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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
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.
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.
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.
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Cognitive Function
Changes in Cognitive Function assessed with Mini-Mental State Examination (30-point questionnaire; scale of 0 \[worst\] to 30 \[best\]).
Time frame: Baseline and Day 30
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline and Day 30
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