CPAx: Responsiveness and Minimal Clinically Important Difference

NCT ID: NCT06419699

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2025-10-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabrina Eggmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern University Hospital, Switzerland; Monash University, Australia

Locations

Monash Health

Clayton, , Australia

Site Status: NOT_YET_RECRUITING

Alfred Health

Melbourne, , Australia

Site Status: NOT_YET_RECRUITING

Inselspital

Bern, , Switzerland

Site Status: RECRUITING

Countries

Australia; Switzerland

Central Contacts

Sabrina Eggmann, PhD

Role: CONTACT

sabrina.grossenbacher@insel.ch

+41 31 632 30 41

Carol Hodgson, Prof

Role: CONTACT

carol.hodgson@monash.edu

+61 3 9903 0598

Facility Contacts

Michelle Paton, PhD

Role: primary

michelle.paton@monashhealth.org

Scott Bradley, PhD

Role: primary

s.bradley@alfred.org.au

Sabrina Eggmann, PhD

Role: primary

sabrina.grossenbacher@insel.ch

Christa Villinger

Role: backup

christa.villinger@insel.ch

References

Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.

Reference Type: BACKGROUND

PMID: 23219649 (View on PubMed)

Eggmann S, Verra ML, Stefanicki V, Kindler A, Seyler D, Hilfiker R, Schefold JC, Bastiaenen CHG, Zante B. German version of the Chelsea Critical Care Physical Assessment Tool (CPAx-GE): translation, cross-cultural adaptation, validity, and reliability. Disabil Rehabil. 2022 Aug;44(16):4509-4518. doi: 10.1080/09638288.2021.1909152. Epub 2021 Apr 19.

Reference Type: BACKGROUND

PMID: 33874842 (View on PubMed)

Eggmann S, Verra ML, Stefanicki V, Kindler A, Schefold JC, Zante B, Bastiaenen CHG. Predictive validity of the Chelsea Critical Care Physical Assessment tool (CPAx) in critically ill, mechanically ventilated adults: a prospective clinimetric study. Disabil Rehabil. 2023 Jan;45(1):111-116. doi: 10.1080/09638288.2021.2022785. Epub 2022 Jan 7.

Reference Type: BACKGROUND

PMID: 34994664 (View on PubMed)

Eggmann S, Paton M, Villinger C, Bradley S, Hellings T, Hills A, Venetz P, Broadley T, Charles-Nelson A, Hodgson C. Responsiveness and the minimal clinically important difference of the Chelsea Critical Care Physical Assessment tool (CPAx) in critically ill, mechanically ventilated adults: a study protocol for a prospective, multicentre, cohort study. BMJ Open. 2025 Sep 18;15(9):e102374. doi: 10.1136/bmjopen-2025-102374.

Reference Type: DERIVED

PMID: 40973373 (View on PubMed)

Other Identifiers

5678

Identifier Type: -

Identifier Source: org_study_id