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Respiratory Physiotherapy in Severe COVID-19 Patients (FTR-COVID)

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ClinicalTrials.gov Identifier: NCT04459819
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:

COVID-19 is an infectious disease caused by SARS-CoV2 virus. COVID-19 patients can develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU). Early rehabilitation is known to be effective in critically ill patients and in ARDS.

The role of respiratory physiotherapy in critical COVID-19 patients is still unclear.

The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.


Condition or disease Intervention/treatment
COVID-19 Other: Respiratory physiotherapy

Detailed Description:

COVID-19 is an infectious disease caused by SARS-CoV2 virus, that first appeared in China in 2019 and in Italy in February 2020.

Approximately 80% of people infected with COVID-19 have mild to moderate disease with few symptoms, while more than 10% develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU) needing invasive mechanical ventilation (IMV) and hospitalization for a long period.

Early rehabilitation is known to be effective in critically ill patients and in ARDS, to reduce functional impairment due to the prolonged stay in ICU. Many works demonstrated that early rehabilitation programs in ICU correlated with faster recovery and discharge at home of ARDS patients and better outcomes in the walking test at discharge from the hospital.

Due to the recent development of COVID-19, few data and guidelines to menage severe COVID-19 patients are available and the role of respiratory physiotherapy is still unclear.

The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID Study.
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Intervention Details:
  • Other: Respiratory physiotherapy

    Respiratory physiotherapy consists of:

    • early mobilization (passive and active mobilization, muscle-strengthening exercises, mobilization out of bed, standing, walking, ADL)
    • patients positioning
    • non-invasive mechanical ventilation / CPAP
    • tracheostomy management
    • invasive mechanical ventilation weaning
    • airway clearance
    • oxygen titration


Primary Outcome Measures :
  1. Number of physiotherapy treatments [ Time Frame: Through study completion, an average of 60 days ]
    Total number of physiotherapy treatments performed on patients during hospitalization

  2. Type of physiotherapy treatments [ Time Frame: Through study completion, an average of 60 days ]
    Number of each activity performed on patients among early mobilization, positioning, Uso of non invasive ventilation (NIV) and/or continuous positive airway pressure (CPAP), oxygen titration, airway clearance.

  3. Time of the first physiotherapy treatment [ Time Frame: From patient intubation to first time patient was treated by a physiotherapist; up to 60 days ]
    Median number of days from patients intubation to the first physiotherapy treatment


Secondary Outcome Measures :
  1. First time standing [ Time Frame: From patient intubation to first time standing; up to 60 days ]
    Median number of days from patients intubation to standing

  2. First time walking [ Time Frame: From patient intubation to first time walking; up to 60 days ]
    Median number of days from patients intubation to walking

  3. First time sitting out of bed [ Time Frame: From patient intubation to first time sitting out of bed; up to 60 days ]
    Median number of days from patients intubation to sitting out of bed

  4. 6 minutes walking test (6MWT) [ Time Frame: Assessed when patients are discharged from the hospital; up to 60 days ]
    Median distance (metres) obtained at the 6MWT

  5. 1 minute sit-to-stand test (1m-STST) [ Time Frame: Assessed when patients are discharged from the hospital; up to 60 days ]
    Median number of sit-to-stand repetitions obtained

  6. Upper extremity muscles strength [ Time Frame: Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. ]
    Median upper extremity muscle strength measured by the Medical Research Council sum score (MRC-SS). The muscle scale grades muscle power on a scale of 0 (no visible muscle contraction) to 5 (active movement against full resistance). The movement tested are wrist flexion, forearm flexion and shoulder abduction.

  7. Lower extremity muscles strength [ Time Frame: Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. ]
    Median lower extremity muscle strength measured by the Medical Research Council sum score (MRC-SS). The muscle scale grades muscle power on a scale of 0 (no visible muscle contraction) to 5 (active movement against full resistance). The movement tested are ankle dorsiflexion, knee extension and hip flexion.

  8. Functional independence in ADL [ Time Frame: Assessed when the patient is discharged from the hospital; up to 60 days. ]
    Median score obtained th the Barthel Index for Activities of Daily Living (ADL). The Barthel Index measures functional independence in ADL. Scores range from 0 to 100, with higher scores indicating greater independence in ADL.

  9. ICU stay length [ Time Frame: From ICU admission to ICU discharge; up to 60 days. ]
    Mean number of days patients stayed in ICU

  10. Length of hospitalization [ Time Frame: From hospital admission to hospital discharge; up to 60 days. ]
    Mean number of days patients stayed at the hospital

  11. Duration of invasive mechanical ventilation (IMV) [ Time Frame: From first day patient are mechanically ventilated to IMV stop; up to 60 days. ]
    Mean number of days patients were invasively mechanically ventilated

  12. Patients returned home [ Time Frame: Up to 60 days. ]
    Number of patients that following hospital discharge returned home

  13. Patients discharged to in-patient rehabilitation [ Time Frame: Up to 60 days. ]
    Number of patients that were discharged from acute hospital to in-patient rehabilitation

  14. Patients transferred to other hospitals [ Time Frame: Up to 60 days. ]
    Number of patients that following hospital discharge were transferred to other hospitals

  15. Exitus [ Time Frame: From ICU admission until date of death from any cause, assessed up to 60 days. ]
    Number of patients that died from any cause during hospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators will study patients accessing acute hospital ICU with hypoxemic acute respiratory failure (hARF) due to laboratory confirmed COVID-19 pneumonia form March 1st to May 1st, that were treated by respiratory physiotherapists during the whole hospitalization period.
Criteria

Inclusion Criteria:

  • Having laboratory confirmed COVID-19 pneumonia
  • Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
  • Treated by respiratory physiotherapists during the hospitalization period

Exclusion Criteria:

  • Previously documented neurological or neuromuscular diseases
  • Passed over 1 month in bed before COVID-19 diagnosis
  • Documented cognitive impairment (mini mental state examination <24)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459819


Contacts
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Contact: Emilia Privitera, MSC 0039 3385670909 emilia.privitera@policlinico.mi.it
Contact: Martina Santambrogio, PhD 0039 3393838807 martina.santambrogio@policlinico.mi.it

Locations
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Italy
Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Emilia Privitera, MSC    0039 3385670909    emilia.privitera@policlinico.mi.it   
Contact: Martina Santambrogio, PhD    0039 3393838807    martina.santambrogio@policlinico.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Emilia Privitera, MSC Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Publications of Results:

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT04459819    
Other Study ID Numbers: FTR-COVID
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
ICU
Respiratory Physiotherapy
Early Rehabilitation