TEAM: Trial of Early Activity and Mobilization
NCT01674608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 192
Last updated 2015-05-06
Summary
Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weakness even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, but the nature of such weakness is poorly understood.
The weakness that develops in ICU is more substantial than that which would result from bed rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due to the combination of inflammation and immobility. The exact mechanisms leading to the nerve and muscle damage which occurs in critical illness are not yet fully understood and require further investigation. However, it is known that ICUAW has an effect on a patient's ability to breathe without a ventilator, walk and perform simple activities (like washing and toileting) and often results in longer mechanical ventilation time and hence, longer hospital stays than might otherwise be expected. It may also affect a patient's ability to return home after their hospital stay. The recovery period in Australian and New Zealand ICU patients is unknown but a trial from Canada has reported ongoing weakness five years after leaving ICU. Weakness in survivors of intensive care is known to be a substantial problem. It is currently not known whether ICUAW may be avoided or its severity reduced with simple strategies of early exercise in ICU.
There are no data about the level of activity and mobility in critically ill patients in Australian and New Zealand ICUs. These data are urgently required to plan a program of research to test whether increasing the level of mobility and activity in our critically ill patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and improving patient-centred outcomes. The program of research will first include a study to observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety, barriers to mobility and what type of activities are undertaken by our patients.
From the observational data we plan to develop a pilot randomised controlled trial of early mobility and activity in intensive care units across Australia and New Zealand. This simple, cost-effective strategy may improve functional ability, decrease time on mechanical ventilation and improve long term outcomes in this patient group. By initiating such a program, ANZ investigators might be able to change future patient outcomes worldwide.
Conditions
- Critically Ill Adults Ventilated >24 Hours in Intensive Care
Sponsors & Collaborators
-
Intensive Care Foundation, Australia
collaborator UNKNOWN -
Australian and New Zealand Intensive Care Research Centre
lead OTHER
Principal Investigators
-
Carol Hodgson, PhD · ANZIC-RC
-
Steve Webb, MD · ANZICS CTG
-
Rinaldo Bellomo, MD · ANZIC-RC
-
Megan Harrold, PhD Candidate · Royal Perth Hospital
-
Susan Berney, PhD · Austin Health
-
Heidi Buhr, RN · Royal Prince Alfred Hospital, Sydney, Australia
-
Manoj Saxena, MD · St George Hospital
-
Paul Young, MD · Wellington Hospital
-
Oystein Tronstad, PT · Prince Charles Hospital
-
Neil Orford, MD · Barwon Health
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2014-03-31
- Completion
- 2014-03-31
Countries
- Australia
- New Zealand
Study Locations
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