主要结果是通过心肺运动试验和通气气体分析测量的峰值摄氧量（VO2峰值）。次要结果是通过标准化问卷短表36测量自我评估的心理健康。此外，还将评估长期医疗保健利用和死亡率以及生物化学、超声心动图和成本效益。混合方法设计用于评估定性和定量结果，包括试验前基于调查的研究和干预前和干预后的定性研究。该研究得到了当地区域研究伦理委员会（H-1-2011-157）和丹麦数据保护局（j.nr.）的批准。2007-58-0015)。ClinicalTrials.gov (http://NCT01558765)。
Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov (http://NCT01558765).
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DOI：
10.1249/00005768-198205000-00012
发表时间：
1982-01-01
期刊：
MEDICINE AND SCIENCE IN SPORTS AND EXERCISE
影响因子：
--
作者：
BORG, GAV
通讯作者：
BORG, GAV
影响因子：
3.3
作者：
Brooks, R
通讯作者：
Brooks, R
影响因子：
120.7
作者：
Alehagen, Urban;Dahlstroem, Ulf;Goetze, Jens P.
通讯作者：
Goetze, Jens P.
影响因子：
2.1
作者：
Berg SK;Svendsen JH;Zwisler AD;Pedersen BD;Preisler P;Siersbæk-Hansen L;Hansen MB;Nielsen RH;Pedersen PU
通讯作者：
Pedersen PU
具有分层排序多个目标的临床试验中的树形结构把关测试
影响因子：
2
作者：
Dmitrienko, Alex;Wiens, Brian L.;Wang, Xin
通讯作者：
Wang, Xin