Mild Cognitive ImpairmentNCT05483790
The Effects of Multidomain Non-pharmacological Interventions on the Elderly With or Without Mild Cognitive Impairment
A study testing the multimodal intervention in people with Mild Cognitive Impairment and The Cognitive Normal Elderly, run by Huashan Hospital at 1 site in China.
Trial summary
The study aiming to investigate the efficacy, safety, and potential mechanism of a multimodal intervention on cognitive function in individuals with MCI or the cognitive normal elderly living in a community. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, The Cognitive Normal Elderly
- What is being tested?
- the multimodal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2024
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥50 and ≤75 years, Male or Female
- The resident elderly or those who have lived in the sampled community for more than 6 months
- Be able to communicate with investigators and understand the questionnaire questions
- More than 6 years of education
- Mild cognitive impairment according to the Peterson criteria
- Volunteer to participate in the study
Who cannot join
- Individuals with neurological diseases
- Cognitive decline due to other disorders (cerebrovascular disease, central nervous system infections, etc.)
- Mental Disorders included in The Diagnostic and Statistical Manual of Mental Disorders of The American Psychiatric Association
- Blindness, aphasia, or severe hearing impairment
- History of myocardial infarction within the previous year, Unstable cardiac, renal, lung, liver or other severe chronic diseases
- Coincident participation in another intervention trial
- Using pharmacologic therapeutics for cognitive impairment.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Enhancing Latent Cognitive Capacity in Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment（MCI): a RCT Study
The study aiming to investigate the efficacy, safety, and potential mechanism of a multimodal intervention on cognitive function in individuals with MCI or the cognitive normal elderly living in a community. The recruited elderly aged 50-75 years with normal cognitive function or MCI will be divided into the intervention group or the control group randomly. The intervention group will be accepted a multidimensional non-pharmacological intervention (cognitive training, physical exercise, healthy lifestyle intervention, and computerized interaction training) while the control group receives health education. Sociodemographics will be collected before the intervention. comprehensive neuropsychological tests and MRI will be collected before and 6 weeks, 12 weeks, 3 months, 6 months, 12 months after the randomization respectively.
Read the detailed description
This study is a 6-week training phase and 6-week maintenance phase randomized controlled trial, conducted at Xinzhuang Town, Minhang District, Shanghai, China.
All participants (control and intervention group) complete the data collection. Demographic data will be collected before intervention including age, sex, education, marriage, etc. A comprehensive cognitive assessment and MRI will be done before and 6 weeks, 12 weeks,3 months, 6 months, 12 months after the randomization respectively.
The intervention group receive four intervention components including cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training. a multimodal intervention program (with schedule) was conducted in the intervention group for 6-week training phase and 6-week maintenance, including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. Throughout the 12-week period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks).
The in-person training course started with a 10-minute period of reminiscence and discussion. Subsequently, cognitive training activities were conducted for 25 minutes, followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, participants summarized the all-training activities, either through writing or discussion, and planed their homework during a 15-minute wrap-up session.
The cognitive training encompassed memory-related training (i.e. picture recall, categorization, cueing, repetition, association, sentence formation, story construction, utilization of the Roman room method, face-name association, and verbalization to aid retention) and attention-related training (i.e. character-picture association, idiom-picture association, and spot-the-difference tasks were incorporated). The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills, such as managing stressful life events and handling anger and frustration. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.
The instructor-supervised, computer program-based computerized interaction training three times weekly included spatial cognition (i.e. participants manipulated identical cubes or two-dimensional figures in different orientations using a control handle), left and right brain balance tasks (i.e. replicating graphics from one computer screen to another using action tracking or screen touching technology), clock imitation exercises (i.e. participants mimicked the movements of hour and minute hands to match the time displayed on the computer screen), and automatic teller machine simulation (i.e. wherein participants performed transactions like cash withdrawals, money transfers, and balance checks using a computer interface similar to an ATM, while also recalling passwords and transaction amounts.
The every-day homework encompassed activities such as calligraphy practice (2 days per week) and physical exercise (the other 5 days per week). Participants were asked to complete their homework within approximately 30 minutes and share pictures or videos of their homework in a WeChat group each day, allowing for assessment of their adherence.
