NCT04396197

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 17, 2020

Last Update Submit

May 19, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mobility level

    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 taken to first mobilise, defined as sitting on the edge of the bed or higher

    during ICU admission, up to 3 weeks

Secondary Outcomes (1)

  • Discharge location

    Hospital discharge, up to 2 months

Study Arms (1)

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

Interventions

Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning

Also known as: Rehabilitation
COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHB NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

Related Publications (1)

  • McWilliams D, Weblin J, Hodson J, Veenith T, Whitehouse T, Snelson C. Rehabilitation Levels in Patients with COVID-19 Admitted to Intensive Care Requiring Invasive Ventilation. An Observational Study. Ann Am Thorac Soc. 2021 Jan;18(1):122-129. doi: 10.1513/AnnalsATS.202005-560OC.

MeSH Terms

Conditions

COVID-19Critical IllnessAcute Lung Injury

Interventions

Physical Therapy ModalitiesRehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Injury

Intervention Hierarchy (Ancestors)

TherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physiotherapist

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 20, 2020

Study Start

March 1, 2020

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations