Applied Research on a Non-pharmacological Intervention Program for Older Adults With Subjective Cognitive Decline
1 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
218
Фаза
- Непригодный
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Non-Pharmacological Interventions
|
6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)
|
|
Другой: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Episodic memory
Временное ограничение: 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
|
|
Gobal cognitive function
Временное ограничение: 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
Временное ограничение: 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
|
|
Attention
Временное ограничение: 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.
|
week0，week12，week24
|
|
Linguistic function
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Depression
Временное ограничение: 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
|
|
Anxiety
Временное ограничение: 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.
|
week0，week12，week24
|
|
Social network
Временное ограничение: 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.
|
week0，week12，week24
|
|
Social participation
Временное ограничение: 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.
|
week0，week12，week24
|
|
Timed "Up and Go" test
Временное ограничение: week0，week12，week24
|
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.
|
week0，week12，week24
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
30 июня 2026 г.
Первичное завершение (Оцененный)
30 июня 2029 г.
Завершение исследования (Оцененный)
1 декабря 2029 г.
Даты регистрации исследования
Первый отправленный
20 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
1 июня 2026 г.
Первый опубликованный (Действительный)
5 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
5 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
1 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 【2026】161
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .