Corona Virus Disease 19 (COVID-19)COVID_REHABNCT04381338
Rehabilitation for People With COVID-19 in ICU
A study testing Pulmonary and Motor Rehabilitation in people with Corona Virus Disease 19 (COVID-19) and COVID, run by University of Padova at 2 sites in Italy.
Trial summary
COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Disease 19 (COVID-19), COVID, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Pulmonary and Motor Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesItaly
- Study dates
- 28 Feb 2020to 31 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Confirmed COVID-19 diagnosis, admitted to ICU with ARDS
Who cannot join
- Neuromuscular disease, severe heart failure (class IV), persistent severe hypotension (systolic BP \< 90mmHg), disorder of consciousness (DoC)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Teaching Hospital, University of Padova
Padova
Teaching Hospital, University of Verona
Verona, 37126
About this study
Official title: Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital
COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury.
ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge.
Read more
ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years.
Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency.
Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days.
The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Read the detailed description
People that develop ARDS due to COVID-19 and requiring admission to ICU (both invasive and non-invasive mechanical ventilation) will be enrolled. Two tertiary referral centers, part of the same region (Veneto) but located in different cities, will recruit participants. ICU standard of care is the same as defined by regional and national guidelines; rehabilitation in ICU COVID-19 subjects is provided only in one center due to local technical and organizational limitations. Non contamination between centers is possible due to restrictions of mobility and strict admission criteria based on catchment area.
Early physiotherapy treatment will start from the day of admission. Baseline measurement of physical function will performed using the Physical Function in ICU Test (PFIT). The PFIT is a submaximal exercise test that was developed for patients in the ICU who may not be able to mobilize away from the bedside.
Participants will start rehabilitation if they will not experiment one of the following conditions or should cease exercise because of the following (see exclusion criteria).
Rehabilitation Intervention
Rehabilitation program will start at admission in ICU. The program is based on the clinical characteristics of the individual to be treated. Participants will commence a hierarchical, standardized protocol that includes functional, respiratory and strength training. If participants will be unable to sit out of bed, assisted active exercises will be performed in bed. Exercise training will be provided for 15 minutes 3 times/day, 6 days per week.
Intensity of strength training: Until fatigue (Borg Scale) Type of strength training: >Grade 3 Medical Research Council (MRC) strength, active to resisted; <Grade 3 MRC strength, active assist to active Repetitions for strength training: Start 5 repetitions each limb, Progress to 3 sets of 10 repetitions as able Functional retraining: Sit-to-stand (using tilt table or standing walker if unable), rolling, supine to sitting, trunk control/balance
Motor program
- Intubated patient Glasgow Coma Scale (GCS) >8: passive mobilisation; postural positioning Glasgow Coma Scale < 8 (weaning): passive and active-assist mobilisation; postural positioning
- Weaned off patient Non-invasively ventilated/O2 high fluxes
- If strength < 3 MRC: passive and/or active-assist; tentative functional retraining
- If strength ≥3 MRC: active-assist and active; strength training; functional retraining Pulmonary Rehabilitation
- Intubated patient Glasgow Coma Scale >8: postural positioning Glasgow Coma Scale < 8 (weaning): postural positioning, cautious inspiratory muscle training
- Weaned off patient Non-invasively ventilated/O2 high fluxes
- If strength < 3 MRC: postural positioning, positive pressure expiration exercise, cautious inspiratory muscle training
- If strength ≥3 MRC: postural positioning, positive pressure expiration exercise, inspiratory muscle training
The intensity of exercise will prescribed based on the results of the PFIT. Rehabilitation programs will individualized for each patient. Programs will progressed using rates of perceived exertion (RPE) of the modified Borg Scale.
Total session time composition:15 min to complete:
- Whole-body bed exercises + strength + functional retraining
- respiratory rehabilitation Frequency of sessions: 3×15 min/day
- Conditions
- Corona Virus Disease 19 (COVID-19), COVID, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Critical Illness
- Being tested
- Pulmonary and Motor Rehabilitation
- Keywords
- Recovery, Outcome, retraining, corona virus disease 19
- Medical subject headings
- COVID-19, Acute Lung Injury, Respiratory Distress Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary and Motor RehabilitationOther
Pulmonary and Motor Rehabilitation in ICU
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation in COVID-19 patients in ICU | Experimental | Every person admitted to ICU for ARDS with a confirmed diagnosis of COVID-19 Motor program
* Intubated patient GCS >8: passive mobilization; postural positioning GCS< 8: passive and active-assist mobilization; postural positioning
* Extubated patient
* If strength < 3 MRC: passive and/or active-assist; functional retraining
* If strength ≥3 MRC: active-assist and active; strength training; functional retraining Pulmonary Rehabilitation
* Intubated patient GCS >8: postural positioning GCS< 8: postural positioning, cautious inspiratory muscle training
* Extubated patient
* If strength < 3 MRC: postural positioning, positive pressure expiration exercise,inspiratory muscle training
* If strength ≥3 MRC: postural positioning, positive pressure expiration exercise, inspiratory muscle training The intensity of exercise will prescribed based on the results of the PFIT. and modified Borg Scale.
