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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| ANZICS Clinical Trials Group | NETWORK |
| Medical Research Institute of New Zealand | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early activity and Mobilisation intervention | Experimental | 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. |
|
| Standard of care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early activity and mobilisation | Behavioral | The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days alive and out of hospital | Any days spent in rehabilitation or a nursing home counted as days in hospital | between randomisation and 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | From date of randomisation up to180days. | |
| Time from randomisation until death | From date of randomisation unitl date of death from all cause, censored at 180days | |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium free days | Will be measured using CAM-ICU and RASS score | From date of randomisation until day 28 |
| Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) | Assessed at 180days |
Inclusion Criteria:
Aged 18 years or older.
Intubated and expected to remain invasively mechanically ventilated the day after tomorrow.
Sufficient cardiovascular stability to make mobilisation potentially possible, as indicated by:
Sufficient respiratory stability to make mobilisation potentially possible, as indicated by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Hodgson, Prof | ANZIC-RC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| St George Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26968024 | Background | 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. | |
| 27864615 |
| Label | URL |
|---|---|
| TEAM study website | View source |
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| Intensive Care National Audit & Research Centre |
| OTHER |
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| Ventilator-free days |
patients who die prior to day 28 will be assigned zero ventilator-free days |
| From date of randomisation until day 28 |
| ICU-free days | patients who die prior to day 28 will be assigned zero ICU-free days | From date of randomisation until day 28 |
| Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) | Assessed at 180days |
| 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 |
| Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) | Assessed at 180days |
| Psychological function measured using Hospital Anxiety and Depression scale (HADS) | Assessed at 180days |
| Psychological function measured using Impact of Event Scale - Revised (IES-R) | Assessed at 180 days |
| All-cause mortality | From date of randomisation up to 28 days |
| Days alive and out of hospital according to survival status | Any days spent in rehabilitation or a nursing home counted as days in hospital. | From date of randomisation up to 180 days |
| Days in hospital, rehabilitation facility or nursing home according to survival status | According to D180 survival status | From date of randomisation up to 180 days |
| Time from randomisation to ICU discharge | From date of randomisation up to 180 days |
| Time from randomisation to hospital discharge | From date of randomisation up to 180 days |
| Sydney |
| New South Wales |
| 2217 |
| Australia |
| John Hunter Hospital | Sydney | New South Wales | Australia |
| Royal North Shore Hospital | Sydney | New South Wales | Australia |
| Wollongong Hospital | Wollongong | New South Wales | Australia |
| Sunshine Coast University Hospital | Birtinya | Queensland | Australia |
| Mater Health | Brisbane | Queensland | Australia |
| Mater Private Hospital | Brisbane | Queensland | Australia |
| Caboolture Hospital | Caboolture | Queensland | Australia |
| The Prince Charles Hospital | Chermside West | Queensland | Australia |
| Redcliffe Hospital | Redcliffe | Queensland | Australia |
| Rockhampton Hospital | Rockhampton | Queensland | Australia |
| Toowoomba Hospital | Toowoomba | Queensland | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Launceston General Hospital | Launceston | Tasmania | Australia |
| Geelong Hospital - Barwon Health | Geelong | Victoria | 3220 | Australia |
| St Vincent's Hospital Melbourne | Melbourne | Victoria | 3065 | Australia |
| Austin Health | Melbourne | Victoria | Australia |
| Cabrini Health | Melbourne | Victoria | Australia |
| Epworth Richmond | Melbourne | Victoria | Australia |
| Western Health | Melbourne | Victoria | Australia |
| Alfred Hospital | Prahran | Victoria | 3004 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | Australia |
| Fiona Stanley Hospital | Perth | Western Australia | 6150 | Australia |
| Royal Perth Hospital | Perth | Western Australia | Australia |
| St John of God Hospital | Subiaco | Western Australia | Australia |
| Royal Melbourne Hospital | Melbourne | Australia |
| The Charité | Berlin | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Klinikum rechts der Isar der Technischen Universität Mϋnchen | Munich | Germany |
| Beacon Hospital | Dublin | Ireland |
| St Vincent's Hospital | Dublin | Ireland |
| Galway Hospital | Galway | Ireland |
| Tallaght Hospital | Tallaght | Ireland |
| Auckland City Hospital (CVICU) | Auckland | New Zealand |
| Auckland City Hospital (DCCM) | Auckland | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |
| Tauranga Hospital | Tauranga | New Zealand |
| Wellington Hospital | Wellington | New Zealand |
| Bristol Royal Infirmary | Bristol | United Kingdom |
| Frimley Park Hospital | Frimley | United Kingdom |
| University Hospital Lewisham | Lewisham | United Kingdom |
| King's College Hospital | London | United Kingdom |
| Nottingham University Hospitals | Nottingham | United Kingdom |
| Royal Berkshire Hospital | Reading | United Kingdom |
| Morriston Hospital | Swansea | United Kingdom |
| Royal Cornwall Hospital | Truro | United Kingdom |
| Queen Elizabeth Hospital Woolwich | Woolwich | United Kingdom |
| Background |
| 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. |
| 27707476 | Background | 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. No abstract available. |
| 40439527 | Derived | Higgins AM, Lee YY, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ, Hodgson CL; Treatment of Mechanically Ventilated Adults With Early Activity and Mobilization (TEAM) Study Investigators. The Cost-Effectiveness of Early Active Mobilization During Mechanical Ventilation in the ICU: An Economic Evaluation Alongside the Treatment of Mechanically Ventilated Adults With Early Activity and Mobilization (TEAM) Trial. Crit Care Med. 2025 Sep 1;53(9):e1725-e1735. doi: 10.1097/CCM.0000000000006715. Epub 2025 May 27. |
| 39826257 | Derived | Broadley T, Serpa Neto A, Bailey M, Bellomo R, Brickell K, Buhr H, Gabbe BJ, Gould DW, Harrold M, Hurford S, Iwashyna TJ, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ, Higgins AM, Hodgson CL; TEAM Trial Investigators. Adverse events during and after early mobilisation: A post hoc analysis of the TEAM trial. Aust Crit Care. 2025 May;38(3):101156. doi: 10.1016/j.aucc.2024.101156. Epub 2025 Jan 17. |
| 38046085 | Derived | Presneill JJ, Bellomo R, Brickell K, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna T, Neto AS, Nichol A, Schaller SJ, Sivasuthan J, Tipping C, Webb S, Young P, Hodgson CL; TEAM Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. Crit Care Resusc. 2023 Oct 18;23(3):262-272. doi: 10.51893/2021.3.OA3. eCollection 2021 Sep 6. |
| 36286256 | Derived | TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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