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NCT Number: NCT06960642

Dosage of Early Rehabilitation of ICU Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Highest level of mobility at ICU discharge and 90 days

    Time frame: 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).

  2. Physical function at 90 days

    Time frame: 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.

  3. Frailty/ Functional status at ICU discharge and 90 days

    Time frame: 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.

  4. ICU LOS

    Time frame: ICU admission until ICU discharge (up to Day 28)

    Length of stay in the ICU

  5. Hospital LOS

    Time frame: ICU admission until hospital discharge

    Length of stay in the hospital

  6. ICU mortality

    Time frame: ICU admission until ICU discharge (up to Day 28)

    Mortality during ICU stay

  7. Hospital mortality

    Time frame: ICU admission until hospital discharge

    Mortality during hospital stay

  8. 90-day mortality

    Time frame: Day 90

    Mortality at day 90

  9. Disability at 90 days

    Time frame: 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.

  10. Activities of Daily Living (ADLs) at ICU discharge and 90 days

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan J Schaller, MD

CONTACT

[email protected]

+4314040041020

Vera Karner, MSc

CONTACT

[email protected]

+4314040041020

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • European Society of Intensive Care Medicine

Registry information

Official study title

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

Acronym: ERUPT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 7, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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