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临床试验/NCT05199844
NCT05199844已完成不适用

Accuracy of Apple Watch to Measure Cardiovascular Indices in Patients With Cardiac Diseases: Observational Study

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2022年11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
260
试验地点
1
主要终点
Heart rate

研究概览

简要总结

Background: Apple Watch validity to measure the heart rate (HR) and oxygen saturation (Spo2) in healthy subjects has been investigated, but its accuracy and validity for patients with cardiac diseases is still unclear. The HR is an important measure to determine the recommended exercise training intensity and to monitor the training intensity in patients with cardiac diseases. The target exercise training intensity during cardiac rehabilitation is between 40% to 70% of heart rate reserve (HRR). Also, cardiac patients who have hypoxemia are advised to continuously monitor their Spo2. Therefore, this study aims to investigate the accuracy of the Apple Watch in measuring the HR and Spo2 in Saudi patients with cardiac diseases.

Method: A cross sectional study will be invited one-hundred cardiac patients will be invited and recruited to participate in this study and the eligible participants will be randomly allocated into two groups. The first group (Group-A) will include the cardiac patients with regular HR and the second group (Group-B) will include the cardiac patients with irregular HR. Both groups will use the apple watch to evaluate the HR and the Spo2 against the Polar HR monitor and pulse oximeter at rest, during, and after the mild to moderate intensity exercise training session (40% to 70% HRR). The HR and the Spo2 monitoring, and recording will run on a 30 second schedule at rest (pre-session; for 3-minutes), during the 15-minutes session and over 5-minutes after the session). The main outcomes will be the HR and the Spo2 and will be evaluated before, during and after the exercise session using the Apple watch and the Polar HR monitor. All participants will receive the mild to moderate exercise training session (40 to 70 % HRR) using cycling and treadmill instruments for 15 minutes, proceeded, and followed by a 3-minutes warm-up and cool-down.

详细描述

Introduction:

Measuring the heart rate (HR) is important to estimate the suitable exercise training intensity and to determine the recommended exercise intensity (1). The 12-leads electrocardiogram (ECG) is the gold standers to measure heart rate, but it may be not suitable to be used outside the laboratory, therefore using the polar chest strap is the alternative to be used outside the lab and it has been tested against the 12-leads ECG during exercise and at rest in healthy subjects [2,3,4] and cardiac patients [5]. The HR following exercise is called heart rate recovery and it is important to predict mortality risk and cardiorespiratory fitness [6].

There is a liner relationship between the HR and oxygen consumption [7]. The Oxygen saturation (Spo2) is recommended to be monitored in patients with hypoxemia to extend their survival [8]. Some cardiac patients have hypoxemia particularly cardiac patients after cardiac arrest [9]. Pulse oximeter is a gold standard to measure the Spo2 [10].

The Apple Watch all versions can measure heart rate, but the latest versions-6 and 7 can measure blood Spo2. Photoplethysmography (PPT) is a non-invasive measurement procedure to evaluate the HR through wrist-worn devise by detecting each heartbeat changes in blood flow and changes colors in blood flow. The PPT has been used to measure Spo2, cardiac output, and blood pressure in many medical devices [11]. The PPT technology can help in early detection of some cardiovascular diseases such as atherosclerosis and atrial fibrillation [12].

A pilot study measured the HR agonist the telemetry in 50 cardiac patients (half of them with atrial fibrillation (AF) and other half with normal HR rhythm) during rest, through assessments of the HR 3-times/ day for two days. They found that the HR accuracy in patients with AF (r=86) was more than the cardiac patients who have normal rhythm (r= 0.64) and the overall accuracy was (r=070) but this still pilot study and more studies with large sample size are needed to confirm this findings in addition to presence of some limitations in this pilot study, as including of 3 black participants that could affect the accuracy of the results, presence of other interfering devices near the Apple Watches devices during evaluations in the cardiac wards and the fluid and edema after operation[13]. Moreover, the accuracy of the Apple Watch in measuring the HR during exercise is still unknown with cardiac patients and cardiac patients with AF.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • eligible participants will be cardiac patients as those with myocardial infarction (6-weeks post-insult), coronary bypass graft surgery (CABG), cardiac patients with valve diseases, stable atrial fibrillation (AF), heart failure (HF)-I,II and III, with and resting ejection fraction (EF) greater than 50%.

排除标准

  • Cardiac patients with unstable angina, uncontrolled high blood pressure, unstable arrythmia, presence of complex ventricular arrhythmias, ST-segment depression ≥2mm from baseline during exercise testing or recovery, pacemaker patients will be all excluded from the study

结局指标

主要结局

Heart rate

时间窗: over 31 minutes

Heart rate

次要结局

  • Spo2(over 10 minutes at rest and after exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Khushhal

Principal Investigator

Umm Al-Qura University

研究点 (1)

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