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Post Intensive Care Unit SyndromeNCT04762056

CPAx for Assessing Functional Status of COVID-19 Patients After Intensive Care Unit Discharge

An observational study of Post Intensive Care Unit Syndrome and Covid19, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present assessment tools for assessing physical function after intensive care unit (ICU) can be categorized as (1) functional tests (2) walk tests (3) strength test (4) Health-related quality of life (HRQOL). Strength tests such as Medical Research Council Scale and HRQOL (e.g. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Post Intensive Care Unit Syndrome, Covid19
What is being tested?
Chelsea Critical Care Physical Assessment Tool
How many people
16 participants
Where
2 sitesTurkey (Türkiye)
Study dates
22 Feb 2021to 30 May 2021
Phase
Observational
Are there results?
None posted in the registry

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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (patients over 18 years of age) who suffered COVID-19 pneumonia and stayed in ICU and discharged and who who are able to follow at least 2 of the commands from De Jonghe and colleagues' awakening criteria (presented below) De Jonghe and colleagues' awakening criteria Can patient follow the command? "Open/close your eyes." "Look at me." "Open your mouth and stick out your tongue." "Nod your head." "Raise your eyebrows when I have counted to 5."

Who may be able to join

  • Adult patients (patients over 18 years of age)
  • Patients who suffered COVID-19 pneumonia and stayed in ICU and discharged. The patient will be assessed within 48 hours discharge
  • Patients who are able to follow at least 2 of the commands from De Jonghe and colleagues''(8) awakening criteria as follows:
  • Can patient follow the command? "Open/close your eyes." "Look at me." "Open your mouth and stick out your tongue." "Nod your head." "Raise your eyebrows when I have counted to 5."

Who cannot join

  • Patients with previous neurologic impairment
  • Pregnancy
  • Patients whose grip muscle strength cannot be evaluated (dominant extremity amputation etc.)

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Deniz

    Gaziosmanpaşa, Istanbul, 34255

  • Koç Univercity Hospital

    Istanbul, None Selected, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: Validation of Chelsea Physical Assessment Tool (CPAx) in COVID-19 Patients for Assessing Functional Status After Intensive Care Unit Discharge

The present assessment tools for assessing physical function after intensive care unit (ICU) can be categorized as (1) functional tests (2) walk tests (3) strength test (4) Health-related quality of life (HRQOL). Strength tests such as Medical Research Council Scale and HRQOL (e.g. Short form-36 (SF-36) tests may require awakening and appropriate mental health. However, mental impairments were seen in a considerable number of patients (2). Walk tests such as Six-Minute Walk Test (6MWT) or Timed Up\&Go (TUG) can be impractical, some patients could not be able to perform these due to severe impairment. These tests require space to perform and may require management of several drips, drains, and oxygen delivery systems while the patient is walking and turning which render the test difficult to carry out. Among these three specific tools, CPAx seems to be the assessment tool that can be considered easy to use in the clinical setting due to the short time required for assessment and relatively minimal use of equipment (hand dynamometer for grip strength measurement).

This study aims to investigate validation of Chelsea Critical Care Physical Assessment Tool in the assessment of the functional status of COVID patients discharged from ICU and investigate the feasibility of commonly used assessment tools for assessing physical function after ICU in COVID patients discharged from ICU.

Read the detailed description

The present assessment tools for assessing physical function after intensive care unit (ICU) can be categorized as (1) functional tests (2) walk tests (3) strength test (4) Health-related quality of life (HRQOL). Strength tests such as Medical Research Council Scale and HRQOL (e.g. SF-36) tests may require awakening and appropriate mental health. However, mental impairments were seen in a considerable number of patients (2). Walk tests such as Six-Minute Walk Test (6MWT) or Timed Up\&Go (TUG) can be impractical, some patients could not be able to perform these due to severe impairment. These tests require space to perform and may require management of several drips, drains, and oxygen delivery systems while the patient is walking and turning which render the test difficult to carry out. Among functional tests, the Physical Function in Intensive Care Test (PFIT) Functional Status Score for the ICU and the Chelsea Critical Care Physical Assessment Tool (CPAx) are specifically designed to assess function after ICU while Barthel and Katz are nonspecific to this population. According to a systematic review of 26 different outcome measures, the CPAx and the Physical Function in Intensive Care Test demonstrated the strongest psychometric properties, however, the Physical Function in Intensive Care Test has a significant floor effect. The PFIT and CPAx may be more suitable for the assessment of patients who may never reach the ability to perform submaximal exercise tests.

