Title: EMPRESS: A feasibility study of Very Early Mobilisation PRogrammES in Critical Care
Funder: Department of Health and Social Care

Abstract: Background Early intensive care unit (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 and rapidly after ICU admission. ICU based rehabilitation in the form of mobilisation, has the potential to improve physical function outcomes through mitigating muscle wasting. We successfully introduced a very early ICU mobilisation intervention delivered by physiotherapists and physiotherapy technicians in our institution (Southampton) which has resulted in reduced duration of mechanical ventilation (and increased ventilator free days) and reduced length of ICU stay. The aim of this study is to explore the feasibility of delivering this very early ICU mobilisation intervention in other ICUs within the context of a randomised controlled trial in order to inform the design of a future fully powered randomised controlled trial (RCT) into very early mobilisation wihtin ICUs in the UK National Health Service. Methods: 90 acute medical patients from 2 mixed medical-surgical ICUs will be randomised to standard care plus very early mobilisation or standard care. We will include previously ambulatory patients over the age of 42 who have been ventilated for less than 72 hours and are expected to be ventilated for at least a further 48 hours. After informed consent, patients will be block randomised using a centralised web-based system on a 1:1 basis, to standard care or standard care plus 2 x 30minute mobilisation sessions 5 days per week. We will measure patients muscle strength ( Medical Research Council sum score), hand dynamometry and physical function (Chelsea critical care physical assessment tool) and intensive care mobility score within ICU, and short physical performance battery and 6 minute walk test on ICU discharge, hospital discharge and 3 month post ICU discharge. Our feasibility criteria include: (i) recruitment rates of at least 2 patients per month per site; (ii) at least 75% of patient receiving cycling intervention within 72 hours of admission; (iii) at least 75% adherence to standard physiotherapy protocol in both control group and intervention group AND at least 50% of planned very early mobilisation interventions delivered in the intervetion group; (iv) blinded outcome measures recorded at least 3 time points in 75% of recruited patients. Feasibility parameters will be calculated and presented using 95% confidence intervals and descriptive statistics will be used for other outcomes. The analyses will be used to inform selection of outcomes to be used in the definitive trial. Ethics and dissemination: Local Research Ethics approval will be obtained for each of the 2 centres. The results of the study will be published in peer reviewed publications and presented at scientific conferences. The analyses will be used to explore outcomes and inform the design and conduct of a multicenter RCT.

Lay abstract: Over 250,000 patients were admitted to a Critical Care Unit in the UK in 2014-2015. More than 25,000 (10%) of these patients required a breathing machine (ventilator) for more than 3 days. Patients on a ventilator develop muscle wasting early (within 24 hours), and rapidly (up to one third reduction in thigh muscle size within 7 days). This causes weakness which can persist for months or years after recovery from the critical illness and the resulting disability often dramatically affects quality of life long after hospital discharge. Physiotherapy given early during a patient's stay in the intensive care unit (ICU) is the only intervention shown to improve long-term physical function in these patients. Although challenging to undertake, we believe very early mobilisation is key because this is when the muscle wasting begins. Getting patients to exercise and mobilise early during their illness has been shown to be safe and feasible. However, these studies were undertaken in North America and it cannot be assumed these results will be duplicated in the NHS. A study of this intervention so early after admission to ICU has not been undertaken in the NHS. In 2012, we introduced very early mobilisation (within 72 hours of ICU admission) into Southampton Hospital ICU, which resulted in patients requiring ventilators for fewer days and spending 2 days less in ICU. We want to see whether the Southampton service can be successfully delivered in other NHS centres and to determine if this intervention improves patients physical outcomes. This 2 centre study will compare standard ICU physiotherapy with standard physiotherapy AND very early mobilisation in two ICUs (Portsmouth and Brighton) outside of Southampton. Results will guide the design of a larger multi-centre randomised controlled clinical trial to examine whether very early mobilisation is effective and cost-effective in criticaly ill patients.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL;RESPIRATORY