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CompletedNCT04860206PostCovidZRSUpdated Sep 21, 2022

Post COVID19 Functional and Cognitive Assessments

An observational study in Covid19, Respiratory Disease and Walking, Difficulty, sponsored by Science and Research Centre Koper. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Science and Research Centre Koper · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Ages
18 Years to 100 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Covid19
  • Respiratory Disease
  • Walking, Difficulty
  • Cognitive Decline

Keywords

  • COVID19
  • functional outcomes
  • respiratory function
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 43 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Science and Research Centre Koper is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Completed hospital treatment after a positive COVID-19 test
  • Signed written consent

Exclusion criteria

Exclusion Criteria:

  • Still testing positive for COVID -19 at discharge.
  • Severe musculoskeletal injuries (e.g., disability).
  • Inability to follow instructions when performing the test.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Timed up and go test (TUG)

    Functional performance of the patients from sitting to standing, walking and turning

    Time frame: Change in time on TUG between both assessment points (pre- to 2 months post-measurement)

  2. Pulse wave velocity (PWV)

    Measuring endothelium function in supine

    Time frame: Change in PWV between both assessment points (pre- to 2 months post-measurement)

  3. Spirometry

    Measurement of lung function, specifically the forced vital capacity (FVC)

    Time frame: Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)

Secondary outcomes

  1. Walking velocity

    measurement of gait velocity on the 4m path.

    Time frame: Change in gait velocity between both assessment points (pre- to 2 months post-measurement)

  2. Trail making test B

    Measurement of executive control using the TMT B test

    Time frame: Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)

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Study locations

1 site
  • SB Izola
    Izola, Slovenia
08

References and documents

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 32867287 ↗
  • Ammar 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 32481594 ↗
  • Pisot 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 26823343 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04860206
Lead sponsor
Science and Research Centre Koper
Collaborators
Hospital of Izola, University of Trieste, University of Padova, University of Graz
Responsible party
Sponsor
First posted
Apr 26, 2021
Start date
Jan 5, 2021
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Sep 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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