Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults. (INNOLFACT 2)
28 mei 2026 bijgewerkt door: Fundacion Miguel Servet
Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults: A Randomised Clinical Trial
This randomized controlled trial will evaluate the effects of olfactory stimulation and/or multicomponent physical training in adults aged 60 years and older. Eligible participants will be cognitively normal, community-dwelling outpatients recruited from Primary Care and Geriatrics services. After baseline assessment, participants will be randomized to one of four groups: usual care, olfactory training/stimulation, multicomponent physical exercise, or combined olfactory and exercise intervention.
Primary and secondary assessments will include olfactory function, cognition, physical function, quality of life, nutritional status, mood, frailty, multimorbidity, polypharmacy, blood-based molecular biomarkers, and exhaled-air biomarkers.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Navarre
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Pamplona, Navarre, Spanje
- Hospital Universitario de Navarra
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria
- Adults aged ≥60 years under the care of Primary Care and/or the Geriatrics Service of the Hospital Universitario de Navarra;
- Normal cognitive function as determined at baseline assessment (Mini-Mental State Examination [MMSE] score ≥23; ≥21 for individuals without formal education);
- Fluent in speaking, reading, and understanding Spanish;
- Adequate olfactory function;
- Adequate visual and auditory acuity to complete neuropsychological and computerized assessments;
- In good general health, with no condition expected to interfere with study participation;
- Willing and able to comply with study procedures and to participate for the entire study duration;
- Willing to refrain from the use of scented candles, essential oils, or air fresheners during study participation.
Exclusion Criteria
- Refusal or inability of the participant, primary caregiver, or legal representative to provide informed consent;
- Diagnosis of a neurodegenerative disease or severe dementia (Global Deterioration Scale [GDS] stage 6-7);
- Conditions affecting the olfactory system (e.g., nasal polyps);
- Life expectancy <3 months;
- History of asthma, allergies, or olfactory-triggered responses producing allergy-like symptoms (e.g., rhinorrhea, lacrimation, sneezing, or skin rash);
- History of neurological disorders such as Parkinson's disease, multiple sclerosis, brain cyst, tumor, or aneurysm;
- Significant medical conditions, including uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiencies, or thyroid disorders;
- History of major psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorders, or attention-deficit/hyperactivity disorder;
- History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria), including use of cigarettes, e-cigarettes, cigars, marijuana, or any substance that may produce odors interfering with the study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Control group.
Participants assigned to the control group will receive usual care and will not undergo any specific intervention related to olfactory or physical training during the study period.
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Experimenteel: Olfactory stimulation intervention.
Participants assigned to this group will undergo a structured olfactory stimulation program (overnight olfactory enrichment) aimed at improving or maintaining olfactory and congnitive function through repeated exposure to selected odors over the intervention period.
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Participants assigned to this group will undergo a structured olfactory stimulation program aimed at improving or maintaining olfactory and cognitive function through repeated and exposure to selected odors over the intervention period.
Andere namen:
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Experimenteel: Multicomponent physical training intervention.
Participants in this group will take part in a multicomponent physical training program including exercises targeting strength, balance, and aerobic capacity, adapted to older adults and conducted following established safety guidelines.
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Participants in this group will take part in a multicomponent physical training program including exercises targeting strength, balance, and aerobic capacity, adapted to older adults and conducted following established safety guidelines.
Andere namen:
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Experimenteel: Combined olfactory training/stimulation and multicomponent physical training intervention.
Participants assigned to this group will receive a combined intervention consisting of both the olfactory stimulation program and the multicomponent physical training program, delivered concurrently during the study period.
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Participants assigned to this group will receive a combined intervention consisting of both the olfactory stimulation program and the multicomponent physical training program, delivered concurrently during the study period.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cognitive Function
Tijdsspanne: Baseline and Day 30
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Changes in Cognitive Function assessed with Mini-Mental State Examination (30-point questionnaire; scale of 0 [worst] to 30 [best]).
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Baseline and Day 30
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Olfactory Function (Sniffin' Sticks Test - TDI Score)
Tijdsspanne: Baseline and Day 30
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Olfactory performance will be assessed using the Sniffin' Sticks Test (SST), providing a composite Threshold, Discrimination, and Identification (TDI) score.
Odorants will be presented using CE-marked pen devices approximately 2 cm in front of both nostrils for 2 seconds.
The Sniffin Sticks Score ranges from 0 (worst) to 48 (best).
Normative values: less than or equal 15 = Functional Anosmia; 16 - 30 = Hyposmia; 31 - 48 = Normosmia.
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Baseline and Day 30
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Physical Function
Tijdsspanne: Baseline and Day 30
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Physical Function: Assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait velocity, and leg strength as a single score on a 0 (worst) to 12 (best scale).
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Baseline and Day 30
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Mini-Cog - Quick Screening for early dementia detection
Tijdsspanne: Baseline and day 30
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Mini-Cog (5-point abreviated spanish version, the total score combines word recall (3 points) and a clock drawing task (2 points).
