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Completed

NCT Number: NCT04459819

Respiratory Physiotherapy in Severe COVID-19 Patients

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Respiratory physiotherapy

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID Study.

Acronym: FTR-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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