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Clinical Trials in Australia / NCT06419699
Active, not recruiting Observational

CPAx: Responsiveness and Minimal Clinically Important Difference

NCT06419699 · tracked via the Priya Life Science Australia tracker
Phase
Observational
Started
2024-05-23
Last updated
2026-05-27

Condition(s) studied

Muscle WeaknessCritical Illness MyopathyCritical Illness PolyneuropathyCritical Illness PolyneuromyopathyPhysical Inactivity

Study summary

Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Mechanical ventilation ≥ 72 hours * Expected to remain for ≥ 48 hours in the ICU * Physiotherapy referral Exclusion Criteria: * Not expected to survive to hospital discharge (imminent to death) * Second or subsequent ICU admission for this hospital stay * Transfer from external ICU (with an ICU stay of \>72 hours) * Primary neurological admission diagnosis (i.e., of the central nervous system including stroke, intracerebral haemorrhage, traumatic brain injury) * Known pregnancy * Living in a care facility pre-admission (severe pre-existing mental or physical disability) * Local regulations (i.e. Switzerland: refusal of general consent)

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Monash Health Clayton Australia
Alfred Health Melbourne Australia
Inselspital Bern Switzerland

More Insel Gruppe AG, University Hospital Bern trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06419699 on ClinicalTrials.gov ↗ ← All trials in Australia