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

Sponsor
University Hospital Birmingham NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04396197
Collaborator
(none)
92
Enrollment
1
Location
2.2
Actual Duration (Months)
41.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Mar 1, 2020
Actual Primary Completion Date :
May 8, 2020
Actual Study Completion Date :
May 8, 2020

Arms and Interventions

Arm 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 Names:
  • Rehabilitation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mobility level [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 [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 [Hospital discharge, up to 2 months]

      Discharged to home, home with rehab, or a community rehab facility

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UHB NHS Foundation Trust Birmingham United Kingdom B15 2GW

    Sponsors and Collaborators

    • University Hospital Birmingham NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    May 20, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Critical Illness

    Study Results

    No Results Posted as of May 20, 2020