Post Intensive Care Unit SyndromeNCT04608994
Long-term Follow up in Survivors of Critical Illness
An observational study of Post Intensive Care Unit Syndrome, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Survivors of critical illness may suffer from persistent physical, cognitive and mental impairments, such as muscle weakness, dysfunction in the memory and executive domains, post-traumatic stress disorders, depression, and anxiety. This syndrome is referred to as Post Intensive Care Syndrome (PICS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Intensive Care Unit Syndrome
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will enroll all patients admitted to the ICUs with SARS-CoV-2 pneumonia and ARDS.
Who may be able to join
- All COVID-19 patients admitted to the ICUs of the Spedali Civili University Hospital in Brescia, Italy.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST- Spedali Civili di Brescia
Brescia, 25123
Simone Piva, +393332564230 ext. +393332564230, simone.piva@unibs.it
Nicola Latronico, Professor, +393384842664, nicola.latronico@unibs.it
About this study
Official title: Long-term Follow-up in Survivors of Critical Illness: An Longitudinal Assessment of Critically Ill Patients Discharged Alive From the Intensive Care Unit
Survivors of critical illness may suffer from persistent physical, cognitive and mental impairments, such as muscle weakness, dysfunction in the memory and executive domains, post-traumatic stress disorders, depression, and anxiety. This syndrome is referred to as Post Intensive Care Syndrome (PICS).
This study aims to assess the frequency of impairments, their evolution over time, and to understand the pathogenetic mechanisms and the association between long-term sequelae and acute care events.
Read the detailed description
PICS describes 'new or worsening impairments in physical, cognitive or mental health status arising after critical illness and persisting beyond acute care hospitalization'. Different critical care professional and scientific societies have identified long-term functional outcomes after critical illness as an important target for research and clinical improvements, and there is general agreement that research on PICS should be a priority for the critical care community.
Post-ICU subjects may experience physical problems, such as muscles weakness and wasting, caused by prolonged bed rest and immobility during the ICU stay and by critical illness polyneuropathy and myopathy developing during the acute illness; organ dysfunction; chronic pain; mental health problems including depression, anxiety or post-traumatic stress disorder (PTSD); and neurocognitive impairments which are predominantly represented by memory dysfunction and executive function impairment. The impact of these problems on the subject's health status is huge, which reduced quality of life, and impaired functional status, and daily functioning.
Many survivors incur substantial healthcare costs, lose employment, and find their social networks wholly changed. The costs to subjects and families are high: ICU survivorship is associated with decreased return to work, and the loss of earnings plagues both patients and caregivers.
Prior studies in which researchers have examined outcomes among ICU survivors have been mainly restricted their assessments to specific patient populations and have used only limited outcome measures or the follow-up period was relatively short-term. Moreover, few studies have explored the association between acute care events and long-term sequelae as well as the underlying pathophysiological mechanisms.
The researchers appertaining to the present study implemented a follow-up clinic to describe the frequency of physical, cognitive, and mental impairments and their evolution over time in subjects surviving critical illness. The researchers also aim at understanding the pathogenetic mechanisms underlying these impairments and their association with acute care events.
- Conditions
- Post Intensive Care Unit Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Research Council (MRC) sum score
Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (<36).
Measured: 3 months
Medical Research Council (MRC) sum score
Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (<36).
Measured: 6 months
Medical Research Council (MRC) sum score
Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (<36).
Measured: 12 months
Dominand Handgrip Test
Dynamometry will be considered normal if >11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: <20% PNV; 20%<=PNV< 40%; 40%<=PNV< 60%; 60%<= PNV< 80%, and >=80 PNV. [DOI: 10.1016/j.clnu.2008.04.004]
Measured: 3 months
Dominand Handgrip Test
Dynamometry will be considered normal if >11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: <20% PNV; 20%<=PNV< 40%; 40%<=PNV< 60%; 60%<= PNV< 80%, and >=80 PNV. [DOI: 10.1016/j.clnu.2008.04.004]
Measured: 6 months
Dominand Handgrip Test
Dynamometry will be considered normal if >11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: <20% PNV; 20%<=PNV< 40%; 40%<=PNV< 60%; 60%<= PNV< 80%, and >=80 PNV. [DOI: 10.1016/j.clnu.2008.04.004]
Measured: 12 months
Six Minutes Walking Test
Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight
Measured: 3 months
Six Minutes Walking Test
Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight
Measured: 6 months
SIX Minutes Walking Test
Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight
Measured: 12 months
Fatigue Severity Scale (FSS)
The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.
