Post COVID19 Functional and Cognitive Assessments

Covid19 Clinical Trial

— PostCovidZRS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860206
• Other study ID #: PC-ZRS-SBI
• Status: Completed
• Start date: January 5, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2022
• Source: Science and Research Centre Koper
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• COVID-19
• Covid19
• Mobility Limitation
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Walking, Difficulty

Locations

Country	Name	City	State
Slovenia	SB Izola	Izola

Sponsors (5)

Lead Sponsor	Collaborator
Science and Research Centre Koper	Hospital of Izola, University of Graz, University of Padova, University of Trieste

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

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, Šimunic 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. — View Citation

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, Šimunic 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. — View Citation

Pišot 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 Blenkuš M, Šimunic 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and go test (TUG)	Functional performance of the patients from sitting to standing, walking and turning	Change in time on TUG between both assessment points (pre- to 2 months post-measurement)
Primary	Pulse wave velocity (PWV)	Measuring endothelium function in supine	Change in PWV between both assessment points (pre- to 2 months post-measurement)
Primary	Spirometry	Measurement of lung function, specifically the forced vital capacity (FVC)	Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)
Secondary	Walking velocity	measurement of gait velocity on the 4m path.	Change in gait velocity between both assessment points (pre- to 2 months post-measurement)
Secondary	Trail making test B	Measurement of executive control using the TMT B test	Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)