## Protocol Section
### Identification Module
**NCT ID:** NCT06419699

**Brief Title:** CPAx: Responsiveness and Minimal Clinically Important Difference

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

#### Organization Study ID Info
**ID:** 5678
#### Organization
**Class:** OTHER
**Full Name:** Insel Gruppe AG, University Hospital Bern
### Status Module
#### Completion Date
**Date:** 2025-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Monash University

#### Lead Sponsor

**Class:** OTHER

**Name:** Insel Gruppe AG, University Hospital Bern

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Chelsea Critical Care Physical Assessment tool (CPAx) change score

**Time Frame:** Assessed at ICU discharge (within 24 hours before or after ICU discharge)

#### Secondary Outcomes

**Description:** CPAx change score for hospital period (ICU to hospital discharge); CPAx ranges from 0 (worst score) to 50 (best score)

**Measure:** CPAx change score

**Time Frame:** Assessed at hospital discharge (last value before discharge)

**Description:** 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)

**Measure:** Global rating of change scale

**Time Frame:** ICU and hospital discharge (change for ICU and hospital period)

**Description:** To evaluate mobility level, the score ranges from 0 (worst) to 10 (best)

**Measure:** ICU Mobility Scale

**Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

**Description:** To assess muscle strength, the minimal score is 0 (worst), the maximal score 60 (best), ICUAW is defined as \<48 points

**Measure:** Medical Research Council Sum Score

**Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

**Description:** To assess the level of sedation and/or cooperation, score ranges from -5 (unarousable) to +4 (combative)

**Measure:** Richmond Agitation-Sedation Scale

**Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

**Description:** To determine assistance in functional tasks, the score ranges from 0 (worst) to 36 (best)

**Measure:** Modified Iowa Level of Assistance Scale

**Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge

**Description:** Categorical variable (death, external/internal hospital ward, external ICU/hospital, rehabilitation, home, other) to assess the predictive validity of the CPAx score

**Measure:** ICU and discharge destinations

**Time Frame:** ICU and hospital discharge

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sabrina.grossenbacher@insel.ch

**Name:** Sabrina Eggmann, PhD

**Phone:** +41 31 632 30 41

**Role:** CONTACT

**Contact 2:**

**Email:** carol.hodgson@monash.edu

**Name:** Carol Hodgson, Prof

**Phone:** +61 3 9903 0598

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bern

**Contacts:**

***Contact 1:***

- **Email:** sabrina.grossenbacher@insel.ch

- **Name:** Sabrina Eggmann, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** christa.villinger@insel.ch

- **Name:** Christa Villinger

- **Role:** CONTACT

**Country:** Switzerland

**Facility:** Inselspital

#### Overall Officials

**Official 1:**

**Affiliation:** Inselspital, Bern University Hospital, Switzerland; Monash University, Australia

**Name:** Sabrina Eggmann, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Solely anonymised main outcome data

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**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.

**PMID:** 33874842

**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.

**PMID:** 34994664

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M20944

- Name: Muscle Weakness

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M13204

- Name: Paresis

- Relevance: LOW

- As Found: Unknown

- ID: M4554

- Name: Asthenia

- Relevance: LOW

- As Found: Unknown

- ID: M13999

- Name: Polyneuropathies

- Relevance: HIGH

- As Found: Critical Illness Polyneuropathy

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018908

- Term: Muscle Weakness

- ID: D000011115

- Term: Polyneuropathies

- ID: D000016638

- Term: Critical Illness

### Misc Info Module

- Version Holder: 2024-05-31