The trial is conducted by local health workers, who were trained by a team comprising neurologists and geriatrics experts from Huashan Hospital. The training manuals, demo videos, education resources (such as PowerPoint files and materials) and standardized health education study materials were also distributed to them.
The control group receives regular health advice weekly through brochures, home visits, or telephone calls during 6-week training phase and 6-week maintenance period, detail including (1) patients with cognitive impairment education: prevention from self-injury, falling injury, accidental injury, medication, lost and bad habits; (2) inmates or caregivers education; (3) cognitive impairment knowledge education; (4) prevention of cognitive dysfunction education. The intervention committee ensures that health education activities are consistent across sites and unlikely to increase physical activity.
- Being tested
- the multimodal intervention
- Keywords
- mild cognitive impairment, the elderly, non-pharmacological intervention, cognitive function, magnetic resonance imaging, randomized controlled trial
- 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 multimodal interventionBehavioural
The in-person training course included 25 minutescognitive training activities were conducted for , followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, 15 minutes wrap-up session.
The cognitive training encompassed memory-related training and attention-related training. The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.
| Study group | Role | What they receive |
|---|---|---|
| multidomain intervention | Experimental | The interventions were conducted for 6-week training phase and 6-week maintenance phase. Including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks). Receives: Behavioral: the multimodal intervention |
| the control | No intervention | Throughout the 6-week training phase and 6-week maintenance period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function assessed by the Mini-Mental State Examination (MMSE)
MMSE using the Chinese version revised by Zhang Mingyuan, the scale includes 30 items, including orientation, instantaneous memory, attention, computation, recall, language and visuospatial. The MMSE score ranges from 0 to 30 (30=best).
Measured: Before the intervention
cognitive function assessed by the Mini-Mental State Examination (MMSE)
MMSE using the Chinese version revised by Zhang Mingyuan, the scale includes 30 items, including orientation, instantaneous memory, attention, computation, recall, language and visuospatial. The MMSE score ranges from 0 to 30 (30=best).
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
Secondary outcomes (28)
memory function assessed by AVLT
Auditory Verbal Learning Test（AVLT）to rate immediate (sum of words recalled on the 5 learning trials) and delayed episodic verbal memory.
Measured: Before the intervention
memory function assessed by AVLT
Auditory Verbal Learning Test（AVLT）to rate immediate (sum of words recalled on the 5 learning trials) and delayed episodic verbal memory.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
memory function assessed by LMT
Logic memory test (LMT): which assesses memory for brief passages, similar to newspaper stories. Subjects were assessed on immediate recall and 30 minute interval for delayed recall, according to standard practice. Subjects were not instructed in advance that they would be re-tested on the story after a delay of 30 minutes.
Measured: Before the intervention
memory function assessed by LMT
Logic memory test (LMT): which assesses memory for brief passages, similar to newspaper stories. Subjects were assessed on immediate recall and 30 minute interval for delayed recall, according to standard practice. Subjects were not instructed in advance that they would be re-tested on the story after a delay of 30 minutes.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
executive function assessed by TMT-A
The trail marking test A (TMT-A): The TMT-A consisted of a standardized page on which the numbers 1 to 25 are scattered within circles, and the participants were asked to connect the numbers in order as quickly as possible. A maximum time of 300 seconds was allowed before discontinuing the test. Direct scores of TMT-A were the time in seconds taken to complete task.
Measured: Before the intervention
executive function assessed by TMT-A
The trail marking test A (TMT-A): The TMT-A consisted of a standardized page on which the numbers 1 to 25 are scattered within circles, and the participants were asked to connect the numbers in order as quickly as possible. A maximum time of 300 seconds was allowed before discontinuing the test. Direct scores of TMT-A were the time in seconds taken to complete task.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
executive function assessed by DSST
Digit Symbol Substitution Test (DSST): The DSST was used to assess visual search, and perceptual and graphomotor speed. The number of correct substitutions during a 90-second interval was used as the score.
Measured: Before the intervention
executive function assessed by DSST
Digit Symbol Substitution Test (DSST): The DSST was used to assess visual search, and perceptual and graphomotor speed. The number of correct substitutions during a 90-second interval was used as the score.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
concentration function assessed by DST
Digit Span Test (DST): including digit span forwards (DSF) and digit span backwards (DSB)
Measured: Before the intervention
concentration function assessed by DST
Digit Span Test (DST): including digit span forwards (DSF) and digit span backwards (DSB)
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by the Barthel index
Barthel index:The main aim is to establish degree of independence from any help, physical or verbal, however minor and for whatever reason.
Measured: Before the intervention
quality of life assessed by the Barthel index
Barthel index:The main aim is to establish degree of independence from any help, physical or verbal, however minor and for whatever reason.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by EQ-5D-5L
European quality of life-5 dimensions with 5 level (EQ-5D-5L): The descriptive system of the EQ-5D comprises five dimensions: mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD); each dimension is described at five levels, corresponding roughly to no, slight, moderate, severe, and extreme problems.
Measured: Before the intervention
quality of life assessed by EQ-5D-5L
European quality of life-5 dimensions with 5 level (EQ-5D-5L): The descriptive system of the EQ-5D comprises five dimensions: mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD); each dimension is described at five levels, corresponding roughly to no, slight, moderate, severe, and extreme problems.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by IADL
The Lawton instrumental activities of daily living scale (IADL): IADL is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: Before the intervention
quality of life assessed by IADL
The Lawton instrumental activities of daily living scale (IADL): IADL is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by PSMS
Physical Self-Maintenance Scale (PSMS): To assess functional abilities in elderly patients. The format the PSMS is first a six item based on the ADL and then eight-items based on the IADL scale. A 5-point scale for responses ranges from total independence to total dependence.
Measured: Before the intervention
quality of life assessed by PSMS
Physical Self-Maintenance Scale (PSMS): To assess functional abilities in elderly patients. The format the PSMS is first a six item based on the ADL and then eight-items based on the IADL scale. A 5-point scale for responses ranges from total independence to total dependence.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by SF-36
The short-form 36 item health survey (SF-36): The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: Before the intervention
quality of life assessed by SF-36
The short-form 36 item health survey (SF-36): The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
social support assessed by SSRS
Social Support Rating Scale (SSRS): SSRS developed by Xiao was utilized to measure social support. The 10-item scale consists of 3 dimensions including objective support, subjective support and availability. Higher scores indicate higher levels of social support. The scale has presented impressive validity and reliability in Chinese population.
Measured: Before the intervention
social support assessed by SSRS
Social Support Rating Scale (SSRS): SSRS developed by Xiao was utilized to measure social support. The 10-item scale consists of 3 dimensions including objective support, subjective support and availability. Higher scores indicate higher levels of social support. The scale has presented impressive validity and reliability in Chinese population.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of sleep assessed by PSQI
Pittsburgh sleep quality index (PSQI): Sleep quality was assessed using the Chinese version of the PSQI, which is composed of 19 items classified into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction during the past month. Each component is weighted from 0 to 3, generating one global score ranging from 0 to 21. The higher score the poorer sleep quality.
Measured: Before the intervention
quality of sleep assessed by PSQI
Pittsburgh sleep quality index (PSQI): Sleep quality was assessed using the Chinese version of the PSQI, which is composed of 19 items classified into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction during the past month. Each component is weighted from 0 to 3, generating one global score ranging from 0 to 21. The higher score the poorer sleep quality.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
emotion assessed by GDS-15
Geriatric Depression Scale (GDS-15): The short form including 15 items. Items represent characteristics of depression in the elderly in the affective (e.g., sadness, apathy, crying) and cognitive domains (e.g., thoughts of hopelessness, helplessness, guilt, worthlessness. Higher GDS scores are indicative of more severe depression.
Measured: Before the intervention
emotion assessed by GDS-15
Geriatric Depression Scale (GDS-15): The short form including 15 items. Items represent characteristics of depression in the elderly in the affective (e.g., sadness, apathy, crying) and cognitive domains (e.g., thoughts of hopelessness, helplessness, guilt, worthlessness. Higher GDS scores are indicative of more severe depression.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
cognitive function assessed by The Montreal Cognitive Assessment (MoCA)
The MoCA is a 1-page test that measures several cognitive domains (visual perception, executive skills, language, attention, memory and orientation). The MoCA score ranges from 0 to 30 (30 = best) and was chosen for its relatively high sensitivity for mild cognitive impairment.
