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Completed

NCT Number: NCT07623122

Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults.

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olfactory stimulation

Other

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.

Other names: Group 1

Multicomponent physical training

Other

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.

Other names: Group 2

Combined olfactory stimulation and multicomponent physical training

Other

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.

Other names: Group 3

Primary outcomes

  1. Cognitive Function

    Time frame: Baseline and Day 30

    Changes in Cognitive Function assessed with Mini-Mental State Examination (30-point questionnaire; scale of 0 [worst] to 30 [best]).

Secondary outcomes

  1. Olfactory Function (Sniffin' Sticks Test - TDI Score)

    Time frame: Baseline and Day 30

    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.

  2. Physical Function

    Time frame: Baseline and Day 30

    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).

  3. Mini-Cog - Quick Screening for early dementia detection

    Time frame: Baseline and day 30

    Mini-Cog (5-point abreviated spanish version, the total score combines word recall (3 points) and a clock drawing task (2 points).

  4. Quality of life (QoL)

    Time frame: Baseline and Day 30

    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.

  5. Nutritional Status

    Time frame: Baseline and Day 30

    Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points), or malnourished (<17points).

  6. Barthel Index

    Time frame: Baseline to Day 30

    Barthel Index of independence during activities of daily living (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).

  7. Blood Biomarkers

    Time frame: Baseline and Day 30

    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.

  8. Mood state

    Time frame: Baseline an Day 30

    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.

  9. Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline and Day 30

    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.

  10. Trail Making Test - part A

    Time frame: Baseline and day 30

    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).

  11. Multimorbidity

    Time frame: Baseline and Day 30

    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).

  12. Strength

    Time frame: Baseline an Day 30

    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.

  13. Medication Use (Polypharmacy and Psychotropic Drugs)

    Time frame: Baseline and Day 30

    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

  14. Exhaled Air Biomarkers (FeNO)

    Time frame: Baseline and Day 30

    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.

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Collaborators

  • Hospital of Navarra

Registry information

Official study title

Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults: A Randomised Clinical Trial

Acronym: INNOLFACT 2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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