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

NCT07623122 | Completed

• 1 other identifier: INNOLFACT 2.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging; Frailty; Olfactory Dysfunction; Cognitive Decline; Physical Performance Decline in Older Adults

Keywords

Olfactory stimulation; Olfactory trainning; Multicomponent physical exercise; Cognition; Older adults; Biomarkers; Exhaled nitric oxide; Geriatrics; Precision medicine

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

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

  Baseline and Day 30

Secondary Outcomes (14)

• Olfactory Function (Sniffin' Sticks Test - TDI Score)

  Baseline and Day 30

• Physical Function

  Baseline and Day 30

• Mini-Cog - Quick Screening for early dementia detection

  Baseline and day 30

• Quality of life (QoL)

  Baseline and Day 30

• Nutritional Status

  Baseline and Day 30

Study Arms (4)

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.

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.

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.

Other: Combined olfactory stimulation and multicomponent physical training

Interventions

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.

Also known as: Group 1

Olfactory stimulation intervention.

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.

Also known as: Group 2

Multicomponent physical training intervention.

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.

Also known as: Group 3

Combined olfactory training/stimulation and multicomponent physical training intervention.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital of Navarra: collaborator
• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Location

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nicolas Martinez-Velilla

  Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 3, 2026
• Study Start: June 6, 2024
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

ES (1)