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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381338
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
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
Information provided by (Responsible Party):
Alessandra Del Felice, University of Padova

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.


Condition or disease Intervention/treatment Phase
Corona Virus Disease 19 (COVID-19) COVID Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Critical Illness Other: Pulmonary and Motor Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clustered, due to catchment area of Hospital with no chance of contamination because of lock down in the area.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital
Estimated Study Start Date : May 10, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020


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



Primary Outcome Measures :
  1. Length of ICU stay [ Time Frame: up to 60 days ]
    days of ICU stay


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: up to 90 days ]
    days of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 &lt; 90mmHg), disorder of consciousness (DoC)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381338


Contacts
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Contact: Alessandra Del Felice, MD, PhD +39-0498212598 alessandra.delfelice@unipd.it

Locations
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Italy
Teaching Hospital, University of Padova
Padova, Italy
Contact: Alessandra Del Felice, MD, PhD    0039(0)498211270    alessandra.delfelice@unipd.it   
Teaching Hospital, University of Verona
Verona, Italy, 37126
Contact: Katia Donadello, MD, PhD       katia.donadello@univr.it   
Sponsors and Collaborators
University of Padova
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
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Principal Investigator: Alessandra Del Felice, MD, PhD University of Padova
Publications:

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Responsible Party: Alessandra Del Felice, MD, PhD, University of Padova
ClinicalTrials.gov Identifier: NCT04381338    
Other Study ID Numbers: UPadova_1
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandra Del Felice, University of Padova:
Recovery
Outcome
retraining
corona virus disease 19
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease Attributes
Pathologic Processes
Thoracic Injuries
Wounds and Injuries
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections