ExerciseNCT06214962
Comprehensive Dementia Management : From Translational Medicine to Innovative Care
An observational study of Exercise, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this stage is to conduct analysis and discussion through expert meetings (consultation) based on the current data of the elderly in each dementia base and Rizhao Center, as well as the weekly courses and activities of the service site (base, Rizhao), and make recommendations. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Exercise
- What is being tested?
- (multiple training modalities, MTM)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 652 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2022to 28 Feb 2026
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The objects of data collection are the elders, their families, and caregivers in the bases and Rizhao. The research team only makes suggestions on the courses in the institutions that are willing to participate, and makes suggestions on the implementation of course activities with the personnel who originally booked the courses. It is not the project that sends people to the base or directly leads the activities in Rizhao. The researchers of this project are Facilitator of course activities and data collector or evaluator of effectiveness items.
Who may be able to join
- Recruit the elders (and their family members) in community bases and Rizhao centers, caregivers of bases and Rizhao centers.
Who cannot join
- Because the plan hopes to conduct an extensive inventory/detection of the dementia and disability status of the elderly in the dementia stronghold and Rizhao Center, unless the subjects do not want to To join the research, there are no conditions for case scheduling in this plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Dementia Management : From Translational Medicine to Innovative Care--Innovative Care Model for Community Care Center and Day-Care Center: Development of Classification Standard for Precision Care
The purpose of this stage is to conduct analysis and discussion through expert meetings (consultation) based on the current data of the elderly in each dementia base and Rizhao Center, as well as the weekly courses and activities of the service site (base, Rizhao), and make recommendations.
Read the detailed description
(1) Course content confirmation: (A) Continuing the results of the first-stage expert meeting, experts in various fields will be divided into groups to form an "activity curriculum planning group" (such as humanities and society, psychology, medical personnel, family members of dementia, etc.), and based on empirical research (type, Time, frequency, etc.) as a planning basis to develop care plans for different types of community dementia service locations and verify their effectiveness.
According to empirical research, such as for different types (dementia or mixed type) of strongholds or sunshine, plan compulsory (common activity) courses, and plan elective activity courses according to different attributes or needs, such as:
- Common compulsory activities: physical fitness exercise, cognitive training, physical fitness combined with cognition, etc., and plan the dosage (intensity, each time and weekly frequency, etc.) according to the low, medium and high differences in physical fitness;
- Elective activity courses: Considering the elder attributes of each service location to plan "group common elective" and "individual elective" activities, such as: integrating favorite music elements and nostalgic elements of personal life experience into "daily life activities" The main activities (such as: planting/gardening, cooking, shopping or going out, etc. (B) Solicit and establish a connection and cooperation model between the community service organization and surrounding resources (such as clinics, foundations, volunteer groups, universities, etc.) Jointly participate in the care plan of this service agency.
The research team develops modular courses and establishes a professional teacher group for each module to provide teaching materials for service locations and personnel training.
(A) Continuing the results of the first-stage expert meeting, experts in various fields will be divided into groups to form an "activity curriculum planning group" (such as humanities and society, psychology, medical personnel, family members of dementia, etc.), and based on empirical research (type, Time, frequency, etc.) as a planning basis to develop care plans for different types of community dementia service locations and verify their effectiveness.
According to empirical research, such as for different types (dementia or mixed type) of strongholds or sunshine, plan compulsory (common activity) courses, and plan elective activity courses according to different attributes or needs, such as:
- Common compulsory activities: physical fitness exercise, cognitive training, physical fitness combined with cognition, etc., and plan the dosage (intensity, each time and weekly frequency, etc.) according to the low, medium and high differences in physical fitness;
- Elective activity courses: Considering the elder attributes of each service location to plan "group common elective" and "individual elective" activities, such as: integrating favorite music elements and nostalgic elements of personal life experience into "daily life activities" The main activities (such as: planting/gardening, cooking, shopping or going out, etc. (B) Solicit and establish a connection and cooperation model between the community service organization and surrounding resources (such as clinics, foundations, volunteer groups, universities, etc.) Jointly participate in the care plan of this service agency. (C) The research team develops modular courses and establishes a professional teacher group for each module to provide teaching materials for service sites and personnel empowerment training. (2) Data collection steps After the stronghold and Rizhao agreed to cooperate with the "Experts' Suggestion on Curriculum Adjustment", the first data collection was carried out, and then the new curriculum adjustment was carried out for three months, and then two data collections were carried out. The researchers conducted at least three to four times on these strongholds and Rizhao data collection (The first complete data collection is completed within one to two weeks before the formal adjustment of the course; the second time is collected within two weeks after the course is implemented for three months; the third time is 6 months after the start of implementation; the fourth time Collected 9-12 months after start of implementation. (3) Description of the data collection role of the researchers of this project: The objects of data collection are the elders, their families, and caregivers in the bases and Rizhao. The research team only makes suggestions on the courses in the institutions that are willing to participate, and makes suggestions on the implementation of course activities with the personnel who originally booked the courses. It is not the project that sends people to the base or directly leads the activities in Rizhao. The researchers of this project are Facilitator of course activities and data collector or evaluator of effectiveness items. (4) Objects and contents of data collection in strongholds and Rizhao Data collection content of the elders, their family members, and care workers in the base and Rizhao, except for the data collection content of the first stage In addition, in order to have a more comprehensive understanding of the changes in the performance of the elderly, the functions in the following table 2. will be collected again.
