A Feasibility Study of Early Mobilisation Programmes in Critical Care (EMPRESS)

EMPRESS: A Feasibility Study of Early Mobilisation Programmes in Critical Care

The objective of this study is to determine the feasibility of delivering a very early mobility rehabilitation program in Intensive Care Units (ICU), within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating very early ICU rehabilitation in the UK National Health Service.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Early mobility

Detailed Description

Early ICU-based physical rehabilitation may benefit patients with acute severe respiratory failure by attenuating the development of severe and persistent weakness and impaired physical function seen in these patients.

Muscle wasting occurs early (within 12 hours) and progresses rapidly after ICU admission. Patients may suffer from consequent physical impairment for months or years following their discharge.

ICU based rehabilitation has the potential to improve physical function outcomes, through mitigating muscle wasting.

The investigators have successfully introduced a very early ICU mobility program in their institution, which results in increased ventilator free days and reduced length of ICU stay.

The primary aim is to investigate whether this method will work in other ICUs. EMPRESS will test the feasibility of running this intervention as an RCT. The results and a concurrent process evaluation will inform the design of a future, multi-centre randomised controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Gillingham, Kent, United Kingdom
      • Medway Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute/unplanned medical admissions to the ICU.
• > 42 years old.
• Functionally independent prior to ICU admission (Barthel >80).
• In hospital for <5 days prior to intubation and ventilation.
• Intubated and ventilated for <72 hrs.
• Expected to remain ventilated for a further 48 hours.

Exclusion Criteria:

• In hospital for 5 days or more prior to ITU admission.
• Patients with acute brain or spinal cord injury.
• Known or suspected neurological / muscular impairment.
• Condition limiting use of cycle ergometer e.g. lower limb fracture / amputation.
• Not expected to survive >48hrs.
• Persistent therapy exemptions in first 3 days of mechanical ventilation.
• Body habitus such as unable to use cycle ergometer.
• Consultant clinician view that patient not suitable or not expected to survive admission.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early mobility; Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week.	Other: Early mobility; This progressive mobility pathway commenced with passive cycling within 48 hours of intubation and ventilation and progressing through assisted cycling, active cycling, bed exercises, sitting, mobilising out of bed to walking
No Intervention: Standard care; Patients will receive standard physiotherapy regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function ICU Test-scored	This is a reliable and valid 4 item scale ( arm strength, leg strength, ability to stand and step cadence),with a score range of 0-10 and is responsive to change and predictive of key outcomes.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Research Council Manual Muscle Test Sum Score ( MRC-ss)	Test of muscle strength and function, where full strength is defined as a score of 60/60 and ICU-AW as a score of <48/60	Up to 28 days
Hand held dynamometry (HHD)	Assessment of hand grip strength	Up to 12 weeks
Chelsea Critical Care Physical Assessment tool (CPAX)	This validated tool reliably grades physical morbidity from complete dependence on admission though progressive independence. Scores on ICU discharge may predict recovery trajectory.	Up to 28 days
ICU Mobility Scale	Best level of function achieved in ICU using an 11-point ordinal scale	Up to 28 days
Timed up and go	The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	Up to 6 months
Clinical Frailty Score	An 8 point score to classify patients as fit, vulnerable or frail and correlates with outcome in both elderly and younger patients. Pre illness frailty will be assessed by proxy on admission from information gathered from family member /NOK and from patient at the 3 follow-up assessment	Up to 6 months
Barthel Index for Activities of Daily Living	Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.	Up to 6 months
Six minute walk test	Widely used to assess functional exercise capacity in patients following an ICU admission	Up to 6 months
The Hospital Anxiety and Depression Scale - HADS	Measure of anxiety and depression in general medical population of patients. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	6 months
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	A generic assessment instrument for health and disability	6 months
EQ-5D-5L	The descriptive system comprises self-assessment of five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	6 months

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Rebecca Cusack, MD, University Hospital Southampton NHS Foundation Trust

Publications and helpful links

General Publications

• Cusack R, Bates A, Mitchell K, van Willigen Z, Denehy L, Hart N, Dushianthan A, Reading I, Chorozoglou M, Sturmey G, Davey I, Grocott M. Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial. BMJ Open. 2022 Apr 15;12(4):e055285. doi: 10.1136/bmjopen-2021-055285.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; intensive care; physiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: UHSEmpress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results manuscript will be de-identified and shared on request
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Proposals should be addressed to EMPRESS@uhs.nhs.uk
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No