Frequency of sessions: 3×15 min/day Receives: Other: Pulmonary and Motor Rehabilitation |
| COVID-19 in ICU without Rehabilitation | No intervention | Standard of care without rehabilitation in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU stay
days of ICU stay
Measured: up to 60 days
Secondary outcomes (1)
Length of hospital stay
days of hospital stay
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start28 Feb 2020
- Primary completion1 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Corona Virus Disease 19 (COVID-19)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Clustered, due to catchment area of Hospital with no chance of contamination because of lock down in the area.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Padova, Prof. P. Zanatta, University Hosiptal, Verona, Italy, Prof. E. Polati, University Hospital, Verona, Italy, Prof. K. Donadello, University Hospital, Verona, Italy
- Responsible party
- Principal investigator, Alessandra Del Felice, University of Padova
- Investigators
- Alessandra Del Felice, MD, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381338
- Sponsor's protocol ID
- UPadova_1
- Acronym
- COVID_REHAB
- Status last verified
- Nov 2023
- First submitted
- 4 May 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Bednarik J, Vondracek P, Dusek L, Moravcova E, Cundrle I. Risk factors for critical illness polyneuromyopathy. J Neurol. 2005 Mar;252(3):343-51. doi: 10.1007/s00415-005-0654-x. Epub 2005 Mar 30.
PubMed 15791390De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
PubMed 12472328TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
PubMed 25715872Griffiths RD, Hall JB. Intensive care unit-acquired weakness. Crit Care Med. 2010 Mar;38(3):779-87. doi: 10.1097/CCM.0b013e3181cc4b53.
PubMed 20048676Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
PubMed 24758618Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
PubMed 16763220Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
PubMed 21470008Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
PubMed 20978258Adhikari NKJ, Tansey CM, McAndrews MP, Matte A, Pinto R, Cheung AM, Diaz-Granados N, Herridge MS. Self-reported depressive symptoms and memory complaints in survivors five years after ARDS. Chest. 2011 Dec;140(6):1484-1493. doi: 10.1378/chest.11-1667. Epub 2011 Oct 13.
PubMed 21998261Bienvenu OJ, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Shanholtz C, Husain N, Dennison CR, Herridge MS, Pronovost PJ, Needham DM. Depressive symptoms and impaired physical function after acute lung injury: a 2-year longitudinal study. Am J Respir Crit Care Med. 2012 Mar 1;185(5):517-24. doi: 10.1164/rccm.201103-0503OC. Epub 2011 Dec 8.
PubMed 22161158Barnato AE, Albert SM, Angus DC, Lave JR, Degenholtz HB. Disability among elderly survivors of mechanical ventilation. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1037-42. doi: 10.1164/rccm.201002-0301OC. Epub 2010 Nov 5.
PubMed 21057004Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312Kress JP, Herridge MS. Medical and economic implications of physical disability of survivorship. Semin Respir Crit Care Med. 2012 Aug;33(4):339-47. doi: 10.1055/s-0032-1321983. Epub 2012 Aug 8.
PubMed 22875379
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital
- ClinicalTrials.gov ID
- NCT04381338
- Acronym / sponsor ID
- COVID_REHAB / UPadova_1
- Conditions
- Corona Virus Disease 19 (COVID-19), COVID, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Critical Illness
- Keywords
- Recovery, Outcome, retraining, corona virus disease 19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- University Hospital Padova, Prof. P. Zanatta, University Hosiptal, Verona, Italy, Prof. E. Polati, University Hospital, Verona, Italy, Prof. K. Donadello, University Hospital, Verona, Italy
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 May 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.
COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury.
ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge.
ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years.
Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency.
Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days.
The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Detailed description
People that develop ARDS due to COVID-19 and requiring admission to ICU (both invasive and non-invasive mechanical ventilation) will be enrolled. Two tertiary referral centers, part of the same region (Veneto) but located in different cities, will recruit participants. ICU standard of care is the same as defined by regional and national guidelines; rehabilitation in ICU COVID-19 subjects is provided only in one center due to local technical and organizational limitations. Non contamination between centers is possible due to restrictions of mobility and strict admission criteria based on catchment area.
Early physiotherapy treatment will start from the day of admission. Baseline measurement of physical function will performed using the Physical Function in ICU Test (PFIT). The PFIT is a submaximal exercise test that was developed for patients in the ICU who may not be able to mobilize away from the bedside.
Participants will start rehabilitation if they will not experiment one of the following conditions or should cease exercise because of the following (see exclusion criteria).
Rehabilitation Intervention
Rehabilitation program will start at admission in ICU. The program is based on the clinical characteristics of the individual to be treated. Participants will commence a hierarchical, standardized protocol that includes functional, respiratory and strength training. If participants will be unable to sit out of bed, assisted active exercises will be performed in bed. Exercise training will be provided for 15 minutes 3 times/day, 6 days per week.
