CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 750 enrolled
Drug / intervention
Early activity and mobilisationbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03133377
NCT03133377Phase 3Completed
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A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care

Australian and New Zealand Intensive Care Research Centre·interventional·Posted Apr 28, 2017·Updated Dec 18, 2023

In Brief

A Phase 3 clinical trial evaluating Early activity and mobilisation for Critically Ill, Mechanically Ventilated. Completed, enrolled 750 participants across 49 sites in 5 countries.

Detailed Summary

The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The effect of the intervention on mortality, physical, cognitive and psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes. The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritically Ill, Mechanically Ventilated
CountriesAustralia, Germany, Ireland, New Zealand, United Kingdom
CollaboratorsNational Health and Medical Research Council, Australia, ANZICS Clinical Trials Group, Medical Research Institute of New Zealand, Intensive Care National Audit & Research Centre

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 28, 2017
Enrollment StartFeb 28, 2018
Primary CompletionMay 18, 2022
Study CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.2 years ago

Interventions

Early activity and mobilisationbehavioral

The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities