Evidence map›Paper›PMID 33180023›Full record

ArticleJMIR research protocols2020

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

Giulia Lorenzoni, Danila Azzolina, Chiara Fraccaro, Alessandro Di Liberti, Augusto D'Onofrio, Chiara Cavalli, Tommaso Fabris, Gianpiero D'Amico, Giorgia Cibin, Luca Nai Fovino and 4 more

Registry-linked trialAbstract read
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In one paragraph

Article in JMIR research protocols, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03843320 (Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03843320 suspendednot on this mapstarted 2021, after this paper: background citation

Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study

TypeobservationalSponsorUniversity of PadovaRan2021 to 2024Enrolled340ConditionsAortic Valve StenosisArmsSAPIEN 3, SAPIEN XT, INSPIRIS RESILIA, EDWARDS INTUITY, Carpentier-Edwards PERIMOUNT Magna-Ease
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Giulia LorenzoniUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0003-1771-4686
Danila AzzolinaUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-8185-5742
Chiara FraccaroInterventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-3972-4642
Alessandro Di LibertiInterventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-1357-6143
Augusto D'OnofrioCardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-9835-9091
Chiara CavalliCardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0001-5568-8365
Tommaso FabrisInterventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0003-0818-3094
Gianpiero D'AmicoInterventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0003-1259-5163
Giorgia CibinCardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-2584-2613
Luca Nai FovinoInterventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-5823-2088
Honoria OcagliUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-5823-1659
Gino GerosaCardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-6261-699X
Giuseppe TarantiniInterventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0002-5055-2917
Dario GregoriUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.ORCID https://orcid.org/0000-0001-7906-0580

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

objectiveThis 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.

methodsThis 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.

resultsThe 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.

conclusionsThe 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 registrationClinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20072.

Indexed as

physical functionsurgical aortic valve replacementtranscatheter aortic valve replacementwearable devices

Identifiers

PMID33180023
PMCPMC7691084

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.