TEAM: A Trial of Early Activity and Mobility in ICU

Study Overview
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Brief Summary
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Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weaknesses even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, delay functional recovery and delay their return home and to work. Weakness may be avoided with simple strategies of early exercise in ICU. This pilot study aims to test the hypothesis that early mobilisation may improve functional recovery in this patient group and gather pilot data to support a larger randomised trial across Australia and New Zealand.

Detailed Description
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Patients who are admitted and treated in the intensive care unit (ICU) generally have potentially reversible critical illness. While many patients survive, substantial proportions of patients fail to recover completely and do not return to their pre-morbid level of health. Critically ill patients receive mechanical ventilation, as a lifesaving intervention, but this is routinely managed with deep sedation and immobility, which results in prolonged periods of bed rest. Severe muscle weakness, termed ICUAW, is common and associated with prolonged duration of mechanical ventilation and hospital stay in the ICU, as well as poor recovery of physical function. Early mobilisation, exercising patients while they are still receiving mechanical ventilation, has been proposed as a candidate intervention to prevent ICU acquired weakness (ICUAW). Observational studies indicate that early mobilisation is not used routinely in critically ill patients in Australia and New Zealand. TEAM is a pilot RCT designed to obtain data to assist in the planning of an adequately powered RCT that will test the hypothesis that early mobilisation of critically ill patients improves one or more functional outcomes, quality of survival, and proportion of patients who survive.

Official Title
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Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.

Conditions
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Critically Ill

Intervention / Treatment
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* Behavioral: Early mobilisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > or + to 18 years old admitted to the ICU Invasively ventilated and expected to be ventilated the day after tomorrow Written informed consent from person responsible/ net of kin (or consent as per individual HREC if delayed or telephone consent is acceptable) Exclusion Criteria: INSTABILITY A. Cardiovascular Unresolved rhythm disturbance with any bradycardia requiring pharmacological support Any tachycardia with ventricular rate > 150 beats/min Lactacte > 4.0 due to inadequate tissue perfusion Any external mechanical cardiovascular support (eg. VA ECMO or intra-aortic balloon pump) Norad > 0.2mcg/kg/min (or unit equivalent) or any dose of norad between 0.1 and 0.2mcg/kg/min with more than a 25% increase in last 6 hours Cardiac index < 2.0L/min/m^2 B. Respiratory FiO2 > 0.6 PEEP > 15 Requirement for hypoxaemic rescue interventions eg. NO, prone, ECMO, prostacyclin, HFOV RR > 45 Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury Proven or suspected actue spinal cord injury Proven or suspected Guillain-Barre Syndrome Second or subsequent ICU admission during a single hospital admission Unable to follow simple verbal commands in English Death inevitable and imminent Inability to walk without assistance of another person prior to onset of acute illness necessitating ICU admission Cognitive impairment prior to current acute illness Agitation which int he opinion of the treating clinician precludes safe implementation of EGDM Written rest in bed orders due to documented injury or process the precludes mobilisation such as suspected or proven instability of spine or pelvis In the opinion of the treating clinician it is unsafe to commence EGDM Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early mobilisation<br>intervention of early mobilisation | Behavioral: Early mobilisation<br> <br> * Other names: Rehabilitation;|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest daily level of activity measured using the ICU mobillity scale | ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid) | Duration of ICU stay (an average of 10 days) | 
| Total Duration of Active Mobilisation |  | Radomisation to removal of invasive ventilation (an average of 7 days) | 
| Mean (or Median) Daily Duration of Active Mobilisation | Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement. | Randomisation to removal of invasive ventilation (daily for an average of 7 days) | 
| Total Duration of Active Mobilisation | Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours | Randomisation to ICU discharge, an average of 10 days | 
| Mean (or Median) Daily Duration of Active Mobilisation | Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days) | Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days | 
| Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day | Measured using the ICU mobility scale (0-10) | Randomisation to Extubation, an average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | Highest level of activity, measured using the IADL | At 6 months from randomisation | 
| Recruitment Rates |  | Entirety of Study | 
| Staff Utilisation Costs | Number of staff required for mobilisation, minutes spent with the patient on active mobilisation activities, and type of staff such as assistant, physiotherapist or nurse, and specific equipment used during mobilisation ie: tilt table/standing frame. | ICU admission (approximately 10 days) | 
| Ventilator and IC free days at Day 28 | Intensive care free defined as ward ready; free of inotropes, RRT and mechanical ventilation for 24 hours and remaining free of these supports until the time of actual ICU discharge | Randomisation to Day 28 | 
| Health related quality of life | EQ5D measured using a trained, blinded assessor via telephone interview | 6 Months after ICU admission | 
| Return to previous work level | Has the participant returned to the work level prior to critical illness? | At 6 months from randomisation | 

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