- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396197
Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care
May 19, 2020 updated by: David McWilliams, University Hospital Birmingham NHS Foundation Trust
Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care Requiring Invasive Ventilation: An Observational Study
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Birmingham, United Kingdom, B15 2GW
- UHB NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
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Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility level
Time Frame: At ICU discharge, an average of 3 weeks
|
Highest level of mobility achieved at the point of ICU discharge
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At ICU discharge, an average of 3 weeks
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Time taken to first mobilise
Time Frame: during ICU admission, up to 3 weeks
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Time taken to first mobilise, defined as sitting on the edge of the bed or higher
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during ICU admission, up to 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discharge location
Time Frame: Hospital discharge, up to 2 months
|
Discharged to home, home with rehab, or a community rehab facility
|
Hospital discharge, up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
May 8, 2020
Study Completion (Actual)
May 8, 2020
Study Registration Dates
First Submitted
May 17, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 20, 2020
Study Record Updates
Last Update Posted (Actual)
May 20, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PhysioCOVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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