Dosage of Early Rehabilitation of ICU Patients

NCT ID: NCT06960642

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Independent

Patients who have been functionally independent before ICU admission

No interventions assigned to this group

Dependent

Patients who have been functionally dependent before ICU admissoin

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Stefan Schaller

Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Central Contacts

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Vera Karner, MSc

Role: CONTACT

+4314040041020

Stefan J Schaller, MD

Role: CONTACT

+4314040041020

Facility Contacts

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Stefan J Schaller, MD

Role: primary

+4314040041020

Vera Karner, MSc

Role: backup

+4314040041020

Related Links

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https://www.erupt-study.eu

Study Webpage English

https://www.erupt.at

Study Webpage German

Other Identifiers

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ERUPT

Identifier Type: -

Identifier Source: org_study_id

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