The University of Southampton
University of Southampton Institutional Repository

Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial

Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial
Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial
Introduction: physical rehabilitation delivered early following admission to the intensive care unit (ICU) has the potential to improve short-term and long-term outcomes. The use of supine cycling together with other rehabilitation techniques has potential as a method of introducing rehabilitation earlier in the patient journey. The aim of the study is to determine the feasibility of delivering the designed protocol of a randomised clinical trial comparing a protocolised early rehabilitation programme including cycling with usual care. This feasibility study will inform a larger multicentre study.

Methods and analysis: 90 acute care medical patients from two mixed medical–surgical ICUs will be recruited. We will include ventilated patients within 72 hours of initiation of mechanical ventilation and expected to be ventilated a further 48 hours or more. Patients will receive usual care or usual care plus two 30 min rehabilitation sessions 5 days/week.Feasibility outcomes are (1) recruitment of one to two patients per month per site; (2) protocol fidelity with >75% of patients commencing interventions within 72 hours of mechanical ventilation, with >70% interventions delivered; and (3) blinded outcome measures recorded at three time points in >80% of patients. Secondary outcomes are (1) strength and function, the Physical Function ICU Test–scored measured on ICU discharge; (2) hospital length of stay; and (3) mental health and physical ability at 3 months using the WHO Disability Assessment Schedule 2. An economic analysis using hospital health services data reported with an embedded health economic study will collect and assess economic and quality of life data including the Hospital Anxiety and Depression Scales core, the Euroqol-5 Dimension-5 Level and the Impact of Event Score.

Ethics and dissemination: the study has ethical approval from the South Central Hampshire A Research Ethics Committee (19/SC/0016). All amendments will be approved by this committee. An independent trial monitoring committee is overseeing the study. Results will be made available to critical care survivors, their caregivers, the critical care societies and other researchers.
Critical Care/methods, Feasibility Studies, Humans, Intensive Care Units, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Respiration, Artificial
2044-6055
e055285
Cusack, Rebecca
dfb1595f-2792-4f76-ac6d-da027cf40146
Bates, Andrew
46ff2189-9345-45bb-bb83-c90971ccccb4
Mitchell, Kay
f57f07cd-0e3a-48b2-a871-c436eec325ae
van Willigen, Zoe
7d32d6f7-f7c2-4990-afa4-43b899d63e81
Denehy, Linda
77ddbcaa-6710-47c8-a19e-ec6e66f5fe19
Hart, Nicholas
4e7fb60a-0da1-4033-b16f-0e2616961298
Dushianthan, Ahilanandan
013692a2-cf26-4278-80bd-9d8fcdb17751
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Sturmey, Gordon
03c25186-926c-41a8-9d3b-a6a5e7310ba5
Davey, Iain
e45362ed-cfa6-4be1-873d-af0de7c53702
Grocott, Michael
1e87b741-513e-4a22-be13-0f7bb344e8c2
Cusack, Rebecca
dfb1595f-2792-4f76-ac6d-da027cf40146
Bates, Andrew
46ff2189-9345-45bb-bb83-c90971ccccb4
Mitchell, Kay
f57f07cd-0e3a-48b2-a871-c436eec325ae
van Willigen, Zoe
7d32d6f7-f7c2-4990-afa4-43b899d63e81
Denehy, Linda
77ddbcaa-6710-47c8-a19e-ec6e66f5fe19
Hart, Nicholas
4e7fb60a-0da1-4033-b16f-0e2616961298
Dushianthan, Ahilanandan
013692a2-cf26-4278-80bd-9d8fcdb17751
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Sturmey, Gordon
03c25186-926c-41a8-9d3b-a6a5e7310ba5
Davey, Iain
e45362ed-cfa6-4be1-873d-af0de7c53702
Grocott, Michael
1e87b741-513e-4a22-be13-0f7bb344e8c2

Cusack, Rebecca, Bates, Andrew, Mitchell, Kay, van Willigen, Zoe, Denehy, Linda, Hart, Nicholas, Dushianthan, Ahilanandan, Reading, Isabel, Chorozoglou, Maria, Sturmey, Gordon, Davey, Iain and Grocott, Michael (2022) Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial. BMJ Open, 12 (4), e055285, [e055285]. (doi:10.1136/bmjopen-2021-055285).

Record type: Article

Abstract

Introduction: physical rehabilitation delivered early following admission to the intensive care unit (ICU) has the potential to improve short-term and long-term outcomes. The use of supine cycling together with other rehabilitation techniques has potential as a method of introducing rehabilitation earlier in the patient journey. The aim of the study is to determine the feasibility of delivering the designed protocol of a randomised clinical trial comparing a protocolised early rehabilitation programme including cycling with usual care. This feasibility study will inform a larger multicentre study.

Methods and analysis: 90 acute care medical patients from two mixed medical–surgical ICUs will be recruited. We will include ventilated patients within 72 hours of initiation of mechanical ventilation and expected to be ventilated a further 48 hours or more. Patients will receive usual care or usual care plus two 30 min rehabilitation sessions 5 days/week.Feasibility outcomes are (1) recruitment of one to two patients per month per site; (2) protocol fidelity with >75% of patients commencing interventions within 72 hours of mechanical ventilation, with >70% interventions delivered; and (3) blinded outcome measures recorded at three time points in >80% of patients. Secondary outcomes are (1) strength and function, the Physical Function ICU Test–scored measured on ICU discharge; (2) hospital length of stay; and (3) mental health and physical ability at 3 months using the WHO Disability Assessment Schedule 2. An economic analysis using hospital health services data reported with an embedded health economic study will collect and assess economic and quality of life data including the Hospital Anxiety and Depression Scales core, the Euroqol-5 Dimension-5 Level and the Impact of Event Score.

Ethics and dissemination: the study has ethical approval from the South Central Hampshire A Research Ethics Committee (19/SC/0016). All amendments will be approved by this committee. An independent trial monitoring committee is overseeing the study. Results will be made available to critical care survivors, their caregivers, the critical care societies and other researchers.

Text
e055285.full - Version of Record
Available under License Creative Commons Attribution.
Download (1MB)

More information

Accepted/In Press date: 22 March 2022
Published date: 15 April 2022
Additional Information: Funding Information: The study has been supported by patient advisory representatives. These representatives are members of the trial steering committee. Patient advisors partnered with us for the design of the study, the informational material to support the intervention, the burden of the intervention from the patient’s perspective and contributed to the dissemination plan Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.
Keywords: Critical Care/methods, Feasibility Studies, Humans, Intensive Care Units, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Respiration, Artificial

Identifiers

Local EPrints ID: 457735
URI: http://eprints.soton.ac.uk/id/eprint/457735
ISSN: 2044-6055
PURE UUID: 298f4a42-b4f0-488e-a412-b190cc23a0fc
ORCID for Andrew Bates: ORCID iD orcid.org/0000-0002-3614-0270
ORCID for Kay Mitchell: ORCID iD orcid.org/0000-0001-6393-8475
ORCID for Ahilanandan Dushianthan: ORCID iD orcid.org/0000-0002-0165-3359
ORCID for Isabel Reading: ORCID iD orcid.org/0000-0002-1457-6532
ORCID for Maria Chorozoglou: ORCID iD orcid.org/0000-0001-5070-4653
ORCID for Michael Grocott: ORCID iD orcid.org/0000-0002-9484-7581

Catalogue record

Date deposited: 16 Jun 2022 00:28
Last modified: 20 Oct 2022 02:01

Export record

Altmetrics

Contributors

Author: Rebecca Cusack
Author: Andrew Bates ORCID iD
Author: Kay Mitchell ORCID iD
Author: Zoe van Willigen
Author: Linda Denehy
Author: Nicholas Hart
Author: Ahilanandan Dushianthan ORCID iD
Author: Isabel Reading ORCID iD
Author: Gordon Sturmey
Author: Iain Davey
Author: Michael Grocott ORCID iD

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×