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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03133377




Registration number
NCT03133377
Ethics application status
Date submitted
10/04/2017
Date registered
28/04/2017
Date last updated
24/08/2018

Titles & IDs
Public title
Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation
Scientific title
A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care
Secondary ID [1] 0 0
TEAM U1111-1195-3567
Universal Trial Number (UTN)
Trial acronym
TEAM(III)
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Early activity and mobilisation

Experimental: Early activity and Mobilisation intervention - Patients will be assessed daily by an ICU physiotherapist using the ICU Mobility Scale (IMS) to determine the dosage and type of active exercises the patient will receive, using the early activity and mobilisation protocol. This protocol is hierarchical, with the objective of each intervention session beginning with the highest level of activity possible for the longest time possible, which then steps down to lower levels of activity if the patient fatigues. The intervention will be administered on all days in which the patient is admitted to ICU during the index hospitalisation, censored at 28days after.

No Intervention: Standard of care - The control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed.


Behaviour: Early activity and mobilisation
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of days alive and out of hospital - Any days spent in rehabilitation or a nursing home counted as days in hospital
Timepoint [1] 0 0
between randomisation and 180 days
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
From date of randomisation up to180days.
Secondary outcome [2] 0 0
Time from randomisation until death
Timepoint [2] 0 0
From date of randomisation unitl date of death from all cause, censored at 180days
Secondary outcome [3] 0 0
Ventilator-free days - patients who die prior to day 28 will be assigned zero ventilator-free days
Timepoint [3] 0 0
From date of randomisation until day 28
Secondary outcome [4] 0 0
ICU-free days - patients who die prior to day 28 will be assigned zero ICU-free days
Timepoint [4] 0 0
From date of randomisation until day 28
Secondary outcome [5] 0 0
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Timepoint [5] 0 0
Assessed at 180days
Secondary outcome [6] 0 0
Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL)
Timepoint [6] 0 0
Assessed at 180days
Secondary outcome [7] 0 0
Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)
Timepoint [7] 0 0
Assessed at 180days

Eligibility
Key inclusion criteria
1. Aged 18 years or older.

2. Intubated and expected to remain invasively mechanically ventilated the day after
tomorrow.

3. Sufficient cardiovascular stability to make mobilisation potentially possible, as
indicated by:

1. the absence of current brady-arrhythmia requiring pharmacological support

2. a current ventricular rate = 150 bpm

3. most recent lactate = 4.0 mmol/L

4. current combined noradrenaline/adrenaline infusion rate of = 0.2 mcg/kg/min, OR
if noradrenaline/adrenaline infusion rate has increased by more than 25% in the
last 6 hours, dose must be <0.1 mcg/kg/min.

5. most recent cardiac index = 2.0 L/min/m2 (where measured)

6. no current requirement for VA ECMO

4. Sufficient respiratory stability to make mobilisation potentially possible, as
indicated by:

1. current FiO2 = 0.6

2. current PEEP = 16 cm H20

3. an absence of current requirement for NO, prone ventilation, neuromuscular
blockers, ventilation, prostacyclin, VV ECMO or HFOV

4. current RR = 45 bpm
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dependent for activities of daily living in the month prior to current ICU admission
(gait aids are acceptable).

2. Documented cognitive impairment.

3. Proven or suspected acute primary brain pathology (e.g. traumatic brain injury,
stroke, hypoxic brain injury).

4. Proven or suspected spinal cord injury or other neuromuscular disease that will result
in permanent or prolonged weakness (not including ICU acquired weakness).

5. Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower
limbs.

6. Life expectancy less than 180 days due to a chronic or underlying medical condition.

7. Death is deemed inevitable as a result of the current illness and either the patient
or treating clinical or substitute decision maker are not committed to full active
treatment.

8. Unable to communicate in the official local language.

9. This is not the first ICU admission in the index hospital admission.

10. Fulfilled all inclusion criteria and none of the exclusion criteria = 72 hours

Study design
Purpose of the study
Prevention
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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St George Hospital - Sydney
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside West
Recruitment hospital [5] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [6] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [10] 0 0
Geelong Hospital - Barwon Health - Geelong
Recruitment hospital [11] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [12] 0 0
Austin Health - Melbourne
Recruitment hospital [13] 0 0
Cabrini Health - Melbourne
Recruitment hospital [14] 0 0
Epworth Richmond - Melbourne
Recruitment hospital [15] 0 0
Western Health - Melbourne
Recruitment hospital [16] 0 0
Alfred Hospital - Prahran
Recruitment hospital [17] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [18] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [19] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [20] 0 0
St John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment postcode(s) [3] 0 0
- Birtinya
Recruitment postcode(s) [4] 0 0
- Chermside West
Recruitment postcode(s) [5] 0 0
- Redcliffe
Recruitment postcode(s) [6] 0 0
- Toowoomba
Recruitment postcode(s) [7] 0 0
- Woolloongabba
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3065 - Melbourne
Recruitment postcode(s) [12] 0 0
- Melbourne
Recruitment postcode(s) [13] 0 0
3004 - Prahran
Recruitment postcode(s) [14] 0 0
- Nedlands
Recruitment postcode(s) [15] 0 0
6150 - Perth
Recruitment postcode(s) [16] 0 0
- Perth
Recruitment postcode(s) [17] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Munich
Country [2] 0 0
Ireland
State/province [2] 0 0
Dublin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
New Zealand
State/province [5] 0 0
Tauranga
Country [6] 0 0
New Zealand
State/province [6] 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
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
ANZICS Clinical Trials Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to evaluate the effect of early activity and mobilisation during
prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The
effect of the intervention on mortality, physical, cognitive and Psychological function at
180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The
study will also explore process of care measures and baseline physiology and ICU mobility
outcomes.

The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and
mobilisation increases the number of days alive and at home to day 180 when compared with
standard care.
Trial website
https://clinicaltrials.gov/show/NCT03133377
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.
Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18. Review.
Iwashyna TJ, Hodgson CL. Early mobilisation in ICU is far more than just exercise. Lancet. 2016 Oct 1;388(10052):1351-1352. doi: 10.1016/S0140-6736(16)31745-7.
Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson
Address 0 0
ANZIC-RC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Janani Sivasuthan
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0932
Fax 0 0
Email 0 0
Janani.Sivasuthan@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03133377