Measured: 3 months
Fatigue Severity Scale (FSS)
The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.
Measured: 6 months
Fatigue Severity Scale (FSS)
The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.
Measured: 12 months
Elettromyography
Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value <5.26 mV present in both legs was considered as abnormal.
Measured: 3 months
Elettromyography
Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value <5.26 mV present in both legs was considered as abnormal.
Measured: 6 months
Elettromyography
Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value <5.26 mV present in both legs was considered as abnormal.
Measured: 12 months
Montreal Cognitive Assessment Test (MoCA)
Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment
Measured: 3 months
Montreal Cognitive Assessment Test (MoCA)
Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment
Measured: 6 months
Montreal Cognitive Assessment Test (MoCA)
Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment
Measured: 12 months
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).
Measured: 3 months
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).
Measured: 6 months
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).
Measured: 12 months
The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD >32 is strongly associated with the presence of PTSD.
Measured: 3 months
The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD >32 is strongly associated with the presence of PTSD.
Measured: 6 months
The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD >32 is strongly associated with the presence of PTSD.
Measured: 12 months
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).
Measured: 3 months
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).
Measured: 6 months
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).
Measured: 12 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value.
The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.
Measured: 3 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value.
The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.
Measured: 6 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value.
The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.
Measured: 12 months
Barthel Index (BI)
BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (<20).
Measured: 3 months
Barthel Index (BI)
BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (<20).
Measured: 6 months
Barthel Index (BI)
BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (<20).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care Unit 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Responsible party
- Principal investigator, Piva Simone, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608994
- Sponsor's protocol ID
- NP2595
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
Pini L, Guerini M, Giordani J, Levi G, Latronico N, Piva S, Peli E, Benoni R, Pini A, Zucchi G, Piras S, El Masri Y, Visca D, Caminati M, Senna G, De Ciuceis C, Rosei CA, Muiesan ML, Tantucci C. 24-Month assessment of respiratory function in patients hospitalized for severe SARS-CoV-2 pneumonia: a follow-up study. Intern Emerg Med. 2025 Nov;20(8):2455-2462. doi: 10.1007/s11739-025-04153-5. Epub 2025 Nov 3.
PubMed 41182495Latronico N, Peli E, Calza S, Rodella F, Novelli MP, Cella A, Marshall J, Needham DM, Rasulo FA, Piva S; LOTO Investigators. Physical, cognitive and mental health outcomes in 1-year survivors of COVID-19-associated ARDS. Thorax. 2022 Mar;77(3):300-303. doi: 10.1136/thoraxjnl-2021-218064. Epub 2021 Sep 29.
PubMed 34588274
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up in Survivors of Critical Illness: An Longitudinal Assessment of Critically Ill Patients Discharged Alive From the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04608994
- Acronym / sponsor ID
- NP2595
- Conditions
- Post Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 30 Oct 2020 (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.
Survivors of critical illness may suffer from persistent physical, cognitive and mental impairments, such as muscle weakness, dysfunction in the memory and executive domains, post-traumatic stress disorders, depression, and anxiety. This syndrome is referred to as Post Intensive Care Syndrome (PICS).
This study aims to assess the frequency of impairments, their evolution over time, and to understand the pathogenetic mechanisms and the association between long-term sequelae and acute care events.
Detailed description
PICS describes 'new or worsening impairments in physical, cognitive or mental health status arising after critical illness and persisting beyond acute care hospitalization'. Different critical care professional and scientific societies have identified long-term functional outcomes after critical illness as an important target for research and clinical improvements, and there is general agreement that research on PICS should be a priority for the critical care community.
