The Effects of Multidomain Non-pharmacological Interventions on the Elderly With or Without Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Enhancing Latent Cognitive Capacity in Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment（MCI): a RCT Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05483790
• Other study ID #: 2017YFC1310504
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess a multidomain non-pharmacological intervention for improvement or maintenance of cognitive functioning and reduction of cognitive decline in the non-demented elderly from the general population. To investigate brain structural and functional imaging changes following a multidomain intervention. The recruited elderly aged 55-75 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 6-week multidimensional non-pharmacological intervention (cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training) while the control group receives a 6-week health education. Sociodemographics will be collected before the intervention. comprehensive neuropsychological tests and MRI will be collected before and 6 weeks after the intervention respectively.

Description:

This study is a 6-week 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 after the intervention respectively. Data will be collected by self-report, home visit, or telephone visit.

The intervention group receive four intervention components including cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training. The intervention includes group and individual sessions. Participants will be divided into 3 groups to accept the sessions successively, and each group has a monitor regarded as the communication bridge between participants and teachers as well as remind participants to attend the training and do homework in time. The training sessions (once times per week, 90 min per session, 6 weeks) referred to the schedule. The group sessions with educational content on cognitive training, healthy lifestyle intervention, and physical exercise, the detail include memory methods and strategies, attention training, brain function development which belong to cognitive training, nutrition recommendation, sleep guidance, and emotional regulation which belong to lifestyle intervention, and the session also include parts of physical exercise such as gymnastics by finger or elastic band. The intervention will be trained by general practitioners and community health workers who accepted trained before the intervention. Individual sessions consist of human-computer interaction and physical exercise. Human-computer interaction is a kind of computer program-based cognitive training guided by professional staff at the study site, conducted in 6 weeks, 3 times per week, 20-30 minutes per session, and 12 sessions. The training program is a web-based in-house developed computer program including several tasks: spatial cognition (participants regulate and merge a couple of cubes or two-dimensional figures that are exactly alike but in different directions by control handle), left and right brain balance (copy the graphics on one computer screen to another computer screen by action tracking or screen touching technology), clock (participants imitate the hour and minute hands of a clock by swinging arms and show a time as same as in the computer screen) and ATM simulation (participants withdraw cash, transfer money, check balances through operating computer similar with ATM, among which need them to remember the password and the amount of money). Individual aerobic training included activities preferred by each participant (5 times per week,30 minutes per time), such as Tai Ji, Baduanjin, elastic band gymnastics or yoga, etc. The training will be guided and supervised by trained staff.

The control group receives regular health advice weekly through brochures, home visits, or telephone calls during 6 weeks of the intervention, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 55-75 years old, Male or Female

2. The resident elderly or those who have lived in the sampled community for more than 6 months

3. Be able to communicate with investigators and understand the questionnaire questions

4. More than 6 years of education

5. Mild cognitive impairment or cognitively normal within the past year

6. Volunteer to participate in the study

Exclusion Criteria:

1. Individuals with neurological diseases

2. Cognitive decline due to other disorders (cerebrovascular disease, central nervous system infections, etc.)

3. Mental Disorders included in The Diagnostic and Statistical Manual of Mental Disorders of The American Psychiatric Association

4. Blindness, aphasia, or severe hearing impairment

5. History of myocardial infarction within the previous year, Unstable cardiac, renal, lung, liver or other severe chronic diseases

6. Coincident participation in another intervention trial

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• multidomain intervention
The intervention including: exercise training :The participants chose an activity that they could do for the long term, such as taiji, eight brocade, elastic belt, yoga and so on.which will consist of 5 times a week and lasting half an hour at most once time; cognitive intervention :which including memory method/strategy and life application, attention training, lifestyle intervention, the development of brain function and will undergo 7 sessions, 90 minutes peer week); man-machine intervention :choose developed and mature module tasks, participants will operate on the computer with the help of the project team members, including spatial cognition, brain balance, clock, ATM simulation)programs will be 20-30 minutes peer day, 3 times a week, for a total of 12 training sessions.

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Huashan Hospital	Medicine-Mental Health Center of Minhang District, School of Public Health,Fudan University, Xinzhuang Community Health Service Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 after the intervention
Primary	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
Primary	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 after the intervention
Secondary	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.	Before the intervention
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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.	6 weeks after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	concentration function assessed by DST	Digit Span Test (DST): including digit span forwards (DSF) and digit span backwards (DSB)	Before the intervention
Secondary	concentration function assessed by DST	Digit Span Test (DST): including digit span forwards (DSF) and digit span backwards (DSB)	6 weeks after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention
Secondary	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
Secondary	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 after the intervention