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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 11, 2020
Open Peer Review Period: May 11, 2020 - Jun 27, 2020
Date Accepted: Aug 25, 2020
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

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

Lorenzoni G, Azzolina D, Fraccaro C, Di Liberti A, D'Onofrio A, Cavalli C, Fabris T, D'Amico G, Cibin G, Nai Fovino L, Ocagli H, Gerosa G, Tarantini G, Gregori D

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

JMIR Res Protoc 2020;9(11):e20072

DOI: 10.2196/20072

PMID: 33180023

PMCID: 7691084

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Using wearable devices to monitor physical activity in patients undergoing aortic valve replacement: the CAPABILITY study protocol

  • Giulia Lorenzoni; 
  • Danila Azzolina; 
  • Chiara Fraccaro; 
  • Alessandro Di Liberti; 
  • Augusto D'Onofrio; 
  • Chiara Cavalli; 
  • Tommaso Fabris; 
  • Gianpiero D'Amico; 
  • Giorgia Cibin; 
  • Luca Nai Fovino; 
  • Honoria Ocagli; 
  • Gino Gerosa; 
  • Giuseppe Tarantini; 
  • Dario Gregori

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:

NA

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


 Citation

Please cite as:

Lorenzoni G, Azzolina D, Fraccaro C, Di Liberti A, D'Onofrio A, Cavalli C, Fabris T, D'Amico G, Cibin G, Nai Fovino L, Ocagli H, Gerosa G, Tarantini G, Gregori D

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

JMIR Res Protoc 2020;9(11):e20072

DOI: 10.2196/20072

PMID: 33180023

PMCID: 7691084

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