Rehabilitation for People With COVID-19 in ICU

NCT04381338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-11-18

No results posted yet for this study

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. 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.

Conditions

  • Corona Virus Disease 19 (COVID-19)
  • COVID
  • Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
  • Critical Illness

Interventions

OTHER

Pulmonary and Motor Rehabilitation

Pulmonary and Motor Rehabilitation in ICU

Sponsors & Collaborators

  • Prof. S Masiero, University of Padova, Italy

    collaborator UNKNOWN
  • Dr. A. Venturin, General Hosipital, Padova, Italy

    collaborator UNKNOWN
  • Dr. I. Tiberio, General Hospital, Padova, Italy

    collaborator UNKNOWN
  • Dr. D. Zampieri, University of Padova, Italy

    collaborator UNKNOWN
  • Dr.ssa M Cattelan, University of Padova, Italy

    collaborator UNKNOWN
  • Prof. P. Zanatta, University Hosiptal, Verona, Italy

    collaborator UNKNOWN
  • Dr.ssa C. Carollo, General Hospital, Padova, Italy

    collaborator UNKNOWN
  • Prof. E. Polati, University Hospital, Verona, Italy

    collaborator UNKNOWN
  • Prof. K. Donadello, University Hospital, Verona, Italy

    collaborator UNKNOWN
  • University of Padova

    lead OTHER

Principal Investigators

  • Alessandra Del Felice, MD, PhD · University of Padova

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2020-06-01
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04381338 on ClinicalTrials.gov