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

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.

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.

Outcome assessment at ICU discharge, hospital discharge and 3 month follow-up will be undertaken by an assessor, blinded to study group allocation.

Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week.

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

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.

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

This validated tool reliably grades physical morbidity from complete dependence on admission though progressive independence. Scores on ICU discharge may predict recovery trajectory.

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.

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

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.

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.

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.

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.

Individual participant data that underlie the results manuscript will be de-identified and shared on request

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.