Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy

Critical Illness Clinical Trial

Official title: Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy: Comparison of Patient Outcomes Between Enhanced and Conventional ICU Physiotherapy

Status Completed

Clinical Trial Summary

Patients who have been admitted to Intensive Care Units (ICU) and are intubated and mechanically ventilated for longer than 48 hours have impaired physical, psychological and social health and well-being six to twelve months after discharge. The advocacy of intensive physiotherapy and mobilization early in the course of critical illness has been established. It is of great importance to study the long-term outcomes (physical function and quality of life) in intubated and ventilated patients who start exercising and ambulating mobilizing) as soon as possible during ICU stay because the most effective mode, intensity or frequency of exercise needs to be identified.

The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and upright position in critically ill patients on prolonged invasive ventilation and to develop principles to guide physiotherapists in their clinical decision making in the ICU.

Clinical Trial Description

Mobilization is an intervention prescribed by physiotherapists, for critically ill patients in the ICU, to prevent as well as remediate a range of multisystem problems and complications. Mobilization which refers to low levels of exercise and progressive position changes from being supine to being upright and moving, is both a gravitational and an exercise stimulus. Given the hemodynamic status of patients in the ICU can change suddenly, physiotherapists gauge the patient's status moment by moment, and change the parameters of an intervention accordingly, i.e., the type and level of an intervention, its duration and rest periods. The aim of this research is to study the short- and long-term outcomes of enhanced early physiotherapy, with mobilization and upright position, in critically ill patients on prolonged invasive ventilation. This is a prospective, randomized, single blind trial where the intervention permits variation in the physiotherapist's clinical decision making to simulate the general practice. This study started in November 2011, data collection and intervention will continue until November 2014 with 12 months follow up until november 2015. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

• NCT number: NCT02301273
• Study type: Interventional
• Source: Landspitali University Hospital
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Completion date: November 2015