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Completed

NCT Number: NCT04860206

Post COVID19 Functional and Cognitive Assessments

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.

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Key information

Conditions

Covid19 COVID-19 Cognition Disorders Cognitive Decline Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Mobility Limitation Neurocognitive Disorders Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Aspiration Respiratory Disease Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases Walking, Difficulty

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SB Izola

Izola, Slovenia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Science and Research Centre Koper

Other

Collaborators

  • Hospital of Izola
  • University of Graz
  • University of Padova
  • University of Trieste

Registry information

Official study 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

Acronym: PostCovidZRS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2021
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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