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

March 21, 2023 updated by: Emmanouil D. Zacharakis

Levels of Physical Activity After SARS-CoV-2 Infection in Greek Adults: the Role of Pre-illness Vaccination and the Number of Reinfections.

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 17237
        • Recruiting
        • National and Kapodistrian University of Athens
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dimitrios I. Bourdas, PhD
        • Sub-Investigator:
          • Antonios K. Travlos, PhD
        • Sub-Investigator:
          • Panteleimon Bakritzoglou, PhD
        • Sub-Investigator:
          • Vasileios Andrianopoulos, PhD
        • Principal Investigator:
          • Emmanouil D. Zacharakis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 recovered individuals aged from 18 to 80 years old who are residents of Greece and have been diagnostically confirmed with COVID-19 infection and recovered at least one month before answering the survey instrument.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of Physical Activity (PA)
Time Frame: One (1) month at least after recovery from COVID-19 infection
Levels of PA, before and after COVID-19 infection, will be recorded
One (1) month at least after recovery from COVID-19 infection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protective effect of vaccination in post-COVID-19 burden on Physical Activity (PA)
Time Frame: 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
One (1) month at least after recovery from COVID-19 infection
The role of the number of re-infections and post-COVID-19 burden on PA
Time Frame: 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
One (1) month at least after recovery from the last COVID-19 infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emmanouil D. Zacharakis

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

July 15, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1454/11-01-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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