Intensity of strength training: Until fatigue (Borg Scale) Type of strength training: >Grade 3 Medical Research Council (MRC) strength, active to resisted; <Grade 3 MRC strength, active assist to active Repetitions for strength training: Start 5 repetitions each limb, Progress to 3 sets of 10 repetitions as able Functional retraining: Sit-to-stand (using tilt table or standing walker if unable), rolling, supine to sitting, trunk control/balance
Motor program
- Intubated patient Glasgow Coma Scale (GCS) >8: passive mobilisation; postural positioning Glasgow Coma Scale < 8 (weaning): passive and active-assist mobilisation; postural positioning
- Weaned off patient Non-invasively ventilated/O2 high fluxes
- If strength < 3 MRC: passive and/or active-assist; tentative functional retraining
- If strength ≥3 MRC: active-assist and active; strength training; functional retraining Pulmonary Rehabilitation
- Intubated patient Glasgow Coma Scale >8: postural positioning Glasgow Coma Scale < 8 (weaning): postural positioning, cautious inspiratory muscle training
- Weaned off patient Non-invasively ventilated/O2 high fluxes
- If strength < 3 MRC: postural positioning, positive pressure expiration exercise, cautious inspiratory muscle training
- If strength ≥3 MRC: postural positioning, positive pressure expiration exercise, inspiratory muscle training
The intensity of exercise will prescribed based on the results of the PFIT. Rehabilitation programs will individualized for each patient. Programs will progressed using rates of perceived exertion (RPE) of the modified Borg Scale.
Total session time composition:15 min to complete:
- Whole-body bed exercises + strength + functional retraining
- respiratory rehabilitation Frequency of sessions: 3×15 min/day
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clustered, due to catchment area of Hospital with no chance of contamination because of lock down in the area.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation in COVID-19 patients in ICU | Experimental | Other: Pulmonary and Motor RehabilitationEvery person admitted to ICU for ARDS with a confirmed diagnosis of COVID-19 Motor program * Intubated patient GCS >8: passive mobilization; postural positioning GCS< 8: passive and active-assist mobilization; postural positioning * Extubated patient * If strength < 3 MRC: passive and/or active-assist; functional retraining * If strength ≥3 MRC: active-assist and active; strength training; functional retraining Pulmonary Rehabilitation * Intubated patient GCS >8: postural positioning GCS< 8: postural positioning, cautious inspiratory muscle training * Extubated patient * If strength < 3 MRC: postural positioning, positive pressure expiration exercise,inspiratory muscle training * If strength ≥3 MRC: postural positioning, positive pressure expiration exercise, inspiratory muscle training The intensity of exercise will prescribed based on the results of the PFIT. and modified Borg Scale. Frequency of sessions: 3×15 min/day |
| COVID-19 in ICU without Rehabilitation | No intervention | –Standard of care without rehabilitation in ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed COVID-19 diagnosis, admitted to ICU with ARDS
Key exclusion criteria (1 listed)
- Neuromuscular disease, severe heart failure (class IV), persistent severe hypotension (systolic BP \< 90mmHg), disorder of consciousness (DoC)
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 |
|---|---|---|
| Pulmonary and Motor RehabilitationPulmonary and Motor Rehabilitation in ICU | Other | Rehabilitation in COVID-19 patients in ICU |
Primary outcome
Length of ICU stay
Time frame: up to 60 days
days of ICU stay
1 secondary outcome
Length of hospital stay
Time frame: up to 90 days
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 18 Nov 2023.
- Background: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 15791390Bednarik J, Vondracek P, Dusek L, Moravcova E, Cundrle I. Risk factors for critical illness polyneuromyopathy. J Neurol. 2005 Mar;252(3):343-51. doi: 10.1007/s00415-005-0654-x. Epub 2005 Mar 30.
- Background: PubMed 12472328De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
- Background: PubMed 25715872TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
- Background: PubMed 20048676Griffiths RD, Hall JB. Intensive care unit-acquired weakness. Crit Care Med. 2010 Mar;38(3):779-87. doi: 10.1097/CCM.0b013e3181cc4b53.
- Background: PubMed 24758618Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
- Background: PubMed 16763220Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
- Background: PubMed 21470008Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
- Background: PubMed 20978258Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
- Background: PubMed 21998261Adhikari NKJ, Tansey CM, McAndrews MP, Matte A, Pinto R, Cheung AM, Diaz-Granados N, Herridge MS. Self-reported depressive symptoms and memory complaints in survivors five years after ARDS. Chest. 2011 Dec;140(6):1484-1493. doi: 10.1378/chest.11-1667. Epub 2011 Oct 13.
- Background: PubMed 22161158Bienvenu OJ, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Shanholtz C, Husain N, Dennison CR, Herridge MS, Pronovost PJ, Needham DM. Depressive symptoms and impaired physical function after acute lung injury: a 2-year longitudinal study. Am J Respir Crit Care Med. 2012 Mar 1;185(5):517-24. doi: 10.1164/rccm.201103-0503OC. Epub 2011 Dec 8.
- Individual participant dataSharing planned: No
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.
Alessandra Del Felice, MD, PhD principal investigator
University of Padova
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary and Motor Rehabilitation in people with Corona Virus Disease 19 (COVID-19) and COVID, run by University of Padova at 2 sites 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Length of ICU stay (time frame: up to 60 days). 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 NCT04381338, which also lists 22 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 18 Nov 2023.