TEAM(III): Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

• Sponsor: Australian and New Zealand Intensive Care Research Centre (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03133377
• Collaborator: National Health and Medical Research Council, Australia (Other), ANZICS Clinical Trials Group (Other), Medical Research Institute of New Zealand (Other), Intensive Care National Audit & Research Centre (Other)
• Enrollment: 750
• Locations: 49
• Arms: 2
• Anticipated Duration (Months): 51.6
• Patients Per Site: 15.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill, Mechanically Ventilated	Behavioral: Early activity and mobilisation	Phase 3

Detailed Description

The TEAM Trial is a definitive phase III multi-centre randomised controlled trial in mechanically ventilated patients. Supported by compelling preliminary data, the trial will determine whether early activity and mobilisation during mechanical ventilation improves days alive and at home at 6 months compared to standard care. Recruiting 750 patients, this will be the largest trial ever conducted of early mobilisation.

Patients allocated to the early activity and mobilisation protocol (intervention group) will be assessed by a physiotherapist daily during the ICU stay to determine the highest level of mobility. This will determine the dosage and type of exercise that will be delivered, led by the physiotherapist with assistance from the multidisciplinary team. For both groups, concomitant care will be guided by the treating clinician. In addition, all post-ICU patient management will be at the discretion of the patient's ward-based treating physicians.

Patients will be randomized via web-based system and de-identified data will be collected on the following: baseline demographics; comorbidities; sedatives, analgesics, corticosteroids and neuromuscular blockers; pain/sedation/delirium scores; tracheostomy, intubation and renal replacement therapy. The intervention will be administered during the ICU stay upto 28days and the Day 180 follow up will be conducted centrally.

Study Design

• Study Type: Interventional
• Actual Enrollment: 750 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official 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
• Actual Study Start Date: Feb 28, 2018
• Anticipated Primary Completion Date: Jun 17, 2022
• Anticipated Study Completion Date: Jun 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: 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
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.

Outcome Measures

Primary Outcome Measures

1. Number of days alive and out of hospital [between randomisation and 180 days]

   Any days spent in rehabilitation or a nursing home counted as days in hospital

Secondary Outcome Measures

1. All-cause mortality [From date of randomisation up to180days.]

2. Time from randomisation until death [From date of randomisation unitl date of death from all cause, censored at 180days]

3. Ventilator-free days [From date of randomisation until day 28]

   patients who die prior to day 28 will be assigned zero ventilator-free days

4. ICU-free days [From date of randomisation until day 28]

   patients who die prior to day 28 will be assigned zero ICU-free days

5. Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Assessed at 180days]

6. Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL) [Assessed at 180days]

7. Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) [Assessed at 180days]

Other Outcome Measures

1. Delirium free days [From date of randomisation until day 28]

   Will be measured using CAM-ICU and RASS score

2. Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) [Assessed at 180days]

3. Psychological function measured using Hospital Anxiety and Depression scale (HADS) [Assessed at 180days]

4. Psychological function measured using Impact of Event Scale - Revised (IES-R) [Assessed at 180 days]

5. All-cause mortality [From date of randomisation up to 28 days]

6. Days alive and out of hospital according to survival status [From date of randomisation up to 180 days]

   Any days spent in rehabilitation or a nursing home counted as days in hospital.

7. Days in hospital, rehabilitation facility or nursing home according to survival status [From date of randomisation up to 180 days]

   According to D180 survival status

8. Time from randomisation to ICU discharge [From date of randomisation up to 180 days]

9. Time from randomisation to hospital discharge [From date of randomisation up to 180 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

5. a current ventricular rate ≤ 150 bpm

6. most recent lactate ≤ 4.0 mmol/L

7. 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.

