Dosage of Early Rehabilitation of ICU Patients

Not yet recruiting

• Conditions: Critical Care, Intensive Care; Critical Illness; Physiotherapy; Early Ambulation; Interprofessional Team Collaboration

• Registration Number: NCT06960642
• Lead Sponsor: Medical University of Vienna

Brief Summary

Rehabilitation already begins in the intensive care unit (ICU) to maintain or restore the functional capacity of ICU patients and to counteract the long-term effects of intensive care treatment. Mobilisation is an important component.

The aim of this multinational observational study is to record and evaluate the different mobilisation practices for ICU patients worldwide. The investigators want to find out which forms of mobilisation in intensive care patients achieve the best results in terms of physical function, functional status and quality of life.

The goal is to recruit over 6,000 patients internationally. No interventions will be carried out, only routine clinical data will be documented and standardised and already established physical tests and questionnaires will be used.

Detailed Description

Intensive care treatment can have long-term effects on patients. Around 40% of intensive care unit (ICU) patients develop an Intensive Care Unit Acquired Weakness (ICUAW), which leads to functional limitations and an impairment of independence, participation in everyday life, quality of life and ability to work. Recent studies have shown that early mobilisation has a positive effect on the course of the disease, including improved physical function and independence, shorter ventilation times, and shorter ICU and hospital stays. However, there is currently no standardised approach to mobilisation and the dosage required to achieve the best health outcomes in ICU patients is unknown. There is also a lack of data on patients who were functionally dependent before hospital admission and on patients who were not on invasive mechanical ventilation.

The main objectives of the observational study are:

1. Assessment of the variety of different mobilisation practices worldwide.

2. The analysis of the association of mobilisation dosage on patient outcomes.

3. The evaluation of the association of the prehospital functional status or invasive mechanical ventilation on patient outcomes.

The investigators aim to recruit over 6,000 patients internationally from a minimum of 200 intensive care units. The total duration of the study is 21 months, with participation per patients being 90 days. Routine clinical data and mobilisation data from ICU will be documented, and standardised functional tests and questionnaires will be conducted.

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Study Start: 2025-10
• Primary Completion: 2027-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Adults (≥ 18 years old) within 48 hours of ICU admission
• Expected to stay > 24 hours in the ICU

Exclusion Criteria

• Patients who receive end-of-life care at the time of screening
• Patients whose treatment plans are still under discussion and/or not all team members are committed to full active treatment
• Patients whose functional status is unlikely to be obtainable
• Patients with language barriers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical function at ICU discharge	ICU discharge (up to Day 28)	Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function.

Secondary Outcome Measures

Name	Time	Method
Hospital LOS	ICU admission until hospital discharge	Length of stay in the hospital
ICU mortality	ICU admission until ICU discharge (up to Day 28)	Mortality during ICU stay
Hospital mortality	ICU admission until hospital discharge	Mortality during hospital stay
90-day mortality	Day 90	Mortality at day 90
Highest level of mobility at ICU discharge and 90 days	ICU discharge (up to Day 28) and Day 90	Highest level of mobility measured with the ICU Mobility Scale (IMS). The scale ranges from 0 to 10, with higher scores indicating a higher level of mobility (up to independent walking).
Physical function at 90 days	Day 90	Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function.
Frailty/ Functional status at ICU discharge and 90 days	ICU discharge (up to Day 28) and Day 90	Frailty/ Functional status measured with the Clinical Frailty Scale (CFS). The scale ranges from 1 (very fit) to 9 (terminally ill), with higher scores indicating a higher degree of frailty.
ICU LOS	ICU admission until ICU discharge (up to Day 28)	Length of stay in the ICU
Disability at 90 days	Day 90	Disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item version). Each item is rated on a scale from 1 (no difficulty) to 5 (extreme or cannot do), with higher scores indicating greater disability.
Activities of Daily Living (ADLs) at ICU discharge and 90 days	ICU discharge (up to Day 28) and Day 90	Activities of Daily Living (ADLs) measured with the Barthel Score. The total score ranges from 0 to 100, with higher scores indicating less assistance and greater independence in performing ADLs.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria