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Smart Watch, Heart Rate and So2 in Cardiac Patients

NCT05199844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2023-11-29

No results posted yet for this study

Summary

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.

Conditions

  • Apple Watch

Interventions

DEVICE

Apple Watch

Apple Watch device measures heart rate and oxygen saturation

Sponsors & Collaborators

  • Umm Al-Qura University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-07-30
Completion
2023-09-30
FDA Device
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199844 on ClinicalTrials.gov