COVID-19 (Coronavirus Disease 2019)NCT05787431
Levels of Physical Activity After SARS-CoV-2 Infection in Pre-illness Vaccinated and Unvaccinated Greek Adults.
An observational study of COVID-19 (Coronavirus Disease 2019), run by Emmanouil D. Zacharakis at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 (Coronavirus Disease 2019)
- Type of treatment
- Vaccines
- How many people
- 2,000 participants
- Where
- 1 siteGreece
- Study dates
- 7 Feb 2023to 15 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- COVID-19 recovered individuals aged from 18 to 80 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
National and Kapodistrian University of Athens
Athens, Attica, 17237
Emmanuil D. Zacharakis, PhD, emzach@phed.uoa.gr
Panteleimon Bakirtzoglou, PhD, bakirtzoglou@phed.auth.gr
About this study
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.
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.
Read the 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:
- 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;
- 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
- COVID-19 (Coronavirus Disease 2019)
- Keywords
- Physical Activity, exercise, public health, Post COVID
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Levels of Physical Activity (PA)
Levels of PA, before and after COVID-19 infection, will be recorded
Measured: One (1) month at least after recovery from COVID-19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start7 Feb 2023
- Primary completion31 May 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 (Coronavirus Disease 2019)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emmanouil D. Zacharakis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emmanouil D. Zacharakis, National and Kapodistrian University of Athens
- Investigators
- Emmanouil D. Zacharakis, PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787431
- Sponsor's protocol ID
- 1454/11-01-2023
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33096721Bourdas 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.
PubMed 34664028Bourdas 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.
PubMed 32934972Bourdas 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.
PubMed 34204988
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05787431
- Acronym / sponsor ID
- 1454/11-01-2023
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Keywords
- Physical Activity, exercise, public health, Post COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Emmanouil D. ZacharakisUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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;
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- COVID-19 recovered individuals aged from 18 to 80 years old.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Results publication: PubMed 33096721Bourdas 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.
- Results publication: PubMed 34664028Bourdas 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.
- Results publication: PubMed 32934972Bourdas 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.
- Results publication: PubMed 34204988Bourdas 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.
- Official web-page of the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanouil D. Zacharakis, PhD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 (Coronavirus Disease 2019), run by Emmanouil D. Zacharakis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanouil D. Zacharakis, PhD ((+30), emzach@phed.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Physical Activity (PA) (time frame: One (1) month at least after recovery from COVID-19 infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05787431, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.