Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly

Study Overview
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Brief Summary
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Given the rapid growth of the elderly population, the concept of successful aging is highly regarded. Depp and Jeste (2006) define successful aging as the absence of disability/physical impairment, cognitive functioning, life satisfaction/well-being, social engagement/productivity, disease perception, longevity, self-rated health, personality, environment/economic factors, and self-perceived successful aging. Additionally, the World Health Organization's (2017) Integrated Care for Older People (ICOPE) guidelines propose six key indicators related to older adults' psychosocial functioning: cognitive function, mobility, nutrition, vision, hearing, and depression, serving as criteria for assessing healthy aging. Furthermore, factors influencing cognitive decline in old age, such as cardiovascular, metabolic, depressive, psychosocial, unhealthy diet, smoking, and excessive alcohol consumption (Kivipelto et al., 2018), should be considered alongside factors promoting successful aging to enhance elderly care.

Official Title
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Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly

Conditions
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Multidomain Intervention)

Intervention / Treatment
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* Behavioral: multidomain intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≧ 60 An initial MMSE scores ≧ 20,ability to follow instructions and perform tasks Self-reported or caregiver-reported memory or cognitive-related issues; No diagnosis of any type of dementia. Exclusion Criteria: Having unstable medical conditions (e.g., experiencing a myocardial infarction or heart failure in the past year, recent cardiac surgery, severe asthma, accompanying other neurological disorders, or joint deformities) that make participation in exercise training unsafe; Participating in other research studies; Unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention grou[<br> | Behavioral: multidomain intervention<br>* 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.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores of Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) will be 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. | baseline, after the intervention 12 weeks | 
| Change scores of Color trials test | 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. | 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 | baseline, after the intervention 12 weeks | 
| Change scores of Wechsler Adult Intelligence Scale; WAIS | The digit symbol test involves a key consisting of the numbers 1-9, each paired with a unique, easy-to-draw symbol such as a V, + or >. Matrix Reasoning This is a nonverbal reasoning task in which individuals are asked to identify patterns in designs. This subtest measures: non-verbal reasoning skills broad visual intelligence perceptual organization skills | baseline, after the intervention 12 weeks | 
| Change scores of Wechsler Memory Scale | Including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function. | baseline, after the intervention 12 weeks | 
| Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12) | The short (12-item) form of the Everyday Cognition Scale (ECog-12), which was 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 were 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). | baseline, after the intervention 12 weeks | 
| Change scores of Timed up and go (TUG) | The TUG assesses the dynamic balance ability and 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 was excellent . | baseline, after the intervention 12 weeks | 
| Change scores of short physical performance battery,SPPB | The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests . 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. | baseline, after the intervention 12 weeks | 
| Change scores of The Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale | The Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale is an assessment tool used to measure an individual's ability to perform more complex, independent activities necessary for daily living. The Lawton-Brody IADL Scale assesses a person's competence in eight instrumental activities, which are considered more complex and socially oriented than basic activities of daily living (BADLs). These activities are typically necessary for maintaining an independent and self-sufficient lifestyle in the community. In the Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale, a higher score indicates greater independence and functional ability in performing instrumental activities necessary for daily living. The scale is often 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. | baseline, after the intervention 12 weeks | 
| Change scores of Geriatric Depression Scale (GDS) | The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression. | baseline, after the intervention 12 weeks | 
| Change scores of Community Integration Questionnaire, CIQ | The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. 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. | baseline, after the intervention 12 weeks | 
| Change scores of WHOQOL-bref Taiwan Version | As with the standard WHOQOL-BREF questionnaires the WHOQOL-BREF Taiwan version was simplified from the WHOQOL long form for Taiwan. For the purpose of cross-cultural comparison, the first 26 items were the same as the standard WHOQOL-BREF, which was developed from global studies. In addition to the 26 items, we 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. | baseline, after the intervention 12 weeks |