Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: A Prospective Observational Study (Preprint)

Background In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. Objective This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. Methods This is a prospective observational study. The enrollment will be conducted 1 month before patients’ SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. Results The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. Conclusions The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. Trial Registration Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y International Registered Report Identifier (IRRID) DERR1-10.2196/20072

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Physiologic Response to the COVID-19 Vaccine Measured Using Wearable Devices (Preprint)

10.2196/preprints.28568 ◽

2021 ◽

Author(s):

Alexander George Hajduczok ◽

Kara Marie DiJoseph ◽

Brinnae Bent ◽

Audrey K Thorp ◽

Jon B Mullholland ◽

...

Keyword(s):

Heart Rate ◽

Immune Response ◽

Observational Study ◽

Sleep Duration ◽

Vaccine Dose ◽

Wearable Devices ◽

Initial Increase ◽

Percent Change ◽

Physiologic Response ◽

Immune Biomarkers

BACKGROUND The Pfizer COVID-19 Vaccine employs a novel technology which utilizes messenger Ribonucleic Acid (mRNA) to deliver viral proteins to the host and elicit a protective immune response, but the short-term physiologic response to the vaccine has yet to be studied using wearable devices. OBJECTIVE Using wearable devices, we aim to characterize physiologic changes in response to COVID-19 vaccination in a small cohort of subjects. METHODS In this prospective observational study, physiologic data from 19 internal medicine residents at a single institution who received both doses of the Pfizer COVID-19 vaccine were collected using the WHOOP strap 3.0 to determine participant baseline resting heart rate (RHR), heart rate variability (HRV), respiratory rate (RR), and sleep duration. Primary outcomes included change from baseline in HRV, RHR, RR, and sleep duration. Percent change and standard deviation from baseline (defined as the 30 days of wear prior to vaccination) were calculated for six days after the first and second dose of the Pfizer COVID-19 for all participants who met inclusion and exclusion criteria. Symptom type, severity, and duration were reported as secondary outcomes. RESULTS In 19 individuals, mean age 28.8 (+/- 2.2), 53% female, percent change in HRV was decreased on day 1 (-13.44% +/- 13.62%) following administration of the first vaccine dose, and this response was blunted following dose 2 (-9.25% +/- 22.6%). RHR had a slight initial increase (+2.73% +/- 5.50%, +4.20% +/- 9.42%) after each dose and normalized after one day and RR showed no change compared to baseline after either vaccine dose. Sleep duration was increased up to 6 days post vaccine and peaked on day 3. Increased sleep duration prior to vaccine also demonstrated a more significant change in HRV compared to those who were sleep deprived (as determined by Pearson correlations). A more robust response in terms of symptom severity and duration was seen following dose 2. Arm soreness was the most reported symptom for both doses. CONCLUSIONS This represents the first observational study of the physiologic response in humans to any of the novel COVID-19 vaccines, as measured using wearable devices. We provide evidence that HRV decreases in response to both vaccine doses, with no consequent changes in RHR or RR. Sleep duration initially decreased following each dose and subsequently increased thereafter. Future studies with a larger cohort and comparison to other inflammatory and immune biomarkers, such as antibody response, will be needed to determine the true utility of this type of continuous wearable monitoring in regards to vaccine responses. Our data raises the possibility that increased sleep prior to vaccination may impact physiologic response, which could be used to track immune response to vaccination. CLINICALTRIAL NCT04304703: https://www.clinicaltrials.gov/ct2/show/NCT04304703

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Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study (Preprint)

10.2196/preprints.20072 ◽

2020 ◽

Author(s):

Giulia Lorenzoni ◽

Danila Azzolina ◽

Chiara Fraccaro ◽

Alessandro Di Liberti ◽

Augusto D'Onofrio ◽

...

Keyword(s):

Physical Activity ◽

Aortic Valve ◽

Observational Study ◽

Aortic Valve Replacement ◽

Physical Function ◽

Valve Replacement ◽

Prospective Observational Study ◽

Wearable Devices ◽

Postoperative Changes

BACKGROUND In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. OBJECTIVE This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. METHODS This is a prospective observational study. The enrollment will be conducted 1 month before patients’ SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. RESULTS The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. CONCLUSIONS The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. CLINICALTRIAL Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20072

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