A Feasibility Study of Early Mobilisation Programmes in Critical Care

Critical Illness Clinical Trial

— EMPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771014
• Other study ID #: UHSEmpress
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: September 23, 2022

Study information

• Verified date: October 2022
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Medway NHS Foundation Trust	Gillingham	Kent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hand held dynamometry (HHD)	Assessment of hand grip strength	Up to 12 weeks
Secondary	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
Secondary	ICU Mobility Scale	Best level of function achieved in ICU using an 11-point ordinal scale	Up to 28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Six minute walk test	Widely used to assess functional exercise capacity in patients following an ICU admission	Up to 6 months
Secondary	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
Secondary	WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	A generic assessment instrument for health and disability	6 months
Secondary	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