Clinical trial NCT01674608: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Adults Ventilated >24 Hours in Intensive Care
Keywords: intensive care
mobilization
rehabilitation
critical care
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Intensive Care Foundation, Australia
First posted: 2012-08-29
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit patients

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.


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

Primary outcomes:
measure: Best level of activity in ICU
timeFrame: ICU stay (average 7 days)
measure: Dosage of the best level of activity
timeFrame: Intensive care unit stay (average 7 days)
measure: Time to standing in ICU
timeFrame: Intensive care stay (average 7 days)
Secondary outcomes:
measure: Best level of activity at hospital discharge
timeFrame: Hospital stay (median days 14)
measure: Time to first sit out of bed
timeFrame: ICU stay (average 7 days)
measure: Barriers to mobilisation
timeFrame: Intensive care unit stay (average 7 days)
measure: Mobilization related adverse events
timeFrame: Intensive care unit stay (average 7 days)
measure: Time to first physiotherapy
timeFrame: Intensive care unit stay (average 7 days)
measure: Mechanical ventilation free days
timeFrame: 28 days
measure: Intensive care unit free days
timeFrame: Day 28
measure: 90 day mortality
timeFrame: 90 days
measure: Health related quality of life at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Wellington
country: New Zealand
facility: Wellington hospital
Study officials:
affiliation: ANZIC-RC
name: Carol Hodgson, PhD
role: STUDY_CHAIR
affiliation: ANZICS CTG
name: Steve Webb, MD
role: STUDY_DIRECTOR
affiliation: ANZIC-RC
name: Rinaldo Bellomo, MD
role: STUDY_DIRECTOR
affiliation: Royal Perth Hospital
name: Megan Harrold, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Health
name: Susan Berney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Heidi Buhr, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: St George Hospital
name: Manoj Saxena, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellington Hospital
name: Paul Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince Charles Hospital
name: Oystein Tronstad, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Barwon Health
name: Neil Orford, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.