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Post COVID19 Functional and Cognitive Assessments (PostCovidZRS)

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ClinicalTrials.gov Identifier: NCT04860206
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
Hospital of Izola
University of Trieste
University of Padova
University of Graz
Information provided by (Responsible Party):
Science and Research Centre Koper

Study Description
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Brief 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.

Condition or disease
Covid19 Respiratory Disease Walking, Difficulty Cognitive Decline

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
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Pulse wave velocity (PWV) [ Time Frame: Change in PWV between both assessment points (pre- to 2 months post-measurement) ]
    Measuring endothelium function in supine

  3. 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)


Secondary Outcome Measures :
  1. Walking velocity [ Time Frame: Change in gait velocity between both assessment points (pre- to 2 months post-measurement) ]
    measurement of gait velocity on the 4m path.

  2. 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) ]
    Measurement of executive control using the TMT B test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Still testing positive for COVID -19 at discharge.
  • Severe musculoskeletal injuries (e.g., disability).
  • Inability to follow instructions when performing the test.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860206


Contacts
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Contact: Rado Pisot, PhD +386 5 663 77 00 rado.pisot@zrs-kp.si
Contact: Mladen Gasparini, PhD, MD +386 5 660 60 00 mladen.gasparini@sb-izola.si

Locations
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Slovenia
SB Izola Recruiting
Izola, Slovenia
Contact: Rado Pisot, PhD       rado.pisot@zrs-kp.si   
Sponsors and Collaborators
Science and Research Centre Koper
Hospital of Izola
University of Trieste
University of Padova
University of Graz
More Information
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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, Gómez-Raja J, Epstein M, Sanderman R, Schulz S, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Šimunič B, Pišot R, Pišot 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). pii: E6237. doi: 10.3390/ijerph17176237.
Ammar A, Brach M, Trabelsi K, Chtourou H, Boukhris O, Masmoudi L, Bouaziz B, Bentlage E, How D, Ahmed M, Müller P, Müller 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, Gómez-Raja J, Epstein M, Sanderman R, Schulz SV, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Šimunič B, Pišot 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). pii: E1583. doi: 10.3390/nu12061583.

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Responsible Party: Science and Research Centre Koper
ClinicalTrials.gov Identifier: NCT04860206    
Other Study ID Numbers: PC-ZRS-SBI
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Science and Research Centre Koper:
COVID19
functional outcomes
respiratory function
Additional relevant MeSH terms:
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COVID-19
Respiration Disorders
Respiratory Tract Diseases
Mobility Limitation
Cognitive Dysfunction
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders