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CPAx: Responsiveness and Minimal Clinically Important Difference

NCT06419699 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-10-22

No results posted yet for this 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.

Conditions

  • Muscle Weakness
  • Critical Illness Myopathy
  • Critical Illness Polyneuropathy
  • Critical Illness Polyneuromyopathy
  • Physical Inactivity

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Sabrina Eggmann, PhD · Inselspital, Bern University Hospital, Switzerland; Monash University, Australia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Australia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419699 on ClinicalTrials.gov