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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06419699




Registration number
NCT06419699
Ethics application status
Date submitted
13/05/2024
Date registered
17/05/2024
Date last updated
22/10/2024

Titles & IDs
Public title
CPAx: Responsiveness and Minimal Clinically Important Difference
Scientific title
Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults
Secondary ID [1] 0 0
5678
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Weakness 0 0
Critical Illness Myopathy 0 0
Critical Illness Polyneuropathy 0 0
Critical Illness Polyneuromyopathy 0 0
Physical Inactivity 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Chelsea Critical Care Physical Assessment tool (CPAx) change score
Timepoint [1] 0 0
Assessed at ICU discharge (within 24 hours before or after ICU discharge)
Secondary outcome [1] 0 0
CPAx change score
Timepoint [1] 0 0
Assessed at hospital discharge (last value before discharge)
Secondary outcome [2] 0 0
Global rating of change scale
Timepoint [2] 0 0
ICU and hospital discharge (change for ICU and hospital period)
Secondary outcome [3] 0 0
ICU Mobility Scale
Timepoint [3] 0 0
ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary outcome [4] 0 0
Medical Research Council Sum Score
Timepoint [4] 0 0
ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary outcome [5] 0 0
Richmond Agitation-Sedation Scale
Timepoint [5] 0 0
ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary outcome [6] 0 0
Modified Iowa Level of Assistance Scale
Timepoint [6] 0 0
ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
Secondary outcome [7] 0 0
ICU and discharge destinations
Timepoint [7] 0 0
ICU and hospital discharge

Eligibility
Key inclusion criteria
* Age = 18 years
* Mechanical ventilation = 72 hours
* Expected to remain for = 48 hours in the ICU
* Physiotherapy referral
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Switzerland
State/province [1] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Insel Gruppe AG, University Hospital Bern
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06419699
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Sabrina Eggmann, PhD
Address 0 0
Inselspital, Bern University Hospital, Switzerland; Monash University, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabrina Eggmann, PhD
Address 0 0
Country 0 0
Phone 0 0
+41 31 632 30 41
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06419699