Post-ICU subjects may experience physical problems, such as muscles weakness and wasting, caused by prolonged bed rest and immobility during the ICU stay and by critical illness polyneuropathy and myopathy developing during the acute illness; organ dysfunction; chronic pain; mental health problems including depression, anxiety or post-traumatic stress disorder (PTSD); and neurocognitive impairments which are predominantly represented by memory dysfunction and executive function impairment. The impact of these problems on the subject's health status is huge, which reduced quality of life, and impaired functional status, and daily functioning.
Many survivors incur substantial healthcare costs, lose employment, and find their social networks wholly changed. The costs to subjects and families are high: ICU survivorship is associated with decreased return to work, and the loss of earnings plagues both patients and caregivers.
Prior studies in which researchers have examined outcomes among ICU survivors have been mainly restricted their assessments to specific patient populations and have used only limited outcome measures or the follow-up period was relatively short-term. Moreover, few studies have explored the association between acute care events and long-term sequelae as well as the underlying pathophysiological mechanisms.
The researchers appertaining to the present study implemented a follow-up clinic to describe the frequency of physical, cognitive, and mental impairments and their evolution over time in subjects surviving critical illness. The researchers also aim at understanding the pathogenetic mechanisms underlying these impairments and their association with acute care events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will enroll all patients admitted to the ICUs with SARS-CoV-2 pneumonia and ARDS.
Key inclusion criteria (1 listed)
- All COVID-19 patients admitted to the ICUs of the Spedali Civili University Hospital in Brescia, Italy.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medical Research Council (MRC) sum score
Time frame: 3 months
Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (<36).
Medical Research Council (MRC) sum score
Time frame: 6 months
Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (<36).
Medical Research Council (MRC) sum score
Time frame: 12 months
Medical Research Council (MRC)-sum score evaluates global muscle strength, and it has been proposed in PICS syndrome post-COVID-19. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using the MRC-sumscore. The summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (<36).
Dominand Handgrip Test
Time frame: 3 months
Dynamometry will be considered normal if >11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: <20% PNV; 20%<=PNV< 40%; 40%<=PNV< 60%; 60%<= PNV< 80%, and >=80 PNV. [DOI: 10.1016/j.clnu.2008.04.004]
Dominand Handgrip Test
Time frame: 6 months
Dynamometry will be considered normal if >11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: <20% PNV; 20%<=PNV< 40%; 40%<=PNV< 60%; 60%<= PNV< 80%, and >=80 PNV. [DOI: 10.1016/j.clnu.2008.04.004]
Dominand Handgrip Test
Time frame: 12 months
Dynamometry will be considered normal if >11Kg in Male and 7.5 kg in Female. Moreover, the researcher will standardized the result as percentage of the predicted normal value (PNV) as follow: <20% PNV; 20%<=PNV< 40%; 40%<=PNV< 60%; 60%<= PNV< 80%, and >=80 PNV. [DOI: 10.1016/j.clnu.2008.04.004]
Six Minutes Walking Test
Time frame: 3 months
Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight
Six Minutes Walking Test
Time frame: 6 months
Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight
SIX Minutes Walking Test
Time frame: 12 months
Six-minute walking test will be performed in accordance with the America Thoracic Society recommendations and it will be adjusted for age, sex, height, and body weight
Fatigue Severity Scale (FSS)
Time frame: 3 months
The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.
Fatigue Severity Scale (FSS)
Time frame: 6 months
The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.
Fatigue Severity Scale (FSS)
Time frame: 12 months
The Fatigue severity score is a nine-item unidimensional questionnaire that measures the severity of fatigue symptoms on a seven-point ordinal scale (maximum score of seven). An FSS ≥36 will be considered as an indicator of fatigue.
Elettromyography
Time frame: 3 months
Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value <5.26 mV present in both legs was considered as abnormal.
