ICU Acquired WeaknessCPAx-PredictNCT07167121
Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge
An observational study of ICU Acquired Weakness and Intensive Care Neuropathy, run by Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil at 1 site in France.
Trial summary
This single-center observational study aims to explore the relationship between the CPAx score (Chelsea Critical Care Physical Assessment Tool), measured at ICU discharge, and the 6-minute walk test (6MWT) distance performed 3 months after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness, Intensive Care Neuropathy
- What is being tested?
- CPAx
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 30 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness (icuaw), or post-traumatic stress symptoms
Who may be able to join
- Patient affiliated with, or entitled to benefit from, a French social security system.
- Patient who has received clear and comprehensive information about the study
- Age ≥ 18 years.
- Having received at least 48 hours of invasive mechanical ventilation.
- Previous hospitalization in the intensive care unit (ICU) at CHI Elbeuf-Louviers-Val-de-Reuil.
- Prescription of physiotherapy during the ICU stay.
Show all 12Show fewer
- Eligible for the 3-month post-ICU follow-up in the day hospital based on at least one of the following criteria:
- Mechanical ventilation or catecholamine treatment (norepinephrine) for ≥ 5 days;
- Weight loss ≥ 5% during hospitalization (criterion for malnutrition);
- Significant muscle weakness (MRC score < 28/60);
- Presence of post-traumatic stress symptoms related to ICU stay (evaluated by the psychologist).
- Ability to walk (with or without assistive devices) prior to ICU admission.
Who cannot join
- Patient not affiliated with the French national health insurance system.
- Documented pre-existing cognitive impairment likely to limit understanding of instructions and participation in functional assessments (e.g., dementia, intellectual disability, severe uncontrolled psychiatric disorder).
- History of disabling chronic neuromuscular disease (e.g., amyotrophic lateral sclerosis, myopathy, progressive chronic polyneuropathy).
- History of major pre-existing locomotor impairment preventing autonomous walking (e.g., paraplegia, uncompensated disabling arthropathy).
- Refusal to participate in the study or withdrawal of consent at any time.
- Person under legal guardianship, curatorship, or any other legal protection measure.
- Simultaneous participation in another interventional study likely to interfere with the evaluation criteria of the present study.
- Medical contraindication to performing the 6-minute walk test at 3 months (e.g., cardiovascular decompensation, acute pulmonary disease, persistent hemodynamic instability).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Saint-Aubin-lès-Elbeuf, 76410
About this study
Official title: Etude de validité Predictive du Chelsea Critical Care Physical Assessment Tool (CPAx) Quant au Retour de l'Autonomie à la Marche 3 Mois après la Sortie de réanimation
This single-center observational study aims to explore the relationship between the CPAx score (Chelsea Critical Care Physical Assessment Tool), measured at ICU discharge, and the 6-minute walk test (6MWT) distance performed 3 months after discharge. The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness, or post-traumatic stress symptoms. Data collection includes the CPAx score, 6MWT distance, MRC score, and relevant clinical and demographic information. The primary objective is to determine whether the CPAx score can predict long-term functional recovery and guide post-ICU rehabilitation strategies. Participants will be evaluated during routine follow-up in the day hospital. This non-interventional study poses minimal risk to participants.
- Conditions
- ICU Acquired Weakness, Intensive Care Neuropathy
- Being tested
- CPAx
- Keywords
- ICU, Physiotherapy, ICU Acquired Weakness, CPAx, Predictive Validity, Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAxDiagnostic test
Evaluation of :
Respiratory function Cough Moving within the bed Supine to sitting on the edge of the bed Dynamic sitting Standing balance Sit to stand (starting position ≥ 90°) Transfering from bed to chair Stepping Grip strength (predicted mean for age and gender on the strongest hand)
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Assessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge. Receives: Diagnostic Test: CPAx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive validity beetween CPAx test and 6MWT
Evaluation Criteria:
The statistical analysis will primarily aim to assess the correlation between the CPAx score, a discrete quantitative variable (ranging from 0 to 50), and the distance covered in the 6-Minute Walk Test (6MWT), a continuous quantitative variable. The alpha risk is set at 5% and the beta risk at 80%. A sample size of 25 patients has been determined to allow for an initial estimate, accounting for an anticipated 20% loss to follow-up, in line with recommendations for feasibility studies in intensive care settings.
Method :
The choice of correlation test will depend on data distribution:
- If CPAx and 6MWT distributions are normal (as verified by Shapiro-Wilk or Kolmogorov-Smirnov tests), Pearson's correlation will be used.
- In the absence of normality or in the presence of significant skewness, Spearman's correlation (a non-parametric test) will be preferred.
Measured: Three months after discharge
Secondary outcomes (1)
Correlation between CPAx and SF-36 questionnary
Analysis of the correlation between each item of the CPAx and the results of the 6-minute walk test three months after ICU discharge.
Analysis of the correlation between individual CPAx item scores and SF-36 questionnaire results three months after ICU discharge
Methods for Secondary Outcomes:
- Correlation between CPAx items and 6MWT: Each CPAx item will be analyzed individually as a discrete ordinal variable. Spearman's correlation will be used.
- Correlation between overall CPAx score and SF-36 dimensions: These correlations will be assessed using Spearman's test, unless normality of SF-36 subscales is confirmed.
Exploratory analyses using simple or multiple linear regression may also be conducted to model the relationship between CPAx and 6MWT, adjusting for clinical variables (age, BMI, duration of ventilation, etc.).
