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TEAM: A Trial of Early Activity and Mobility in ICU (TEAM-RCT)

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ClinicalTrials.gov Identifier: NCT01927510
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Australian and New Zealand Intensive Care Society Clinical Trials Group
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Tracking Information
First Submitted Date  ICMJE August 15, 2013
First Posted Date  ICMJE August 22, 2013
Last Update Posted Date August 22, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • Highest daily level of activity measured using the ICU mobillity scale [ Time Frame: Duration of ICU stay (an average of 10 days) ]
    ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
  • Total Duration of Active Mobilisation [ Time Frame: Radomisation to removal of invasive ventilation (an average of 7 days) ]
  • Mean (or Median) Daily Duration of Active Mobilisation [ Time Frame: Randomisation to removal of invasive ventilation (daily for an average of 7 days) ]
    Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
  • Total Duration of Active Mobilisation [ Time Frame: Randomisation to ICU discharge, an average of 10 days ]
    Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
  • Mean (or Median) Daily Duration of Active Mobilisation [ Time Frame: Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days ]
    Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
  • Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day [ Time Frame: Randomisation to Extubation, an average of 7 days ]
    Measured using the ICU mobility scale (0-10)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • Physical Function [ Time Frame: At 6 months from randomisation ]
    Highest level of activity, measured using the IADL
  • Recruitment Rates [ Time Frame: Entirety of Study ]
  • Staff Utilisation Costs [ Time Frame: ICU admission (approximately 10 days) ]
    Number of staff required for mobilisation, minutes spent with the patient on active mobilisation activities, and type of staff such as assistant, physiotherapist or nurse, and specific equipment used during mobilisation ie: tilt table/standing frame.
  • Ventilator and IC free days at Day 28 [ Time Frame: Randomisation to Day 28 ]
    Intensive care free defined as ward ready; free of inotropes, RRT and mechanical ventilation for 24 hours and remaining free of these supports until the time of actual ICU discharge
  • Health related quality of life [ Time Frame: 6 Months after ICU admission ]
    EQ5D measured using a trained, blinded assessor via telephone interview
  • Return to previous work level [ Time Frame: At 6 months from randomisation ]
    Has the participant returned to the work level prior to critical illness?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TEAM: A Trial of Early Activity and Mobility in ICU
Official Title  ICMJE Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
Brief Summary Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weaknesses even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, delay functional recovery and delay their return home and to work. Weakness may be avoided with simple strategies of early exercise in ICU. This pilot study aims to test the hypothesis that early mobilisation may improve functional recovery in this patient group and gather pilot data to support a larger randomised trial across Australia and New Zealand.
Detailed Description Patients who are admitted and treated in the intensive care unit (ICU) generally have potentially reversible critical illness. While many patients survive, substantial proportions of patients fail to recover completely and do not return to their pre-morbid level of health. Critically ill patients receive mechanical ventilation, as a lifesaving intervention, but this is routinely managed with deep sedation and immobility, which results in prolonged periods of bed rest. Severe muscle weakness, termed ICUAW, is common and associated with prolonged duration of mechanical ventilation and hospital stay in the ICU, as well as poor recovery of physical function. Early mobilisation, exercising patients while they are still receiving mechanical ventilation, has been proposed as a candidate intervention to prevent ICU acquired weakness (ICUAW). Observational studies indicate that early mobilisation is not used routinely in critically ill patients in Australia and New Zealand. TEAM is a pilot RCT designed to obtain data to assist in the planning of an adequately powered RCT that will test the hypothesis that early mobilisation of critically ill patients improves one or more functional outcomes, quality of survival, and proportion of patients who survive.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Critically Ill
Intervention  ICMJE Behavioral: Early mobilisation
Other Name: Rehabilitation
Study Arms  ICMJE
  • Experimental: early mobilisation
    intervention of early mobilisation
    Intervention: Behavioral: Early mobilisation
  • No Intervention: Control
    Standard care
Publications * Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S; Trial of Early Activity and Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med. 2016 Jun;44(6):1145-52. doi: 10.1097/CCM.0000000000001643.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2013)
80
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults > or + to 18 years old admitted to the ICU
  • Invasively ventilated and expected to be ventilated the day after tomorrow
  • Written informed consent from person responsible/ net of kin (or consent as per individual HREC if delayed or telephone consent is acceptable)

Exclusion Criteria:

  1. INSTABILITY A. Cardiovascular

    • Unresolved rhythm disturbance with any bradycardia requiring pharmacological support
    • Any tachycardia with ventricular rate > 150 beats/min
    • Lactacte > 4.0 due to inadequate tissue perfusion
    • Any external mechanical cardiovascular support (eg. VA ECMO or intra-aortic balloon pump)
    • Norad > 0.2mcg/kg/min (or unit equivalent) or any dose of norad between 0.1 and 0.2mcg/kg/min with more than a 25% increase in last 6 hours
    • Cardiac index < 2.0L/min/m^2

    B. Respiratory

    • FiO2 > 0.6
    • PEEP > 15
    • Requirement for hypoxaemic rescue interventions eg. NO, prone, ECMO, prostacyclin, HFOV
    • RR > 45
  2. Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury
  3. Proven or suspected actue spinal cord injury
  4. Proven or suspected Guillain-Barre Syndrome
  5. Second or subsequent ICU admission during a single hospital admission
  6. Unable to follow simple verbal commands in English
  7. Death inevitable and imminent
  8. Inability to walk without assistance of another person prior to onset of acute illness necessitating ICU admission
  9. Cognitive impairment prior to current acute illness
  10. Agitation which int he opinion of the treating clinician precludes safe implementation of EGDM
  11. Written rest in bed orders due to documented injury or process the precludes mobilisation such as suspected or proven instability of spine or pelvis
  12. In the opinion of the treating clinician it is unsafe to commence EGDM
  13. Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01927510
Other Study ID Numbers  ICMJE Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Australian and New Zealand Intensive Care Research Centre
Study Sponsor  ICMJE Australian and New Zealand Intensive Care Research Centre
Collaborators  ICMJE Australian and New Zealand Intensive Care Society Clinical Trials Group
Investigators  ICMJE
Study Chair: Carol L Hodgson, PhD Australian and New Zealand Intensive Care Research Centre
PRS Account Australian and New Zealand Intensive Care Research Centre
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP