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Clinical and Functional Characteristics of Patients Admitted for Severe COVID-19 Pneumonia

NCT06727474 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2026-04-17

No results posted yet for this study

Summary

This research protocol aims to evaluate the impact of severe COVID-19 pneumonia requiring invasive mechanical ventilation (IMV) on health-related quality of life (HRQoL), functional capacity, muscle strength, and nutritional status one year after discharge from the ICU. The study is analytical, longitudinal, and prospective, involving patients over 18 years who received IMV for more than 72 hours and were discharged alive. Primary outcomes include changes in HRQoL (assessed using EQ-5D-3L and VAS), functional capacity (Katz Index and Timed Up and Go test), muscle strength (MRC scale), and nutritional status (BMI and limb circumferences). Secondary outcomes include time to return to work and one-year mortality. Data collection occurs at discharge and at one, six, and twelve months post-discharge. Statistical analyses involve descriptive statistics and longitudinal comparisons using Friedman and Dunn-Bonferroni tests. Ethical approval has been secured, and patient anonymity will be ensured. The protocol emphasizes multidisciplinary follow-up to identify and address physical and psychological sequelae effectively.

Conditions

Interventions

DIAGNOSTIC_TEST

Health-Related Quality of Life (HRQoL) with EQ-5D-3L

The EQ-5D-3L and EQ-VAS questionnaires, administered at all visits, evaluated five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Responses generated a Health Status sequence and calculated the EQ-5D-3L Index. A visual analogue scale (VAS) rated health from 0 (worst) to 100 (best). Functional capacity was assessed using the Katz Index (IK) and Timed Up and Go (TUG), which measured the time to rise from a chair, walk 3 meters, and return. Anthropometric variables, measured by the same researcher (LP) at 1 month and 1 year, included limb circumferences using specific techniques. Muscle strength, evaluated with the EF-MRC scale, involved verbal commands for movement tests. Calf circumference was measured on the largest circumference area. Living conditions and work reintegration were recorded. Health issues detected during follow-up were referred to the clinic's coordinating physician for appropriate care.

Sponsors & Collaborators

  • Hospital Nacional Profesor Alejandro Posadas

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-12-31
Completion
2021-04-01

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06727474 on ClinicalTrials.gov