TEAM: A Trial of Early Activity and Mobility in ICU (TEAM-RCT)

• ClinicalTrials.gov Identifier: NCT01927510
• Recruitment Status: Completed
• First Posted: August 22, 2013
• Last Update Posted: August 22, 2018
• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborator: Australian and New Zealand Intensive Care Society Clinical Trials Group
• Information provided by (Responsible Party): Australian and New Zealand Intensive Care Research Centre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Critically Ill	Behavioral: Early mobilisation	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
• Study Start Date: August 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: early mobilisation; intervention of early mobilisation	Behavioral: Early mobilisation; Other Name: Rehabilitation
No Intervention: Control; Standard care

Outcome Measures

Primary Outcome Measures :

1. Highest daily level of activity measured using the ICU mobillity scale [ Time Frame: Duration of ICU stay (an average of 10 days) ]
   ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
2. Total Duration of Active Mobilisation [ Time Frame: Radomisation to removal of invasive ventilation (an average of 7 days) ]
3. Mean (or Median) Daily Duration of Active Mobilisation [ Time Frame: Randomisation to removal of invasive ventilation (daily for an average of 7 days) ]
   Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
4. Total Duration of Active Mobilisation [ Time Frame: Randomisation to ICU discharge, an average of 10 days ]
   Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
5. Mean (or Median) Daily Duration of Active Mobilisation [ Time Frame: Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days ]
   Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
6. Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day [ Time Frame: Randomisation to Extubation, an average of 7 days ]
   Measured using the ICU mobility scale (0-10)

Secondary Outcome Measures :

1. Physical Function [ Time Frame: At 6 months from randomisation ]
   Highest level of activity, measured using the IADL
2. Recruitment Rates [ Time Frame: Entirety of Study ]
3. Staff Utilisation Costs [ Time Frame: ICU admission (approximately 10 days) ]
   Number of staff required for mobilisation, minutes spent with the patient on active mobilisation activities, and type of staff such as assistant, physiotherapist or nurse, and specific equipment used during mobilisation ie: tilt table/standing frame.
4. Ventilator and IC free days at Day 28 [ Time Frame: Randomisation to Day 28 ]
   Intensive care free defined as ward ready; free of inotropes, RRT and mechanical ventilation for 24 hours and remaining free of these supports until the time of actual ICU discharge
5. Health related quality of life [ Time Frame: 6 Months after ICU admission ]
   EQ5D measured using a trained, blinded assessor via telephone interview
6. Return to previous work level [ Time Frame: At 6 months from randomisation ]
   Has the participant returned to the work level prior to critical illness?

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
13. Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours

Contacts and Locations

Locations

Australia, Victoria

The Austin Hospital

Heidelberg, Victoria, Australia, 3084

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Australia, Western Australia

Fremantle Hospital

Fremantle, Western Australia, Australia, 6160

New Zealand

Auckland CIty Hospital CVICU

Grafton, Auckland, New Zealand, 1023

Wellington Hospital

Newtown, Wellington, New Zealand, 6021

Sponsors and Collaborators

Australian and New Zealand Intensive Care Research Centre

Australian and New Zealand Intensive Care Society Clinical Trials Group

Investigators

• Study Chair: Carol L Hodgson, PhD; Australian and New Zealand Intensive Care Research Centre

More Information

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.

• Responsible Party: Australian and New Zealand Intensive Care Research Centre
• ClinicalTrials.gov Identifier: NCT01927510
• First Posted: August 22, 2013
• Last Update Posted: August 22, 2018
• Last Verified: June 2015

Keywords provided by Australian and New Zealand Intensive Care Research Centre:

Early mobilization, rehabilitation, intensive care

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes