A Feasibility Study of Early Mobilisation Programmes in Critical Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Early mobility


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Feasibility study of two-arm pilot RCT, randomised 1:1 with blinded outcome assessments
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobility<br>Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week. | Other: Early mobility<br>* 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<br>|
| No Intervention: Standard care<br>Patients will receive standard physiotherapy regimen | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care, physiotherapy, rehabilitation