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临床试验/NCT04022590
NCT04022590招募中不适用

Tri-service General Hospital

Shang-Lin Chiang2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Aerobic capacity (VO2 max in ml/kg/min )

研究概览

简要总结

Investigators assume that the wearable clothes can be applied to home-based health care and integrated into a case management model through telehealthcare. While prior to complete the case management, the feasibility should be tested and evaluate its reliability and validity of the physical information collected from the clothes. Therefore, investigators try to conduct a feasibility study to evaluate the reliability and validity of the exercise heart rate sensing e-clothes and after that, investigators will incorporate this wearable clothes to home-based exercise training as one of the major components in our case management model.

详细描述

Easy-to-use and service touch points allow patients/ users to realize the value and status of their physiological functions/ parameters based on their evidence is important. According to the U.S. survey, 90% of people can change their lifestyle behaviors, improve their personal health awareness, achieve holistic health care and improve their quality of life due to "Quantify Self". Therefore, a broader health care system, health consumption services or ecological system has been building to integrate health care resources, extend health care services from hospital to communities and individual' homes. When people consume in their daily life, immediate public health guidance or professional intervention can be offered at the same time, not only can effectively maintain individuals' health, early detection of possible physiological signs/ parameters, can also delay the progression of the disease and reduce the burden of first-line health care workers. Therefore, it is the era of smart healthcare that provides a health service platform with APPs(Applications) to provide personalized integrated medical services. However, in order to monitor or evaluate the effect of treatment (i.e., exercise training) still needs to be provided through the actual feedback of individual physiological data.

Clothes with smart function which is able to connect with social media and APPs has been promoting and marketing as smart sports or lifestyle-monitor goods, such as exercise-related physical parameters and sleep quality quantifying. Sleep physiology information collected through the clothes including degree and quality of sleep can be recorded and transmitted to the remote health system via APP and cloud service platform. On this cloud platform, health information can exchange with clinician's physicians, offering advises for users to whether to go to the hospital for further examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • more than two chronic disease.(multiple morbidity)
  • able to speak and understand Mandarin
  • able to walk without assistance
  • able to use smart phones and understand how to use the e-clothes and related app
  • agreed to be randomized to one of the two groups

排除标准

  • a history of cancer
  • confirmed psychiatric disease
  • inability to participate due to comorbid neurological and musculoskeletal conditions
  • a history of arrhythmia

结局指标

主要结局

Aerobic capacity (VO2 max in ml/kg/min )

时间窗: 30 minutes

Maximal VO2 during testing, also means aerobic capacity

Working load in watt

时间窗: 30 minutes

Maximal Working load during testing

O2 pulse in ml/beat,

时间窗: 30 minutes

It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.

Rest/Max Heart rate in beat/min

时间窗: 30 minutes

resting and maximal heart rate during exercise testing,

systolic and diastolic blood pressure in mm Hg,

时间窗: 30 minutes

The resting and maximal blood pressure during exercise testing

次要结局

  • Physical activity (scores)(10 minutes)

研究者

发起方
Shang-Lin Chiang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shang-Lin Chiang

Attending physician

National Defense Medical Center, Taiwan

研究点 (2)

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