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Critically IllPhase 1/2TEAM-RCTNCT01927510

TEAM: A Trial of Early Activity and Mobility in ICU

A Phase 1/2 study testing Early mobilisation in people with Critically Ill, run by Australian and New Zealand Intensive Care Research Centre at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critically Ill
What is being tested?
Early mobilisation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesin 2 countries
Study dates
Aug 2013to Feb 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 24Show fewer
  • Cardiac index < 2.0L/min/m^2
  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Australia3 sites

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • The Austin Hospital

    Heidelberg, Victoria, 3084

  • The Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

New Zealand2 sites

  • Auckland CIty Hospital CVICU

    Grafton, Auckland, 1023

  • Wellington Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Conditions
Critically Ill
Being tested
Early mobilisation
Keywords
Early mobilization, rehabilitation, intensive care
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early mobilisationBehavioural

    Also called Rehabilitation

Study groups in NCT01927510
Study groupRoleWhat they receive
early mobilisationExperimentalintervention of early mobilisation
Receives: Behavioral: Early mobilisation
ControlNo interventionStandard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Duration of ICU stay (an average of 10 days)

  2. Total Duration of Active Mobilisation

    Measured: Radomisation to removal of invasive ventilation (an average of 7 days)

  3. 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.

    Measured: Randomisation to removal of invasive ventilation (daily for an average of 7 days)

  4. Total Duration of Active Mobilisation

    Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours

    Measured: Randomisation to ICU discharge, an average of 10 days

  5. 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)

    Measured: Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days

  6. Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day

    Measured using the ICU mobility scale (0-10)

    Measured: Randomisation to Extubation, an average of 7 days

Secondary outcomes (6)

  1. Physical Function

    Highest level of activity, measured using the IADL

    Measured: At 6 months from randomisation

  2. Recruitment Rates

    Measured: Entirety of Study

  3. 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.

    Measured: ICU admission (approximately 10 days)

  4. 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

    Measured: Randomisation to Day 28

  5. Health related quality of life

    EQ5D measured using a trained, blinded assessor via telephone interview

    Measured: 6 Months after ICU admission

  6. Return to previous work level

    Has the participant returned to the work level prior to critical illness?

    Measured: At 6 months from randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionNov 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01927510
Sponsor's protocol ID
NCT01927510
Acronym
TEAM-RCT
Status last verified
Jun 2015
First submitted
15 Aug 2013
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26968024

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Early mobilisation in people with Critically Ill, run by Australian and New Zealand Intensive Care Research Centre at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Highest daily level of activity measured using the ICU mobillity scale (time frame: Duration of ICU stay (an average of 10 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01927510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.

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