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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07588867
Acronym
CMintervention
Enrollment
235
Registered
2026-05-15
Start date
2024-08-15
Completion date
2025-10-11
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI)

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.

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.

Interventions

BEHAVIORALthe 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.

Sponsors

Xiaoying Wang
Lead SponsorOTHER
Xiamen University
CollaboratorOTHER
The First Affiliated Hospital of Xiamen University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive FunctionFrom enrollment to the end of intervention at 48 weeksCognitive 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.

Secondary

MeasureTime frameDescription
Body Mass IndexFrom enrollment to the end of intervention at 48 weeksHeight (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).
Waist circumferenceFrom enrollment to the end of intervention at 48 weeksWaist 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.
Blood pressureFrom enrollment to the end of intervention at 48 weeksBlood pressure was assessed by measuring systolic and diastolic pressures (mmHg).
Activities of daily livingFrom enrollment to the end of intervention at 48 weeksActivities 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.
Physical performanceFrom enrollment to the end of intervention at 48 weeksPhysical 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.
Participant adherenceFrom enrollment to the end of intervention at 48 weeksParticipant 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.
Participant satisfactionFrom intervention at 36 weeks to the end of intervention at 48 weeksParticipant satisfaction was assessed using a self-developed scale, with a total score of 30 points; higher scores indicated greater satisfaction with the program.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026