JMIR Publications

ABSTRACT

Background:

In the last decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice.

Objective:

The present study aims to describe preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing AS treatment with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and to evaluate the feasibility of wearable devices in assessing physical function in such patients.

Methods:

Prospective observational study. The enrolment will be performed 1-month before TAVR/SAVR. Patients will be provided with the wearable device at baseline (activity tracker vívoactive® 3 devices by Garmin©). 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-month after TAVR/SAVR. After baseline assessment, they will undergo four follow-up assessments at 1, 3, 6, and 12-month after SAVR/TAVR. At baseline and at 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 study was approved by the ethics committee of the province of Vicenza, Veneto Region, Italy (prot. n 943 of 4th of January 2019). The enrollment is ongoing.

Conclusions:

The use of the wearable devices for the real-time monitor 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 Clinical Trial: Clinicaltrials.gov: NCT03843320