Clinical trial NCT04860206: Post COVID19 Functional and Cognitive Assessments
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Respiratory Disease
Walking, Difficulty
Cognitive Decline
Keywords: COVID19
functional outcomes
respiratory function
Lead sponsor: Science and Research Centre Koper
Sponsor class: OTHER
Collaborators: name: Hospital of Izola
name: University of Trieste
name: University of Padova
name: University of Graz
First posted: 2021-04-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Timed up and go test (TUG)
timeFrame: Change in time on TUG between both assessment points (pre- to 2 months post-measurement)
measure: Pulse wave velocity (PWV)
timeFrame: Change in PWV between both assessment points (pre- to 2 months post-measurement)
measure: Spirometry
timeFrame: Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)
Secondary outcomes:
measure: Walking velocity
timeFrame: Change in gait velocity between both assessment points (pre- to 2 months post-measurement)
measure: Trail making test B
timeFrame: Change in time to solve the TMT B test between both assessment points (pre- to 2 months post-measurement)
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: SB Izola
Study officials:
References:
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