Covid19PostCovidZRSNCT04860206
Post COVID19 Functional and Cognitive Assessments
An observational study of Covid19 and Respiratory Disease, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial summary
The main objective of the proposed study is to evaluate the impact of coronavirus (2019-nCoV), hereafter COVID -19, on patients' loss of functional capacity after completion of hospital treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, Respiratory Disease, Walking, Difficulty
- How many people
- 43 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Jan 2021to 30 Sep 2021
- 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 100 years
- All sexes
- Adult, Older adult
Study population: All male and female patients who tested positive for COVID -19 and were discharged from hospital care will be enrolled in the study.
Who may be able to join
- Completed hospital treatment after a positive COVID-19 test
- Signed written consent
Who cannot join
- Still testing positive for COVID -19 at discharge.
- Severe musculoskeletal injuries (e.g., disability).
- Inability to follow instructions when performing the test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vpliv COVID19 na Izgubo Funkcionalnih zmožnosti Pacientov po zaključenem bolnišničnem Zdravljenju The Effect of COVID19 on the Loss of Functional Capacity of Patients After Hospitalization
The main objective of the proposed study is to evaluate the impact of coronavirus (2019-nCoV), hereafter COVID -19, on patients' loss of functional capacity after completion of hospital treatment. Specifically, the research will focus on examining changes in musculoskeletal, cardiovascular, and respiratory function, as well as motor control. In addition, we aim to evaluate rehabilitation treatments after recovery from COVID -19 and consider additional preventive measures based on previous experience.
Read the detailed description
The combination of such a severe respiratory disease as COVID -19 with motor inactivity could have very serious consequences for a person's general health even after COVID -19 symptoms have subsided. To date, the effects of COVID -19 on individual muscle status have not been extensively studied. Therefore, the main objective of this study will be to evaluate the muscle status of patients after COVID -19. In addition, we will be interested in longitudinal monitoring of individuals' rehabilitation, where they will receive instructions based on measured outcomes at hospital discharge. We will also be interested in considering additional preventive measures for future patients based on previous experience of infected and hospitalized COVID -19 patients.
- Conditions
- Covid19, Respiratory Disease, Walking, Difficulty, Cognitive Decline
- Keywords
- COVID19, functional outcomes, respiratory function
- Medical subject headings
- COVID-19, Respiration Disorders, Mobility Limitation, Cognitive Dysfunction, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test (TUG)
Functional performance of the patients from sitting to standing, walking and turning
Measured: Change in time on TUG between both assessment points (pre- to 2 months post-measurement)
Pulse wave velocity (PWV)
Measuring endothelium function in supine
Measured: Change in PWV between both assessment points (pre- to 2 months post-measurement)
Spirometry
Measurement of lung function, specifically the forced vital capacity (FVC)
Measured: Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)
Secondary outcomes (2)
Walking velocity
measurement of gait velocity on the 4m path.
Measured: Change in gait velocity between both assessment points (pre- to 2 months post-measurement)
Trail making test B
Measurement of executive control using the TMT B test
Measured: Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start5 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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 Covid19Studies 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
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Izola, University of Trieste, University of Padova, University of Graz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860206
- Sponsor's protocol ID
- PC-ZRS-SBI
- Acronym
- PostCovidZRS
- Status last verified
- Sep 2022
- First submitted
- 20 Apr 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ammar A, Chtourou H, Boukhris O, Trabelsi K, Masmoudi L, Brach M, Bouaziz B, Bentlage E, How D, Ahmed M, Mueller P, Mueller N, Hsouna H, Aloui A, Hammouda O, Paineiras-Domingos LL, Braakman-Jansen A, Wrede C, Bastoni S, Pernambuco CS, Mataruna L, Taheri M, Irandoust K, Khacharem A, Bragazzi NL, Strahler J, Washif JA, Andreeva A, Khoshnami SC, Samara E, Zisi V, Sankar P, Ahmed WN, Romdhani M, Delhey J, Bailey SJ, Bott NT, Gargouri F, Chaari L, Batatia H, Ali GM, Abdelkarim O, Jarraya M, Abed KE, Souissi N, Gemert-Pijnen LV, Riemann BL, Riemann L, Moalla W, Gomez-Raja J, Epstein M, Sanderman R, Schulz S, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Simunic B, Pisot R, Pisot S, Gaggioli A, Zmijewski P, Apfelbacher C, Steinacker J, Saad HB, Glenn JM, Chamari K, Driss T, Hoekelmann A, On Behalf Of The Eclb-Covid Consortium. COVID-19 Home Confinement Negatively Impacts Social Participation and Life Satisfaction: A Worldwide Multicenter Study. Int J Environ Res Public Health. 2020 Aug 27;17(17):6237. doi: 10.3390/ijerph17176237.
