Applied Research on a Non-pharmacological Intervention Program for Older Adults With Subjective Cognitive Decline
2026年6月1日 更新者：Zhi Cai、China Medical University, China
Applied Research on a Group-based Non-pharmacological Intervention Program for Community-dwelling Older Adults With Subjective Cognitive Decline
This study aims to verify the short-term and long-term effects of a group-based non-pharmacological intervention program for community-dwelling older adults with subjective cognitive decline, and to evaluate its implementation outcomes, through a rigorously designed cluster randomized controlled trial.
調査の概要
詳細な説明
This study adopts a cluster randomized controlled design to implement a group-based non-pharmacological intervention for older adults with subjective cognitive decline.
The effects of the intervention on global cognitive function, episodic memory, executive function, attention, language function, subjective memory function, anxiety, depression, social participation, gait speed, physical activity level, and healthy lifestyle behaviors will be evaluated.
In addition, implementation outcomes will be assessed based on the RE-AIM framework and the CFIR framework.
研究の種類
介入
入学 (推定)
218
段階
- 適用できない
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
いいえ
説明
Inclusion Criteria Aged ≥60 Community dwelling Subjective memory decline, confirmed by Subjective Cognitive Decline Questionnaire(SCD-Q9)≥5 Montreal Cognitive Assessment (MoCA) scores ≥19, 22, or 24 for participants who had primary school, middle school, or higher education, respectively Overall intact activities of daily living No planned exercise or cognitive intervention activities within the past six months Voluntary participants who will be informed of the study objectives by the researcher and will sign the informed consent form.
Exclusion Criteria Any other neurodegenerative diseases (such as mild cognitive impairment, dementia, Parkinson's disease, stroke, etc.) Any severe or unstable internal medical conditions (i.e., unstable or severe asthma or heart disease, liver and kidney diseases, uncontrolled hypertension, severe metabolic diseases, etc.) Severe depressive, anxiety or other psychiatric disorders Movement contraindications Those currently participating in other research trials.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Non-Pharmacological Interventions
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6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)
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他の：Waiting List Control Group
To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.
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To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.
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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 |
|---|---|---|
|
Episodic memory
時間枠：week0，week12，week24
|
Using the Huashan version of the Auditory Verbal Learning Test (AVLT) for assessment, it is mainly used to evaluate immediate recall, short-delay recall, long-delay recall, and other key components.
The test includes 12 words belonging to three semantic categories (4 words per category).
The testing procedure is as follows: The examiner reads out the 12 words in sequence, and the subject immediately recalls them.
This process is repeated three consecutive times to form the immediate memory test.
After an interval of 5 minutes, short-delay recall is conducted, and after 20 minutes, long-delay recall is implemented.
The scoring rule is that each correctly recalled word earns 1 point.
The immediate memory score is the sum of correct recalls from the first three trials (maximum score 36).
This study records the scores for immediate recall, short-delay recall, and long-delay recall, with higher scores indicating better memory function.
|
week0，week12，week24
|
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Gobal cognitive function
時間枠：week0，week12，week24
|
The assessment uses the Montreal Cognitive Assessment (MoCA).
Higher scores indicate better performance, with a minimum score of 0 and a maximum score of 30.
|
week0，week12，week24
|
|
Executive function
時間枠：week0，week12，week24
|
The Shape Trail Test (STT) was used to assess executive function.
The test consists of two parts: Part A requires participants to connect 25 numbers in ascending order; Part B involves 25 numbers presented within two different shapes.
The scoring indicators are the time taken to complete STT-A and STT-B, with shorter completion times indicating better executive function.
|
week0，week12，week24
|
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Attention
時間枠：week0，week12，week24
|
The Digit Symbol Substitution Test (DSST) is used to assess the patient's attention.
The subject is required to match the corresponding symbols to the numbers (1-9) as quickly as possible within 90 seconds.
Each correctly filled symbol earns 1 point, and a reversed symbol earns 0.5 points.
The maximum score for the test is 90.
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week0，week12，week24
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Linguistic function
時間枠：week0，weel12，week24
|
Animal verbal fluency is used to assess a patient's language fluency.
The test requires the subject to name as many examples as possible within the category of animals in one minute.
Scoring is typically based on the total number of correctly named animal names.
Lower scores indicate reduced language ability.
|
week0，weel12，week24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression
時間枠：week0，weel12，week24
|
The short version of the Geriatric Depression Scale (Geriatric Depression Scale-15, GDS-15) is used for assessment.
The total score ranges from 0 to 15, and the score is positively correlated with the severity of depression.
|
week0，weel12，week24
|
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Anxiety
時間枠：week0，week12，week24
|
The Geriatric Anxiety Inventory-20 (GAI-20) is used for assessment.
This scale consists of 20 items, and respondents answer based on their emotional feelings over the past week.
A response of "Yes" is scored as 1 point, while "No" is scored as 0 points.
The total score ranges from 0 to 20, with higher scores indicating more severe anxiety.
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week0，week12，week24
|
|
Social network
時間枠：week0，week12，week24
|
The Lubben Social Network Scale-6 (LSNS-6) is a short version of the Lubben Social Network Scale.
It is primarily used to measure an individual's level of social connectedness in two dimensions: family relationships and peer interactions.
The scale consists of six assessment items and uses a graded scoring system: 0 points indicate no such social members, 1 point corresponds to 1 person, 2 points to 2 people, 3 points to 3-4 people, 4 points to 5-8 people, and 5 points applies to groups of 9 or more individuals.
Lower scores indicate poorer levels of social network connectedness.
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week0，week12，week24
|
|
Social participation
時間枠：week0，week12，week24
|
This study employed the Social Participation Level Assessment Tool revised by Wei Xiuping, which was developed based on national health survey data of the elderly population.
The measurement tool comprises two main dimensions: cultural organization participation and family/personal affairs, encompassing a total of 10 specific items.
A five-point Likert scale was used for measurement, and the total score is positively correlated with the level of social participation-that is, a higher score indicates a more significant degree of social participation among the respondents.
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week0，week12，week24
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Timed "Up and Go" test
時間枠：week0，week12，week24
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During the test, the participant sits on a chair with armrests and a backrest.
Upon hearing the instruction, they stand up, walk 3 meters forward at their usual gait, then turn around, return to the chair, and sit down.
The average of two test trials is recorded.
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week0，week12，week24
|
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。
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 (推定)
2026年6月30日
一次修了 (推定)
2029年6月30日
研究の完了 (推定)
2029年12月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
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