Cognitive DeclineNCT06180161
Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly
A study testing multidomain intervention in people with Cognitive Decline, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aging population has contributed to an increase in cognitive decline. To mitigate the rise in the dementia population, it is crucial to prevent cognitive decline in older adults with normal functioning, subjective cognitive decline (SCD), and mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- multidomain intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2023to 31 Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years old
- Mini-Mental State Examination (MMSE) score > 20 (Folstein et al., 1975), able to follow instructions and participate in activities
- With self-reported or caregiver-reported memory or cognitive-related problems
- No diagnosis of any type of dementia
Who cannot join
- Unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities)
- Participation in other studies
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memotial Hospital
Taoyuan, 333
Ching-Yi Wu, ScD, +886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
About this study
The aging population has contributed to an increase in cognitive decline. To mitigate the rise in the dementia population, it is crucial to prevent cognitive decline in older adults with normal functioning, subjective cognitive decline (SCD), and mild cognitive impairment (MCI). Maintaining cognitive abilities as early as possible is essential for improved overall health and quality of life.
Healthcare for the elderly should focus on strengthening health promotion related to aging factors, such as cognitive function, mobility, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep. Additionally, as the etiology of dementia is multifactorial, numerous studies have been devoted to multidomain intervention, targeting multiple factors and domains in combination to enhance functions. The cumulative or synergistic effects of multidomain have garnered significant attention for their effectiveness in improving or maintaining the function of the elderly.
Therefore, this study aims to evaluate the effects of multidomain intervention, including combined physical and cognitive training, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep, on cognitive function in community-dwelling older adults.
- Conditions
- Cognitive Decline
- Being tested
- multidomain 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.
multidomain interventionBehavioural
"Integrating exercise cognitive training with nutrition, chronic disease management, oral health, fall prevention, traffic safety, psychosocial well-being, and sleep to enhance the effectiveness of improving cognitive function in the elderly community."
| Study group | Role | What they receive |
|---|---|---|
| intervention grou[ | Experimental | Behavioral: multidomain intervention Dosage: a 2-hour session once a week for 12 weeks. Each multidomain intervention session includes 1 hour of combined physical (balance, strength and aerobic exercises) and cognitive (attention, memory, calculation, visual-spatial ability, processing speed and executive function) training and 1 hour of risk factor prevention and management strategies (nutrition, chronic disease management, oral health, fall prevention and transportation safety, psychosocial factors and sleep). Receives: Behavioral: multidomain intervention |
| control group | No intervention | Waiting for 12 weeks (waiting-list control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Montreal Cognitive Assessment (MoCA)
The MoCA is used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
Measured: baseline, after the intervention 12 weeks
Change scores of Color Trials Test (CTT)
The CTT is used to access executive function. For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
Measured: baseline, after the intervention 12 weeks
Change scores of Stroop test
The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition. Shorter time and less error indicate better inhibitory control.
Measured: baseline, after the intervention 12 weeks
Change scores of Digit symbol substitution test (DSST) of Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
The DSST is used to assess information processing speed. The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy-to-draw symbol such as a "V", "+" or ">". Participant is asked to match symbols to numbers and copy the symbols into spaces within a 120-second timeframe. More correct symbols indicate better information processing speed.
Measured: baseline, after the intervention 12 weeks
Change scores of Spatial span test (SST) of Wechsler Memory Scale-Third Edition (WMS-III)
The SST is used to assess working memory. Participants watch the assessor tap a sequence of blocks and are asked to tap it in order or reverse-order. More correct responses indicate better working memory.
Measured: baseline, after the intervention 12 weeks
Change scores of the Everyday Cognition scales-12 items (ECog-12)
The ECog-12 is developed as an informant-rated report of cognitively mediated functional abilities in older adults. The ECog-12 asks participants to rate their current ability to perform cognitively mediated daily tasks related to everyday memory, language, visuospatial abilities, and executive functions compared with their ability to do the same task 10 years ago. Items are rated on a scale of 1-4, with 1 = Better or no change and 4 = Consistently much worse. The global, executive, and memory ECog-12 sub-domain scores are generated by averaging over the component items (sum of items/number of items) to maintain a range of 1 to 4 (with higher scores reflecting greater self-reported SCD).
Measured: baseline, after the intervention 12 weeks
Change scores of Timed up and go (TUG)
The TUG assesses the dynamic balance ability and functional mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly. The test-retest reliability of TUG on individuals with cognitive impairment is excellent.