Among these three specific tools, CPAx seems to be the assessment tool that can be considered easy to use in the clinical setting due to the short time required for assessment and relatively minimal use of equipment (hand dynamometer for grip strength measurement).

Patients over 18 years of age who suffered COVID-19 pneumonia and stayed in ICU and discharged will be included in the study. Patients who are able to follow at least 2 of the commands from De Jonghe and colleagues' awakening criteria will be evaluated within 48 hours discharge. Patients will be assessed by using Chelsea Critical Care Physical Assessment Tool, Barthel Index, Katz Index, 5 times Sit-To-Stand test, 30 seconds Sit-To-Stand test, Glasgow coma scale, handheld dynamometers, Medical Research Council sum score (MRC-SS) and modified Medical Research Council dyspnea scale. The number (%) of the patients who will be able to complete the tests will be recorded. Another physiatrist will also complete Chelsea Critical Care Physical Assessment Tool at the same time without discussion and will be blinded to score of the other rater. Patients' demographic characteristics such as age, gender, comorbidities will be recorded. Length of stay in ICU, duration of mechanical ventilation, history of Extra Corporeal Membrane Oxygenation (ECMO), presence of tracheostomy, intubation status, the sequential organ failure assessment score (SOFA score) at the day of ICU admission and acute physiology and chronic health evaluation (APACHE II) on ICU admission will be recorded.

For construct validation, the correlation between CPAx and Barthel, Katz, Medical Research Council sum score and grip strength will be calculated. Kappa and weighed Kappa analysis will be conducted for inter-rater reliability. Descriptive analysis (Number (%) of the patients who will be able to complete the tests) will be performed to assess feasibility.

This study aims to investigate validation of the Chelsea Critical Care Physical Assessment Tool in the assessment of the functional status of COVID patients discharged from ICU and investigate the feasibility of commonly used assessment tools for assessing physical function after ICU in COVID patients discharged from ICU.

Being tested
Chelsea Critical Care Physical Assessment Tool
Keywords
post-intensive care syndrome, COVID-19, functional status, coronavirus
Medical subject headings
COVID-19, postintensive care syndrome, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chelsea Critical Care Physical Assessment ToolOther

    Chelsea Critical Care Physical Assessment Tool is a bedside assessment tool firstly reported in 2013 to measure physical morbidity in the critical care population, consisting of 10 items (respiratory function, cough, moving within the bed, supine to sitting on the edge of bed, dynamic sitting, standing balance, sit to stand, transferring from bed to chair, stepping, and grip strength) rated on a 6-point scale from complete dependency (level=0) to independency (level=5). Therefore, the CPAx sum score ranges from 0 (worst condition) to 50 (best functioning/independence)

Study groups in NCT04762056
Study groupRoleWhat they receive
COVID-19 patients after ICU dischargePatients who suffered COVID-19 pneumonia and stayed in ICU and discharged
Receives: Other: Chelsea Critical Care Physical Assessment Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chelsea Critical Care Physical Assessment Tool (CPAx)

    The CPAx is a bedside assessment tool firstly reported in 2013 to measure physical morbidity in critical care population (12), consisting of 10 items (respiratory function, cough, moving within the bed, supine to sitting on the edge of bed, dynamic sitting, standing balance, sit to stand, transferring from bed to chair, stepping, and grip strength) rated on a 6-point scale from complete dependency (level=0) to independency (level=5), as depicted by Figure 1. Therefore, the CPAx sum score ranges from 0 (worst condition) to 50 (best functioning/independence)

    Measured: Within 48 hours discharge

Secondary outcomes (7)

  1. Barthel Index

    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-61 indicate "severe" dependency, 62-90 indicate "moderate" dependency, 91-99 indicates "slight" dependency, and 100 indicate ''full'' independent.

    Measured: Within 48 hours discharge

  2. Katz Index

    The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.