Measured: Three months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Aug 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167121
- Sponsor's protocol ID
- 2025-A01335-44
- Acronym
- CPAx-Predict
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Corner EJ, Soni N, Handy JM, Brett SJ. Construct validity of the Chelsea critical care physical assessment tool: an observational study of recovery from critical illness. Crit Care. 2014 Mar 27;18(2):R55. doi: 10.1186/cc13801.
PubMed 24669784Skinner EH, Thomas P, Reeve JC, Patman S. Minimum standards of clinical practice for physiotherapists working in critical care settings in Australia and New Zealand: A modified Delphi technique. Physiother Theory Pract. 2016 Aug;32(6):468-482. doi: 10.3109/09593985.2016.1145311. Epub 2016 Jun 3.
PubMed 27259819Corner 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.
PubMed 23219649De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
PubMed 17855814Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
PubMed 12472328Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.
PubMed 21939902Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.
PubMed 27864615
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de validité Predictive du Chelsea Critical Care Physical Assessment Tool (CPAx) Quant au Retour de l'Autonomie à la Marche 3 Mois après la Sortie de réanimation
- ClinicalTrials.gov ID
- NCT07167121
- Acronym / sponsor ID
- CPAx-Predict / 2025-A01335-44
- Conditions
- ICU Acquired Weakness, Intensive Care Neuropathy
- Keywords
- ICU, Physiotherapy, ICU Acquired Weakness, CPAx, Predictive Validity, Test
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de ReuilOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center observational study aims to explore the relationship between the CPAx score (Chelsea Critical Care Physical Assessment Tool), measured at ICU discharge, and the 6-minute walk test (6MWT) distance performed 3 months after discharge. The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness, or post-traumatic stress symptoms. Data collection includes the CPAx score, 6MWT distance, MRC score, and relevant clinical and demographic information. The primary objective is to determine whether the CPAx score can predict long-term functional recovery and guide post-ICU rehabilitation strategies. Participants will be evaluated during routine follow-up in the day hospital. This non-interventional study poses minimal risk to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | – | Diagnostic Test: CPAxAssessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness (icuaw), or post-traumatic stress symptoms
Key inclusion criteria (12 listed)
- Patient affiliated with, or entitled to benefit from, a French social security system.
- Patient who has received clear and comprehensive information about the study
- Age ≥ 18 years.
- Having received at least 48 hours of invasive mechanical ventilation.
- Previous hospitalization in the intensive care unit (ICU) at CHI Elbeuf-Louviers-Val-de-Reuil.
Key exclusion criteria (8 listed)
- Patient not affiliated with the French national health insurance system.
- Documented pre-existing cognitive impairment likely to limit understanding of instructions and participation in functional assessments (e.g., dementia, intellectual disability, severe uncontrolled psychiatric disorder).
- History of disabling chronic neuromuscular disease (e.g., amyotrophic lateral sclerosis, myopathy, progressive chronic polyneuropathy).
- History of major pre-existing locomotor impairment preventing autonomous walking (e.g., paraplegia, uncompensated disabling arthropathy).
- Refusal to participate in the study or withdrawal of consent at any time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAxEvaluation of : Respiratory function Cough Moving within the bed Supine to sitting on the edge of the bed Dynamic sitting Standing balance Sit to stand (starting position ≥ 90°) Transfering from bed to chair Stepping Grip strength (predicted mean for age and gender on the strongest hand) | Diagnostic test | Interventional Group |
Primary outcome
Predictive validity beetween CPAx test and 6MWT
Time frame: Three months after discharge
Evaluation Criteria: The statistical analysis will primarily aim to assess the correlation between the CPAx score, a discrete quantitative variable (ranging from 0 to 50), and the distance covered in the 6-Minute Walk Test (6MWT), a continuous quantitative variable. The alpha risk is set at 5% and the beta risk at 80%. A sample size of 25 patients has been determined to allow for an initial estimate, accounting for an anticipated 20% loss to follow-up, in line with recommendations for feasibility studies in intensive care settings. Method : The choice of correlation test will depend on data distribution: * If CPAx and 6MWT distributions are normal (as verified by Shapiro-Wilk or Kolmogorov-Smirnov tests), Pearson's correlation will be used. * In the absence of normality or in the presence of significant skewness, Spearman's correlation (a non-parametric test) will be preferred.
1 secondary outcome
Correlation between CPAx and SF-36 questionnary
Time frame: Three months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 24669784Corner EJ, Soni N, Handy JM, Brett SJ. Construct validity of the Chelsea critical care physical assessment tool: an observational study of recovery from critical illness. Crit Care. 2014 Mar 27;18(2):R55. doi: 10.1186/cc13801.
- Results publication: PubMed 27259819Skinner EH, Thomas P, Reeve JC, Patman S. Minimum standards of clinical practice for physiotherapists working in critical care settings in Australia and New Zealand: A modified Delphi technique. Physiother Theory Pract. 2016 Aug;32(6):468-482. doi: 10.3109/09593985.2016.1145311. Epub 2016 Jun 3.
- Results publication: PubMed 23219649Corner 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.
- Results publication: PubMed 17855814De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
- Results publication: PubMed 18511703Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
- Results publication: PubMed 12472328De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
- Results publication: PubMed 12594312Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
- Results publication: PubMed 21939902Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.
- Results publication: PubMed 27864615Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.
- Rehabilitation after critical illness in adults (Clinical guideline \[CG83\])Link provided by the sponsor.
- Diagnostic et prise en charge des patients adultes avec un syndrome post-réanimation (PICS) et de leur entourageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Acquired Weakness and Intensive Care Neuropathy, run by Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive validity beetween CPAx test and 6MWT (time frame: Three months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07167121, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.