Smart Watch, Heart Rate and So2 in Cardiac Patients

NCT05199844 | Completed DMC FDA Device

• 1 other identifier: HAPO-02-K-012
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiac rehabilitation; Validity

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Heart rate

  over 31 minutes

Secondary Outcomes (1)

• Spo2

  over 10 minutes at rest and after exercise

Study Arms (2)

Group A

cardiac patients with regular heart rate

Device: Apple Watch

Group B

cardiac patients with irregular heart rate

Interventions

Apple Watch DEVICE

Apple Watch device measures heart rate and oxygen saturation

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cardiac patients with sinus heart rate and irregular heart rate

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University Medical Center

Mecca, 24243 7512, Saudi Arabia

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: November 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

SA (1)