Measured: Before the intervention
cognitive function assessed by The Montreal Cognitive Assessment (MoCA)
The MoCA is a 1-page test that measures several cognitive domains (visual perception, executive skills, language, attention, memory and orientation). The MoCA score ranges from 0 to 30 (30 = best) and was chosen for its relatively high sensitivity for mild cognitive impairment.
Measured: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jun 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- the intervention group and the control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- School of Public Health，Fudan University, Medicine-Mental Health Center of Minhang District, Xinzhuang Community Health Service Center
- Responsible party
- Principal investigator, Huang Yanyan, Huashan Hospital
- Investigators
- Ying Wang, professor, Study chair, Deputy Director, Professor, School of Public Health, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483790
- Sponsor's protocol ID
- 2017YFC1310504
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2022
- Last updated
- 15 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Latent Cognitive Capacity in Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment（MCI): a RCT Study
- ClinicalTrials.gov ID
- NCT05483790
- Acronym / sponsor ID
- 2017YFC1310504
- Keywords
- mild cognitive impairment, the elderly, non-pharmacological intervention, cognitive function, magnetic resonance imaging, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- School of Public Health，Fudan University, Medicine-Mental Health Center of Minhang District, Xinzhuang Community Health Service Center
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Aug 2022 (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.
The study aiming to investigate the efficacy, safety, and potential mechanism of a multimodal intervention on cognitive function in individuals with MCI or the cognitive normal elderly living in a community. The recruited elderly aged 50-75 years with normal cognitive function or MCI will be divided into the intervention group or the control group randomly. The intervention group will be accepted a multidimensional non-pharmacological intervention (cognitive training, physical exercise, healthy lifestyle intervention, and computerized interaction training) while the control group receives health education. Sociodemographics will be collected before the intervention. comprehensive neuropsychological tests and MRI will be collected before and 6 weeks, 12 weeks, 3 months, 6 months, 12 months after the randomization respectively.
Detailed description
This study is a 6-week training phase and 6-week maintenance phase randomized controlled trial, conducted at Xinzhuang Town, Minhang District, Shanghai, China.
All participants (control and intervention group) complete the data collection. Demographic data will be collected before intervention including age, sex, education, marriage, etc. A comprehensive cognitive assessment and MRI will be done before and 6 weeks, 12 weeks,3 months, 6 months, 12 months after the randomization respectively.
The intervention group receive four intervention components including cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training. a multimodal intervention program (with schedule) was conducted in the intervention group for 6-week training phase and 6-week maintenance, including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. Throughout the 12-week period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks).
The in-person training course started with a 10-minute period of reminiscence and discussion. Subsequently, cognitive training activities were conducted for 25 minutes, followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, participants summarized the all-training activities, either through writing or discussion, and planed their homework during a 15-minute wrap-up session.
The cognitive training encompassed memory-related training (i.e. picture recall, categorization, cueing, repetition, association, sentence formation, story construction, utilization of the Roman room method, face-name association, and verbalization to aid retention) and attention-related training (i.e. character-picture association, idiom-picture association, and spot-the-difference tasks were incorporated). The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills, such as managing stressful life events and handling anger and frustration. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.
The instructor-supervised, computer program-based computerized interaction training three times weekly included spatial cognition (i.e. participants manipulated identical cubes or two-dimensional figures in different orientations using a control handle), left and right brain balance tasks (i.e. replicating graphics from one computer screen to another using action tracking or screen touching technology), clock imitation exercises (i.e. participants mimicked the movements of hour and minute hands to match the time displayed on the computer screen), and automatic teller machine simulation (i.e. wherein participants performed transactions like cash withdrawals, money transfers, and balance checks using a computer interface similar to an ATM, while also recalling passwords and transaction amounts.
The every-day homework encompassed activities such as calligraphy practice (2 days per week) and physical exercise (the other 5 days per week). Participants were asked to complete their homework within approximately 30 minutes and share pictures or videos of their homework in a WeChat group each day, allowing for assessment of their adherence.
The trial is conducted by local health workers, who were trained by a team comprising neurologists and geriatrics experts from Huashan Hospital. The training manuals, demo videos, education resources (such as PowerPoint files and materials) and standardized health education study materials were also distributed to them.
