<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674608</url>
  </required_header>
  <id_info>
    <org_study_id>ICF</org_study_id>
    <nct_id>NCT01674608</nct_id>
  </id_info>
  <brief_title>TEAM: Trial of Early Activity and Mobilization</brief_title>
  <acronym>TEAM</acronym>
  <official_title>TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Australian and New Zealand Intensive Care Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Intensive Care Foundation, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Australian and New Zealand Intensive Care Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their&#xD;
      care. They develop muscle weakness even after only a few days of mechanical ventilation that&#xD;
      may prolong their time in ICU and in hospital, but the nature of such weakness is poorly&#xD;
      understood.&#xD;
&#xD;
      The weakness that develops in ICU is more substantial than that which would result from bed&#xD;
      rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due to&#xD;
      the combination of inflammation and immobility. The exact mechanisms leading to the nerve and&#xD;
      muscle damage which occurs in critical illness are not yet fully understood and require&#xD;
      further investigation. However, it is known that ICUAW has an effect on a patient's ability&#xD;
      to breathe without a ventilator, walk and perform simple activities (like washing and&#xD;
      toileting) and often results in longer mechanical ventilation time and hence, longer hospital&#xD;
      stays than might otherwise be expected. It may also affect a patient's ability to return home&#xD;
      after their hospital stay. The recovery period in Australian and New Zealand ICU patients is&#xD;
      unknown but a trial from Canada has reported ongoing weakness five years after leaving ICU.&#xD;
      Weakness in survivors of intensive care is known to be a substantial problem. It is currently&#xD;
      not known whether ICUAW may be avoided or its severity reduced with simple strategies of&#xD;
      early exercise in ICU.&#xD;
&#xD;
      There are no data about the level of activity and mobility in critically ill patients in&#xD;
      Australian and New Zealand ICUs. These data are urgently required to plan a program of&#xD;
      research to test whether increasing the level of mobility and activity in our critically ill&#xD;
      patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and&#xD;
      improving patient-centred outcomes. The program of research will first include a study to&#xD;
      observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety,&#xD;
      barriers to mobility and what type of activities are undertaken by our patients.&#xD;
&#xD;
      From the observational data we plan to develop a pilot randomised controlled trial of early&#xD;
      mobility and activity in intensive care units across Australia and New Zealand. This simple,&#xD;
      cost-effective strategy may improve functional ability, decrease time on mechanical&#xD;
      ventilation and improve long term outcomes in this patient group. By initiating such a&#xD;
      program, ANZ investigators might be able to change future patient outcomes worldwide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Best level of activity in ICU</measure>
    <time_frame>ICU stay (average 7 days)</time_frame>
    <description>Highest level of activity (11 point scale) including:&#xD;
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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage of the best level of activity</measure>
    <time_frame>Intensive care unit stay (average 7 days)</time_frame>
    <description>The time spent performing the best level of activity and the number of times it is achieved</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to standing in ICU</measure>
    <time_frame>Intensive care stay (average 7 days)</time_frame>
    <description>The number of days in ICU before a patient can stand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best level of activity at hospital discharge</measure>
    <time_frame>Hospital stay (median days 14)</time_frame>
    <description>Highest level of activity (11 point scale) including:&#xD;
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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first sit out of bed</measure>
    <time_frame>ICU stay (average 7 days)</time_frame>
    <description>The number of days until the patient can sit out of bed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers to mobilisation</measure>
    <time_frame>Intensive care unit stay (average 7 days)</time_frame>
    <description>Factors that may have been a barrier to mobilizing patients in the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobilization related adverse events</measure>
    <time_frame>Intensive care unit stay (average 7 days)</time_frame>
    <description>Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first physiotherapy</measure>
    <time_frame>Intensive care unit stay (average 7 days)</time_frame>
    <description>The number of days in intensive care before the patient was reviewed by a physiotherapist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation free days</measure>
    <time_frame>28 days</time_frame>
    <description>The number of mechanical ventilation free days to day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit free days</measure>
    <time_frame>Day 28</time_frame>
    <description>The number of days the patient spent out of ICU to day 28 (if dead = 0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 day mortality</measure>
    <time_frame>90 days</time_frame>
    <description>The mortality at day 90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D</description>
  </secondary_outcome>
  <enrollment type="Actual">192</enrollment>
  <condition>Critically Ill Adults Ventilated &gt;24 Hours in Intensive Care</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Intensive care unit patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  they have received invasive mechanical ventilation for at least 24 hours, and have&#xD;
             been in ICU less than 72 hours&#xD;
&#xD;
          -  the treating clinician expects the patient to still be receiving invasive mechanical&#xD;
             ventilation in the ICU the day after tomorrow.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years old&#xD;
