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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Pharmacological Interventions
• Intervention / Treatment: Other: non-pharmacological interventions; Other: Waiting List

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Pharmacological Interventions	Other: non-pharmacological interventions; 6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodic memory	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	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	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	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	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	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

Collaborators and Investigators

• Sponsor: China Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: 【2026】161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No