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Dosage of Early Rehabilitation of ICU Patients

Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06960642
Acronym
ERUPT
Enrollment
6000
Registered
2025-05-07
Start date
2025-12-14
Completion date
2027-06-01
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Intensive Care, Critical Illness, Early Ambulation, Interprofessional Team Collaboration, Physiotherapy

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

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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER
European Society of Intensive Care Medicine
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical function at ICU dischargeICU 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

MeasureTime frameDescription
Highest level of mobility at ICU discharge and 90 daysICU discharge (up to Day 28) and Day 90Highest 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 daysDay 90Physical 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 daysICU discharge (up to Day 28) and Day 90Frailty/ 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 LOSICU admission until ICU discharge (up to Day 28)Length of stay in the ICU
Hospital LOSICU admission until hospital dischargeLength of stay in the hospital
ICU mortalityICU admission until ICU discharge (up to Day 28)Mortality during ICU stay
Hospital mortalityICU admission until hospital dischargeMortality during hospital stay
90-day mortalityDay 90Mortality at day 90
Disability at 90 daysDay 90Disability 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 daysICU discharge (up to Day 28) and Day 90Activities 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.

Countries

Austria

Contacts

CONTACTVera Karner, MSc
erupt@muv.ac.at+4314040041020
CONTACTStefan J Schaller, MD
aai-research@meduniwien.ac.at+4314040041020
PRINCIPAL_INVESTIGATORStefan J Schaller, MD

Medical University of Vienna

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026