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Respiratory Physiotherapy in Severe COVID-19 Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04459819
Acronym
FTR-COVID
Enrollment
84
Registered
2020-07-07
Start date
2020-03-01
Completion date
2020-09-30
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

ICU, Respiratory Physiotherapy, Early Rehabilitation

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.

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.

Interventions

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

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of physiotherapy treatmentsThrough study completion, an average of 60 daysTotal number of physiotherapy treatments performed on patients during hospitalization
Type of physiotherapy treatmentsThrough study completion, an average of 60 daysNumber 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.
Time of the first physiotherapy treatmentFrom patient intubation to first time patient was treated by a physiotherapist; up to 60 daysMedian number of days from patients intubation to the first physiotherapy treatment

Secondary

MeasureTime frameDescription
6 minutes walking test (6MWT)Assessed when patients are discharged from the hospital; up to 60 daysMedian distance (metres) obtained at the 6MWT
1 minute sit-to-stand test (1m-STST)Assessed when patients are discharged from the hospital; up to 60 daysMedian number of sit-to-stand repetitions obtained
Upper extremity muscles strengthAssessed 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.
Lower extremity muscles strengthAssessed 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.
Functional independence in ADLAssessed 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.
ICU stay lengthFrom ICU admission to ICU discharge; up to 60 days.Mean number of days patients stayed in ICU
First time standingFrom patient intubation to first time standing; up to 60 daysMedian number of days from patients intubation to standing
Duration of invasive mechanical ventilation (IMV)From first day patient are mechanically ventilated to IMV stop; up to 60 days.Mean number of days patients were invasively mechanically ventilated
Patients returned homeUp to 60 days.Number of patients that following hospital discharge returned home
Patients discharged to in-patient rehabilitationUp to 60 days.Number of patients that were discharged from acute hospital to in-patient rehabilitation
Patients transferred to other hospitalsUp to 60 days.Number of patients that following hospital discharge were transferred to other hospitals
ExitusFrom ICU admission until date of death from any cause, assessed up to 60 days.Number of patients that died from any cause during hospitalization
Length of hospitalizationFrom hospital admission to hospital discharge; up to 60 days.Mean number of days patients stayed at the hospital
First time walkingFrom patient intubation to first time walking; up to 60 daysMedian number of days from patients intubation to walking
First time sitting out of bedFrom patient intubation to first time sitting out of bed; up to 60 daysMedian number of days from patients intubation to sitting out of bed

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026