PostCovidZRS: Post COVID19 Functional and Cognitive Assessments

Sponsor
Science and Research Centre Koper (Other)
Overall Status
Recruiting
CT.gov ID
NCT04860206
Collaborator
Hospital of Izola (Other), University of Trieste (Other), University of Padova (Other), University of Graz (Other)
80
1
5.8
13.8

Study Details

Study Description

Brief Summary

The main objective of the proposed study is to evaluate the impact of coronavirus (2019-nCoV), hereafter COVID -19, on patients' loss of functional capacity after completion of hospital treatment. Specifically, the research will focus on examining changes in musculoskeletal, cardiovascular, and respiratory function, as well as motor control. In addition, we aim to evaluate rehabilitation treatments after recovery from COVID -19 and consider additional preventive measures based on previous experience.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The combination of such a severe respiratory disease as COVID -19 with motor inactivity could have very serious consequences for a person's general health even after COVID -19 symptoms have subsided. To date, the effects of COVID -19 on individual muscle status have not been extensively studied. Therefore, the main objective of this study will be to evaluate the muscle status of patients after COVID -19. In addition, we will be interested in longitudinal monitoring of individuals' rehabilitation, where they will receive instructions based on measured outcomes at hospital discharge. We will also be interested in considering additional preventive measures for future patients based on previous experience of infected and hospitalized COVID -19 patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Vpliv COVID19 na Izgubo Funkcionalnih zmožnosti Pacientov po zaključenem bolnišničnem Zdravljenju The Effect of COVID19 on the Loss of Functional Capacity of Patients After Hospitalization
    Actual Study Start Date :
    Jan 5, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2021
    Anticipated Study Completion Date :
    Jun 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Timed up and go test (TUG) [Change in time on TUG between both assessment points (pre- to 2 months post-measurement)]

      Functional performance of the patients from sitting to standing, walking and turning

    2. Pulse wave velocity (PWV) [Change in PWV between both assessment points (pre- to 2 months post-measurement)]

      Measuring endothelium function in supine

    3. Spirometry [Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)]

      Measurement of lung function, specifically the forced vital capacity (FVC)

    Secondary Outcome Measures

    1. Walking velocity [Change in gait velocity between both assessment points (pre- to 2 months post-measurement)]

      measurement of gait velocity on the 4m path.

    2. Trail making test B [Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)]

      Measurement of executive control using the TMT B test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Completed hospital treatment after a positive COVID-19 test

    • Signed written consent

    Exclusion Criteria:
    • Still testing positive for COVID -19 at discharge.

    • Severe musculoskeletal injuries (e.g., disability).

    • Inability to follow instructions when performing the test.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SB Izola Izola Slovenia

    Sponsors and Collaborators

    • Science and Research Centre Koper
    • Hospital of Izola
    • University of Trieste
    • University of Padova
    • University of Graz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Science and Research Centre Koper
    ClinicalTrials.gov Identifier:
    NCT04860206
    Other Study ID Numbers:
    • PC-ZRS-SBI
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Apr 26, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Science and Research Centre Koper
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 26, 2021