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Healthy AgingINNOLFACT 2NCT07623122

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

A study testing Olfactory stimulation, Multicomponent physical training and Combined olfactory stimulation and multicomponent physical training in people with Healthy Aging and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.

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

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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Aging, Frailty, Cognitive Decline
What is being tested?
Olfactory stimulation, Multicomponent physical training and Combined olfactory stimulation and multicomponent physical training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
6 Jun 2024to 4 Dec 2025
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario de Navarra

    Pamplona, Navarre

Other trials in Spain

About this study

Official title: 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.

Being tested
Olfactory stimulation, Multicomponent physical training, Combined olfactory stimulation and multicomponent physical training
Keywords
Olfactory stimulation, Olfactory trainning, Multicomponent physical exercise, Cognition, Older adults, Biomarkers, Exhaled nitric oxide, Geriatrics, Precision medicine
Medical subject headings
Frailty, Cognitive Dysfunction

What participants receive

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

  • Olfactory stimulationOther

    Also called Group 1

    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.

  • Multicomponent physical trainingOther

    Also called Group 2

    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.

  • Combined olfactory stimulation and multicomponent physical trainingOther

    Also called Group 3

    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.

Study groups in NCT07623122
Study groupRoleWhat they receive
Control group.No interventionParticipants 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.
Olfactory stimulation intervention.ExperimentalParticipants 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.
Receives: Other: Olfactory stimulation
Multicomponent physical training intervention.ExperimentalParticipants 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.
Receives: Other: Multicomponent physical training
Combined olfactory training/stimulation and multicomponent physical training intervention.ExperimentalParticipants 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.
Receives: Other: Combined olfactory stimulation and multicomponent physical training

What is being measured

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

  1. Cognitive Function

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

    Measured: Baseline and Day 30

Secondary outcomes (14)
  1. Olfactory Function (Sniffin' Sticks Test - TDI Score)

    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.

    Measured: Baseline and Day 30

  2. Physical Function

    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).

    Measured: Baseline and Day 30

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

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

    Measured: Baseline and day 30

  4. Quality of life (QoL)

    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.

    Measured: Baseline and Day 30

  5. Nutritional Status

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

    Measured: Baseline and Day 30

  6. Barthel Index

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

    Measured: Baseline to Day 30

  7. Blood Biomarkers

    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.

    Measured: Baseline and Day 30

  8. Mood state

    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.

    Measured: Baseline an Day 30

  9. Symbol Digit Modalities Test (SDMT)

    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.

    Measured: Baseline and Day 30

  10. Trail Making Test - part A

    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).

    Measured: Baseline and day 30

  11. Multimorbidity

    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).

    Measured: Baseline and Day 30

  12. Strength

    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.

    Measured: Baseline an Day 30

  13. Medication Use (Polypharmacy and Psychotropic Drugs)

    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

    Measured: Baseline and Day 30

  14. Exhaled Air Biomarkers (FeNO)

    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.

    Measured: Baseline and Day 30

Timeline

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

  1. First posted3 Jun 2026
  2. Study start6 Jun 2024
  3. Primary completion4 Dec 2025
  4. Study completion4 Dec 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07623122
Sponsor's protocol ID
INNOLFACT 2.0
Acronym
INNOLFACT 2
Status last verified
May 2026
First submitted
11 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Olfactory stimulation, Multicomponent physical training and Combined olfactory stimulation and multicomponent physical training in people with Healthy Aging and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.

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 8 inclusion and 9 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 3 Jun 2026. 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 Spain. 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?

Cognitive Function (time frame: Baseline and Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Jun 2026.

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