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

NCT07588867 | Completed

• 2 other identifiers: No. XDYX202411K772022YFC3603000
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Body Mass Index

  From enrollment to the end of intervention at 48 weeks

• Waist circumference

  From enrollment to the end of intervention at 48 weeks

• Blood pressure

  From enrollment to the end of intervention at 48 weeks

• Activities of daily living

  From enrollment to the end of intervention at 48 weeks

• Physical performance

  From enrollment to the end of intervention at 48 weeks

Study Arms (2)

CM intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

the group that does not receive the intervention

Interventions

the Combined Multicomponent(CM) Intervention BEHAVIORAL

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.

CM intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Xiaoying Wang: lead
• Xiamen University: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

Yuxi, Gucuo, Su'an, Qianhong village

Quanzhou, Fujian, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Methods

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: The community-based study, conducted among rural adults aged 60 and above in Jinjiang City, Fujian Province, China, was initially designed as a randomized controlled trial (RCT). However, the randomization protocol could not be implemented due to variability in participants' willingness to enroll. The present study was therefore conducted as a non-randomized trial using a volunteer cohort, where non-participating older adults served as the control group. Both the intervention and control groups consisted of older adults at high risk for MCI.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 15, 2026
• Study Start: August 15, 2024
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)