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Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care

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: NCT04396197
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
David McWilliams, University Hospital Birmingham NHS Foundation Trust

Study Description
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Brief Summary:
This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19

Condition or disease Intervention/treatment
COVID-19 Critical Illness Ards ICU Acquired Weakness Other: Physiotherapy

Detailed Description:
An admission to an intensive care unit (ICU) often results in significant muscle weakness and physical deconditioning, which can take many months or even years for recovery. Early and progressive programmes of rehabilitation are recommended to limit any muscle loss and support recovery as early as possible. Patients admitted to intensive care with COVID-19 have been found to require prolonged periods of mechanical ventilation, high sedation and neuromuscular blocking use and as a result require prolonged stays in the ICU. As yet no data exists to examine the specific physical impact this may have, or whether it is safe and feasible to commence this earlier rehabilitation within the ICU for patients with a diagnosis of COVID-19. Our study set out to evaluate the levels of rehabilitation which were delivered in a large acute NHS trust.
Study Design
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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care Requiring Invasive Ventilation: An Observational Study
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : May 8, 2020
Actual Study Completion Date : May 8, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
COVID-19
Observations taken of standard physiotherapy practice. All patients are assessed daily and receive respiratory care and rehabilitation as deemed appropriate by the treating therapist
 Other: Physiotherapy
Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning
Other Name: Rehabilitation


Outcome Measures
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Primary Outcome Measures :
  1. Mobility level [ Time Frame: At ICU discharge, an average of 3 weeks ]
    Highest level of mobility achieved at the point of ICU discharge

  2. Time taken to first mobilise [ Time Frame: during ICU admission, up to 3 weeks ]
    Time taken to first mobilise, defined as sitting on the edge of the bed or higher


Secondary Outcome Measures :
  1. Discharge location [ Time Frame: Hospital discharge, up to 2 months ]
    Discharged to home, home with rehab, or a community rehab facility


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults admitted to ICU with a confirmed diagnosis of COVID-19, mechanically ventilated for >24 hours and surviving to ICU discharge were included.
Criteria

Inclusion Criteria:

  • having a confirmed diagnosis of COVID-19
  • being mechanically ventilated for at least 24 hours
  • surviving to critical care discharge.

Exclusion Criteria:

  • none
Contacts and Locations
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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): NCT04396197


Locations
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United Kingdom
UHB NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: David McWilliams, Consultant Physiotherapist, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04396197    
Other Study ID Numbers: PhysioCOVID-19
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 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
Additional relevant MeSH terms:
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COVID-19
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes