Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge

NCT07167121 | Recruiting

• 1 other identifier: 2025-A01335-44
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

ICU; Physiotherapy; ICU Acquired Weakness; CPAx; Predictive Validity; Test

Outcome Measures

Primary Outcomes (1)

• 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.

  Three months after discharge

Secondary Outcomes (1)

• Correlation between CPAx and SF-36 questionnary

  Three months after discharge

Study Arms (1)

Interventional Group

Assessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge.

Diagnostic Test: CPAx

Interventions

CPAx DIAGNOSTIC_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)

Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Patient affiliated with, or entitled to benefit from, a French social security system.
• Patient who has received clear and comprehensive information about the study and has signed the informed consent form together with the investigator.
• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil: lead

Study Sites (1)

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

Saint-Aubin-lès-Elbeuf, 76410, France

RECRUITING

Related Publications (9)

• 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.

  PMID: 24669784 BACKGROUND

• Skinner 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.

  PMID: 27259819 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.

  PMID: 23219649 BACKGROUND

• De 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.

  PMID: 17855814 BACKGROUND

• Ali 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.

  PMID: 18511703 BACKGROUND

• De 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.

  PMID: 12472328 BACKGROUND

• Herridge 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.

  PMID: 12594312 BACKGROUND

• Latronico 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.

  PMID: 21939902 BACKGROUND

• Tipping 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.

  PMID: 27864615 BACKGROUND

Related Links

• Rehabilitation after critical illness in adults (Clinical guideline \[CG83\])
• Diagnostic et prise en charge des patients adultes avec un syndrome post-réanimation (PICS) et de leur entourage

Central Study Contacts

Arthur SAUNIER, MKDE

CONTACT

0232962296; arthur.saunier@chi-elbeuf-louviers.fr

Pierre HUNKELER

CONTACT

0232963439; pierre.hunkeler@chi-elbeuf-louviers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (1)