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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01674608




Registration number
NCT01674608
Ethics application status
Date submitted
14/08/2012
Date registered
29/08/2012
Date last updated
6/05/2015

Titles & IDs
Public title
TEAM: Trial of Early Activity and Mobilization
Scientific title
TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand
Secondary ID [1] 0 0
ICF
Universal Trial Number (UTN)
Trial acronym
TEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill Adults Ventilated >24 Hours in Intensive Care 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best level of activity in ICU
Timepoint [1] 0 0
ICU stay (average 7 days)
Primary outcome [2] 0 0
Dosage of the best level of activity
Timepoint [2] 0 0
Intensive care unit stay (average 7 days)
Primary outcome [3] 0 0
Time to standing in ICU
Timepoint [3] 0 0
Intensive care stay (average 7 days)
Secondary outcome [1] 0 0
Best level of activity at hospital discharge
Timepoint [1] 0 0
Hospital stay (median days 14)
Secondary outcome [2] 0 0
Time to first sit out of bed
Timepoint [2] 0 0
ICU stay (average 7 days)
Secondary outcome [3] 0 0
Barriers to mobilisation
Timepoint [3] 0 0
Intensive care unit stay (average 7 days)
Secondary outcome [4] 0 0
Mobilization related adverse events
Timepoint [4] 0 0
Intensive care unit stay (average 7 days)
Secondary outcome [5] 0 0
Time to first physiotherapy
Timepoint [5] 0 0
Intensive care unit stay (average 7 days)
Secondary outcome [6] 0 0
Mechanical ventilation free days
Timepoint [6] 0 0
28 days
Secondary outcome [7] 0 0
Intensive care unit free days
Timepoint [7] 0 0
Day 28
Secondary outcome [8] 0 0
90 day mortality
Timepoint [8] 0 0
90 days
Secondary outcome [9] 0 0
Health related quality of life at 6 months
Timepoint [9] 0 0
6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3104 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Intensive Care Foundation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01674608
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson, PhD
Address 0 0
ANZIC-RC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01674608