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Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease (EPICURE)

2020年7月1日 更新者:AIT Austrian Institute of Technology GmbH

Auswertung Von Multi-modalen unterstützenden Maßnahmen in Der Ambulant Kardiologischen Rehabilitation Bei Patienten Mit Einer kardiovaskulären Erkrankung

Cariovascular diseases (CVD) are the most common cause of death worldwide with high micro- as well as macro-economic burden. Several modifiable risk factors increase the probability of contracting a CVE. These risk factors can be positively influenced by a cardiac rehabilitation measure (CR), which has been shown to reduce mortality in CVD patients and to reduce the economic burden. An increase in physical activity and performance are central goals in CR, as they have a positive effect on several cardiovascular risk factors and correlate strongly with a reduction in mortality in CVD patients. These goals can be achieved in most CVD patients but can only be achieved by a modification of lifestyle.

In order to positively influence this lifestyle modification beyond the duration of the CR measure and thus in the long term, CR Phase II should begin as soon as the patient fulfils one of the well-defined inclusion criteria. CR Phase II can be carried out as an inpatient or outpatient procedure and depends on the patient's state of health, personal preference and availability of an outpatient CR facility in the vicinity of the patient. In the Austrian healthcare system, inpatient CR and thus differs from other European countries. After completion of phase II, the patient is offered an outpatient phase III with weekly visits to the outpatient CR facility, so that lifestyle changes achieved at short notice can be sustainably maintained.

For the secondary prevention of the CVD beyond the CR measure recommend international guidelines a physical activity of ≥ 150 min with moderate intensity or ≥ 60 to 75 min high intensity per week. The current study situation allows the statement that a greater benefit can be expected from more physical activity and that the training should be personalized and highly titrated. Patients in advanced stages of CVD and very inactive patients, defined as <14 mets h/week, achieve the greatest health benefit from increased physical activity. Despite the well-studied benefits, even adherence to the above minimum recommendations for CVD patients after completion of CR is low. This deficit has been addressed in the latest European prevention guideline and recommended that patients i) set clearly defined goals, ii) exercise in the iii) Identify obstacles on the way to achieving the goals so that lifestyle changes are effective and sustainable and the benefits of physical activity can be achieved and maintained.

The planned study will investigate the effect of multi-modal support measures to help patients during the home training phase and their influence on the patients' lifestyle.

研究概览

研究类型

观察性的

注册 (预期的)

150

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。

学习联系方式

研究联系人备份

学习地点

    • Upper Austria
      • Linz、Upper Austria、奥地利、4020
        • 招聘中
        • Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
        • 接触:

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 至 99年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients who undergo the final examination for OUT-III at one of the outpatient rehabilitation facilities participating in the study are checked by the examining physician for the above-mentioned inclusion and exclusion criteria. Patients will be included if they are willing to participate and sign the consent form.

描述

Inclusion Criteria:

  • Age >= 18 years
  • Participation rehabilitation phase III new
  • Documented cardiovascular disease
  • Signed informed-consent

Exclusion Criteria:

-

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

  • 观测模型:其他
  • 时间观点:其他

队列和干预

团体/队列
Patients who used supportive measures during home training
patients who did not use supp. measures during home training

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The change of maximal workload during ergometry pre and post home-training
大体时间:1 year
1 year

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。

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 (实际的)

2019年12月10日

初级完成 (预期的)

2020年9月9日

研究完成 (预期的)

2020年9月9日

研究注册日期

首次提交

2020年7月1日

首先提交符合 QC 标准的

2020年7月1日

首次发布 (实际的)

2020年7月7日

研究记录更新

最后更新发布 (实际的)

2020年7月7日

上次提交的符合 QC 标准的更新

2020年7月1日

最后验证

2020年7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

  • EPICURE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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