Post-intensive Care SyndromeEQOL-COVIDNCT06727474
Clinical and Functional Characteristics of Patients Admitted for Severe COVID-19 Pneumonia
An observational study of Post-intensive Care Syndrome and COVID-19, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-intensive Care Syndrome, COVID-19
- What is being tested?
- Health-Related Quality of Life (HRQoL) with EQ-5D-3L
- How many people
- 51 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the period between June and December 2020, all patients who were discharged alive from the ICU, were referred to the general hospitalization ward and were discharged from hospital were included
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Post-intensive Care Syndrome, COVID-19
- Being tested
- Health-Related Quality of Life (HRQoL) with EQ-5D-3L
- Keywords
- COVID-19, health-related quality of life, functional capacity, nutritional status, reintegration into work, post-intensive care syndrome
- Medical subject headings
- postintensive care syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-Related Quality of Life (HRQoL) with EQ-5D-3LDiagnostic test
Also called EuroQol-5D VAS (Analog visual scale), Medical Reseacrh Council Strength Scale, Katz index for functional independence, Timed Up to Go 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.
| Study group | Role | What they receive |
|---|---|---|
| Follow up cohort | Discharged alive from the ICU and admitted to the follow-up program. Programed scheduled visits, which included an evaluation at one month, six months, and one year after hospital discharge Receives: Diagnostic Test: Health-Related Quality of Life (HRQoL) with EQ-5D-3L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL)
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.
Measured: 1 year
Functional capacity
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).
Measured: 1 year
Functional capacity
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).
Measured: 1 year
Muscle Strength
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).
Measured: 1 year
Anthropometric variables - Body mass index
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.
Measured: 1 year
Anthropometric variables -
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).
Measured: 1 year
Anthropometric variables - Arm Circumference (AC)
AC is measured at the midpoint between the acromion and the olecranon. Unit of Measure: Circumference in centimeters (cm).
Measured: 1 year
Anthropometric variables - Calf Circumference (CC)
CC is measured at the point of maximum circumference of the calf. Unit of Measure: Circumference in centimeters (cm).
Measured: 1 year
Secondary outcomes (2)
Number of patients who returned to work
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).
Measured: 1 year
Number of Participants Who Died During the One-Year Follow-Up
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post-intensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Profesor Alejandro Posadas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727474
- Sponsor's protocol ID
- 01-2024
- Acronym
- EQOL-COVID
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PubMed 21946660Demoule A, Morawiec E, Decavele M, Ohayon R, Malrin R, Galarza-Jimenez MA, Laveneziana P, Morelot-Panzini C, Similowski T, De Rycke Y, Gonzalez-Bermejo J. Health-related quality of life of COVID-19 two and 12 months after intensive care unit admission. Ann Intensive Care. 2022 Feb 20;12(1):16. doi: 10.1186/s13613-022-00991-0.
PubMed 35184214Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Wang X, Xu H, Jiang H, Wang L, Lu C, Wei X, Liu J, Xu S. Clinical features and outcomes of discharged coronavirus disease 2019 patients: a prospective cohort study. QJM. 2020 Sep 1;113(9):657-665. doi: 10.1093/qjmed/hcaa178.
PubMed 32442308Pironi L, Sasdelli AS, Ravaioli F, Baracco B, Battaiola C, Bocedi G, Brodosi L, Leoni L, Mari GA, Musio A. Malnutrition and nutritional therapy in patients with SARS-CoV-2 disease. Clin Nutr. 2021 Mar;40(3):1330-1337. doi: 10.1016/j.clnu.2020.08.021. Epub 2020 Aug 27.
PubMed 32900518Whittle J, Molinger J, MacLeod D, Haines K, Wischmeyer PE; LEEP-COVID Study Group. Persistent hypermetabolism and longitudinal energy expenditure in critically ill patients with COVID-19. Crit Care. 2020 Sep 28;24(1):581. doi: 10.1186/s13054-020-03286-7. No abstract available.
PubMed 32988390Alvarez-Hernandez J, Matia-Martin P, Cancer-Minchot E, Cuerda C; NUTRICOVID study group of SENDIMAD. Long-term outcomes in critically ill patients who survived COVID-19: The NUTRICOVID observational cohort study. Clin Nutr. 2023 Oct;42(10):2029-2035. doi: 10.1016/j.clnu.2023.08.008. Epub 2023 Aug 16.
PubMed 37659250Kamdar BB, Suri R, Suchyta MR, Digrande KF, Sherwood KD, Colantuoni E, Dinglas VD, Needham DM, Hopkins RO. Return to work after critical illness: a systematic review and meta-analysis. Thorax. 2020 Jan;75(1):17-27. doi: 10.1136/thoraxjnl-2019-213803. Epub 2019 Nov 8.
