FrailtyNCT04761458
Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality
A study testing Olfactory function testing, Edmonton Frail Scale and Clinical Frailty Scale in people with Frailty and Perioperative/Postoperative Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aims of this research project are to evaluate whether global olfactory impairment is a reliable indicator of preoperative frailty and cognitive impairment, and whether it may predict postoperative neurocognitive disorders, morbidity and mortality in a population of older patients scheduled for elective… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Perioperative/Postoperative Complications, Olfactory Disorder
- What is being tested?
- Olfactory function testing, Edmonton Frail Scale and Clinical Frailty Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 22 Dec 2023
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Scheduled for elective surgery (covering orthopedic, spine and cardiovascular surgery)
Who cannot join
- History of neurological or psychiatric disorder
- History of severe head trauma
- History of olfactory trouble or chronic rhinosinusitis or sinus surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Preoperative Global Olfactory Function With Frailty, Preoperative Cognitive Status, Postoperative Neurocognitive Disorders and Mortality Following Elective Surgery
The aims of this research project are to evaluate whether global olfactory impairment is a reliable indicator of preoperative frailty and cognitive impairment, and whether it may predict postoperative neurocognitive disorders, morbidity and mortality in a population of older patients scheduled for elective intermediate- to high-risk elective surgery.
- We will measure preoperative global olfactory function (threshold, discrimination, identification) and evaluate whether olfactory impairment predicts preoperative frailty (using the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength) and postoperative complications and mortality.
- We will address the question whether preoperative olfactory impairment may be associated with a preoperative cognitive impairment (through a neuropsychological test battery) and whether it may predict a decrease in postoperative neurocognitive function.
Read the detailed description
Olfactory impairment increases with age, affecting more than 50% of the population aged between 65 and 80 years old. Recently, many studies have demonstrated a strong association between olfactory impairment and overall mortality risk. At the moment, the underlying physiopathology linking olfactory impairment to mortality remains unknown and only putative mechanisms are suggested.
Among them, accelerated physiological brain aging seems to be involved, making olfactory decline a possible marker of frailty. To date, only a few studies (mostly using subjective olfactory assessment) investigated the potential relationship between olfactory impairment and frailty. Moreover, neurodegenerative diseases, through cognitive dysfunction, seem likely to represent a second mechanism potentially underlying the link between olfactory impairment and mortality.
Surgery, and more broadly the perioperative period, remains a major source of morbidity and mortality. Meanwhile, the average age of the surgical population continues to rise, making preoperative risk assessment an essential step in order to detect the most vulnerable patients. Yet, it is well-known that frailty is predictive of complications and mortality and that preoperative cognitive impairment is associated with postoperative neurocognitive disorders.
The first objective of this research project is thus to evaluate global olfactory function of preoperative older surgical patients in light of an assessment of their frailty and cognitive status. Frailty will be tested with the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength. Cognitive function will be tested through a neuropsychological test battery preoperatively and postoperatively. The second and third objectives are to correlate preoperative olfactory function with, on the one hand, postoperative neurocognitive disorders, and on the other hand, postoperative morbidity and mortality.
- Conditions
- Frailty, Perioperative/Postoperative Complications, Olfactory Disorder, Neurocognitive Disorders, Postoperative Cognitive Dysfunction
- Being tested
- Olfactory function testing, Edmonton Frail Scale, Clinical Frailty Scale, Neuropsychological test battery
- Medical subject headings
- Frailty, Postoperative Complications, Neurocognitive Disorders, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory function testingDiagnostic test
Olfactory function will be evaluated through the Burghart Sniffin' Sticks test which is a validated psychophysical testing method. Sniffin' Sticks test is based on pen-like odor dispensing devices that will be presented to the patients. The extended version of this test will be used and consist of three tests of olfactory function, namely tests for odor threshold, odor discrimination and odor identification.
Edmonton Frail ScaleDiagnostic test
The Edmonton Frail Scale (EFS) involves nine domains of frailty : functional performance, cognitive function, general health, functional independence, social support, used medications, nutrition, mood and continence. It has been validated with respect to comprehensive geriatric assessment and to other screening tools related to frail state. EFS test is considered most appropriate for use in routine preoperative screening and only requires 5 minutes.
