Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults. (INNOLFACT 2)
28 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Navarre
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Pamplona, Navarre, Spanien
- Hospital Universitario de Navarra
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: 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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Experimentell: 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.
Andra namn:
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Experimentell: 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.
Andra namn:
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cognitive Function
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Olfactory Function (Sniffin' Sticks Test - TDI Score)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Nicolas Martinez-Velilla, Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
6 juni 2024
Primärt slutförande (Faktisk)
4 december 2025
Avslutad studie (Faktisk)
4 december 2025
Studieregistreringsdatum
Först inskickad
11 maj 2026
Först inskickad som uppfyllde QC-kriterierna
28 maj 2026
Första postat (Faktisk)
3 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- INNOLFACT 2.0
Läkemedels- och apparatinformation, studiedokument
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