Measured: baseline, after the intervention 12 weeks
Change scores of Short Physical Performance Battery (SPPB)
The SPPB is an objective assessment tool for global physical function. The SPPB is a group of measures that combines the results of the side-by-side, semi-tandem and tandem stands (10 s), and 4 m walk test at a comfortable speed, and 5 quickly sit to stand. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
Measured: baseline, after the intervention 12 weeks
Change scores of the Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL Scale)
The Lawton-Brody IADL Scale is a self-report questionnaire used to assess an individual's ability to perform instrumental activities of daily living, which are considered more complex and socially oriented than basic activities of daily living (BADLs). The scale is structured in a way that assigns points for each activity based on the individual's level of independence. The scoring may range from 0 to a maximum score, with a higher total score indicating a higher level of independence.
Measured: baseline, after the intervention 12 weeks
Change scores of 15-item Geriatric Depression Scale (GDS-15)
The GDS-15 is a self-report scale used to evaluate depressive state in elderly individuals. The score range is 0-15, and a score of 5 or greater is taken as a possible indicator of depression.
Measured: baseline, after the intervention 12 weeks
Change scores of Community Integration Questionnaire (CIQ)
The CIQ is designed to assess social participation, including home integration, social integration, and productive activity. The instrument consists of 15 items and can be completed by self-report or with the assistance of a family member or caregiver familiar with the person's health status and social activities.
Measured: baseline, after the intervention 12 weeks
Change scores of World Health Organization Quality of Life-brief version (WHOQOL-BREF) Taiwan Version
The WHOQOL-BREF Taiwan version is used to access subjective quality of life. As with the standard WHOQOL-BREF questionnaires, the WHOQOL-BREF Taiwan version is simplified from the WHOQOL long form for Taiwan. For cross-cultural comparison, the first 26 items are the same as the standard WHOQOL-BREF, which is developed from global studies. In addition to the 26 items, applied the psychometric criteria proposed by the WHOQOL Group to select two more items from each of the two new facets to form the WHOQOL-BREF Taiwan version using data from the same 1,068 subjects. The selection process used for national items is described in the Results section. Thus, the WHOQOL-BREF Taiwan version contains 28 items classified into the same four domains as the standard WHOQOL-BREF. The scale administration and scoring procedures are the same as for the WHOQOL long form except that the facet score is based on only one item.
Measured: baseline, after the intervention 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start31 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180161
- Sponsor's protocol ID
- 202300820B0
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly
- ClinicalTrials.gov ID
- NCT06180161
- Acronym / sponsor ID
- 202300820B0
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 2023 (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 aging population has contributed to an increase in cognitive decline. To mitigate the rise in the dementia population, it is crucial to prevent cognitive decline in older adults with normal functioning, subjective cognitive decline (SCD), and mild cognitive impairment (MCI). Maintaining cognitive abilities as early as possible is essential for improved overall health and quality of life.
Healthcare for the elderly should focus on strengthening health promotion related to aging factors, such as cognitive function, mobility, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep. Additionally, as the etiology of dementia is multifactorial, numerous studies have been devoted to multidomain intervention, targeting multiple factors and domains in combination to enhance functions. The cumulative or synergistic effects of multidomain have garnered significant attention for their effectiveness in improving or maintaining the function of the elderly.
Therefore, this study aims to evaluate the effects of multidomain intervention, including combined physical and cognitive training, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep, on cognitive function in community-dwelling older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention grou[ | Experimental | Behavioral: multidomain interventionBehavioral: multidomain intervention Dosage: a 2-hour session once a week for 12 weeks. Each multidomain intervention session includes 1 hour of combined physical (balance, strength and aerobic exercises) and cognitive (attention, memory, calculation, visual-spatial ability, processing speed and executive function) training and 1 hour of risk factor prevention and management strategies (nutrition, chronic disease management, oral health, fall prevention and transportation safety, psychosocial factors and sleep). |
| control group | No intervention | –Waiting for 12 weeks (waiting-list control group) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60 years old
- Mini-Mental State Examination (MMSE) score > 20 (Folstein et al., 1975), able to follow instructions and participate in activities
- With self-reported or caregiver-reported memory or cognitive-related problems
- No diagnosis of any type of dementia
Key exclusion criteria (3 listed)
- Unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities)
- Participation in other studies
- Inability to provide informed consent
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 |
|---|---|---|
| multidomain intervention"Integrating exercise cognitive training with nutrition, chronic disease management, oral health, fall prevention, traffic safety, psychosocial well-being, and sleep to enhance the effectiveness of improving cognitive function in the elderly community." | Behavioural | intervention grou[ |
Primary outcome
Change scores of Montreal Cognitive Assessment (MoCA)
Time frame: baseline, after the intervention 12 weeks
The MoCA is used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
Change scores of Color Trials Test (CTT)
Time frame: baseline, after the intervention 12 weeks
The CTT is used to access executive function. For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
Change scores of Stroop test
Time frame: baseline, after the intervention 12 weeks
The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition. Shorter time and less error indicate better inhibitory control.
