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| Name | Class |
|---|---|
| School of Public Health，Fudan University | UNKNOWN |
| Medicine-Mental Health Center of Minhang District | UNKNOWN |
| Xinzhuang Community Health Service Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the multimodal intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before the intervention |
| memory function assessed by AVLT |
| Measure | Description | Time Frame |
|---|---|---|
| MRI--T1-weighted structure imaging | For the T1 MRI images, we first performed quality control using CAT12 to exclude subjects with quality scores lower than "B". Next, we used the recon-all command of FreeSurfer 6.0.0 for brain extraction, tissue segmentation, cortical reconstruction, and brain region labeling for each subject's brain images. We extracted the thickness, surface area, volume for cortical structures, and volume of subcortical structures in different brain regions based on the DK+Aseg parcellation template. Finally, the brain images of each subject were nonlinearly aligned to the MNI152 template using ANTs alignment toolkit for subsequent analysis of BOLD fMRI and DWI images. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Wang, professor | Deputy Director, Professor, School of Public Health, Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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the intervention group and the control group
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single-blinding was pursued as much as possible: group allocation was not actively disclosed to participants, they were advised not to discuss the intervention during testing sessions, opportunities for between-group interactions were restricted, and outcome assessors were blinded to allocation and were not involved in the intervention activities.
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Auditory Verbal Learning Test（AVLT）to rate immediate (sum of words recalled on the 5 learning trials) and delayed episodic verbal memory.
| 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. | 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. | 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. | 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. | 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. | 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. | 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) | Before the intervention |
| concentration function assessed by DST | Digit Span Test (DST): including digit span forwards (DSF) and digit span backwards (DSB) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention |
| Before the intervention |
| MRI--T1-weighted structure imaging | For the T1 MRI images, we first performed quality control using CAT12 to exclude subjects with quality scores lower than "B". Next, we used the recon-all command of FreeSurfer 6.0.0 for brain extraction, tissue segmentation, cortical reconstruction, and brain region labeling for each subject's brain images. We extracted the thickness, surface area, volume for cortical structures, and volume of subcortical structures in different brain regions based on the DK+Aseg parcellation template. Finally, the brain images of each subject were nonlinearly aligned to the MNI152 template using ANTs alignment toolkit for subsequent analysis of BOLD fMRI and DWI images. | 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention |
| MRI--resting functional MRI (rfMRI) imaging | We used the alignment results of the T1-weighted image of each subject to transform the resting-state images into MNI152 space , and calculated the functional connectivity between all brain regions, as well as the ALFF, fALFF mean values for each brain region according to the DK+Aseg partitioning template. | 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention |
| MRI--resting functional MRI (rfMRI) imaging | We used the alignment results of the T1-weighted image of each subject to transform the resting-state images into MNI152 space , and calculated the functional connectivity between all brain regions, as well as the ALFF, fALFF mean values for each brain region according to the DK+Aseg partitioning template. | Before the intervention |
| MRI--diffusion-weighted imaging (DWI). | For DWI images, we mainly used the FSL toolkit for processing. First, the b0 images of each subject were aligned with the T1 images, followed by eddy correction and head motion correction, and detection and replacement of outliers. Next, we used the DK+Aseg parcellation template for probabilistic fiber tracking of DWI images for each subject, and finally generated a probabilistic white matter connectivity matrix for each brain region for subsequent extraction of graph theoretical metrics. | Before the intervention |
| MRI--diffusion-weighted imaging (DWI). | For DWI images, we mainly used the FSL toolkit for processing. First, the b0 images of each subject were aligned with the T1 images, followed by eddy correction and head motion correction, and detection and replacement of outliers. Next, we used the DK+Aseg parcellation template for probabilistic fiber tracking of DWI images for each subject, and finally generated a probabilistic white matter connectivity matrix for each brain region for subsequent extraction of graph theoretical metrics. | 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention |