CompletedNot Applicable

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

Spain120 participantsStarted 2024-06-06

Plain-language 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. 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, unco…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive Function

Timeframe: Baseline and Day 30

Trial details

NCT IDNCT07623122

SponsorFundacion Miguel Servet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-04

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