TEAM: A Trial of Early Activity and Mobility in ICU

NCT ID: NCT01927510

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

early mobilisation

intervention of early mobilisation

Group Type: EXPERIMENTAL

Early mobilisation

Intervention Type: BEHAVIORAL

Control

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early mobilisation

Intervention Type: BEHAVIORAL

Other Intervention Names

Rehabilitation

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Australian and New Zealand Intensive Care Society Clinical Trials Group

NETWORK

Sponsor Role: collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol L Hodgson, PhD

Role: STUDY_CHAIR

Australian and New Zealand Intensive Care Research Centre

Locations

The Austin Hospital

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fremantle Hospital

Fremantle, Western Australia, Australia

Auckland CIty Hospital CVICU

Grafton, Auckland, New Zealand

Wellington Hospital

Newtown, Wellington Region, New Zealand

Countries

Australia; New Zealand

References

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.

Reference Type: BACKGROUND

PMID: 26968024 (View on PubMed)

Other Identifiers

NCT01927510

Identifier Type: -

Identifier Source: org_study_id