NCT06960642

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Jun 2027

First Submitted

Initial submission to the registry

March 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 14, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

March 20, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

early ambulationearly rehabilitationearly mobilisationphysiotherapyPhysical TherapyICUAWPICSIntensive Care Unit Acquired WeaknessPost Intensive Care SyndromPhysical FunctionCritical CareInterprofessionalNursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    ICU discharge (up to Day 28)

Secondary Outcomes (10)

  • Highest level of mobility at ICU discharge and 90 days

    ICU discharge (up to Day 28) and Day 90

  • Physical function at 90 days

    Day 90

  • Frailty/ Functional status at ICU discharge and 90 days

    ICU discharge (up to Day 28) and Day 90

  • ICU LOS

    ICU admission until ICU discharge (up to Day 28)

  • Hospital LOS

    ICU admission until hospital discharge

  • +5 more secondary outcomes

Study Arms (2)

Independent

Patients who have been functionally independent before ICU admission

Dependent

Patients who have been functionally dependent before ICU admissoin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care unit patients

You may qualify if:

  • Adults (≥ 18 years old) within 48 hours of ICU admission
  • Expected to stay \> 24 hours in the ICU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan J Schaller, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Karner, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine

Study Record Dates

First Submitted

March 20, 2025

First Posted

May 7, 2025

Study Start

December 14, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations