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CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery (CopenHeartVR)

2015年11月12日 更新者:Selina Kikkenborg Berg、Rigshospitalet, Denmark

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

地位

完全的

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

介入性

注册 (实际的)

147

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Copenhagen、丹麦、2100
        • Rigshospitalet / Copenhagen University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Intervention group
Patients receive integrated rehabilitation
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).
无干预:Control group
Patients receive usual follow-up care without physical exercise

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
Change in physical capacity
大体时间:1,4,12 months
Measured by Vo2peak by ergospirometry testing
1,4,12 months

次要结果测量

结果测量
措施说明
大体时间
Change in self-rated mental health and quality of life
大体时间:0, 1, 4, 6, 12 and 24 months
Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.
0, 1, 4, 6, 12 and 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2012年3月16日

首先提交符合 QC 标准的

2012年3月19日

首次发布 (估计)

2012年3月20日

研究记录更新

最后更新发布 (估计)

2015年11月13日

上次提交的符合 QC 标准的更新

2015年11月12日

最后验证

2015年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • RHCopenHeartVR

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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