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

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

      • 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
Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning
Other Names:
  • Rehabilitation

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
At ICU discharge, an average of 3 weeks
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
during ICU admission, up to 3 weeks

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

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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