NCT05787431

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 21, 2023

Last Update Submit

March 21, 2023

Conditions

COVID-19 (Coronavirus Disease 2019)

Keywords

Physical Activity, exercise, public health, Post COVID

Outcome Measures

Primary Outcomes (1)

  • Levels of Physical Activity (PA)

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

    One (1) month at least after recovery from COVID-19 infection

Other Outcomes (2)

  • Protective effect of vaccination in post-COVID-19 burden on Physical Activity (PA)

    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

    One (1) month at least after recovery from the last COVID-19 infection

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National and Kapodistrian University of Athens

Athens, Attica, 17237, Greece

RECRUITING

Related Publications (4)

  • 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.

    PMID: 33096721RESULT

  • 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.

    PMID: 34664028RESULT

  • 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.

    PMID: 32934972RESULT

  • 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.

    PMID: 34204988RESULT

Related Links

MeSH Terms

Conditions

COVID-19Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Emmanouil D. Zacharakis, PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanouil D. Zacharakis, PhD

CONTACT

(+30)emzach@phed.uoa.gr

Panteleimon Bakirtzoglou, PhD

CONTACT

(+30) 6972207967bakirtzoglou@phed.auth.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Emmanouil D. Zacharakis, emzach@phed.uoa.gr, +306977915982

Study Record Dates

First Submitted

March 21, 2023

First Posted

March 28, 2023

Study Start

February 7, 2023

Primary Completion

May 31, 2023

Study Completion

July 15, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

GR(1)