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CPAx: Responsiveness and Minimal Clinically Important Difference - Trial NCT06419699

Access comprehensive clinical trial information for NCT06419699 through Pure Global AI's free database. This phase not specified trial is sponsored by Insel Gruppe AG, University Hospital Bern and is currently Not yet recruiting. The study focuses on Muscle Weakness,Critical Illness Myopathy,Critical Illness Polyneuropathy,Critical Illness Polyneuromyopathy,Physical Inactivity. Target enrollment is 120 participants.

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NCT06419699
Not yet recruiting
Trial Details
ClinicalTrials.gov โ€ข NCT06419699
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CPAx: Responsiveness and Minimal Clinically Important Difference
Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults

Sponsor & Location

Insel Gruppe AG, University Hospital Bern

Bern, Switzerland

Timeline & Enrollment

N/A

May 01, 2024

Oct 01, 2025

120 participants

Primary Outcome

Chelsea Critical Care Physical Assessment tool (CPAx) change score

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.

ICD-10 Classifications

Other specified disorders of muscle
Other disorders of muscle
Disorders of muscles
Other primary disorders of muscles
Primary disorders of muscles

Data Source

ClinicalTrials.gov

NCT06419699

Non-Device Trial