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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04381338|
Recruitment Status : Unknown
Verified May 2020 by Alessandra Del Felice, University of Padova.
Recruitment status was: Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|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)|
|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|
Experimental: Rehabilitation in COVID-19 patients in ICU
Every person admitted to ICU for ARDS with a confirmed diagnosis of COVID-19 Motor program
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
- Length of ICU stay [ Time Frame: up to 60 days ]days of ICU stay
- Length of hospital stay [ Time Frame: up to 90 days ]days of hospital stay
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
|Contact: Alessandra Del Felice, MD, PhDfirstname.lastname@example.org|
|Teaching Hospital, University of Padova|
|Contact: Alessandra Del Felice, MD, PhD 0039(0)498211270 email@example.com|
|Teaching Hospital, University of Verona|
|Verona, Italy, 37126|
|Contact: Katia Donadello, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Alessandra Del Felice, MD, PhD||University of Padova|