Critical Care, Intensive CareERUPTNCT06960642
Dosage of Early Rehabilitation of ICU Patients
An observational study of Critical Care, Intensive Care and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care, Critical Illness, Physiotherapy
- How many people
- 6,000 participants
- Where
- 1 siteAustria
- Study dates
- 14 Dec 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patients
Who may be able to join
- Adults (≥ 18 years old) within 48 hours of ICU admission
- Expected to stay > 24 hours in the ICU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Stefan J Schaller, MD, +4314040041020, aai-research@meduniwien.ac.at
Vera Karner, MSc, +4314040041020, erupt@muv.ac.at
About this study
Official title: Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome
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.
Read the 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:
- Assessment of the variety of different mobilisation practices worldwide.
- The analysis of the association of mobilisation dosage on patient outcomes.
- 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.
- 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
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Independent | Patients who have been functionally independent before ICU admission | |
| Dependent | Patients who have been functionally dependent before ICU admissoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function at ICU discharge
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.
Measured: ICU discharge (up to Day 28)
Secondary outcomes (10)
Highest level of mobility at ICU discharge and 90 days
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).
Measured: ICU discharge (up to Day 28) and Day 90
Physical function at 90 days
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.
Measured: Day 90
Frailty/ Functional status at ICU discharge and 90 days
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.
Measured: ICU discharge (up to Day 28) and Day 90
ICU LOS
Length of stay in the ICU
Measured: ICU admission until ICU discharge (up to Day 28)
Hospital LOS
Length of stay in the hospital
Measured: ICU admission until hospital discharge
ICU mortality
Mortality during ICU stay
Measured: ICU admission until ICU discharge (up to Day 28)
Hospital mortality
Mortality during hospital stay
Measured: ICU admission until hospital discharge
90-day mortality
Mortality at day 90
Measured: Day 90
Disability at 90 days
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.
Measured: Day 90
Activities of Daily Living (ADLs) at ICU discharge and 90 days
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.
Measured: ICU discharge (up to Day 28) and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start14 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care, Intensive CareStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Stefan Schaller, Medical University of Vienna
- Investigators
- Stefan J Schaller, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960642
- Sponsor's protocol ID
- ERUPT
- Acronym
- ERUPT
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Priority will have requests from within the study group. Other requests for research purposes will be reviewed and have to sign contract including data protection.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome
- ClinicalTrials.gov ID
- NCT06960642
- Acronym / sponsor ID
- ERUPT / ERUPT
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 14 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assessment of the variety of different mobilisation practices worldwide.
- The analysis of the association of mobilisation dosage on patient outcomes.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Independent | – | –Patients who have been functionally independent before ICU admission |
| Dependent | – | –Patients who have been functionally dependent before ICU admissoin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients
Key inclusion criteria (2 listed)
- Adults (≥ 18 years old) within 48 hours of ICU admission
- Expected to stay > 24 hours in the ICU
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical function at ICU discharge
Time frame: 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.
10 secondary outcomes
Highest level of mobility at ICU discharge and 90 days
Time frame: ICU discharge (up to Day 28) and Day 90
Physical function at 90 days
Time frame: Day 90
Frailty/ Functional status at ICU discharge and 90 days
Time frame: ICU discharge (up to Day 28) and Day 90
ICU LOS
Time frame: ICU admission until ICU discharge (up to Day 28)
Hospital LOS
Time frame: ICU admission until hospital discharge
ICU mortality
Time frame: ICU admission until ICU discharge (up to Day 28)
Hospital mortality
Time frame: ICU admission until hospital discharge
90-day mortality
Time frame: Day 90
Disability at 90 days
Time frame: Day 90
Activities of Daily Living (ADLs) at ICU discharge and 90 days
Time frame: ICU discharge (up to Day 28) and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Study Webpage EnglishLink provided by the sponsor.
- Study Webpage GermanLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Priority will have requests from within the study group. Other requests for research purposes will be reviewed and have to sign contract including data protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan J Schaller, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, Intensive Care and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Karner, MSc (+4314040041020, erupt@muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function at ICU discharge (time frame: ICU discharge (up to Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.