Post COVID19 Functional and Cognitive Assessments (PostCovidZRS)

September 18, 2022 updated by: Science and Research Centre Koper

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change in time on TUG between both assessment points (pre- to 2 months post-measurement)
Pulse wave velocity (PWV)
Time Frame: Change in PWV between both assessment points (pre- to 2 months post-measurement)
Measuring endothelium function in supine
Change in PWV between both assessment points (pre- to 2 months post-measurement)
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)
Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change in gait velocity between both assessment points (pre- to 2 months post-measurement)
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
Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Science and Research Centre Koper

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Trieste
University of Padova
Hospital of Izola
University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PC-ZRS-SBI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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