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.
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.
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.
- Conditions
- Healthy Aging, Frailty, Cognitive Decline, Olfactory Dysfunction, Physical Performance Decline in Older Adults
- 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 group | Role | What they receive |
|---|---|---|
| Control group. | No intervention | 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. |
| Olfactory stimulation intervention. | Experimental | 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. Receives: Other: Olfactory stimulation |
| Multicomponent physical training intervention. | Experimental | 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. Receives: Other: Multicomponent physical training |
| Combined olfactory training/stimulation and multicomponent physical training intervention. | Experimental | 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. 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted3 Jun 2026
- Study start6 Jun 2024
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Navarra
- Responsible party
- Sponsor
- Investigators
- Nicolas Martinez-Velilla, Principal investigator, Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07623122
- Acronym / sponsor ID
- INNOLFACT 2 / INNOLFACT 2.0
- Conditions
- Healthy Aging, Frailty, Cognitive Decline, Olfactory Dysfunction, Physical Performance Decline in Older Adults
- Keywords
- Olfactory stimulation, Olfactory trainning, Multicomponent physical exercise, Cognition, Older adults, Biomarkers, Exhaled nitric oxide, Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Hospital of Navarra
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 3 Jun 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group. | No intervention | –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. |
| Olfactory stimulation intervention. | Experimental | Other: Olfactory stimulationParticipants 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. |
| Multicomponent physical training intervention. | Experimental | Other: Multicomponent physical trainingParticipants 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 training/stimulation and multicomponent physical training intervention. | Experimental | Other: Combined olfactory stimulation and multicomponent physical trainingParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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);
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 stimulationAlso: Group 1Participants 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 | Olfactory stimulation intervention. |
| Multicomponent physical trainingAlso: Group 2Participants 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 | Multicomponent physical training intervention. |
| Combined olfactory stimulation and multicomponent physical trainingAlso: Group 3Participants 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 | Combined olfactory training/stimulation and multicomponent physical training intervention. |
Primary outcome
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]).
14 secondary outcomes
Olfactory Function (Sniffin' Sticks Test - TDI Score)
Time frame: Baseline and Day 30
Physical Function
Time frame: Baseline and Day 30
Mini-Cog - Quick Screening for early dementia detection
Time frame: Baseline and day 30
Quality of life (QoL)
Time frame: Baseline and Day 30
Nutritional Status
Time frame: Baseline and Day 30
Barthel Index
Time frame: Baseline to Day 30
Blood Biomarkers
Time frame: Baseline and Day 30
Mood state
Time frame: Baseline an Day 30
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline and Day 30
Trail Making Test - part A
Time frame: Baseline and day 30
Multimorbidity
Time frame: Baseline and Day 30
Strength
Time frame: Baseline an Day 30
Medication Use (Polypharmacy and Psychotropic Drugs)
Time frame: Baseline and Day 30
Exhaled Air Biomarkers (FeNO)
Time frame: Baseline and Day 30
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 3 Jun 2026.
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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.
Nicolas Martinez-Velilla principal investigator
Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
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 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.