PubMed 32867287Ammar A, Brach M, Trabelsi K, Chtourou H, Boukhris O, Masmoudi L, Bouaziz B, Bentlage E, How D, Ahmed M, Muller P, Muller N, Aloui A, Hammouda O, Paineiras-Domingos LL, Braakman-Jansen A, Wrede C, Bastoni S, Pernambuco CS, Mataruna L, Taheri M, Irandoust K, Khacharem A, Bragazzi NL, Chamari K, Glenn JM, Bott NT, Gargouri F, Chaari L, Batatia H, Ali GM, Abdelkarim O, Jarraya M, Abed KE, Souissi N, Van Gemert-Pijnen L, Riemann BL, Riemann L, Moalla W, Gomez-Raja J, Epstein M, Sanderman R, Schulz SV, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Simunic B, Pisot R, Gaggioli A, Bailey SJ, Steinacker JM, Driss T, Hoekelmann A. Effects of COVID-19 Home Confinement on Eating Behaviour and Physical Activity: Results of the ECLB-COVID19 International Online Survey. Nutrients. 2020 May 28;12(6):1583. doi: 10.3390/nu12061583.
PubMed 32481594Pisot R, Marusic U, Biolo G, Mazzucco S, Lazzer S, Grassi B, Reggiani C, Toniolo L, di Prampero PE, Passaro A, Narici M, Mohammed S, Rittweger J, Gasparini M, Gabrijelcic Blenkus M, Simunic B. Greater loss in muscle mass and function but smaller metabolic alterations in older compared with younger men following 2 wk of bed rest and recovery. J Appl Physiol (1985). 2016 Apr 15;120(8):922-9. doi: 10.1152/japplphysiol.00858.2015. Epub 2016 Jan 28.
PubMed 26823343Teraz K, Simunic B, Pisot R, Pisot S. Mediterranean diet adherence, body composition, and recovery outcomes in hospitalised COVID-19 patients: a mixed-methods study. Front Nutr. 2026 Jun 11;13:1834540. doi: 10.3389/fnut.2026.1834540. eCollection 2026.
PubMed 42370375
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vpliv COVID19 na Izgubo Funkcionalnih zmožnosti Pacientov po zaključenem bolnišničnem Zdravljenju The Effect of COVID19 on the Loss of Functional Capacity of Patients After Hospitalization
- ClinicalTrials.gov ID
- NCT04860206
- Acronym / sponsor ID
- PostCovidZRS / PC-ZRS-SBI
- Conditions
- Covid19, Respiratory Disease, Walking, Difficulty, Cognitive Decline
- Keywords
- COVID19, functional outcomes, respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- Hospital of Izola, University of Trieste, University of Padova, University of Graz
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Apr 2021 (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.
The main objective of the proposed study is to evaluate the impact of coronavirus (2019-nCoV), hereafter COVID -19, on patients' loss of functional capacity after completion of hospital treatment. Specifically, the research will focus on examining changes in musculoskeletal, cardiovascular, and respiratory function, as well as motor control. In addition, we aim to evaluate rehabilitation treatments after recovery from COVID -19 and consider additional preventive measures based on previous experience.
Detailed description
The combination of such a severe respiratory disease as COVID -19 with motor inactivity could have very serious consequences for a person's general health even after COVID -19 symptoms have subsided. To date, the effects of COVID -19 on individual muscle status have not been extensively studied. Therefore, the main objective of this study will be to evaluate the muscle status of patients after COVID -19. In addition, we will be interested in longitudinal monitoring of individuals' rehabilitation, where they will receive instructions based on measured outcomes at hospital discharge. We will also be interested in considering additional preventive measures for future patients based on previous experience of infected and hospitalized COVID -19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All male and female patients who tested positive for COVID -19 and were discharged from hospital care will be enrolled in the study.
Key inclusion criteria (2 listed)
- Completed hospital treatment after a positive COVID-19 test
- Signed written consent
Key exclusion criteria (3 listed)
- Still testing positive for COVID -19 at discharge.
- Severe musculoskeletal injuries (e.g., disability).
- Inability to follow instructions when performing the test.
