TEAM: A Trial of Early Activity and Mobility in ICU

NCT01927510 | Completed Phase 1 DMC

• 1 other identifier: NCT01927510
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

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.

Conditions

Critically Ill

Keywords

Early mobilization, rehabilitation, intensive care

Outcome Measures

Primary Outcomes (6)

• Highest daily level of activity measured using the ICU mobillity scale

  ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)

  Duration of ICU stay (an average of 10 days)

• Total Duration of Active Mobilisation

  Radomisation to removal of invasive ventilation (an average of 7 days)

• Mean (or Median) Daily Duration of Active Mobilisation

  Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.

  Randomisation to removal of invasive ventilation (daily for an average of 7 days)

• Total Duration of Active Mobilisation

  Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours

  Randomisation to ICU discharge, an average of 10 days

• Mean (or Median) Daily Duration of Active Mobilisation

  Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)

  Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days

• Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day

  Measured using the ICU mobility scale (0-10)

  Randomisation to Extubation, an average of 7 days

Secondary Outcomes (6)

• Physical Function

  At 6 months from randomisation

• Recruitment Rates

  Entirety of Study

• Staff Utilisation Costs

  ICU admission (approximately 10 days)

• Ventilator and IC free days at Day 28

  Randomisation to Day 28

• Health related quality of life

  6 Months after ICU admission

Study Arms (2)

early mobilisation

EXPERIMENTAL

intervention of early mobilisation

Behavioral: Early mobilisation

Control

NO INTERVENTION

Standard care

Interventions

Early mobilisation BEHAVIORAL

Also known as: Rehabilitation

early mobilisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury
• Proven or suspected actue spinal cord injury
• Proven or suspected Guillain-Barre Syndrome

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Australian and New Zealand Intensive Care Society Clinical Trials Group: collaborator

Study Sites (5)

The Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Auckland CIty Hospital CVICU

Grafton, Auckland, 1023, New Zealand

Location

Wellington Hospital

Newtown, Wellington Region, 6021, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 26968024 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Carol L Hodgson, PhD

  Australian and New Zealand Intensive Care Research Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 22, 2018

Record last verified: 2015-06

Locations

AU (3); NZ (2)