此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Microfluidic-based Tactile Sensor in Cardiac Rehabilitation

2021年3月19日 更新者:Zhili hao

Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation

This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after exercise (1, 3, 5, 10, 30 and 60 mins). The investigators will study these responses at the first session of cardiac rehabilitation and following 1 and 4 weeks of cardiac rehabilitation (sessions 3 and 6). The investigators will also collect some information from the medical record regarding: age, gender, body mass index, resting cardiovascular measures (heart rate, blood pressure etc), medications, reasons which qualified the participant into cardiac rehabilitation, blood tests related to heart or cardiovascular function, metabolic panel, lipid panel, echocardiogram results, recorded electrocardiogram, known vascular diseases, presence of implantable devices, Seattle Heart Failure Model data and cardiovascular measures and exercise workloads during cardiac rehabilitation.

研究概览

详细说明

The investigators will make the following research measurements (pre-exercise measurement and post-exercise measurement) on the first day of cardiac rehab, and following 1 and 4 weeks of cardiac rehabilitation.

Subjects will have their arterial pulse measured at the radial (wrist), carotid (neck) and temple (side of the head) arteries. The sensor will remain in place for 2-3 minutes while the recordings are made. Light pressure will be applied during this time. Blood pressure will also be obtained in the opposite arm.

The subject will then exercise on the modalities, intensity and duration designated by the staff in the Sentara Heart Hospital Cardiac Rehabilitation. It's important to note, that the normal standard of care will not change by the individual participating in this research study. The participants will follow standard physician ordered cardiac rehabilitation. The order of the modalities performed will be completed in the same order on the day of research testing in weeks 1 and 4.

After finishing the exercise, the subject will sit down for 1hr. The participant's pulse signals will be measured at 0-5min, 10min, 20 min, 30min and 1hr after exercise. Blood pressure will also be obtained from the opposite arm at the same time intervals.

The investigators will be collecting cardiac rehab data from each research day. This data will be entered into Redcap by the Sentara researchers.

The investigators will record from the most recent values/visits prior to start of cardiac rehab therapy, and this information will be entered into Redcap by the Sentara researchers.

The investigators will document at 1, 2 and 3 years from start of cardiac rehab, as to patient survival status.

研究类型

观察性的

注册 (预期的)

30

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

    • Virginia
      • Norfolk、Virginia、美国、23501
        • 招聘中
        • Sentara Heart Hospital
        • 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

45年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Individuals who are undergoing Phase II (outpatient) cardiac rehabilitation at Sentara Heart Hospital (Norfolk, Va) and meet the inclusion and exclusion criteria listed will be recruited for the study.

描述

Inclusion Criteria:

  • Age 45-70
  • Subjects who qualify for cardiac rehabilitation via doctor's orders

Exclusion Criteria:

●Physical limitations which would preclude one from performing exercise.

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

队列和干预

团体/队列
Cardiac Rehabilitation
Individuals assigned to phase II (outpatient) cardiac rehabilitation program will undergo their normal exercise routines while the investigators make the measurements pre and post exercise at 0 week, and following 1 and 4 weeks of 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
Micro-tactile sensor assessment of arterial stiffness change to exercise
大体时间:The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Elasticity (unit measure: pascal) of arterial wall will be assessed.
The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Micro-tactile sensor assessment of arterial viscosity change to exercise
大体时间:The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Damping (unit measure: pascal x sec) of the arterial wall will be assessed.
The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Micro-tactile sensor assessment of arterial radius change to exercise
大体时间:The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Size of the artery lumen (unit measure: mm) will be assessed.
The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise
大体时间:The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.
The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation

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。

赞助

调查人员

  • 首席研究员:Julie Hao, Ph.D.、Old Dominion University

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 (预期的)

2021年3月20日

初级完成 (预期的)

2022年3月20日

研究完成 (预期的)

2022年3月20日

研究注册日期

首次提交

2021年3月17日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月23日

研究记录更新

最后更新发布 (实际的)

2021年3月23日

上次提交的符合 QC 标准的更新

2021年3月19日

最后验证

2021年3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

  • 19-04-FB-0100

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