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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • The Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland City Hospital CVICU
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Wellington Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control
Standard care
EXPERIMENTAL: early mobilisation
intervention of early mobilisation
Behavioral: Early mobilisation
Other Names:
  • Rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Duration of ICU stay (an average of 10 days)
Total Duration of Active Mobilisation
Time Frame: Radomisation to removal of invasive ventilation (an average of 7 days)
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.
Randomisation to removal of invasive ventilation (daily for an average of 7 days)
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
Randomisation to ICU discharge, an average of 10 days
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)
Randomisation to Time of Final Listing for Ward Discharge, an average of 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)
Randomisation to Extubation, an average of 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Function
Time Frame: At 6 months from randomisation
Highest level of activity, measured using the IADL
At 6 months from randomisation
Recruitment Rates
Time Frame: Entirety of Study
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.
ICU admission (approximately 10 days)
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
Randomisation to Day 28
Health related quality of life
Time Frame: 6 Months after ICU admission
EQ5D measured using a trained, blinded assessor via telephone interview
6 Months after ICU admission
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Australian and New Zealand Intensive Care Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Australian and New Zealand Intensive Care Society Clinical Trials Group

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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