COVID-19COVID-MSKNCT05638685
The Bodily Complaints Barometer: The Impact of the Corona Measures and of Contracting a COVID-19 Infection on the Body.
An observational study of COVID-19, run by University Ghent at 1 site in Belgium.
Trial summary
Since December 2019, a new corona virus (SARS-CoV-2) causing COVID-19 disease, has expeditiously spread over the entire globe. Almost a half billion people caught the disease, and in those who survived, it soon became clear that residual complaints are not rare phenomena. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Questionnaire
- How many people
- 490 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Dec 2021to 14 Feb 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dutch-speaking people working or living in Belgium at the time of the pandemic and the lockdown measurements.
Who may be able to join
- Being at least 18 years old
- Living and/or working in Belgium
- Dutch speaking
Who cannot join
- Being younger than 18 years of age
- Not working or living in Belgium during the pandemic and lockdown measures
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University, vakgroep revalidatiewetenschappen
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: The Bodily Complaints Barometer: A Survey to Investigate the Impact of the Corona Measures and of Contracting a COVID-19 Infection on the Body.
Since December 2019, a new corona virus (SARS-CoV-2) causing COVID-19 disease, has expeditiously spread over the entire globe. Almost a half billion people caught the disease, and in those who survived, it soon became clear that residual complaints are not rare phenomena. Early focus lay on diminished lung capacity and cardiovascular-related problems. As time passed however, it became more apparent that those are not the only residual symptoms survivors may experience.
Furthermore, nearly every country in the world took some sort of lockdown measures in order to try contain the spreading of the virus. These measures had great impact on all inhabitants, infected with the virus or not.
This questionnaire-based study therefore aims to investigate (a) the effects of a COVID-19 infection on fatigue and/or musculoskeletal complaints, new or already existing, but also (b) the effects of lockdown measures on fatigue and/or musculoskeletal complaints, new or already existing, in people living, working or studying in Belgium during the pandemic.
Read the detailed description
Since the start of the COVID-19 pandemic, almost half a billion people worldwide were infected with the new coronavirus, SARS-CoV-2, causing COVID-19 disease. In Belgium, 3.6 million people, a third of the population, contracted the disease. More than 30.000 patients did not survive this condition.
Many of those who did survive, however, complained of residual symptoms, even long after their infection. Initially the most reported and investigated complaints were lung and respiratory issues, but as time progressed, it became clear these were not the only residual problems after infection. A great deal of ex-patients reported lasting fatigue and musculoskeletal complaints, both myalgia and arthralgia, after they were deemed 'cured' and therefore discharged from the hospital. Since these complaints only became apparent when patients tried to resume their daily life outside the hospital, condsiderably less attention was given to these symptoms by clinicians and researchers. Therefore, this research aims to investigate the effects of a COVID-19 infection on fatigue and/or musculoskeletal complaints, both new or already existing.
In Belgium, as in many other countries all over the world, lockdown measures were installed to contain the spread of the virus. For certain periods, this meant an obligation to work from home and moreover, to only leave home for vital reasons. Before the pandemic, "telework" was rather exceptional; in a survey from September 2019, only 22% of respondents worked from home, and for just 1 day a week. So for many employees, this meant a hard transition from a fully ergonomic work space to an unadapted home environment. For those who used to walk or bike to work, physical activity levels dropped. Even more so since all sports and recreational facilities were ordered to close. Regardless of having to live through a COVID-19 infection, all these measures were of great impact on the population, and on their levels of physical activity. A second aim of this resaerch is thus to investigate the effect of lockdown measures on fatigue and/or musculoskeletal complaints, both new or already existing, in people living, working or studying in Belgium during these measures.
- Conditions
- COVID-19
- Being tested
- Questionnaire
- Keywords
- COVID-19 infection, Lockdown measures, muskuloskeletal complaints, fatigue, observational study
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The questionnaire comprises demographics, job or school related questions, screen work questions, the International Physical Activity Questionnaire (IPAQ) and questions about the participant's health.
| Study group | Role | What they receive |
|---|---|---|
| Dutch-speaking people living or working in Belgium | Every participant was asked to complete a questionnaire about the impact of a COVID-19 infection and/or the impact of lockdown measures as a result of the COVID-19 pandemic on fatigue and musculoskeletal complaints. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal complaints following a COVID-19 infection, through the International Physical Activities Questionnaire (IPAQ).
Measured: 3 months
Fatigue following a COVID-19 infection, through the Checklist Individual Strength (CIS).
Measured: 3 months
Musculoskeletal complaints caused by lockdown measures, through the IPAQ and the Short Inventory to Monitor Psychosocial Hazards.
No prior COVID-19 infection
Measured: 3 months
Fatigue caused by lockdown measures, through the CIS and the Short Inventory to Monitor Psychosocial Hazards.
No prior COVID-19 infection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start22 Dec 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, Prof, Study director, Ghent University, Pain in Motion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638685
- Sponsor's protocol ID
- B6702021000576
- Acronym
- COVID-MSK
- Status last verified
- Dec 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wrzesinski,D.& Kluppels, L. (2020) Telewerken gedurende COVID-19.Hoe beleven telewerkers het al of niet gedwongen thuiswerken? Brussel, België: Vias institute -INNO_DSU_MOBI
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bodily Complaints Barometer: A Survey to Investigate the Impact of the Corona Measures and of Contracting a COVID-19 Infection on the Body.
- ClinicalTrials.gov ID
- NCT05638685
- Acronym / sponsor ID
- COVID-MSK / B6702021000576
- Conditions
- COVID-19
- Keywords
- COVID-19 infection, Lockdown measures, muskuloskeletal complaints, fatigue, observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 6 Dec 2022 (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.
Since December 2019, a new corona virus (SARS-CoV-2) causing COVID-19 disease, has expeditiously spread over the entire globe. Almost a half billion people caught the disease, and in those who survived, it soon became clear that residual complaints are not rare phenomena. Early focus lay on diminished lung capacity and cardiovascular-related problems. As time passed however, it became more apparent that those are not the only residual symptoms survivors may experience.
Furthermore, nearly every country in the world took some sort of lockdown measures in order to try contain the spreading of the virus. These measures had great impact on all inhabitants, infected with the virus or not.
This questionnaire-based study therefore aims to investigate (a) the effects of a COVID-19 infection on fatigue and/or musculoskeletal complaints, new or already existing, but also (b) the effects of lockdown measures on fatigue and/or musculoskeletal complaints, new or already existing, in people living, working or studying in Belgium during the pandemic.
Detailed description
Since the start of the COVID-19 pandemic, almost half a billion people worldwide were infected with the new coronavirus, SARS-CoV-2, causing COVID-19 disease. In Belgium, 3.6 million people, a third of the population, contracted the disease. More than 30.000 patients did not survive this condition.
Many of those who did survive, however, complained of residual symptoms, even long after their infection. Initially the most reported and investigated complaints were lung and respiratory issues, but as time progressed, it became clear these were not the only residual problems after infection. A great deal of ex-patients reported lasting fatigue and musculoskeletal complaints, both myalgia and arthralgia, after they were deemed 'cured' and therefore discharged from the hospital. Since these complaints only became apparent when patients tried to resume their daily life outside the hospital, condsiderably less attention was given to these symptoms by clinicians and researchers. Therefore, this research aims to investigate the effects of a COVID-19 infection on fatigue and/or musculoskeletal complaints, both new or already existing.
In Belgium, as in many other countries all over the world, lockdown measures were installed to contain the spread of the virus. For certain periods, this meant an obligation to work from home and moreover, to only leave home for vital reasons. Before the pandemic, "telework" was rather exceptional; in a survey from September 2019, only 22% of respondents worked from home, and for just 1 day a week. So for many employees, this meant a hard transition from a fully ergonomic work space to an unadapted home environment. For those who used to walk or bike to work, physical activity levels dropped. Even more so since all sports and recreational facilities were ordered to close. Regardless of having to live through a COVID-19 infection, all these measures were of great impact on the population, and on their levels of physical activity. A second aim of this resaerch is thus to investigate the effect of lockdown measures on fatigue and/or musculoskeletal complaints, both new or already existing, in people living, working or studying in Belgium during these measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutch-speaking people living or working in Belgium | – | Other: QuestionnaireEvery participant was asked to complete a questionnaire about the impact of a COVID-19 infection and/or the impact of lockdown measures as a result of the COVID-19 pandemic on fatigue and musculoskeletal complaints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dutch-speaking people working or living in Belgium at the time of the pandemic and the lockdown measurements.
Key inclusion criteria (3 listed)
- Being at least 18 years old
- Living and/or working in Belgium
- Dutch speaking
Key exclusion criteria (2 listed)
- Being younger than 18 years of age
- Not working or living in Belgium during the pandemic and lockdown measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe questionnaire comprises demographics, job or school related questions, screen work questions, the International Physical Activity Questionnaire (IPAQ) and questions about the participant's health. | Other | Dutch-speaking people living or working in Belgium |
Primary outcome
Musculoskeletal complaints following a COVID-19 infection, through the International Physical Activities Questionnaire (IPAQ).
Time frame: 3 months
Fatigue following a COVID-19 infection, through the Checklist Individual Strength (CIS).
Time frame: 3 months
Musculoskeletal complaints caused by lockdown measures, through the IPAQ and the Short Inventory to Monitor Psychosocial Hazards.
Time frame: 3 months
No prior COVID-19 infection
Fatigue caused by lockdown measures, through the CIS and the Short Inventory to Monitor Psychosocial Hazards.
Time frame: 3 months
No prior COVID-19 infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- BackgroundWrzesinski,D.& Kluppels, L. (2020) Telewerken gedurende COVID-19.Hoe beleven telewerkers het al of niet gedwongen thuiswerken? Brussel, België: Vias institute -INNO_DSU_MOBI
- SciensanoLink provided by the sponsor.
- World Health OrganisationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jessica Van Oosterwijck, Prof study director
Ghent University, Pain in Motion
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, run by University Ghent at 1 site in Belgium.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 Dec 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal complaints following a COVID-19 infection, through the International Physical Activities Questionnaire (IPAQ). (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT05638685, which also lists 1 linked publication.
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 6 Dec 2022.