TEAM: Trial of Early Activity and Mobilization (TEAM)

TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand

Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weakness even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, but the nature of such weakness is poorly understood.

The weakness that develops in ICU is more substantial than that which would result from bed rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due to the combination of inflammation and immobility. The exact mechanisms leading to the nerve and muscle damage which occurs in critical illness are not yet fully understood and require further investigation. However, it is known that ICUAW has an effect on a patient's ability to breathe without a ventilator, walk and perform simple activities (like washing and toileting) and often results in longer mechanical ventilation time and hence, longer hospital stays than might otherwise be expected. It may also affect a patient's ability to return home after their hospital stay. The recovery period in Australian and New Zealand ICU patients is unknown but a trial from Canada has reported ongoing weakness five years after leaving ICU. Weakness in survivors of intensive care is known to be a substantial problem. It is currently not known whether ICUAW may be avoided or its severity reduced with simple strategies of early exercise in ICU.

There are no data about the level of activity and mobility in critically ill patients in Australian and New Zealand ICUs. These data are urgently required to plan a program of research to test whether increasing the level of mobility and activity in our critically ill patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and improving patient-centred outcomes. The program of research will first include a study to observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety, barriers to mobility and what type of activities are undertaken by our patients.

From the observational data we plan to develop a pilot randomised controlled trial of early mobility and activity in intensive care units across Australia and New Zealand. This simple, cost-effective strategy may improve functional ability, decrease time on mechanical ventilation and improve long term outcomes in this patient group. By initiating such a program, ANZ investigators might be able to change future patient outcomes worldwide.

Study Overview

• Status: Completed
• Conditions: Critically Ill Adults Ventilated >24 Hours in Intensive Care

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3104
      • The Alfred
• New Zealand
  • Wellington, New Zealand
    • Wellington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Intensive care unit patients

Description

Inclusion Criteria:

• they have received invasive mechanical ventilation for at least 24 hours, and have been in ICU less than 72 hours
• the treating clinician expects the patient to still be receiving invasive mechanical ventilation in the ICU the day after tomorrow.

Exclusion Criteria:

• Age less than 18 years old

  • Patient has a proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury after cardiac arrest or asphyxiation.
  • Second or subsequent admission to ICU during a single hospital admission
  • Patient does not speak English
  • Patient has proven or suspected primary myopathic or neurological process associated with prolonged weakness, such as Guillain-Barre syndrome
  • Death is deemed imminent and inevitable
  • Inability to walk without assistance prior to the acute illness that is associated with admission to ICU (use of a cane or walker not an exclusion)
  • Cognitive impairment prior to the acute illness that is associated with admission to ICU (refer data dictionary)
  • Any written "Rest In Bed" or non-weight bearing medical order such as may occur with hip fracture, unstable spine or pelvis, pathological fracture

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best level of activity in ICU	Highest level of activity (11 point scale) including: unknown nothing (lying in bed, passive stretches) sitting in bed, active exercises in bed moved to chair (via hoist, slide etc but no standing) sitting over edge of bed standing transferring bed to chair marching on spot (at bedside) walking with assistance of 2 or more people walking with assistance of 1 person walking independently with a gait aid walking independently without a gait aid	ICU stay (average 7 days)
Dosage of the best level of activity	The time spent performing the best level of activity and the number of times it is achieved	Intensive care unit stay (average 7 days)
Time to standing in ICU	The number of days in ICU before a patient can stand	Intensive care stay (average 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best level of activity at hospital discharge	Highest level of activity (11 point scale) including: unknown nothing (lying in bed, passive stretches) sitting in bed, active exercises in bed passively moved to chair (pat slide, hoist but no standing) sitting over edge of bed standing transferring bed to chair marching on spot (at bedside) walking with assistance of 2 or more people walking with assistance of 1 person walking independently with a gait aid walking independently without a gait aid	Hospital stay (median days 14)
Time to first sit out of bed	The number of days until the patient can sit out of bed	ICU stay (average 7 days)
Barriers to mobilisation	Factors that may have been a barrier to mobilizing patients in the ICU	Intensive care unit stay (average 7 days)
Mobilization related adverse events	Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor	Intensive care unit stay (average 7 days)
Time to first physiotherapy	The number of days in intensive care before the patient was reviewed by a physiotherapist	Intensive care unit stay (average 7 days)
Mechanical ventilation free days	The number of mechanical ventilation free days to day 28	28 days
Intensive care unit free days	The number of days the patient spent out of ICU to day 28 (if dead = 0)	Day 28
90 day mortality	The mortality at day 90	90 days
Health related quality of life at 6 months	Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D	6 months

Collaborators and Investigators

• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: Intensive Care Foundation, Australia
• Investigators: Study Chair: Carol Hodgson, PhD, ANZIC-RC; Study Director: Steve Webb, MD, ANZICS CTG; Study Director: Rinaldo Bellomo, MD, ANZIC-RC; Principal Investigator: Megan Harrold, PhD Candidate, Royal Perth Hospital; Principal Investigator: Heidi Buhr, RN, Royal Prince Alfred Hospital, Sydney, Australia; Principal Investigator: Manoj Saxena, MD, St George Hospital; Principal Investigator: Paul Young, MD, Wellington Hospital; Principal Investigator: Oystein Tronstad, PT, Prince Charles Hospital; Principal Investigator: Neil Orford, MD, Barwon Health

Publications and helpful links

General Publications

• TEAM Study Investigators, Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
• Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: critical care; rehabilitation; intensive care; mobilization
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: ICF