A Feasibility Study of Early Mobilisation Programmes in Critical Care
- Conditions
- Critical Illness
- Interventions
- Other: Early mobility
- Registration Number
- NCT03771014
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early mobility Early mobility Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week.
- Primary Outcome Measures
Name Time Method Physical Function ICU Test-scored Up to 28 days 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.
- Secondary Outcome Measures
Name Time Method Hand held dynamometry (HHD) Up to 12 weeks Assessment of hand grip strength
Medical Research Council Manual Muscle Test Sum Score ( MRC-ss) Up to 28 days 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
Chelsea Critical Care Physical Assessment tool (CPAX) Up to 28 days This validated tool reliably grades physical morbidity from complete
dependence on admission though progressive independence. Scores on ICU discharge may predict recovery trajectory.ICU Mobility Scale Up to 28 days Best level of function achieved in ICU using an 11-point ordinal scale
Timed up and go Up to 6 months 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.
Clinical Frailty Score Up to 6 months 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 Index for Activities of Daily Living Up to 6 months 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.Six minute walk test Up to 6 months Widely used to assess functional exercise capacity in patients following an ICU admission
The Hospital Anxiety and Depression Scale - HADS 6 months 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.
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 6 months A generic assessment instrument for health and disability
EQ-5D-5L 6 months 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.
Trial Locations
- Locations (1)
Medway NHS Foundation Trust
🇬🇧Gillingham, Kent, United Kingdom