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

NCT ID: NCT05787431

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-07

Study Completion Date

2023-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 (Coronavirus Disease 2019)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Unvaccinated individuals

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

No interventions assigned to this group

Vaccinated individuals

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emmanouil D. Zacharakis

OTHER

Sponsor Role lead

Responsible Party

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Emmanouil D. Zacharakis

Emmanouil D. Zacharakis, [email protected], +306977915982

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Emmanouil D. Zacharakis, PhD

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

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National and Kapodistrian University of Athens

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Emmanouil D. Zacharakis, PhD

Role: CONTACT

Panteleimon Bakirtzoglou, PhD

Role: CONTACT

(+30) 6972207967

Facility Contacts

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Emmanuil D. Zacharakis, PhD

Role: primary

Panteleimon Bakirtzoglou, PhD

Role: backup

References

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Bourdas DI, Zacharakis ED. Impact of COVID-19 Lockdown on Physical Activity in a Sample of Greek Adults. Sports (Basel). 2020 Oct 21;8(10):139. doi: 10.3390/sports8100139.

Reference Type RESULT
PMID: 33096721 (View on PubMed)

Bourdas DI, Zacharakis ED, Travlos AK, Souglis A, Georgali TI, Gofas DC, Ktistakis IE, Deltsidou A. Impact of lockdown on smoking and sleeping in the early COVID-19 presence: Datasets of Greek Adults sample. Data Brief. 2021 Dec;39:107480. doi: 10.1016/j.dib.2021.107480. Epub 2021 Oct 14.

Reference Type RESULT
PMID: 34664028 (View on PubMed)

Bourdas DI, Zacharakis ED. Evolution of changes in physical activity over lockdown time: Physical activity datasets of four independent adult sample groups corresponding to each of the last four of the six COVID-19 lockdown weeks in Greece. Data Brief. 2020 Oct;32:106301. doi: 10.1016/j.dib.2020.106301. Epub 2020 Sep 11.

Reference Type RESULT
PMID: 32934972 (View on PubMed)

Bourdas DI, Zacharakis ED, Travlos AK, Souglis A. Return to Basketball Play Following COVID-19 Lockdown. Sports (Basel). 2021 Jun 3;9(6):81. doi: 10.3390/sports9060081.

Reference Type RESULT
PMID: 34204988 (View on PubMed)

Related Links

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Other Identifiers

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1454/11-01-2023

Identifier Type: -

Identifier Source: org_study_id

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