Change scores of Digit symbol substitution test (DSST) of Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
Time frame: baseline, after the intervention 12 weeks
The DSST is used to assess information processing speed. The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy-to-draw symbol such as a "V", "+" or ">". Participant is asked to match symbols to numbers and copy the symbols into spaces within a 120-second timeframe. More correct symbols indicate better information processing speed.
Change scores of Spatial span test (SST) of Wechsler Memory Scale-Third Edition (WMS-III)
Time frame: baseline, after the intervention 12 weeks
The SST is used to assess working memory. Participants watch the assessor tap a sequence of blocks and are asked to tap it in order or reverse-order. More correct responses indicate better working memory.
Change scores of the Everyday Cognition scales-12 items (ECog-12)
Time frame: baseline, after the intervention 12 weeks
The ECog-12 is developed as an informant-rated report of cognitively mediated functional abilities in older adults. The ECog-12 asks participants to rate their current ability to perform cognitively mediated daily tasks related to everyday memory, language, visuospatial abilities, and executive functions compared with their ability to do the same task 10 years ago. Items are rated on a scale of 1-4, with 1 = Better or no change and 4 = Consistently much worse. The global, executive, and memory ECog-12 sub-domain scores are generated by averaging over the component items (sum of items/number of items) to maintain a range of 1 to 4 (with higher scores reflecting greater self-reported SCD).
Change scores of Timed up and go (TUG)
Time frame: baseline, after the intervention 12 weeks
The TUG assesses the dynamic balance ability and functional mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly. The test-retest reliability of TUG on individuals with cognitive impairment is excellent.
Change scores of Short Physical Performance Battery (SPPB)
Time frame: baseline, after the intervention 12 weeks
The SPPB is an objective assessment tool for global physical function. The SPPB is a group of measures that combines the results of the side-by-side, semi-tandem and tandem stands (10 s), and 4 m walk test at a comfortable speed, and 5 quickly sit to stand. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
Change scores of the Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL Scale)
Time frame: baseline, after the intervention 12 weeks
The Lawton-Brody IADL Scale is a self-report questionnaire used to assess an individual's ability to perform instrumental activities of daily living, which are considered more complex and socially oriented than basic activities of daily living (BADLs). The scale is structured in a way that assigns points for each activity based on the individual's level of independence. The scoring may range from 0 to a maximum score, with a higher total score indicating a higher level of independence.
Change scores of 15-item Geriatric Depression Scale (GDS-15)
Time frame: baseline, after the intervention 12 weeks
The GDS-15 is a self-report scale used to evaluate depressive state in elderly individuals. The score range is 0-15, and a score of 5 or greater is taken as a possible indicator of depression.
Change scores of Community Integration Questionnaire (CIQ)
Time frame: baseline, after the intervention 12 weeks
The CIQ is designed to assess social participation, including home integration, social integration, and productive activity. The instrument consists of 15 items and can be completed by self-report or with the assistance of a family member or caregiver familiar with the person's health status and social activities.
Change scores of World Health Organization Quality of Life-brief version (WHOQOL-BREF) Taiwan Version
Time frame: baseline, after the intervention 12 weeks
The WHOQOL-BREF Taiwan version is used to access subjective quality of life. As with the standard WHOQOL-BREF questionnaires, the WHOQOL-BREF Taiwan version is simplified from the WHOQOL long form for Taiwan. For cross-cultural comparison, the first 26 items are the same as the standard WHOQOL-BREF, which is developed from global studies. In addition to the 26 items, applied the psychometric criteria proposed by the WHOQOL Group to select two more items from each of the two new facets to form the WHOQOL-BREF Taiwan version using data from the same 1,068 subjects. The selection process used for national items is described in the Results section. Thus, the WHOQOL-BREF Taiwan version contains 28 items classified into the same four domains as the standard WHOQOL-BREF. The scale administration and scoring procedures are the same as for the WHOQOL long form except that the facet score is based on only one item.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidomain intervention in people with Cognitive Decline, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-yi Wu, ScD (#886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Montreal Cognitive Assessment (MoCA) (time frame: baseline, after the intervention 12 weeks). The study lists 12 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 3 Jan 2024.