CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery (CopenHeartVR)
CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.
The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.
The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.
研究概览
详细说明
Worldwide, the incidence of heart valve disease is increasing. Improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. The gap between hospital discharge and returning to normal life is obvious. Integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. Therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention.
A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. The trial is a parallel arm design.
A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.
Along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation.
210 patients will be included.
Validated questionnaires (e.g. SF-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Copenhagen、丹麦、2100
- Rigshospitalet / Copenhagen University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark
- 18 years or older
- Speak and understand Danish
- Providing written informed consent
Exclusion Criteria:
- Known ischemic heart disease prior to heart valve surgery
- Is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention
- Unable to understand and cooperate to study instructions
- Pregnant and/or breast feeding
- Performing exercise training at high level and several times a week
- No written informed consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intervention group
Patients receive integrated rehabilitation
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Integrated rehabilitation consisting of exercise training (3 times per week (1 hour) for 12 weeks) and psycho-educational care (5 consultations over 6 months by special trained nurses).
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无干预:Control group
Patients receive usual follow-up care without physical exercise
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in physical capacity
大体时间:1,4,12 months
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Measured by Vo2peak by ergospirometry testing
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1,4,12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in self-rated mental health and quality of life
大体时间:0, 1, 4, 6, 12 and 24 months
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Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.
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0, 1, 4, 6, 12 and 24 months
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合作者和调查者
调查人员
- 首席研究员:Kirstine Laerum Sibilitz, MD、Rigshospitalet, Denmark
- 首席研究员:Ann-Dorthe Zwisler, MD, Ph.d.、Rigshospitalet / Copenhagen University Hospital, National Institute of Public Health, University of Southern Denmark
- 首席研究员:Selina Kikkenborg Berg, Ph.d.、Rigshospitalet, Denmark
- 首席研究员:Christian Hassager, MD, DMSc、Rigshospitalet, Denmark
- 首席研究员:Lars Køber, MD, DMSc、Rigshospitalet, Denmark
- 首席研究员:Daniel Steinbrüchel, MD, DMSc、Rigshospitalet, Denmark
出版物和有用的链接
一般刊物
- Sibilitz KL, Berg SK, Rasmussen TB, Risom SS, Thygesen LC, Tang L, Hansen TB, Johansen PP, Gluud C, Lindschou J, Schmid JP, Hassager C, Kober L, Taylor RS, Zwisler AD. Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial. Heart. 2016 Dec 15;102(24):1995-2003. doi: 10.1136/heartjnl-2016-309414. Epub 2016 Aug 4.
- Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Gluud C, Thygesen LC, Lindschou J, Schmid JP, Taylor RS, Zwisler AD. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial. Trials. 2015 Feb 5;16:38. doi: 10.1186/s13063-015-0562-z.
- Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Steinbruchel D, Gluud C, Winkel P, Thygesen LC, Hansen JL, Schmid JP, Conraads V, Brocki BC, Zwisler AD. Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial. Trials. 2013 Apr 22;14:104. doi: 10.1186/1745-6215-14-104.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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