TEAM: Trial of Early Activity and Mobilization (TEAM)

• ClinicalTrials.gov Identifier: NCT01674608
• Recruitment Status: Completed
• First Posted: August 29, 2012
• Last Update Posted: May 6, 2015
• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborator: Intensive Care Foundation, Australia
• Information provided by (Responsible Party): Australian and New Zealand Intensive Care Research Centre

Tracking Information

• First Submitted Date: August 14, 2012
• First Posted Date: August 29, 2012
• Last Update Posted Date: May 6, 2015
• Study Start Date: July 2012
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2012)

• Best level of activity in ICU [ Time Frame: ICU stay (average 7 days) ]
  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
• Dosage of the best level of activity [ Time Frame: Intensive care unit stay (average 7 days) ]
  The time spent performing the best level of activity and the number of times it is achieved
• Time to standing in ICU [ Time Frame: Intensive care stay (average 7 days) ]
  The number of days in ICU before a patient can stand

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 27, 2012)

• Best level of activity at hospital discharge [ Time Frame: Hospital stay (median days 14) ]
  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
• Time to first sit out of bed [ Time Frame: ICU stay (average 7 days) ]
  The number of days until the patient can sit out of bed
• Barriers to mobilisation [ Time Frame: Intensive care unit stay (average 7 days) ]
  Factors that may have been a barrier to mobilizing patients in the ICU
• Mobilization related adverse events [ Time Frame: Intensive care unit stay (average 7 days) ]
  Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor
• Time to first physiotherapy [ Time Frame: Intensive care unit stay (average 7 days) ]
  The number of days in intensive care before the patient was reviewed by a physiotherapist
• Mechanical ventilation free days [ Time Frame: 28 days ]
  The number of mechanical ventilation free days to day 28
• Intensive care unit free days [ Time Frame: Day 28 ]
  The number of days the patient spent out of ICU to day 28 (if dead = 0)
• 90 day mortality [ Time Frame: 90 days ]
  The mortality at day 90
• Health related quality of life at 6 months [ Time Frame: 6 months ]
  Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TEAM: Trial of Early Activity and Mobilization
• Official Title: TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Intensive care unit patients
• Condition: Critically Ill Adults Ventilated >24 Hours in Intensive Care
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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;19:81. 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 4, 2015): 192
• Original Estimated Enrollment (submitted: August 27, 2012): 200
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, New Zealand

Administrative Information

• NCT Number: NCT01674608
• Other Study ID Numbers: ICF
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Australian and New Zealand Intensive Care Research Centre
• Study 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: Susan Berney, PhD; Austin Health
• 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

• PRS Account: Australian and New Zealand Intensive Care Research Centre
• Verification Date: May 2015