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

Abstract

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

Wearable Activity Trackers Objectively Measure Incidental Physical Activity in Older Adults Undergoing Aortic Valve Replacement

“…Wearables in this context, therefore, could act as a valuable monitoring tool pre- and post-AVR, providing useful indications of AS patient’s actual incidental PA in their environments. This information may help them understand their physical well-being and assist practitioners to prescribe more personalized recovery recommendations [ 37 ].…”

Evaluating treatment-specific post-discharge quality-of-life and cost-effectiveness of TAVR and SAVR: Current practice & future directions

“…This level of healthcare decentralization is still largely hypothetical; however, a recent pilot study evaluated the effects of wearable activity trackers on physical activity amongst elderly patients at higher risk of CVD [47] . An ongoing prospective study by Lorenzoni et al is currently in the process of using a commercial smartwatch to address the lack of recovery trajectory data for TAVR/SAVR patients [48] . This study will track a variety of physical activity measurements and assess HRQOL using the SF-36 for follow-up periods of 1, 3, 6 and 12 months with the aim of demonstrating the efficacy of wearable devices in assessing longitudinal functional recovery [48] .…”

“…An ongoing prospective study by Lorenzoni et al is currently in the process of using a commercial smartwatch to address the lack of recovery trajectory data for TAVR/SAVR patients [48] . This study will track a variety of physical activity measurements and assess HRQOL using the SF-36 for follow-up periods of 1, 3, 6 and 12 months with the aim of demonstrating the efficacy of wearable devices in assessing longitudinal functional recovery [48] .…”

Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results

“…The study design characteristics and inclusion criteria are described elsewhere [ 22 ]. This is a multicenter prospective observational study, that enrolled patients undergoing SAVR and TAVR according to the evaluation of the local heart team since March 2018 at the University hospital of Padova and the hospital of Vicenza.…”

“…The present work aims to describe the feasibility of using WDs to monitor PROMs in patients who undergoing TAVR/SAVR enrolled in the run-in phase of the Capability study [ 22 ]. In this study, the feasibility and acceptability of using a commercial wearable device in elderly patients undergoing TAVR or SAVR will be explored.…”