CPAx: Responsiveness and Minimal Clinically Important Difference

NCT06419699 | Recruiting

• 1 other identifier: 5678
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Keywords

Physiotherapy; Physical function and activity; Early rehabilitation; Measurement instrument; Critical illness; Critical care outcomes

Outcome Measures

Primary Outcomes (1)

• Chelsea Critical Care Physical Assessment tool (CPAx) change score

  CPAx change score for ICU period (ICU baseline to ICU discharge); CPAx ranges from 0 (worst score) to 50 (best score)

  Assessed at ICU discharge (within 24 hours before or after ICU discharge)

Secondary Outcomes (7)

• CPAx change score

  Assessed at hospital discharge (last value before discharge)

• Global rating of change scale

  ICU and hospital discharge (change for ICU and hospital period)

• ICU Mobility Scale

  ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

• Medical Research Council Sum Score

  ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

• Richmond Agitation-Sedation Scale

  ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population are critically ill adults who are mechanically ventilated for a prolonged period (≥ 72 hours) and who have an increased risk for ICUAW and long-term impairment.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Monash University: collaborator

Study Sites (3)

Monash Health

Clayton, Australia

NOT YET RECRUITING

Alfred Health

Melbourne, Australia

NOT YET RECRUITING

Inselspital

Bern, Switzerland

RECRUITING

Related Publications (4)

• 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.

  PMID: 23219649 BACKGROUND

• 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.

  PMID: 33874842 BACKGROUND

• 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.

  PMID: 34994664 BACKGROUND

• 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.

  PMID: 40973373 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Polyneuropathies; Sedentary Behavior; Motor Activity; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Behavior; Disease Attributes

Study Officials

• Sabrina Eggmann, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Eggmann, PhD

CONTACT

+41 31 632 30 41; sabrina.grossenbacher@insel.ch

Carol Hodgson, Prof

CONTACT

+61 3 9903 0598; carol.hodgson@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: May 23, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CH (1)