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Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction

2010年11月29日 更新者:China Medical University Hospital

Application of Intelligent Wireless and Portable Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction

Although a lot of evidence and guidelines recommend that patients have cardiac rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation program is low, usually less than one third. One of the main hindrances of patients participating cardiac rehabilitation program is insufficient number of medical institutions that can provide rehabilitation services. Patients usually cannot perform exercise program under medical professionals monitoring without having to go far. This spatial and temporal difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk of patients to do exercise is higher than healthy adult.

This project will develop the intelligent portable remote care system for cardiopulmonary exercise to provide an instant ECG monitoring service through the integration of front-end wireless ECG measuring devices, expert system, and back-end tele-care platform. Many patients are inconvenient to go to large hospital regularly for cardiac rehabilitation training. This project will help them to exercise at home after once or twice rehabilitation training in clinic for each month and the medical professional will supervise remotely to see how much exercise they did. For that reason the project can help to break through spatial and temporal difficulty of having cardiac rehabilitation, so that cardiac rehabilitation can be help more patients. Patients have this tele-care system while they are doing exercise at home, the built-in heart rate and cardiac rhythm warning function will remind them to take a break, even to take medical treatment. More importantly, the ECG signal can be almost immediately (real time) uploaded by network to the chest pain unit of hospital. The cardiology expert will be aware of the warning at the first moment. This is an important protection to patients' safety of doing rehabilitation sports at home.

This randomized control trial will recruit 80 patients who had myocardial infarction within 6 weeks, and are not able to attend a hospital based cardiac rehabilitation program regularly. All patient will undergo a three-month home exercise program under the instruction provided by the physiatrists and physiotherapists. Forty of them (the remote-care group) will use the intelligent portable remote care system for cardiopulmonary exercise to monitor their exercise intensity and cardiac rhythm during exercise. The other 40 patients (the control group) undertake the exercise program at home without using the remote care system. The efficacy and safety of exercise program will be compared between the two groups.

研究概览

地位

未知

条件

研究类型

介入性

注册 (预期的)

80

阶段

  • 不适用

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

      • Taichung、台湾、404
        • China Medical 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 至 75年 (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:

  • within 6 weeks after an acute myocardial infarction
  • not able to attend a hospital based cardiac rehabilitation program regularly

Exclusion Criteria:

  • with left ventricular ejection fraction lower than 40%
  • history of cardiac arrest
  • history of cardiogenic shock, heart failure
  • complicated arrhythmia
  • abnormal exercise hemodynamics: blood pressure not increased with exercise
  • any other physical/psychological condition that hinders the patient's walking ability

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:治疗
  • 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:Remote-care
Home exercise monitored by the remote care system
Daily home exercise for 3 months
有源比较器:Control
Home exercise under expert's instruction
Daily home exercise for 3 months

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 from baseline in exercise capacity at 3 months
大体时间:baseline and after a 3-month exercise program
6-minute walk test and maximum oxygen uptake obtained by a graded exercise test
baseline and after a 3-month exercise program

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in quality of life at 3 months.
大体时间:baseline and after a 3-month exercise program
Quality of life questionnaires, including SF-36
baseline and after a 3-month exercise program
Change from baseline in physical activities at 3 months.
大体时间:baseline and after a 3-month exercise program
The International Physical Activity Questionnaire
baseline and after a 3-month exercise program

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:Nai-Hsin Meng, M.D.、China Medical University Hospital

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

2011年1月1日

初级完成 (预期的)

2012年12月1日

研究完成 (预期的)

2013年4月1日

研究注册日期

首次提交

2010年11月26日

首先提交符合 QC 标准的

2010年11月29日

首次发布 (估计)

2010年12月1日

研究记录更新

最后更新发布 (估计)

2010年12月1日

上次提交的符合 QC 标准的更新

2010年11月29日

最后验证

2010年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CMU99-NCTU-12

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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