Clinical trial NCT06960642: Dosage of Early Rehabilitation of ICU Patients
Official title: Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critical Care, Intensive Care
Critical Illness
Physiotherapy
Early Ambulation
Interprofessional Team Collaboration
Keywords: early ambulation
early rehabilitation
early mobilisation
physiotherapy
Physical Therapy
ICUAW
PICS
Intensive Care Unit Acquired Weakness
Post Intensive Care Syndrom
Physical Function
Critical Care
Interprofessional
Nursing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2025-05-07
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical function at ICU discharge
timeFrame: ICU discharge (up to Day 28)
Secondary outcomes:
measure: Highest level of mobility at ICU discharge and 90 days
timeFrame: ICU discharge (up to Day 28) and Day 90
measure: Physical function at 90 days
timeFrame: Day 90
measure: Frailty/ Functional status at ICU discharge and 90 days
timeFrame: ICU discharge (up to Day 28) and Day 90
measure: ICU LOS
timeFrame: ICU admission until ICU discharge (up to Day 28)
measure: Hospital LOS
timeFrame: ICU admission until hospital discharge
measure: ICU mortality
timeFrame: ICU admission until ICU discharge (up to Day 28)
measure: Hospital mortality
timeFrame: ICU admission until hospital discharge
measure: 90-day mortality
timeFrame: Day 90
measure: Disability at 90 days
timeFrame: Day 90
measure: Activities of Daily Living (ADLs) at ICU discharge and 90 days
timeFrame: ICU discharge (up to Day 28) and Day 90
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
References: