Levels of Physical Activity After SARS-CoV-2 Infection in Pre-illness Vaccinated and Unvaccinated Greek Adults.

Sponsor
Emmanouil D. Zacharakis (Other)
Overall Status
Recruiting
CT.gov ID
NCT05787431
Collaborator
(none)
2,000
1
5.2
385.3

Study Details

Study Description

Brief Summary

Coronavirus infection has an impact on several aspects of everyday life including the levels of Physical Activity (PA). Investigators wish to (1) detect changes on PA levels in recovered SARS-CoV-2 (COVID-19) adults compared to the pre-infection levels and (2) identify a potential relationship between changes of PA levels and pre-illness vaccination profile along with individual's number of infection/reinfections. It is assumed that the impact of COVID-19 infection on PA would be more pronounced in cases of repeated infections and/or in the unvaccinated compared to the vaccinated individuals against COVID-19.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Coronavirus identified in 2019, SARS-CoV-2 (COVID-19), has caused a pandemic of respiratory illness in which manifestation ranging from asymptomatic presentation to critically illness with severe pneumonia, acute respiratory distress syndrome, respiratory failure, or multiple organ failure. It may influence several aspects of everyday life including the levels of Physical Activity such as walking, cycling, sports or active recreation and, thus, has negative effect on general health and quality of life. Recent findings demonstrate a relation between COVID-19 infection and impairment in functional capacity, and suggest that may also be associated with an increased risk of acute and post-acute death. Moreover, individuals who have been infected might suffer long-term consequences as a result of their infection (Long COVID), for few weeks (short term) or 10-20 weeks (medium term) or more than six months (long term) post-infection.

    The current study is designed to assess changes in PA (overall and in four domains i.e. daily occupation, transportation to and from daily occupation, leisure time activities, and regular sporting activities) caused by COVID-19 infection (i.e. in the short term, 4 weeks post infection) concerning the pre-illness vaccination profile and the number of infections/reinfections using a web-based validated questionnaire in a large population of Greece. Investigators hypothesize that the impact of COVID-19 infection on PA levels would be more pronounced in cases of repeated infections and/or in the unvaccinated compared to the vaccinated individuals against COVID-19. With regard to the potential burden of COVID-19 in functional capacity, investigators wish:

    1. to detect changes on PA levels in recovered COVID-19 adults compared to the pre-infection levels as a result of a post-effect impact;

    2. to identify a potential relationship between changes of PA levels and pre-illness vaccination profile along with individual's number of infection/reinfections so as to detect correlations amongst different parameters.

    The Greek version of the revised Active-Q (AQGR) which is a self-reported, online, interactive physical activity questionnaire that assesses adult's habitual activity on weekly basis (in four main PA domains: daily occupation, transportation to and from daily occupation, leisure time activities, and regular sporting activities) is employed. Regarding questions of medical treatment during COVID-19 infection, individual's number of infection/reinfections and other relative parameters, additional questionnaire items have been incorporated. In total, the current web-based questionnaire consisted of 60-67 questions, based on previous responses and follow-up patterns, and will be extensively used to address the aims of the current study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Levels of Physical Activity After SARS-CoV-2 Infection in Greek Adults: the Role of Pre-illness Vaccination and the Number of Reinfections.
    Actual Study Start Date :
    Feb 7, 2023
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    Jul 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Unvaccinated individuals

    COVID-19 recovered individuals who are not been vaccinated with any dose of COVID-19 vaccines.

    Vaccinated individuals

    COVID-19 recovered individuals who are vaccinated with one or more dose of COVID-19 vaccines, and stratified by sub-groups.

    Outcome Measures

    Primary Outcome Measures

    1. Levels of Physical Activity (PA) [One (1) month at least after recovery from COVID-19 infection]

      Levels of PA, before and after COVID-19 infection, will be recorded

    Other Outcome Measures

    1. Protective effect of vaccination in post-COVID-19 burden on Physical Activity (PA) [One (1) month at least after recovery from COVID-19 infection]

      Correlations between the number of doses of vaccines and the post-COVID-19 burden on PA will be performed

    2. The role of the number of re-infections and post-COVID-19 burden on PA [One (1) month at least after recovery from the last COVID-19 infection]

      Correlations between the number of re-infections and the post-COVID-19 burden on PA will be performed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    COVID-19 recovered individuals aged from 18 to 80 years old.

    Exclusion Criteria:

    Individuals without any confirmed COVID-19 infection, severe musculoskeletal problems, cognitive impairment/dementia, participation in any strict weight loss control program, gestation or childbirth within one year of the study's start date.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National and Kapodistrian University of Athens Athens Attica Greece 17237

    Sponsors and Collaborators

    • Emmanouil D. Zacharakis

    Investigators

    • Principal Investigator: Emmanouil D. Zacharakis, PhD, National and Kapodistrian University of Athens

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Emmanouil D. Zacharakis, Emmanouil D. Zacharakis, emzach@phed.uoa.gr, +306977915982, National and Kapodistrian University of Athens
    ClinicalTrials.gov Identifier:
    NCT05787431
    Other Study ID Numbers:
    • 1454/11-01-2023
    First Posted:
    Mar 28, 2023
    Last Update Posted:
    Mar 28, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emmanouil D. Zacharakis, Emmanouil D. Zacharakis, emzach@phed.uoa.gr, +306977915982, National and Kapodistrian University of Athens
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 28, 2023