Post COVID19 Functional and Cognitive Assessments

NCT04860206 | Completed

• 1 other identifier: PC-ZRS-SBI
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Respiratory Disease; Walking, Difficulty; Cognitive Decline

Keywords

COVID19; functional outcomes; respiratory function

Outcome Measures

Primary Outcomes (3)

• 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)

• Pulse wave velocity (PWV)

  Measuring endothelium function in supine

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

• 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 Outcomes (2)

• Walking velocity

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

• Trail making test B

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Science and Research Centre Koper: lead
• Hospital of Izola: collaborator
• University of Trieste: collaborator
• University of Padova: collaborator
• University of Graz: collaborator

Study Sites (1)

SB Izola

Izola, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 32867287 BACKGROUND

• 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.

  PMID: 32481594 BACKGROUND

• 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.

  PMID: 26823343 BACKGROUND

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Mobility Limitation; Cognitive Dysfunction; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 26, 2021
• Study Start: January 5, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)