Applied Research on a Non-pharmacological Intervention Program for Older Adults With Subjective Cognitive Decline

Официальное название

Applied Research on a Group-based Non-pharmacological Intervention Program for Community-dwelling Older Adults With Subjective Cognitive Decline

Обзор

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.

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.

Вмешательства

• Другое non-pharmacological interventions
  6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)
• Другое Waiting List
  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.

Первичные конечные точки

• Episodic memory [Срок оценки: week0，week12，week24]
• Gobal cognitive function [Срок оценки: week0，week12，week24]
• Executive function [Срок оценки: week0，week12，week24]
• Attention [Срок оценки: week0，week12，week24]
• Linguistic function [Срок оценки: week0，weel12，week24]

Вторичные конечные точки (5)

• Depression [Срок оценки: week0，weel12，week24]
• Anxiety [Срок оценки: week0，week12，week24]
• Social network [Срок оценки: week0，week12，week24]
• Social participation [Срок оценки: week0，week12，week24]
• Timed "Up and Go" test [Срок оценки: week0，week12，week24]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07629531 · 【2026】161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