The control group receives regular health advice weekly through brochures, home visits, or telephone calls during 6-week training phase and 6-week maintenance period, detail including (1) patients with cognitive impairment education: prevention from self-injury, falling injury, accidental injury, medication, lost and bad habits; (2) inmates or caregivers education; (3) cognitive impairment knowledge education; (4) prevention of cognitive dysfunction education. The intervention committee ensures that health education activities are consistent across sites and unlikely to increase physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- the intervention group and the control group
| Arm | Type | Receives |
|---|---|---|
| multidomain intervention | Experimental | Behavioral: the multimodal interventionThe interventions were conducted for 6-week training phase and 6-week maintenance phase. Including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks). |
| the control | No intervention | –Throughout the 6-week training phase and 6-week maintenance period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥50 and ≤75 years, Male or Female
- The resident elderly or those who have lived in the sampled community for more than 6 months
- Be able to communicate with investigators and understand the questionnaire questions
- More than 6 years of education
- Mild cognitive impairment according to the Peterson criteria
Key exclusion criteria (7 listed)
- Individuals with neurological diseases
- Cognitive decline due to other disorders (cerebrovascular disease, central nervous system infections, etc.)
- Mental Disorders included in The Diagnostic and Statistical Manual of Mental Disorders of The American Psychiatric Association
- Blindness, aphasia, or severe hearing impairment
- History of myocardial infarction within the previous year, Unstable cardiac, renal, lung, liver or other severe chronic diseases
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 multimodal interventionThe in-person training course included 25 minutescognitive training activities were conducted for , followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, 15 minutes wrap-up session. The cognitive training encompassed memory-related training and attention-related training. The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior. | Behavioural | multidomain intervention |
Primary outcome
cognitive function assessed by the Mini-Mental State Examination (MMSE)
Time frame: Before the intervention
MMSE using the Chinese version revised by Zhang Mingyuan, the scale includes 30 items, including orientation, instantaneous memory, attention, computation, recall, language and visuospatial. The MMSE score ranges from 0 to 30 (30=best).
cognitive function assessed by the Mini-Mental State Examination (MMSE)
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
MMSE using the Chinese version revised by Zhang Mingyuan, the scale includes 30 items, including orientation, instantaneous memory, attention, computation, recall, language and visuospatial. The MMSE score ranges from 0 to 30 (30=best).
28 secondary outcomes
memory function assessed by AVLT
Time frame: Before the intervention
memory function assessed by AVLT
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
memory function assessed by LMT
Time frame: Before the intervention
memory function assessed by LMT
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
executive function assessed by TMT-A
Time frame: Before the intervention
executive function assessed by TMT-A
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
executive function assessed by DSST
Time frame: Before the intervention
executive function assessed by DSST
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
concentration function assessed by DST
Time frame: Before the intervention
concentration function assessed by DST
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by the Barthel index
Time frame: Before the intervention
quality of life assessed by the Barthel index
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by EQ-5D-5L
Time frame: Before the intervention
quality of life assessed by EQ-5D-5L
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by IADL
Time frame: Before the intervention
quality of life assessed by IADL
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by PSMS
Time frame: Before the intervention
quality of life assessed by PSMS
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of life assessed by SF-36
Time frame: Before the intervention
quality of life assessed by SF-36
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
social support assessed by SSRS
Time frame: Before the intervention
social support assessed by SSRS
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
quality of sleep assessed by PSQI
Time frame: Before the intervention
quality of sleep assessed by PSQI
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
emotion assessed by GDS-15
Time frame: Before the intervention
emotion assessed by GDS-15
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
cognitive function assessed by The Montreal Cognitive Assessment (MoCA)
Time frame: Before the intervention
cognitive function assessed by The Montreal Cognitive Assessment (MoCA)
Time frame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
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 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Ying Wang, professor study chair
Deputy Director, Professor, School of Public Health, Fudan University
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 multimodal intervention in people with Mild Cognitive Impairment and The Cognitive Normal Elderly, run by Huashan Hospital 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 6 inclusion and 7 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 Sep 2025. 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 assessed by the Mini-Mental State Examination (MMSE) (time frame: Before the intervention). The study lists 2 primary outcomes in all. 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 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.