Post COVID19 Functional and Cognitive Assessments

Completed

• Conditions: Covid19; Cognitive Decline; Respiratory Disease; Walking, Difficulty

• Registration Number: NCT04860206
• Lead Sponsor: Science and Research Centre Koper

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.

Study Timeline

• Study Start: 2021-01-05
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse wave velocity (PWV)	Change in PWV between both assessment points (pre- to 2 months post-measurement)	Measuring endothelium function in supine
Spirometry	Change in FVC (%) between both assessment points (pre- to 2 months post-measurement)	Measurement of lung function, specifically the forced vital capacity (FVC)
Timed up and go test (TUG)	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

Secondary Outcome Measures

Name	Time	Method
Trail making test B	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
Walking velocity	Change in gait velocity between both assessment points (pre- to 2 months post-measurement)	measurement of gait velocity on the 4m path.

Trial Locations

Locations (1)

SB Izola; 🇸🇮 Izola, Slovenia