Rehabilitation for People With COVID-19 in ICU (COVID_REHAB)

November 15, 2023 updated by: Alessandra Del Felice, University of Padova

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Padova, Italy
        • Teaching Hospital, University of Padova
        • Contact:
      • Verona, Italy, 37126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed COVID-19 diagnosis, admitted to ICU with ARDS

Exclusion Criteria:

  • Neuromuscular disease, severe heart failure (class IV), persistent severe hypotension (systolic BP < 90mmHg), disorder of consciousness (DoC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rehabilitation in COVID-19 patients in ICU

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
Other: Pulmonary and Motor Rehabilitation
Pulmonary and Motor Rehabilitation in ICU
No Intervention: COVID-19 in ICU without Rehabilitation
Standard of care without rehabilitation in ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: up to 60 days
days of ICU stay
up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: up to 90 days
days of hospital stay
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Collaborators

Prof. S Masiero, University of Padova, Italy
Dr. A. Venturin, General Hosipital, Padova, Italy
Dr. I. Tiberio, General Hospital, Padova, Italy
Dr. D. Zampieri, University of Padova, Italy
Dr.ssa M Cattelan, University of Padova, Italy
Prof. P. Zanatta, University Hosiptal, Verona, Italy
Dr.ssa C. Carollo, General Hospital, Padova, Italy
Prof. E. Polati, University Hospital, Verona, Italy
Prof. K. Donadello, University Hospital, Verona, Italy

Investigators

  • Principal Investigator: Alessandra Del Felice, MD, PhD, University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPadova_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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