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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01927510




Registration number
NCT01927510
Ethics application status
Date submitted
15/08/2013
Date registered
22/08/2013
Date last updated
22/08/2018

Titles & IDs
Public title
TEAM: A Trial of Early Activity and Mobility in ICU
Scientific title
Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
Secondary ID [1] 0 0
NCT01927510
Universal Trial Number (UTN)
Trial acronym
TEAM-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: early mobilisation - intervention of early mobilisation

No intervention: Control - Standard care
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Highest daily level of activity measured using the ICU mobillity scale
Timepoint [1] 0 0
Duration of ICU stay (an average of 10 days)
Primary outcome [2] 0 0
Total Duration of Active Mobilisation
Timepoint [2] 0 0
Radomisation to removal of invasive ventilation (an average of 7 days)
Primary outcome [3] 0 0
Mean (or Median) Daily Duration of Active Mobilisation
Timepoint [3] 0 0
Randomisation to removal of invasive ventilation (daily for an average of 7 days)
Primary outcome [4] 0 0
Total Duration of Active Mobilisation
Timepoint [4] 0 0
Randomisation to ICU discharge, an average of 10 days
Primary outcome [5] 0 0
Mean (or Median) Daily Duration of Active Mobilisation
Timepoint [5] 0 0
Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
Primary outcome [6] 0 0
Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day
Timepoint [6] 0 0
Randomisation to Extubation, an average of 7 days
Secondary outcome [1] 0 0
Physical Function
Timepoint [1] 0 0
At 6 months from randomisation
Secondary outcome [2] 0 0
Recruitment Rates
Timepoint [2] 0 0
Entirety of Study
Secondary outcome [3] 0 0
Staff Utilisation Costs
Timepoint [3] 0 0
ICU admission (approximately 10 days)
Secondary outcome [4] 0 0
Ventilator and IC free days at Day 28
Timepoint [4] 0 0
Randomisation to Day 28
Secondary outcome [5] 0 0
Health related quality of life
Timepoint [5] 0 0
6 Months after ICU admission
Secondary outcome [6] 0 0
Return to previous work level
Timepoint [6] 0 0
At 6 months from randomisation

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01927510
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Carol L Hodgson, PhD
Address 0 0
Australian and New Zealand Intensive Care Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01927510