CPAx: Responsiveness and Minimal Clinically Important Difference

Phase

N/A

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Treatment

N/A

Clinical Study ID

NCT06419699

5678

Ages > 18
All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Age ≥ 18 years
Mechanical ventilation ≥ 72 hours
Expected to remain for ≥ 48 hours in the ICU
Physiotherapy referral

Exclusion

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 systemincluding stroke, intracerebral haemorrhage, traumatic brain injury)
Known pregnancy
Living in a care facility pre-admission (severe pre-existing mental or physicaldisability)
Local regulations (i.e. Switzerland: refusal of general consent)

Study Design

May 23, 2024

October 31, 2025

Study Description

The use of invasive life support in critically ill patients clearly saves lives but carries substantial risks, including intensive care unit (ICU) acquired weakness and long-term disability. The investigators urgently need a valid, reliable, and responsive measurement tool for this population to use in clinical practice and trials. The Chelsea Critical Care Physical Assessment tool (CPAx) is a promising measurement instrument to measure change in critically ill patients' physical function and activity. After several studies have confirmed its validity and excellent reliability, it is time to confirm responsiveness and to establish the MCID in a large, international sample of the target population. This multi-centre, mixed-methods, longitudinal cohort study will include critically ill, mechanically ventilated (>72h) adults at risk for muscle weakness and collect their mobility, physical function and activity with the CPAx and other relevant measures at ICU baseline, to ICU and hospital discharge. Responsiveness will be determined by the ability of the CPAx to identify change according to a prespecified anchor (criterion validity) and by testing prospective hypotheses about the expected magnitude of change between the CPAx and other relevant measures (construct validity). The MCID will be established with anchor- and distribution-based methods, whereby a seven-point global rating of change scale obtained from treating ICU physiotherapists will serve as anchor to distinguish improved from unchanged patients.

Connect with a study center

Monash Health
Clayton,
Australia
Site Not Available
Alfred Health
Melbourne,
Australia
Site Not Available
Inselspital
Bern,
Switzerland
Active - Recruiting

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