search
Back to results

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

Primary Purpose

Critically Ill

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Early mobilisation
Sponsored by
Australian and New Zealand Intensive Care Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Early mobilization, rehabilitation, intensive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Austin Hospital
  • The Alfred Hospital
  • Fremantle Hospital
  • Auckland CIty Hospital CVICU
  • Wellington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

early mobilisation

Control

Arm Description

intervention of early mobilisation

Standard care

Outcomes

Primary Outcome Measures

Highest daily level of activity measured using the ICU mobillity scale
ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
Total Duration of Active Mobilisation
Mean (or Median) Daily Duration of Active Mobilisation
Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
Total Duration of Active Mobilisation
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
Mean (or Median) Daily Duration of Active Mobilisation
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
Measured using the ICU mobility scale (0-10)

Secondary Outcome Measures

Physical Function
Highest level of activity, measured using the IADL
Recruitment Rates
Staff Utilisation Costs
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
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
EQ5D measured using a trained, blinded assessor via telephone interview
Return to previous work level
Has the participant returned to the work level prior to critical illness?

Full Information

First Posted
August 15, 2013
Last Updated
August 21, 2018
Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
Australian and New Zealand Intensive Care Society Clinical Trials Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01927510
Brief Title
TEAM: A Trial of Early Activity and Mobility in ICU
Acronym
TEAM-RCT
Official Title
Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
Australian and New Zealand Intensive Care Society Clinical Trials Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
Early mobilization, rehabilitation, intensive care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early mobilisation
Arm Type
Experimental
Arm Description
intervention of early mobilisation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Early mobilisation
Other Intervention Name(s)
Rehabilitation
Primary Outcome Measure Information:
Title
Highest daily level of activity measured using the ICU mobillity scale
Description
ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
Time Frame
Duration of ICU stay (an average of 10 days)
Title
Total Duration of Active Mobilisation
Time Frame
Radomisation to removal of invasive ventilation (an average of 7 days)
Title
Mean (or Median) Daily Duration of Active Mobilisation
Description
Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
Time Frame
Randomisation to removal of invasive ventilation (daily for an average of 7 days)
Title
Total Duration of Active Mobilisation
Description
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
Time Frame
Randomisation to ICU discharge, an average of 10 days
Title
Mean (or Median) Daily Duration of Active Mobilisation
Description
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
Time Frame
Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
Title
Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day
Description
Measured using the ICU mobility scale (0-10)
Time Frame
Randomisation to Extubation, an average of 7 days
Secondary Outcome Measure Information:
Title
Physical Function
Description
Highest level of activity, measured using the IADL
Time Frame
At 6 months from randomisation
Title
Recruitment Rates
Time Frame
Entirety of Study
Title
Staff Utilisation Costs
Description
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.
Time Frame
ICU admission (approximately 10 days)
Title
Ventilator and IC free days at Day 28
Description
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
Time Frame
Randomisation to Day 28
Title
Health related quality of life
Description
EQ5D measured using a trained, blinded assessor via telephone interview
Time Frame
6 Months after ICU admission
Title
Return to previous work level
Description
Has the participant returned to the work level prior to critical illness?
Time Frame
At 6 months from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury Proven or suspected actue spinal cord injury Proven or suspected Guillain-Barre Syndrome Second or subsequent ICU admission during a single hospital admission Unable to follow simple verbal commands in English Death inevitable and imminent Inability to walk without assistance of another person prior to onset of acute illness necessitating ICU admission Cognitive impairment prior to current acute illness Agitation which int he opinion of the treating clinician precludes safe implementation of EGDM Written rest in bed orders due to documented injury or process the precludes mobilisation such as suspected or proven instability of spine or pelvis In the opinion of the treating clinician it is unsafe to commence EGDM Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol L Hodgson, PhD
Organizational Affiliation
Australian and New Zealand Intensive Care Research Centre
Official's Role
Study Chair
Facility Information:
Facility Name
The Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Auckland CIty Hospital CVICU
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26968024
Citation
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.
Results Reference
background

Learn more about this trial

TEAM: A Trial of Early Activity and Mobility in ICU

We'll reach out to this number within 24 hrs