Clinical Frailty ScaleDiagnostic test
The Clinical Frailty Scale (CFS) uses clinicians' judgement to evaluate frailty. It comprises assessment of specific domains including comorbidity, function, and cognition. Score ranges from 1 (very fit) to 9 (terminally ill).
Neuropsychological test batteryDiagnostic test
Patients will undergo a neuropsychological test battery preoperatively and postoperatively. This test consists of a battery of psychometric assessments with the ability to objectively assess specific cognitive domains such as attention, executive function, learning and memory, language, perceptual-motor, or social cognition.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for elective surgery aged 65 and + | Experimental | Not described Receives: Diagnostic Test: Olfactory function testing; Diagnostic Test: Edmonton Frail Scale; Diagnostic Test: Clinical Frailty Scale; Diagnostic Test: Neuropsychological test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty assessed by the Edmonton Frail Scale
Analysis of the prevalence of frailty assessed by the Edmonton Frail Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Measured: Preoperative period (within 3 months before surgery)
Prevalence of frailty assessed by the Clinical Frailty Scale
Analysis of the prevalence of frailty assessed by the Clinical Frailty Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Measured: Preoperative period (within 3 months before surgery)
Incidence of postoperative complications
Analysis of the incidence of postoperative complications according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Measured: Up to 1 year postoperatively
Incidence of mortality
Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Measured: Up to 1 year postoperatively
Secondary outcomes (2)
Prevalence of preoperative neurocognitive disorder
Analysis of the prevalence of neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Measured: Preoperative period (within 3 months before surgery)
Incidence of postoperative neurocognitive disorder
Analysis of the incidence of postoperative neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Measured: From 6 weeks to 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Van Regemorter, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761458
- Sponsor's protocol ID
- B403202043093
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pinto JM, Wroblewski KE, Kern DW, Schumm LP, McClintock MK. Olfactory dysfunction predicts 5-year mortality in older adults. PLoS One. 2014 Oct 1;9(10):e107541. doi: 10.1371/journal.pone.0107541. eCollection 2014.
PubMed 25271633Schubert CR, Fischer ME, Pinto AA, Klein BEK, Klein R, Tweed TS, Cruickshanks KJ. Sensory Impairments and Risk of Mortality in Older Adults. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):710-715. doi: 10.1093/gerona/glw036.
PubMed 26946102Van Regemorter V, Hummel T, Rosenzweig F, Mouraux A, Rombaux P, Huart C. Mechanisms Linking Olfactory Impairment and Risk of Mortality. Front Neurosci. 2020 Feb 21;14:140. doi: 10.3389/fnins.2020.00140. eCollection 2020.
PubMed 32153360Somekawa S, Mine T, Ono K, Hayashi N, Obuchi S, Yoshida H, Kawai H, Fujiwara Y, Hirano H, Kojima M, Ihara K, Kim H. Relationship between Sensory Perception and Frailty in a Community-Dwelling Elderly Population. J Nutr Health Aging. 2017;21(6):710-714. doi: 10.1007/s12603-016-0836-5.
PubMed 28537337Laudisio A, Navarini L, Margiotta DPE, Fontana DO, Chiarella I, Spitaleri D, Bandinelli S, Gemma A, Ferrucci L, Incalzi RA. The Association of Olfactory Dysfunction, Frailty, and Mortality Is Mediated by Inflammation: Results from the InCHIANTI Study. J Immunol Res. 2019 Feb 20;2019:3128231. doi: 10.1155/2019/3128231. eCollection 2019.
PubMed 30915369Harita M, Miwa T, Shiga H, Yamada K, Sugiyama E, Okabe Y, Miyake Y, Okuno T, Iritani O, Morimoto S. Association of olfactory impairment with indexes of sarcopenia and frailty in community-dwelling older adults. Geriatr Gerontol Int. 2019 May;19(5):384-391. doi: 10.1111/ggi.13621. Epub 2019 Apr 9.
