Rehabilitation for People With COVID-19 in ICU

NCT04381338 | Completed DMC

• 1 other identifier: UPadova_1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Recovery; Outcome; retraining; corona virus disease 19

Outcome Measures

Primary Outcomes (1)

• Length of ICU stay

  days of ICU stay

  up to 60 days

Secondary Outcomes (1)

• Length of hospital stay

  up to 90 days

Study Arms (2)

Rehabilitation in COVID-19 patients in ICU

EXPERIMENTAL

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

COVID-19 in ICU without Rehabilitation

NO INTERVENTION

Standard of care without rehabilitation in ICU

Interventions

Pulmonary and Motor Rehabilitation OTHER

Pulmonary and Motor Rehabilitation in ICU

Rehabilitation in COVID-19 patients in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Teaching Hospital, University of Padova

Padua, Italy

Location

Teaching Hospital, University of Verona

Verona, 37126, Italy

Location

Related Publications (22)

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MeSH Terms

Conditions

COVID-19; Acute Lung Injury; Respiratory Distress Syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandra Del Felice, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Clustered, due to catchment area of Hospital with no chance of contamination because of lock down in the area.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 8, 2020
• Study Start: February 28, 2020
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)