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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Navarre
-
Pamplona、Navarre、スペイン
- Hospital Universitario de Navarra
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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.
|
|
|
実験的：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.
|
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.
他の名前：
|
|
実験的：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.
|
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.
他の名前：
|
|
実験的：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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive Function
時間枠：Baseline and Day 30
|
Changes in Cognitive Function assessed with Mini-Mental State Examination (30-point questionnaire; scale of 0 [worst] to 30 [best]).
|
Baseline and Day 30
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Olfactory Function (Sniffin' Sticks Test - TDI Score)
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Physical Function
時間枠：Baseline and Day 30
|
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).
|
Baseline and Day 30
|
|
Mini-Cog - Quick Screening for early dementia detection
時間枠：Baseline and day 30
|
Mini-Cog (5-point abreviated spanish version, the total score combines word recall (3 points) and a clock drawing task (2 points).
|
Baseline and day 30
|
|
Quality of life (QoL)
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Nutritional Status
時間枠：Baseline and Day 30
|
Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points),
or malnourished (<17points).
|
Baseline and Day 30
|
|
Barthel Index
時間枠：Baseline to Day 30
|
Barthel Index of independence during activities of daily living (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).
|
Baseline to Day 30
|
|
Blood Biomarkers
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Mood state
時間枠：Baseline an Day 30
|
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.
|
Baseline an Day 30
|
|
Symbol Digit Modalities Test (SDMT)
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Trail Making Test - part A
時間枠：Baseline and day 30
|
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).
|
Baseline and day 30
|
|
Multimorbidity
時間枠：Baseline and Day 30
|
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).
|
Baseline and Day 30
|
|
Strength
時間枠：Baseline an Day 30
|
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.
|
Baseline an Day 30
|
|
Medication Use (Polypharmacy and Psychotropic Drugs)
時間枠：Baseline and Day 30
|
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
|
Baseline and Day 30
|
|
Exhaled Air Biomarkers (FeNO)
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nicolas Martinez-Velilla、Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年6月6日
一次修了 (実際)
2025年12月4日
研究の完了 (実際)
2025年12月4日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- INNOLFACT 2.0
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Olfactory stimulationの臨床試験
-
Biotronik SE & Co. KG完了
-
Biotronik SE & Co. KG完了心臓ペーシング、人工ドイツ, イスラエル, 香港, オーストリア, チェコ共和国, オーストラリア, ブラジル, カナダ, スロバキア, スペイン