PubMed 30968523
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Preoperative Global Olfactory Function With Frailty, Preoperative Cognitive Status, Postoperative Neurocognitive Disorders and Mortality Following Elective Surgery
- ClinicalTrials.gov ID
- NCT04761458
- Acronym / sponsor ID
- B403202043093
- Conditions
- Frailty, Perioperative/Postoperative Complications, Olfactory Disorder, Neurocognitive Disorders, Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 21 Feb 2021 (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.
The aims of this research project are to evaluate whether global olfactory impairment is a reliable indicator of preoperative frailty and cognitive impairment, and whether it may predict postoperative neurocognitive disorders, morbidity and mortality in a population of older patients scheduled for elective intermediate- to high-risk elective surgery.
- We will measure preoperative global olfactory function (threshold, discrimination, identification) and evaluate whether olfactory impairment predicts preoperative frailty (using the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength) and postoperative complications and mortality.
- We will address the question whether preoperative olfactory impairment may be associated with a preoperative cognitive impairment (through a neuropsychological test battery) and whether it may predict a decrease in postoperative neurocognitive function.
Detailed description
Olfactory impairment increases with age, affecting more than 50% of the population aged between 65 and 80 years old. Recently, many studies have demonstrated a strong association between olfactory impairment and overall mortality risk. At the moment, the underlying physiopathology linking olfactory impairment to mortality remains unknown and only putative mechanisms are suggested.
Among them, accelerated physiological brain aging seems to be involved, making olfactory decline a possible marker of frailty. To date, only a few studies (mostly using subjective olfactory assessment) investigated the potential relationship between olfactory impairment and frailty. Moreover, neurodegenerative diseases, through cognitive dysfunction, seem likely to represent a second mechanism potentially underlying the link between olfactory impairment and mortality.
Surgery, and more broadly the perioperative period, remains a major source of morbidity and mortality. Meanwhile, the average age of the surgical population continues to rise, making preoperative risk assessment an essential step in order to detect the most vulnerable patients. Yet, it is well-known that frailty is predictive of complications and mortality and that preoperative cognitive impairment is associated with postoperative neurocognitive disorders.
The first objective of this research project is thus to evaluate global olfactory function of preoperative older surgical patients in light of an assessment of their frailty and cognitive status. Frailty will be tested with the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength. Cognitive function will be tested through a neuropsychological test battery preoperatively and postoperatively. The second and third objectives are to correlate preoperative olfactory function with, on the one hand, postoperative neurocognitive disorders, and on the other hand, postoperative morbidity and mortality.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for elective surgery aged 65 and + | Experimental | Diagnostic Test: Olfactory function testing, Diagnostic Test: Edmonton Frail Scale, Diagnostic Test: Clinical Frailty Scale, Diagnostic Test: Neuropsychological test battery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Scheduled for elective surgery (covering orthopedic, spine and cardiovascular surgery)
Key exclusion criteria (3 listed)
- History of neurological or psychiatric disorder
- History of severe head trauma
- History of olfactory trouble or chronic rhinosinusitis or sinus surgery
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 |
|---|---|---|
| Olfactory function testingOlfactory function will be evaluated through the Burghart Sniffin' Sticks test which is a validated psychophysical testing method. Sniffin' Sticks test is based on pen-like odor dispensing devices that will be presented to the patients. The extended version of this test will be used and consist of three tests of olfactory function, namely tests for odor threshold, odor discrimination and odor identification. | Diagnostic test | Patients scheduled for elective surgery aged 65 and + |