8. most recent cardiac index ≥ 2.0 L/min/m2 (where measured)

9. no current requirement for VA ECMO

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

11. current FiO2 ≤ 0.6

12. current PEEP ≤ 16 cm H20

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

14. current RR ≤ 45 bpm

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
2	St George Hospital	Sydney	New South Wales	Australia	2217
3	John Hunter Hospital	Sydney	New South Wales	Australia
4	Royal North Shore Hospital	Sydney	New South Wales	Australia
5	Wollongong Hospital	Wollongong	New South Wales	Australia
6	Sunshine Coast University Hospital	Birtinya	Queensland	Australia
7	Mater Health	Brisbane	Queensland	Australia
8	Mater Private Hospital	Brisbane	Queensland	Australia
9	Caboolture Hospital	Caboolture	Queensland	Australia
10	The Prince Charles Hospital	Chermside West	Queensland	Australia
11	Redcliffe Hospital	Redcliffe	Queensland	Australia
12	Rockhampton Hospital	Rockhampton	Queensland	Australia
13	Toowoomba Hospital	Toowoomba	Queensland	Australia
14	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia
15	Royal Adelaide Hospital	Adelaide	South Australia	Australia
16	Launceston General Hospital	Launceston	Tasmania	Australia
17	Geelong Hospital - Barwon Health	Geelong	Victoria	Australia	3220
18	St Vincent's Hospital Melbourne	Melbourne	Victoria	Australia	3065
19	Austin Health	Melbourne	Victoria	Australia
20	Cabrini Health	Melbourne	Victoria	Australia
21	Epworth Richmond	Melbourne	Victoria	Australia
22	Western Health	Melbourne	Victoria	Australia
23	Alfred Hospital	Prahran	Victoria	Australia	3004
24	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia
25	Fiona Stanley Hospital	Perth	Western Australia	Australia	6150
26	Royal Perth Hospital	Perth	Western Australia	Australia
27	St John of God Hospital	Subiaco	Western Australia	Australia
28	Royal Melbourne Hospital	Melbourne		Australia
29	The Charité	Berlin		Germany
30	Universitätsklinikum Leipzig	Leipzig		Germany
31	Klinikum rechts der Isar der Technischen Universität Mϋnchen	Munich		Germany
32	Beacon Hospital	Dublin		Ireland
33	St Vincent's Hospital	Dublin		Ireland
34	Galway Hospital	Galway		Ireland
35	Tallaght Hospital	Tallaght		Ireland
36	Auckland City Hospital (CVICU)	Auckland		New Zealand
37	Auckland City Hospital (DCCM)	Auckland		New Zealand
38	Waikato Hospital	Hamilton		New Zealand
39	Tauranga Hospital	Tauranga		New Zealand
40	Wellington Hospital	Wellington		New Zealand
41	Bristol Royal Infirmary	Bristol		United Kingdom
42	Frimley Park Hospital	Frimley		United Kingdom
43	University Hospital Lewisham	Lewisham		United Kingdom
44	King's College Hospital	London		United Kingdom
45	Nottingham University Hospitals	Nottingham		United Kingdom
46	Royal Berkshire Hospital	Reading		United Kingdom
47	Morriston Hospital	Swansea		United Kingdom
48	Royal Cornwall Hospital	Truro		United Kingdom
49	Queen Elizabeth Hospital Woolwich	Woolwich		United Kingdom

Sponsors and Collaborators

• Australian and New Zealand Intensive Care Research Centre
• National Health and Medical Research Council, Australia
• ANZICS Clinical Trials Group
• Medical Research Institute of New Zealand
• Intensive Care National Audit & Research Centre

Investigators

• Study Chair: Carol Hodgson, Prof, ANZIC-RC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• TEAM study website

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.
• 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.
• 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.

• Responsible Party: Australian and New Zealand Intensive Care Research Centre
• ClinicalTrials.gov Identifier: NCT03133377
• Other Study ID Numbers: TEAM U1111-1195-3567
• First Posted: Apr 28, 2017
• Last Update Posted: Apr 15, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Australian and New Zealand Intensive Care Research Centre: Early activity and mobilization, rehabilitation, intensive care
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Apr 15, 2022