Clinical trial NCT01927510: TEAM: A Trial of Early Activity and Mobility in ICU
Official title: Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critically Ill
Keywords: Early mobilization, rehabilitation, intensive care
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Australian and New Zealand Intensive Care Society Clinical Trials Group
First posted: 2013-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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:

1. 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
2. Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury
3. Proven or suspected actue spinal cord injury
4. Proven or suspected Guillain-Barre Syndrome
5. Second or subsequent ICU admission during a single hospital admission
6. Unable to follow simple verbal commands in English
7. Death inevitable and imminent
8. Inability to walk without assistance of another person prior to onset of acute illness necessitating ICU admission
9. Cognitive impairment prior to current acute illness
10. Agitation which int he opinion of the treating clinician precludes safe implementation of EGDM
11. Written rest in bed orders due to documented injury or process the precludes mobilisation such as suspected or proven instability of spine or pelvis
12. In the opinion of the treating clinician it is unsafe to commence EGDM
13. Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours

Primary outcomes:
measure: Highest daily level of activity measured using the ICU mobillity scale
timeFrame: Duration of ICU stay (an average of 10 days)
measure: Total Duration of Active Mobilisation
timeFrame: Radomisation to removal of invasive ventilation (an average of 7 days)
measure: Mean (or Median) Daily Duration of Active Mobilisation
timeFrame: Randomisation to removal of invasive ventilation (daily for an average of 7 days)
measure: Total Duration of Active Mobilisation
timeFrame: Randomisation to ICU discharge, an average of 10 days
measure: Mean (or Median) Daily Duration of Active Mobilisation
timeFrame: Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
measure: Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day
timeFrame: Randomisation to Extubation, an average of 7 days
Secondary outcomes:
measure: Physical Function
timeFrame: At 6 months from randomisation
measure: Recruitment Rates
timeFrame: Entirety of Study
measure: Staff Utilisation Costs
timeFrame: ICU admission (approximately 10 days)
measure: Ventilator and IC free days at Day 28
timeFrame: Randomisation to Day 28
measure: Health related quality of life
timeFrame: 6 Months after ICU admission
measure: Return to previous work level
timeFrame: At 6 months from randomisation
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: The Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Grafton
country: New Zealand
facility: Auckland CIty Hospital CVICU
state: Auckland
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
Study officials:
affiliation: Australian and New Zealand Intensive Care Research Centre
name: Carol L Hodgson, PhD
role: STUDY_CHAIR
References:
citation: Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S; Trial of Early Activity and Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med. 2016 Jun;44(6):1145-52. doi: 10.1097/CCM.0000000000001643.