Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge
NCT ID: NCT07167121
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2025-09-01
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Interventional Group
Assessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge.
CPAx
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)
Interventions
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CPAx
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)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
OTHER_GOV
Responsible Party
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Locations
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Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Saint-Aubin-lès-Elbeuf, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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
Other Identifiers
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2025-A01335-44
Identifier Type: -
Identifier Source: org_study_id
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