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| Name | Class |
|---|---|
| Monash University | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Global rating of change scale |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sabrina Eggmann, PhD | Inselspital, Bern University Hospital, Switzerland; Monash University, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Health | Clayton | Australia | ||||
| Alfred Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23219649 | Background | 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. | |
| 33874842 |
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Solely anonymised main outcome data
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D011115 | Polyneuropathies |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Melbourne |
| Australia |
| Inselspital | Bern | Switzerland |
| 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. |
| 34994664 | 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. |
| 40973373 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001519 | Behavior |
| D020969 | Disease Attributes |