CPAx: Responsiveness and Minimal Clinically Important Difference

Muscle Weakness Clinical Trial

Official title:

Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419699
• Other study ID #: 5678
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Sabrina Eggmann, PhD
• Phone: +41 31 632 30 41
• Email: sabrina.grossenbacher[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Monash University

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CPAx change score	CPAx change score for hospital period (ICU to hospital discharge); CPAx ranges from 0 (worst score) to 50 (best score)	Assessed at hospital discharge (last value before discharge)
Secondary	Global rating of change scale	Seven-point global rating of change scale (GRC): (1) very much improved; (2) much improved; (3) little improved; (4) no change; (5) little deterioration; (6) much deterioration; (7) very much deterioration for 'physical function and activity' (rated by treating physiotherapist)	ICU and hospital discharge (change for ICU and hospital period)
Secondary	ICU Mobility Scale	To evaluate mobility level, the score ranges from 0 (worst) to 10 (best)	ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary	Medical Research Council Sum Score	To assess muscle strength, the minimal score is 0 (worst), the maximal score 60 (best), ICUAW is defined as <48 points	ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary	Richmond Agitation-Sedation Scale	To assess the level of sedation and/or cooperation, score ranges from -5 (unarousable) to +4 (combative)	ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary	Modified Iowa Level of Assistance Scale	To determine assistance in functional tasks, the score ranges from 0 (worst) to 36 (best)	ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary	ICU and discharge destinations	Categorical variable (death, external/internal hospital ward, external ICU/hospital, rehabilitation, home, other) to assess the predictive validity of the CPAx score	ICU and hospital discharge