Elettromyography
Time frame: 6 months
Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value <5.26 mV present in both legs was considered as abnormal.
Elettromyography
Time frame: 12 months
Simplified peroneal nerve test (PENT)wiil be used to diagnose a critical illness polyneuropathy and myopathy; a value <5.26 mV present in both legs was considered as abnormal.
Montreal Cognitive Assessment Test (MoCA)
Time frame: 3 months
Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment
Montreal Cognitive Assessment Test (MoCA)
Time frame: 6 months
Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment
Montreal Cognitive Assessment Test (MoCA)
Time frame: 12 months
Montreal Cognitive Assessment (MoCA) is divided into several cognitive domains with variable scoring among them, adding up to a maximum total of 30 points if all responses are correct. The scale is divided into Visuospatial and executive functioning (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (short-term memory, 5 points), and orientation (6 points). To correct for educational effects found in the original study, one point is added if the subject has less than 12 years of education. The suggested cutoff score for normalcy in the MoCA is 26/30. When patients scored less than 26, we used the following classification: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
Hospital Anxiety and Depression Scale (HADS) was classified as follow: HADS for depression: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) and HADS Anxiety: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case).
The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 3 months
The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD >32 is strongly associated with the presence of PTSD.
The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 6 months
The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD >32 is strongly associated with the presence of PTSD.
The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 12 months
The PCL-5 is a self-report measure that assesses the presence and severity of Post Traumatic Stress Disorder (PTSD) symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. PTSD >32 is strongly associated with the presence of PTSD.
Insomnia Severity Index (ISI)
Time frame: 3 months
Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).
Insomnia Severity Index (ISI)
Time frame: 6 months
Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).
Insomnia Severity Index (ISI)
Time frame: 12 months
Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. ISI will be classified as follows: No clinically significant insomnia (0-7), Subthreshold insomnia (8-14), Moderate insomnia (15-21), and severe insomnia (22-28).
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Time frame: 3 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value. The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Time frame: 6 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value. The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Time frame: 12 months
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a widely used and extensively validated generic QOL measure that consists of 8 multiple-item domains. We applied two different methods for scoring. Firstly, for each item, a scale between 0-100 will be calculated and the percentage of predicted value has been calculated, based on the Italian normalized value. The second method will be been the calculation ofthe physical component summary (PCS) and the mental component summary (MCS), as described by Taft et al. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the Italian general population from an individual's scale score and then dividing by the standard deviation from the Italian general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale.
Barthel Index (BI)
Time frame: 3 months
BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (<20).
Barthel Index (BI)
Time frame: 6 months
BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (<20).
Barthel Index (BI)
Time frame: 12 months
BI will be classified as follow: Independent (80-100); Minimally dependent (60-79);, Partially dependent (40-59), Very dependent (20-39); and Totally dependent (<20).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 41182495Pini L, Guerini M, Giordani J, Levi G, Latronico N, Piva S, Peli E, Benoni R, Pini A, Zucchi G, Piras S, El Masri Y, Visca D, Caminati M, Senna G, De Ciuceis C, Rosei CA, Muiesan ML, Tantucci C. 24-Month assessment of respiratory function in patients hospitalized for severe SARS-CoV-2 pneumonia: a follow-up study. Intern Emerg Med. 2025 Nov;20(8):2455-2462. doi: 10.1007/s11739-025-04153-5. Epub 2025 Nov 3.
- Derived from this study: PubMed 34588274Latronico N, Peli E, Calza S, Rodella F, Novelli MP, Cella A, Marshall J, Needham DM, Rasulo FA, Piva S; LOTO Investigators. Physical, cognitive and mental health outcomes in 1-year survivors of COVID-19-associated ARDS. Thorax. 2022 Mar;77(3):300-303. doi: 10.1136/thoraxjnl-2021-218064. Epub 2021 Sep 29.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
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 Unit Syndrome, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Research Council (MRC) sum score (time frame: 3 months). The study lists 33 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 NCT04608994, which also lists 2 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 30 Oct 2020.