Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 235
- Locations
- 1
- Primary Endpoint
- Cognitive Function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: the Combined Multicomponent(CM) Intervention (Behavioral)
Control group
the group that does not receive the intervention
Outcomes
Primary Outcomes
Cognitive Function
Time Frame: From enrollment to the end of intervention at 48 weeks
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.
Secondary Outcomes
- 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)
- Participant adherence(From enrollment to the end of intervention at 48 weeks)
- Participant satisfaction(From intervention at 36 weeks to the end of intervention at 48 weeks)
Investigators
Xiaoying Wang
Investigator
Xiamen University