Mild Cognitive Impairment (MCI)CMinterventionNCT07588867
The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment
A study testing the Combined Multicomponent(CM) Intervention in people with Mild Cognitive Impairment (MCI), run by Xiaoying Wang at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- the Combined Multicomponent(CM) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 11 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- Age <60;
- Unable to move physically;
- Already suffering from Alzheimer's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- the Combined Multicomponent(CM) Intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Combined Multicomponent(CM) InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: the Combined Multicomponent(CM) Intervention |
| Control group | No intervention | the group that does not receive the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at 48 weeks
Secondary outcomes (7)
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).
Measured: 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.
Measured: From enrollment to the end of intervention at 48 weeks
Blood pressure
Blood pressure was assessed by measuring systolic and diastolic pressures (mmHg).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From intervention at 36 weeks to the end of intervention at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Aug 2024
- Primary completion11 Oct 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoying Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen University, The First Affiliated Hospital of Xiamen University
- Responsible party
- Sponsor-investigator, Xiaoying Wang, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588867
- Sponsor's protocol ID
- No. XDYX202411K77
- Other IDs
- 2022YFC3603000
- Acronym
- CMintervention
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China
- ClinicalTrials.gov ID
- NCT07588867
- Acronym / sponsor ID
- CMintervention / No. XDYX202411K77
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Xiaoying WangUniversity, hospital or other
- Collaborators
- Xiamen University, The First Affiliated Hospital of Xiamen University
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CM intervention group | Experimental | Behavioral: the Combined Multicomponent(CM) InterventionThe 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. |
| Control group | No intervention | –the group that does not receive the intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Age <60;
- Unable to move physically;
- Already suffering from Alzheimer's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Combined Multicomponent(CM) InterventionThe 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. | Behavioural | CM intervention group |
Primary outcome
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.
7 secondary outcomes
Body Mass Index
Time frame: From enrollment to the end of intervention at 48 weeks
Waist circumference
Time frame: From enrollment to the end of intervention at 48 weeks
Blood pressure
Time frame: From enrollment to the end of intervention at 48 weeks
Activities of daily living
Time frame: From enrollment to the end of intervention at 48 weeks
Physical performance
Time frame: From enrollment to the end of intervention at 48 weeks
Participant adherence
Time frame: From enrollment to the end of intervention at 48 weeks
Participant satisfaction
Time frame: From intervention at 36 weeks to the end of intervention at 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Combined Multicomponent(CM) Intervention in people with Mild Cognitive Impairment (MCI), run by Xiaoying Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: From enrollment to the end of intervention at 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.