| Edmonton Frail ScaleThe Edmonton Frail Scale (EFS) involves nine domains of frailty : functional performance, cognitive function, general health, functional independence, social support, used medications, nutrition, mood and continence. It has been validated with respect to comprehensive geriatric assessment and to other screening tools related to frail state. EFS test is considered most appropriate for use in routine preoperative screening and only requires 5 minutes. | Diagnostic test | Patients scheduled for elective surgery aged 65 and + |
| Clinical Frailty ScaleThe Clinical Frailty Scale (CFS) uses clinicians' judgement to evaluate frailty. It comprises assessment of specific domains including comorbidity, function, and cognition. Score ranges from 1 (very fit) to 9 (terminally ill). | Diagnostic test | Patients scheduled for elective surgery aged 65 and + |
| Neuropsychological test batteryPatients will undergo a neuropsychological test battery preoperatively and postoperatively. This test consists of a battery of psychometric assessments with the ability to objectively assess specific cognitive domains such as attention, executive function, learning and memory, language, perceptual-motor, or social cognition. | Diagnostic test | Patients scheduled for elective surgery aged 65 and + |
Primary outcome
Prevalence of frailty assessed by the Edmonton Frail Scale
Time frame: Preoperative period (within 3 months before surgery)
Analysis of the prevalence of frailty assessed by the Edmonton Frail Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Prevalence of frailty assessed by the Clinical Frailty Scale
Time frame: Preoperative period (within 3 months before surgery)
Analysis of the prevalence of frailty assessed by the Clinical Frailty Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Incidence of postoperative complications
Time frame: Up to 1 year postoperatively
Analysis of the incidence of postoperative complications according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Incidence of mortality
Time frame: Up to 1 year postoperatively
Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
2 secondary outcomes
Prevalence of preoperative neurocognitive disorder
Time frame: Preoperative period (within 3 months before surgery)
Incidence of postoperative neurocognitive disorder
Time frame: From 6 weeks to 12 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 25271633Pinto JM, Wroblewski KE, Kern DW, Schumm LP, McClintock MK. Olfactory dysfunction predicts 5-year mortality in older adults. PLoS One. 2014 Oct 1;9(10):e107541. doi: 10.1371/journal.pone.0107541. eCollection 2014.
- Background: PubMed 26946102Schubert CR, Fischer ME, Pinto AA, Klein BEK, Klein R, Tweed TS, Cruickshanks KJ. Sensory Impairments and Risk of Mortality in Older Adults. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):710-715. doi: 10.1093/gerona/glw036.
- Background: PubMed 32153360Van Regemorter V, Hummel T, Rosenzweig F, Mouraux A, Rombaux P, Huart C. Mechanisms Linking Olfactory Impairment and Risk of Mortality. Front Neurosci. 2020 Feb 21;14:140. doi: 10.3389/fnins.2020.00140. eCollection 2020.
- Background: PubMed 28537337Somekawa S, Mine T, Ono K, Hayashi N, Obuchi S, Yoshida H, Kawai H, Fujiwara Y, Hirano H, Kojima M, Ihara K, Kim H. Relationship between Sensory Perception and Frailty in a Community-Dwelling Elderly Population. J Nutr Health Aging. 2017;21(6):710-714. doi: 10.1007/s12603-016-0836-5.
- Background: PubMed 30915369Laudisio A, Navarini L, Margiotta DPE, Fontana DO, Chiarella I, Spitaleri D, Bandinelli S, Gemma A, Ferrucci L, Incalzi RA. The Association of Olfactory Dysfunction, Frailty, and Mortality Is Mediated by Inflammation: Results from the InCHIANTI Study. J Immunol Res. 2019 Feb 20;2019:3128231. doi: 10.1155/2019/3128231. eCollection 2019.
- Background: PubMed 30968523Harita M, Miwa T, Shiga H, Yamada K, Sugiyama E, Okabe Y, Miyake Y, Okuno T, Iritani O, Morimoto S. Association of olfactory impairment with indexes of sarcopenia and frailty in community-dwelling older adults. Geriatr Gerontol Int. 2019 May;19(5):384-391. doi: 10.1111/ggi.13621. Epub 2019 Apr 9.
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
Victoria Van Regemorter, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory function testing, Edmonton Frail Scale and Clinical Frailty Scale in people with Frailty and Perioperative/Postoperative Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 15 Jan 2025. 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 Belgium. 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?
Prevalence of frailty assessed by the Edmonton Frail Scale (time frame: Preoperative period (within 3 months before surgery)). The study lists 4 primary outcomes in all. 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 NCT04761458, which also lists 6 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 15 Jan 2025.