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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]

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

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]

Best level of activity in ICU

Timepoint [1]

ICU stay (average 7 days)

Primary outcome [2]

Dosage of the best level of activity

Timepoint [2]

Intensive care unit stay (average 7 days)

Primary outcome [3]

Time to standing in ICU

Timepoint [3]

Intensive care stay (average 7 days)

Secondary outcome [1]

Best level of activity at hospital discharge

Timepoint [1]

Hospital stay (median days 14)

Secondary outcome [2]

Time to first sit out of bed

Timepoint [2]

ICU stay (average 7 days)

Secondary outcome [3]

Barriers to mobilisation

Timepoint [3]

Intensive care unit stay (average 7 days)

Secondary outcome [4]

Mobilization related adverse events

Timepoint [4]

Intensive care unit stay (average 7 days)

Secondary outcome [5]

Time to first physiotherapy

Timepoint [5]

Intensive care unit stay (average 7 days)

Secondary outcome [6]

Mechanical ventilation free days

Timepoint [6]

28 days

Secondary outcome [7]

Intensive care unit free days

Timepoint [7]

Day 28

Secondary outcome [8]

90 day mortality

Timepoint [8]

90 days

Secondary outcome [9]

Health related quality of life at 6 months

Timepoint [9]

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?

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]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3104 - Melbourne

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Primary sponsor type

Other

Name

Australian and New Zealand Intensive Care Research Centre

Address

Country

Other collaborator category [1]

Other

Name [1]

Intensive Care Foundation, Australia

Address [1]

Country [1]

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

Carol Hodgson, PhD

Address

ANZIC-RC

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Type	Citations or Other Details
Journal	TEAM Study Investigators; Hodgson C, Bellomo R, Be... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01674608

Trial Review

Registering a new trial?

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