The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment (CMintervention)

Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China

This project aims to test whether a combined multicomponent (CM) program - including health education, cognitive training, and traditional Chinese exercises - is feasible and effective for rural older adults who are at high risk of mild cognitive impairment (MCI). The program is designed to help maintain or improve cognitive function and overall well-being.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Behavioral: the Combined Multicomponent(CM) Intervention

Detailed Description

Health education sessions: One 30-minute lecture every 4 weeks, covering topics such as diet, sleep, chronic disease management, and brain health.

Cognitive training: Weekly 45-minute sessions using fun mini-games to train memory, attention, arithmetic, and logical thinking.

Physical exercise: Weekly 45-minute sessions of traditional Chinese exercises (Baduanjin and Shiqiaoshou) to improve balance, flexibility, and fitness.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China
      • Yuxi, Gucuo, Su'an, Qianhong village

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥ 60;
• Suffering from chronic diseases, such as hypertension, diabetes mellitus, hyperlipidemia, cardiovascular and cerebrovascular diseases, or osteoarthritis;
• Mild cognitive impairment (defined as Mini-Mental State Examination (MMSE) score of 21-26 combined with either an AD8 self-rated cognitive impairment score ≥ 2 or a digit span (backward) test (DST) score < 4);
• Mild physical impairment (defined as an Activities of Daily Living (ADL) score < 26 and a Short Physical Performance Battery (SPPB) score of 7-10).

Exclusion Criteria:

• Age <60;
• Unable to move physically;
• Already suffering from Alzheimer's disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM intervention group; The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise. The health education sessions were delivered once every four weeks, with each session lasting 30 minutes. In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.	Behavioral: the Combined Multicomponent(CM) Intervention; The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise. The health education sessions were delivered once every four weeks, with each session lasting 30 minutes. In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.
No Intervention: Control group; the group that does not receive the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function	Cognitive function was assessed using the Minimum Mental State Examination (MMSE) scale (Folstein, Folstein, & McHugh, 1975).The MMSE evaluates five domains: orientation, registration, attention and calculation, recall, and language abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.	From enrollment to the end of intervention at 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Height (cm) was measured using a wall-mounted height board, with the participant standing upright without shoes. Weight (kg) was measured using a electronic load cell scale, with light indoor clothing and after voiding. Body Mass Index (BMI) was calculated by dividing a person's weight in kilograms by the square of their height in meters (kg/m²).	From enrollment to the end of intervention at 48 weeks
Waist circumference	Waist circumference (cm) was measured using a flexible, non-elastic tape measure at the midpoint between the lowest rib and the iliac crest, with the participant standing and breathing normally. The measurement is taken to the nearest 0.1 cm at the end of normal expiration.	From enrollment to the end of intervention at 48 weeks
Blood pressure	Blood pressure was assessed by measuring systolic and diastolic pressures (mmHg).	From enrollment to the end of intervention at 48 weeks
Activities of daily living	Activities of daily living were assessed via the Activities of daily living (ADL) scale (Ferrucci et al., 1996). It employs a scoring range of 14 to 56, with higher scores indicating poorer functional ability.	From enrollment to the end of intervention at 48 weeks
Physical performance	Physical performance was assessed via the Short Physical Performance Battery (SPPB) scale (Cruz-Jentoft et al., 2010). It has a scoring range of 0 to 12, with higher scores reflecting better physical performance.	From enrollment to the end of intervention at 48 weeks
Participant adherence	Participant adherence was summarized as the proportion of total participants who attended at least 50% of the intervention sessions, and separately for those who attended at least 75% of the sessions.	From enrollment to the end of intervention at 48 weeks
Participant satisfaction	Participant satisfaction was assessed using a self-developed scale, with a total score of 30 points; higher scores indicated greater satisfaction with the program.	From intervention at 36 weeks to the end of intervention at 48 weeks

Collaborators and Investigators

• Sponsor: Xiaoying Wang
• Collaborators: Xiamen University; The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Actual): October 11, 2025
• Study Completion (Actual): October 11, 2025

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Investigative Techniques; Methods
• Other Study ID Numbers: No. XDYX202411K77; 2022YFC3603000 (Other Grant/Funding Number: the National Key Research and Development Program of China)

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