PubMed 31704795Das Neves AV, Vasquez DN, Loudet CI, Intile D, Saenz MG, Marchena C, Gonzalez AL, Moreira J, Reina R, Estenssoro E. Symptom burden and health-related quality of life among intensive care unit survivors in Argentina: A prospective cohort study. J Crit Care. 2015 Oct;30(5):1049-54. doi: 10.1016/j.jcrc.2015.05.021. Epub 2015 Jun 3.
PubMed 26105747
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06727474
- Acronym / sponsor ID
- EQOL-COVID / 01-2024
- Conditions
- Post-intensive Care Syndrome, COVID-19
- Keywords
- COVID-19, health-related quality of life, functional capacity, nutritional status, reintegration into work, post-intensive care syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital Nacional Profesor Alejandro PosadasUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow up cohort | – | Diagnostic Test: Health-Related Quality of Life (HRQoL) with EQ-5D-3LDischarged alive from the ICU and admitted to the follow-up program. Programed scheduled visits, which included an evaluation at one month, six months, and one year after hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the period between June and December 2020, all patients who were discharged alive from the ICU, were referred to the general hospitalization ward and were discharged from hospital were included
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-Related Quality of Life (HRQoL) with EQ-5D-3LAlso: EuroQol-5D VAS (Analog visual scale), Medical Reseacrh Council Strength Scale, Katz index for functional independence, Timed Up to Go testThe 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. | Diagnostic test | Follow up cohort |
Primary outcome
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.
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).
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).
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).
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.
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).
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).
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).
2 secondary outcomes
Number of patients who returned to work
Time frame: 1 year
Number of Participants Who Died During the One-Year Follow-Up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 21946660Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
- Results publication: PubMed 35184214Demoule A, Morawiec E, Decavele M, Ohayon R, Malrin R, Galarza-Jimenez MA, Laveneziana P, Morelot-Panzini C, Similowski T, De Rycke Y, Gonzalez-Bermejo J. Health-related quality of life of COVID-19 two and 12 months after intensive care unit admission. Ann Intensive Care. 2022 Feb 20;12(1):16. doi: 10.1186/s13613-022-00991-0.
- Results publication: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Results publication: PubMed 32442308Wang X, Xu H, Jiang H, Wang L, Lu C, Wei X, Liu J, Xu S. Clinical features and outcomes of discharged coronavirus disease 2019 patients: a prospective cohort study. QJM. 2020 Sep 1;113(9):657-665. doi: 10.1093/qjmed/hcaa178.
- Results publication: PubMed 32900518Pironi L, Sasdelli AS, Ravaioli F, Baracco B, Battaiola C, Bocedi G, Brodosi L, Leoni L, Mari GA, Musio A. Malnutrition and nutritional therapy in patients with SARS-CoV-2 disease. Clin Nutr. 2021 Mar;40(3):1330-1337. doi: 10.1016/j.clnu.2020.08.021. Epub 2020 Aug 27.
- Results publication: PubMed 32988390Whittle J, Molinger J, MacLeod D, Haines K, Wischmeyer PE; LEEP-COVID Study Group. Persistent hypermetabolism and longitudinal energy expenditure in critically ill patients with COVID-19. Crit Care. 2020 Sep 28;24(1):581. doi: 10.1186/s13054-020-03286-7. No abstract available.
- Results publication: PubMed 37659250Alvarez-Hernandez J, Matia-Martin P, Cancer-Minchot E, Cuerda C; NUTRICOVID study group of SENDIMAD. Long-term outcomes in critically ill patients who survived COVID-19: The NUTRICOVID observational cohort study. Clin Nutr. 2023 Oct;42(10):2029-2035. doi: 10.1016/j.clnu.2023.08.008. Epub 2023 Aug 16.
- Results publication: PubMed 31704795Kamdar BB, Suri R, Suchyta MR, Digrande KF, Sherwood KD, Colantuoni E, Dinglas VD, Needham DM, Hopkins RO. Return to work after critical illness: a systematic review and meta-analysis. Thorax. 2020 Jan;75(1):17-27. doi: 10.1136/thoraxjnl-2019-213803. Epub 2019 Nov 8.
- Results publication: PubMed 26105747Das Neves AV, Vasquez DN, Loudet CI, Intile D, Saenz MG, Marchena C, Gonzalez AL, Moreira J, Reina R, Estenssoro E. Symptom burden and health-related quality of life among intensive care unit survivors in Argentina: A prospective cohort study. J Crit Care. 2015 Oct;30(5):1049-54. doi: 10.1016/j.jcrc.2015.05.021. Epub 2015 Jun 3.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-intensive Care Syndrome and COVID-19, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06727474, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.