NCT01927510

TEAM: A Trial of Early Activity and Mobility in ICU

Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Australian and New Zealand Intensive Care Research Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Early mobilisation

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-11-01
• Completion: 2015-02-01
• First posted: 2013-08-22
• Last updated: 2018-08-22

Locations

5 sites across 2 countries: Australia, New Zealand