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TEAM: Trial of Early Activity and Mobilization (TEAM)

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

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.


Condition or disease
Critically Ill Adults Ventilated >24 Hours in Intensive Care

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Study Type : Observational
Actual Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014



Primary Outcome Measures :
  1. 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


  2. 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

  3. Time to standing in ICU [ Time Frame: Intensive care stay (average 7 days) ]
    The number of days in ICU before a patient can stand


Secondary Outcome Measures :
  1. 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


  2. 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

  3. 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

  4. 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

  5. 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

  6. Mechanical ventilation free days [ Time Frame: 28 days ]
    The number of mechanical ventilation free days to day 28

  7. 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)

  8. 90 day mortality [ Time Frame: 90 days ]
    The mortality at day 90

  9. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive care unit patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674608


Locations
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Australia, Victoria
The Alfred
Melbourne, Victoria, Australia, 3104
New Zealand
Wellington hospital
Wellington, New Zealand
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Intensive Care Foundation, Australia
Investigators
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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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT01674608    
Other Study ID Numbers: ICF
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
intensive care
mobilization
rehabilitation
critical care
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes