- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01927510
TEAM: A Trial of Early Activity and Mobility in ICU (TEAM-RCT)
August 21, 2018 updated by: Australian and New Zealand Intensive Care Research Centre
Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
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.
Study Overview
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
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Heidelberg, Victoria, Australia, 3084
- The Austin Hospital
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- Fremantle Hospital
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-
-
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Auckland
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Grafton, Auckland, New Zealand, 1023
- Auckland City Hospital CVICU
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Wellington
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Newtown, Wellington, New Zealand, 6021
- Wellington Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
Standard care
|
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EXPERIMENTAL: early mobilisation
intervention of early mobilisation
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Duration of ICU stay (an average of 10 days)
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Total Duration of Active Mobilisation
Time Frame: Radomisation to removal of invasive ventilation (an average of 7 days)
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Radomisation to removal of invasive ventilation (an average of 7 days)
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Mean (or Median) Daily Duration of Active Mobilisation
Time Frame: Randomisation to removal of invasive ventilation (daily for an average of 7 days)
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Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
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Randomisation to removal of invasive ventilation (daily for an average of 7 days)
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Total Duration of Active Mobilisation
Time Frame: Randomisation to ICU discharge, an average of 10 days
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Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
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Randomisation to ICU discharge, an average of 10 days
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Mean (or Median) Daily Duration of Active Mobilisation
Time Frame: Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
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Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
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Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
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Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day
Time Frame: Randomisation to Extubation, an average of 7 days
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Measured using the ICU mobility scale (0-10)
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Randomisation to Extubation, an average of 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function
Time Frame: At 6 months from randomisation
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Highest level of activity, measured using the IADL
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At 6 months from randomisation
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Recruitment Rates
Time Frame: Entirety of Study
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Entirety of Study
|
|
Staff Utilisation Costs
Time Frame: ICU admission (approximately 10 days)
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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.
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ICU admission (approximately 10 days)
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Ventilator and IC free days at Day 28
Time Frame: Randomisation to Day 28
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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
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Randomisation to Day 28
|
Health related quality of life
Time Frame: 6 Months after ICU admission
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EQ5D measured using a trained, blinded assessor via telephone interview
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6 Months after ICU admission
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Return to previous work level
Time Frame: At 6 months from randomisation
|
Has the participant returned to the work level prior to critical illness?
|
At 6 months from randomisation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ACTUAL)
November 1, 2014
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
August 15, 2013
First Submitted That Met QC Criteria
August 20, 2013
First Posted (ESTIMATE)
August 22, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 22, 2018
Last Update Submitted That Met QC Criteria
August 21, 2018
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCT01927510
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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