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
Timed up and go test (TUG)
Time frame: Change in time on TUG between both assessment points (pre- to 2 months post-measurement)
Functional performance of the patients from sitting to standing, walking and turning
Pulse wave velocity (PWV)
Time frame: Change in PWV between both assessment points (pre- to 2 months post-measurement)
Measuring endothelium function in supine
Spirometry
Time frame: Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)
Measurement of lung function, specifically the forced vital capacity (FVC)
2 secondary outcomes
Walking velocity
Time frame: Change in gait velocity between both assessment points (pre- to 2 months post-measurement)
Trail making test B
Time frame: Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)
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 21 Sep 2022.
- Background: PubMed 32867287Ammar A, Chtourou H, Boukhris O, Trabelsi K, Masmoudi L, Brach M, Bouaziz B, Bentlage E, How D, Ahmed M, Mueller P, Mueller N, Hsouna H, Aloui A, Hammouda O, Paineiras-Domingos LL, Braakman-Jansen A, Wrede C, Bastoni S, Pernambuco CS, Mataruna L, Taheri M, Irandoust K, Khacharem A, Bragazzi NL, Strahler J, Washif JA, Andreeva A, Khoshnami SC, Samara E, Zisi V, Sankar P, Ahmed WN, Romdhani M, Delhey J, Bailey SJ, Bott NT, Gargouri F, Chaari L, Batatia H, Ali GM, Abdelkarim O, Jarraya M, Abed KE, Souissi N, Gemert-Pijnen LV, Riemann BL, Riemann L, Moalla W, Gomez-Raja J, Epstein M, Sanderman R, Schulz S, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Simunic B, Pisot R, Pisot S, Gaggioli A, Zmijewski P, Apfelbacher C, Steinacker J, Saad HB, Glenn JM, Chamari K, Driss T, Hoekelmann A, On Behalf Of The Eclb-Covid Consortium. COVID-19 Home Confinement Negatively Impacts Social Participation and Life Satisfaction: A Worldwide Multicenter Study. Int J Environ Res Public Health. 2020 Aug 27;17(17):6237. doi: 10.3390/ijerph17176237.
- Background: PubMed 32481594Ammar A, Brach M, Trabelsi K, Chtourou H, Boukhris O, Masmoudi L, Bouaziz B, Bentlage E, How D, Ahmed M, Muller P, Muller N, Aloui A, Hammouda O, Paineiras-Domingos LL, Braakman-Jansen A, Wrede C, Bastoni S, Pernambuco CS, Mataruna L, Taheri M, Irandoust K, Khacharem A, Bragazzi NL, Chamari K, Glenn JM, Bott NT, Gargouri F, Chaari L, Batatia H, Ali GM, Abdelkarim O, Jarraya M, Abed KE, Souissi N, Van Gemert-Pijnen L, Riemann BL, Riemann L, Moalla W, Gomez-Raja J, Epstein M, Sanderman R, Schulz SV, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Simunic B, Pisot R, Gaggioli A, Bailey SJ, Steinacker JM, Driss T, Hoekelmann A. Effects of COVID-19 Home Confinement on Eating Behaviour and Physical Activity: Results of the ECLB-COVID19 International Online Survey. Nutrients. 2020 May 28;12(6):1583. doi: 10.3390/nu12061583.
- Background: PubMed 26823343Pisot R, Marusic U, Biolo G, Mazzucco S, Lazzer S, Grassi B, Reggiani C, Toniolo L, di Prampero PE, Passaro A, Narici M, Mohammed S, Rittweger J, Gasparini M, Gabrijelcic Blenkus M, Simunic B. Greater loss in muscle mass and function but smaller metabolic alterations in older compared with younger men following 2 wk of bed rest and recovery. J Appl Physiol (1985). 2016 Apr 15;120(8):922-9. doi: 10.1152/japplphysiol.00858.2015. Epub 2016 Jan 28.
- Derived from this study: PubMed 42370375Teraz K, Simunic B, Pisot R, Pisot S. Mediterranean diet adherence, body composition, and recovery outcomes in hospitalised COVID-19 patients: a mixed-methods study. Front Nutr. 2026 Jun 11;13:1834540. doi: 10.3389/fnut.2026.1834540. eCollection 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Respiratory Disease, run by Science and Research Centre Koper at 1 site in Slovenia.
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 2 inclusion and 3 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 21 Sep 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 Slovenia. 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?
Timed up and go test (TUG) (time frame: Change in time on TUG between both assessment points (pre- to 2 months post-measurement)). The study lists 3 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 NCT04860206, 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 21 Sep 2022.