&#xD;
               -  Patient has a proven or suspected acute primary brain process that is likely to&#xD;
                  result in global impairment of conscious level or cognition, such as traumatic&#xD;
                  brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury after&#xD;
                  cardiac arrest or asphyxiation.&#xD;
&#xD;
               -  Second or subsequent admission to ICU during a single hospital admission&#xD;
&#xD;
               -  Patient does not speak English&#xD;
&#xD;
               -  Patient has proven or suspected primary myopathic or neurological process&#xD;
                  associated with prolonged weakness, such as Guillain-Barre syndrome&#xD;
&#xD;
               -  Death is deemed imminent and inevitable&#xD;
&#xD;
               -  Inability to walk without assistance prior to the acute illness that is&#xD;
                  associated with admission to ICU (use of a cane or walker not an exclusion)&#xD;
&#xD;
               -  Cognitive impairment prior to the acute illness that is associated with admission&#xD;
                  to ICU (refer data dictionary)&#xD;
&#xD;
               -  Any written &quot;Rest In Bed&quot; or non-weight bearing medical order such as may occur&#xD;
                  with hip fracture, unstable spine or pelvis, pathological fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol Hodgson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>ANZIC-RC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steve Webb, MD</last_name>
    <role>Study Director</role>
    <affiliation>ANZICS CTG</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rinaldo Bellomo, MD</last_name>
    <role>Study Director</role>
    <affiliation>ANZIC-RC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Megan Harrold, PhD Candidate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Perth Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan Berney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Austin Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heidi Buhr, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Prince Alfred Hospital, Sydney, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manoj Saxena, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St George Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Young, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wellington Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Oystein Tronstad, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince Charles Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neil Orford, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barwon Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Alfred</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3104</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington hospital</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <results_reference>
    <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>
    <PMID>25715872</PMID>
  </results_reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>May 4, 2015</last_update_submitted>
  <last_update_submitted_qc>May 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intensive care</keyword>
  <keyword>mobilization</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>critical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674608
org study id: ICF
nct id: NCT01674608
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Best level of activity in ICU
time frame: ICU stay (average 7 days)
description: 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
measure: Dosage of the best level of activity
time frame: Intensive care unit stay (average 7 days)
description: The time spent performing the best level of activity and the number of times it is achieved
measure: Time to standing in ICU
time frame: Intensive care stay (average 7 days)
description: The number of days in ICU before a patient can stand
measure: Best level of activity at hospital discharge
time frame: Hospital stay (median days 14)
description: 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
measure: Time to first sit out of bed
time frame: ICU stay (average 7 days)
description: The number of days until the patient can sit out of bed
measure: Barriers to mobilisation
time frame: Intensive care unit stay (average 7 days)
description: Factors that may have been a barrier to mobilizing patients in the ICU
measure: Mobilization related adverse events
time frame: Intensive care unit stay (average 7 days)
description: Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor
measure: Time to first physiotherapy
time frame: Intensive care unit stay (average 7 days)
description: The number of days in intensive care before the patient was reviewed by a physiotherapist
measure: Mechanical ventilation free days
time frame: 28 days
description: The number of mechanical ventilation free days to day 28
measure: Intensive care unit free days
time frame: Day 28
description: The number of days the patient spent out of ICU to day 28 (if dead = 0)
measure: 90 day mortality
time frame: 90 days
description: The mortality at day 90
measure: Health related quality of life at 6 months
time frame: 6 months
description: Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carol Hodgson, PhD
role: Study Chair
affiliation: ANZIC-RC
last name: Steve Webb, MD
role: Study Director
affiliation: ANZICS CTG
last name: Rinaldo Bellomo, MD
role: Study Director
affiliation: ANZIC-RC
last name: Megan Harrold, PhD Candidate
role: Principal Investigator
affiliation: Royal Perth Hospital
last name: Susan Berney, PhD
role: Principal Investigator
affiliation: Austin Health
last name: Heidi Buhr, RN
role: Principal Investigator
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
last name: Manoj Saxena, MD
role: Principal Investigator
affiliation: St George Hospital
last name: Paul Young, MD
role: Principal Investigator
affiliation: Wellington Hospital
last name: Oystein Tronstad, PT
role: Principal Investigator
affiliation: Prince Charles Hospital
last name: Neil Orford, MD
role: Principal Investigator
affiliation: Barwon Health
facility: 
facility: 
country: Australia
country: New Zealand
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.
PMID: 25715872
responsible party type: Sponsor
mesh term: Critical Illness