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Completed

NCT Number: NCT06727474

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ladislao Diaz Ballve

Haedo, Buenos Aires, 1706, Argentina

About this study

This study aims to evaluate the long-term impact of severe COVID-19 pneumonia on patients requiring invasive mechanical ventilation (IMV) for more than 72 hours. Specifically, it examines health-related quality of life (HRQoL), functional capacity, muscle strength, nutritional status, and work reintegration at various time points up to one year after ICU discharge. Additionally, it assesses one-year post-hospital discharge mortality and the time required for patients to return to work.

The study employs a prospective, longitudinal design, following a cohort of patients aged 18 years and older discharged alive from the ICU. Participants were selected based on strict inclusion criteria, such as confirmed COVID-19 pneumonia requiring IMV for over 72 hours and the ability to provide informed consent. Exclusion criteria included cognitive impairment, prior tracheostomy, or pre-existing indications for home mechanical ventilation. The population was evaluated across four defined time points: before hospital discharge (Visit 0), at one month (Visit 1), at six months (Visit 2), and at one year post-discharge (Visit 3).

Clinical, demographic, and functional data were collected through validated tools. HRQoL was assessed using the EQ-5D-3L index and visual analog scale (VAS), while functional capacity was measured with the Katz Index and the Timed Up and Go (TUG) test. Muscle strength was evaluated using the Medical Research Council (MRC) scale, and nutritional status was determined through BMI and anthropometric measurements, including arm, waist, and calf circumferences. Additional data included work reintegration and mortality outcomes, tracked through patient interviews and medical records.

Data analysis employed robust statistical methods to identify trends and differences across time points. Descriptive statistics summarized demographic and baseline clinical characteristics. Longitudinal comparisons were conducted using repeated measures ANOVA or Friedman tests, with post-hoc analysis (Bonferroni or Dunn-Bonferroni) to evaluate significant pairwise differences. For comparisons involving only two time points, paired t-tests or Wilcoxon signed-rank tests were used as appropriate. All analyses adhered to a significance threshold of p < 0.05, and data visualization was performed using SPSS and R software packages.

Ethical considerations were rigorously maintained. The study was approved by the Ethics Committee of the Hospital Nacional Prof. Alejandro Posadas, and informed consent was obtained from all participants. Patient anonymity was preserved using unique coded identifiers, and all procedures complied with established guidelines for research integrity and participant safety.

Preliminary results indicate significant improvements in HRQoL, functional capacity, and muscle strength over the one-year follow-up period. However, persistent challenges such as delayed work reintegration and moderate mortality rates highlight the complex recovery trajectory of critically ill COVID-19 survivors. This study underscores the importance of structured, multidisciplinary follow-up programs to address the physical, nutritional, and psychosocial needs of this vulnerable population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • discharged alive from the ICU
  • over 18 years of age
  • diagnosis of admission or reason for hospitalization in the ICU of pneumonia due to COVID-19, all had to have confirmed the presence of SARS-CoV-2 as a causative agent by a positive result of a real-time reverse transcriptase polymerase chain reaction assay with nasopharyngeal swab samples or tracheal aspirated respiratory airway sample.
  • have received invasive mechanical ventilatory assistance for more than 72 hours
  • the patient or a close family member had agreed to participate in the study by signing the informed consent.

Exclusion criteria

  • patients in jail at the time of admission to the ICU.
  • history of dementia or cognitive impairment.
  • those who already had a previous tracheostomy for any reason
  • prior to admission to the ICU indication of prolonged mechanical ventilation at home or in a chronic care institution

Treatment and study plan

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

Diagnostic Test

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.

Other names: EuroQol-5D VAS (Analog visual scale), Medical Reseacrh Council Strength Scale, Katz index for functional independence, Timed Up to Go test, Waist Circunference, Brachial Circumference, Calf Circumference

Primary outcomes

  1. Health-related quality of life (HRQoL)

    Time frame: 1 year

    The percentage of change in health-related quality of life (HRQoL) will be measured. This is a multidimensional concept that assesses the physical, psychological and social aspects of an individual's well-being, specifically as it is influenced by their health status.

    This study assesses health-related quality of life using the EuroQol-5 Dimension 3 Level (EQ-5D-3L) questionnaire. The EQ-5D-3L includes a descriptive system that covers five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (VAS) that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Unit of measurement: EQ-5D-3L Index: a calculated score derived from the descriptive system that reflects overall health-related quality of life.

    EQ-5D VAS: a self-reported numerical score that represents perceived health status.

  2. Functional capacity

    Time frame: 1 year

    Measured through The Katz Index assesses functional independence in six basic activities of daily living: bathing, dressing, toileting, transferring, continence, and feeding.

    Unit of Measure: Score on the Katz Index (range 0-6, where 6 indicates full independence).

    Outcome Measure 2: Functional Mobility - Timed Up and Go (TUG) Test The TUG test measures functional mobility by recording the time (in seconds) it takes for a participant to stand from a seated position, walk 3 meters, turn around, walk back, and sit down.

    Unit of Measure:

    Time in seconds.

    Time Frame:

    Assessed at three time points: at one month, at six months, and one year post-discharge (not applicable before hospital discharge as participants may not be ambulatory).

  3. Functional capacity

    Time frame: 1 year

    Measured through Time up to go (TUG) test. The TUG test measures functional mobility by recording the time (in seconds) it takes for a participant to stand from a seated position, walk 3 meters, turn around, walk back, and sit down.

    Unit of Measure: Time in seconds. The Katz Index assesses functional independence in six basic activities of daily living: bathing, dressing, toileting, transferring, continence, and feeding.

    Unit of Measure: Score on the Katz Index (range 0-6, where 6 indicates full independence).

  4. Muscle Strength

    Time frame: 1 year

    Measured through Medical Research Council (MRC) Strength Scale: The MRC Strength Scale evaluates muscle strength across six muscle groups in both upper and lower limbs. Each group is scored on a 6-point scale ranging from 0 (no movement) to 5 (normal strength), with a total score ranging from 0 to 60.

    Unit of Measure:

    Total score on the MRC Strength Scale (range 0-60, where higher scores indicate better muscle strength).

  5. Anthropometric variables - Body mass index

    Time frame: 1 year

    current Weight in kilograms (kg) and Height in meters (m) for calculation of body mass index (BMI). BMI is calculated as weight (kg) divided by height squared (m²).

    Unit of Measure: BMI in kg/m².

  6. Anthropometric variables -

    Time frame: 1 year

    WC is measured using a non-stretchable measuring tape at the midpoint between the last rib and the iliac crest.

    Unit of Measure: Circumference in centimeters (cm).

  7. Anthropometric variables - Arm Circumference (AC)

    Time frame: 1 year

    AC is measured at the midpoint between the acromion and the olecranon. Unit of Measure: Circumference in centimeters (cm).

  8. Anthropometric variables - Calf Circumference (CC)

    Time frame: 1 year

    CC is measured at the point of maximum circumference of the calf. Unit of Measure: Circumference in centimeters (cm).

Secondary outcomes

  1. Number of patients who returned to work

    Time frame: 1 year

    patients who had stated that they had been working prior to hospitalization were asked about the return to work.

    Unit of Measure: Number of participants (count).

  2. Number of Participants Who Died During the One-Year Follow-Up

    Time frame: 1 year

    Mortality was determined by reviewing medical records and contacting patients or their families if they missed a scheduled clinic visit. The reason for non-attendance was investigated, and deaths were recorded when confirmed.

    Unit of Measure: Number of participants (count).

Sponsors and collaborators

Lead sponsor

Hospital Nacional Profesor Alejandro Posadas

Other

Registry information

Official study title

Evolution of Quality of Life, Functional Capacity, Nutritional Status and Return to Work Activity in Patients Admitted for Severe Pneumonia Due to COVID 19 Requiring Invasive Mechanical Ventilation

Acronym: EQOL-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 11, 2024
Registry last updated
Apr 17, 2026

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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