    Measured: Within 48 hours discharge

  3. Medical Research Council sum score (MRC-SS)

    Medical Research Council (MRC)-sumscore evaluates global muscle strength. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using MRC scale. Summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (< 48) and even better in severe weakness (< 36) [4] which is the main medical interest for treatment in ICU-acquired weakness (ICUAW)

    Measured: Within 48 hours discharge

  4. 30 seconds sit to stand

    The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults. It is part of the Fullerton Functional Fitness Test Battery. This test was developed to overcome the floor effect of the five or ten repetition sit to stand test in older adults.

    Measured: Within 48 hours discharge

  5. 5 times sit to stand test

    The five Times Sit to Stand Test (5x Sit-To-Stand Test) commonly abbreviated as 5XSST is used to assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults

    Measured: Within 48 hours discharge

  6. modified Medical Research Council (mMRC) dyspnea scale

    The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. Describes baseline dyspnea, but does not accurately quantify response to treatment of chronic obstructive pulmonary disease (COPD).

    Measured: Within 48 hours discharge

  7. Modified Borg scale

    Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is use in monitoring progress and mode of exercise in cardiac patients as well as in other patient population undergoing rehabilitation and endurance training.

    Borg RPE scale was developed by Gunnar Borg for rating exertion and breathlessness during physical activity; that is, how hard the activity is as shown by high heart and respiration rate, profuse perspiration and muscle exertion.

    Measured: Within 48 hours discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start22 Feb 2021
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

Resources

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
Other
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762056
Sponsor's protocol ID
1
Status last verified
Jan 2023
First submitted
18 Feb 2021
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.

Publications

  • Elliott D, Denehy L, Berney S, Alison JA. Assessing physical function and activity for survivors of a critical illness: a review of instruments. Aust Crit Care. 2011 Aug;24(3):155-66. doi: 10.1016/j.aucc.2011.05.002. Epub 2011 Jul 1.

    PubMed 21723143

  • Negrini F, Ferrario I, Mazziotti D, Berchicci M, Bonazzi M, de Sire A, Negrini S, Zapparoli L. Neuropsychological Features of Severe Hospitalized Coronavirus Disease 2019 Patients at Clinical Stability and Clues for Postacute Rehabilitation. Arch Phys Med Rehabil. 2021 Jan;102(1):155-158. doi: 10.1016/j.apmr.2020.09.376. Epub 2020 Sep 28.

    PubMed 32991870

  • Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.

    PubMed 23886842

  • Curci C, Pisano F, Bonacci E, Camozzi DM, Ceravolo C, Bergonzi R, De Franceschi S, Moro P, Guarnieri R, Ferrillo M, Negrini F, de Sire A. Early rehabilitation in post-acute COVID-19 patients: data from an Italian COVID-19 Rehabilitation Unit and proposal of a treatment protocol. Eur J Phys Rehabil Med. 2020 Oct;56(5):633-641. doi: 10.23736/S1973-9087.20.06339-X. Epub 2020 Jul 15.

    PubMed 32667150

  • Parry SM, Granger CL, Berney S, Jones J, Beach L, El-Ansary D, Koopman R, Denehy L. Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties. Intensive Care Med. 2015 May;41(5):744-62. doi: 10.1007/s00134-015-3672-x. Epub 2015 Feb 5.

    PubMed 25652888

  • Holdar U, Eriksson F, Siesage K, Corner EJ, Ledstrom V, Svensson-Raskh A, Kierkegaard M. Cross-cultural adaptation and inter-rater reliability of the Swedish version of the Chelsea critical care assessment tool (CPAX-Swe) in critically ill patients. Disabil Rehabil. 2021 Jun;43(11):1600-1604. doi: 10.1080/09638288.2019.1668971. Epub 2019 Sep 26.

    PubMed 31558043

  • Nordon-Craft A, Schenkman M, Edbrooke L, Malone DJ, Moss M, Denehy L. The physical function intensive care test: implementation in survivors of critical illness. Phys Ther. 2014 Oct;94(10):1499-507. doi: 10.2522/ptj.20130451. Epub 2014 May 8.

    PubMed 24810863

  • 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.

    PubMed 12472328

Questions about this trial

What is this clinical trial studying?

An observational study of Post Intensive Care Unit Syndrome and Covid19, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Chelsea Critical Care Physical Assessment Tool (CPAx) (time frame: Within 48 hours 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 NCT04762056, which also lists 8 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 11 Jan 2023.

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