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临床试验/NCT03585985
NCT03585985已完成不适用

Investigation of a Link Between Heart Rate Variability and Frailty in Geriatric Patients Before and After Rehabilitation With Simultaneous Evaluation of a New Camera-based Technology for Measurement of Vital Signs

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Link between heart rate variability and frailty

研究概览

简要总结

The aim of this study is the evaluation of differences in heart rate variability (both time- and frequency-domain) [a]: between frail and non-frail patients and [b] at the beginning and end of a geriatric therapy which included rehabilitation components. Moreover, the suitability of new camera-based technology with regard to measurement of vital signs (heart rate, heart rate variability, respiratory rate) will be evaluated.

详细描述

Frailty is an important geriatric syndrome, which indicates a reduced maximum resilience of patients and their organ system against external stressors. According to Fried's classification, frailty comprises of unintentional weight loss, exhaustion, muscle weakness, slowness while walking and low levels of activity. In geriatric patients, frailty is associated with a higher mortality and morbidity. Moreover, frailty patients are more often dependent on assistance after hospitalisation than non-frailty patients.

During geriatric therapy, geriatric patients are treated with multimodal rehabilitation comprising of activating nursing, physiotherapy, occupational therapy, psychiatric and speech therapy in order to increase mobility and patients' ability to help themselves. Success of rehabilitation measures is measured using the geriatric assessment (e.g. Barthel Index, Timed up and go test, Mini-Mental State Examination, Geriatric Depression Scale, measurement of hand power) at the beginning and end of the therapy. This geriatric therapy including the named geriatric assessment is not study-specific and is not prescribed by a study protocol, but is a routine treatment for frail patients.

Apart from these routinely used tests, recent literature indicated that heart rate variability, which can be easily measured with an ECG, could be an indicator for frailty. Beyond the medical problem whether heart rate variability can be used as a surrogate parameter for frailty, this study also has a technical aspect. In biomedical engineering, non-contact monitoring of vital signs has been an important and promising development in the last decade. Therefore, this study will also investigate if camera-based technologies such as photoplethysmography imaging (PPGI) and infrared thermography (IRT) can be used in a clinical environment for non-contact measurement of vital signs (heart rate, heart rate variability, respiratory rate) in geriatric patients. In this study, monitoring (with conventional and contactless technologies) should not trigger any observable/examining effect, but is merely a means to the end of observing the already existing HRV (and other vital parameters).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Group 1: aged above 70 if they have typical geriatric multimorbidity, otherwise aged above 80, patient on the geriatric ward in the hospital "Franziskhospital Aachen"
  • Group 2 (Healthy volunteers): aged above 70, healthy and in good physical condition
  • Written informed consent by patient / volunteer

排除标准

  • Inability to consent
  • Pace maker

结局指标

主要结局

Link between heart rate variability and frailty

时间窗: approx. 14 days (duration of geriatric complex therapy)

heart rate variability is measured by ECG; frailty is evaluated by geriatric assessment (questionnaires) both investigations are not related to the study but geriatric complex therapy

次要结局

  • Correlation and precision of camera-based heart rate measurement with reference data from standard patient monitor(approx. 14 days (duration of geriatric complex therapy))
  • Correlation and precision of camera-based heart rate variability with reference data from standard patient monitor(approx. 14 days (duration of geriatric complex therapy))
  • Correlation and precision of camera-based respiratory rate with reference data from standard patient monitor(approx. 14 days (duration of geriatric complex therapy))
  • Development of Frailty / geriatric assessment at the beginning and end of the geriatric early-rehabilitation complex-therapy(approx. 14 days (duration of geriatric complex therapy))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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