Characterisation of Functional and Cognitive Responses Following Olfactory Stimulation and/or Functional Training in Older Adults. (INNOLFACT 2)
2026年5月28日 更新者：Fundacion Miguel Servet
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Navarre
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Pamplona、Navarre、西班牙
- Hospital Universitario de Navarra
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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, 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Control group.
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.
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实验性的：Olfactory stimulation intervention.
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.
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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.
其他名称：
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实验性的：Multicomponent physical training intervention.
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.
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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.
其他名称：
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实验性的：Combined olfactory training/stimulation and multicomponent physical training intervention.
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.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cognitive Function
大体时间：Baseline and Day 30
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Changes in Cognitive Function assessed with Mini-Mental State Examination (30-point questionnaire; scale of 0 [worst] to 30 [best]).
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Baseline and Day 30
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Olfactory Function (Sniffin' Sticks Test - TDI Score)
大体时间：Baseline and Day 30
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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.
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Baseline and Day 30
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Physical Function
大体时间：Baseline and Day 30
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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).
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Baseline and Day 30
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Mini-Cog - Quick Screening for early dementia detection
大体时间：Baseline and day 30
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Mini-Cog (5-point abreviated spanish version, the total score combines word recall (3 points) and a clock drawing task (2 points).
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Baseline and day 30
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Quality of life (QoL)
大体时间：Baseline and Day 30
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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.
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Baseline and Day 30
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Nutritional Status
大体时间：Baseline and Day 30
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Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points),
or malnourished (<17points).
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Baseline and Day 30
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Barthel Index
大体时间：Baseline to Day 30
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Barthel Index of independence during activities of daily living (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).
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Baseline to Day 30
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Blood Biomarkers
大体时间：Baseline and Day 30
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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.
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Baseline and Day 30
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Mood state
大体时间：Baseline an Day 30
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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.
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Baseline an Day 30
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Symbol Digit Modalities Test (SDMT)
大体时间：Baseline and Day 30
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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.
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Baseline and Day 30
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Trail Making Test - part A
大体时间：Baseline and day 30
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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).
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Baseline and day 30
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Multimorbidity
大体时间：Baseline and Day 30
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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).
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Baseline and Day 30
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Strength
大体时间：Baseline an Day 30
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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.
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Baseline an Day 30
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Medication Use (Polypharmacy and Psychotropic Drugs)
大体时间：Baseline and Day 30
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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
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Baseline and Day 30
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Exhaled Air Biomarkers (FeNO)
大体时间：Baseline and Day 30
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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.
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Baseline and Day 30
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nicolas Martinez-Velilla、Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年6月6日
初级完成 (实际的)
2025年12月4日
研究完成 (实际的)
2025年12月4日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.