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Baseline and day 30
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Quality of life (QoL)
Tijdsspanne: Baseline and Day 30
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Measurment of quality of life using EQ5D-3L, the patients indicate their health state by choosing one level for each of the five dimensions, creating a 5-digit code representing 243 possible health states.
EQ VAS, includes a vertical Visual Analogue Scale (0-100) where patients rate their self-rated health, with 100 being the "best imaginable health state".
Utility.
The responses can be converted into a single index value (utility score) using country-specific valuation sets, where 1 represents full health and 0 represents death.
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Baseline and Day 30
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Nutritional Status
Tijdsspanne: Baseline and Day 30
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Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points),
or malnourished (<17points).
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Baseline and Day 30
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Barthel Index
Tijdsspanne: Baseline to Day 30
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Barthel Index of independence during activities of daily living (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).
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Baseline to Day 30
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Blood Biomarkers
Tijdsspanne: Baseline and Day 30
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Blood samples (10-20 mL) will be collected alongside routine clinical testing using Vacutainer tubes (EDTA, citrate, or serum tubes as appropriate).
Samples will be left upright for 10 minutes and centrifuged at 3000 rpm for 15 minutes to obtain serum and plasma for analysis.
Aliquots will be stored at -80°C for future specialised analyses, including flow cytometry.
Remaining samples will be stored in the Navarrabiomed Biobank for future research, subject to Ethics Committee approval.
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Baseline and Day 30
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Mood state
Tijdsspanne: Baseline an Day 30
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Yesavage Geriatric Depression Scale (GDS-15, short form) is a validated screening tool designed to detect and assess depresive symtoms specifically in older adults.
The scale ranges from 0 (best) to 15 (worst).
The reference scoring for the Short Form (GDS-15) is: 0-5 = Normal; 6-9 = Mild or posible Depression; >9 = Established/Severe Depression.
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Baseline an Day 30
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Symbol Digit Modalities Test (SDMT)
Tijdsspanne: Baseline and Day 30
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Symbol Digit Modalities Test (SDMT) measures cognitive processing speed, attention, and memory by having participants pair symbols with numbers (1-9) using a key, with a maximum score of 110-120 over 90 seconds.
A 4-point difference in SDMT scores is considered clinically meaningful, often used to detect cognitive dysfunction.
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Baseline and Day 30
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Trail Making Test - part A
Tijdsspanne: Baseline and day 30
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Trail Making Test Part A is scored by measuring the total time in seconds required to connect 25 numbered circles (an average completion time is 29 seconds, with >78 seconds often indicating cognitive impairment - Scores are often adjusted based on age, education, and user-specific norms).
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Baseline and day 30
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Multimorbidity
Tijdsspanne: Baseline and Day 30
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Assessed using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G) alongside ICD-10 classification provides a robust, comprehensive, and validated method for assessing multicomorbidity in older adults, addressing both the structural burden of disease and its functional severity.
Total scores can range from 0 to 64.
The CIRS-G Severity Index (total score divided by the number of organ systems involved) provides an estimate of the overall severity of dysfunction.
System Coverage rates 14 organ systems (e.g., cardiac, vascular, respiratory, psychiatric) on a severity scale from 0 (no problem) to 4 (Extremely severe).
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Baseline and Day 30
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Strength
Tijdsspanne: Baseline an Day 30
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Handgrip strength and maximal concentric strength (leg press, chest press, knee extension, seated row machine).
Changes in "1RM", defined as the maximum resistance/load a person can move in one repetition of an exercise will be assessed.
These values are mesured in Kilograms and results are individualized.
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Baseline an Day 30
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Medication Use (Polypharmacy and Psychotropic Drugs)
Tijdsspanne: Baseline and Day 30
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Number and type of medications will be recorded.
Polypharmacy will be defined as the use of ≥5 medications.
Psychotropic drug use and medications related to comorbid or intercurrent conditions (e.g., antibiotics) will also be documented
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Baseline and Day 30
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Exhaled Air Biomarkers (FeNO)
Tijdsspanne: Baseline and Day 30
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Fractional exhaled nitric oxide (FeNO) will be measured as a non-invasive biomarker of airway inflammation and as a potential indicator of muscle function, inflammatory status, frailty, and sarcopenia.
Measurements will be performed using a CE-marked device currently used in routine clinical practice for asthma management.
The study aims to evaluate its utility for monitoring intervention effects and for early diagnosis, prognosis, and follow-up of frailty and cognitive decline.
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Baseline and Day 30
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nicolas Martinez-Velilla, Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 juni 2024
Primaire voltooiing (Werkelijk)
4 december 2025
Studie voltooiing (Werkelijk)
4 december 2025
Studieregistratiedata
Eerst ingediend
11 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 mei 2026
Eerst geplaatst (Werkelijk)
3 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
28 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- INNOLFACT 2.0
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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