- Conditions
- Exercise
- Being tested
- (multiple training modalities, MTM)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(multiple training modalities, MTM)Behavioural
- Invite experts to discuss the course content of each unit of MTM, and then invite teachers to take pictures , and combine them into one course for the benefit of the elderly in the institution.
- Select 3 units to try out in the dementia base, and make corrections based on the feedback of the elders and the base staff.
- Continue to complete other units based on the experience of the first 3 units. (2) In the Rizhao part, experts are mainly used to develop various course modules suitable for the elderly with dementia in Rizhao, and each module unit is tested on the elderly with dementia and then revised The planning task is mainly to establish a solution strategy. The method is to set up an "activity course module planning or design group" to develop various course modules suitable for Rizhao demented elders.
What is being measured
The primary outcome is the main question the study is designed to answer.
basic information
Including gender, age, height, weight, marital status, education level,
Gender:
This pertains to the participant's biological gender and may be identified as either male or female.
Age:
Represents the participant's age, typically measured in years.
Height:
The participant's height, typically measured in centimeters or inches.
Weight:
The participant's weight, typically measured in kilograms or pounds.
Marital Status:
Describes the participant's current marital status, such as married, unmarried, divorced, etc.
Educational Level:
This indicates the participant's level of education, including degrees or other educational qualifications.
Medical Conditions:
Describes the participant's health condition, which may encompass past medical history, current illnesses, or chronic conditions.
Measured: Two weeks before intervention
cognitive function assessment
(SPMSQ - Short Portable Mental Status Questionnaire): Description: SPMSQ, a concise cognitive screening tool, assesses memory and cognitive function via questions on orientation, memory, and mathematical abilities.
(Mini-Mental State Examination; MMSE): Description: MMSE, widely used for cognitive function assessment, covers domains like orientation, registration, attention, calculation, recall, language, and visuospatial skills.
(Cognitive Abilities Screening Instrument; CASI): Description: CASI, a comprehensive tool, assesses attention, concentration, orientation, short-term memory, language, and visual construction.
Scoring: Scores can range from 0 to 100, with higher scores indicating better cognitive function. Specific cutoff scores may be used to identify different levels of cognitive impairment.
Measured: Two weeks before intervention
Psychiatric and behavioral symptoms
Use NPI or other mental behavioral scales that are more suitable for Rizhao elders
NPI (Neuropsychiatric Inventory):
Description: The NPI is a tool designed to assess neuropsychiatric behaviors, particularly in the elderly. It covers various domains such as hallucinations, anxiety, depression, insomnia, etc., providing insights into the assessed individual's behavioral symptoms.
Scoring: Each domain has corresponding scores, and a total score helps assess the severity of neuropsychiatric symptoms.
Measured: Two weeks before intervention
daily life functions
Measured by Pap scale and IADL.
Barthel Index:
Description: The Barthel Index assesses an individual's activities of daily living and self-care abilities, especially in rehabilitation and residential care settings. It includes basic activities like eating, bathing, dressing, toileting, etc.
Scoring: Each activity is assigned specific scores, and the total score is used to evaluate the overall self-care abilities of the individual. Higher scores indicate better daily living skills.
IADL (Instrumental Activities of Daily Living):
Description: IADL is used to assess more complex daily living skills, such as shopping, cooking, using the phone, handling finances, etc. These skills reflect an individual's level of independence in social and home settings.
Scoring: IADL scores are used to evaluate the individual's capabilities in these more complex activities. Higher scores indicate stronger independent abilities.
Measured: Two weeks before intervention
body movement function
Hand Grip Strength:
Description: Hand grip strength is a test to assess an individual's hand muscle strength, usually measured using a hand dynamometer.
Single Leg Stand:
Description: Single leg stand is a test to assess balance and stability, typically requiring the individual to stand on one leg for a certain duration to test their control of the center of gravity.
Five Times Sit-to-Stand:
Description: This test assesses lower limb strength and the ability to stand up, requiring the individual to stand up and sit down five times to test muscle strength and coordination.
Timed Up and Go:
Description: Timed Up and Go is a test assessing dynamic balance and walking ability. It requires the individual to stand up from a chair, walk a distance, and then return to sit down.
Walking Speed:
Description: Walking speed tests assess the individual's speed during walking, serving as an important indicator of daily activity ability and quality of life.
Measured: Two weeks before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Jun 2022
- Primary completion31 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Li-Jiun Liaw, Study director, Kaohsiung Medical University Department of Physical Therapy Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214962
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20220016
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Dementia Management : From Translational Medicine to Innovative Care--Innovative Care Model for Community Care Center and Day-Care Center: Development of Classification Standard for Precision Care
- ClinicalTrials.gov ID
- NCT06214962
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20220016
- Conditions
- Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 22 Jan 2024 (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 purpose of this stage is to conduct analysis and discussion through expert meetings (consultation) based on the current data of the elderly in each dementia base and Rizhao Center, as well as the weekly courses and activities of the service site (base, Rizhao), and make recommendations.
Detailed description
(1) Course content confirmation: (A) Continuing the results of the first-stage expert meeting, experts in various fields will be divided into groups to form an "activity curriculum planning group" (such as humanities and society, psychology, medical personnel, family members of dementia, etc.), and based on empirical research (type, Time, frequency, etc.) as a planning basis to develop care plans for different types of community dementia service locations and verify their effectiveness.
According to empirical research, such as for different types (dementia or mixed type) of strongholds or sunshine, plan compulsory (common activity) courses, and plan elective activity courses according to different attributes or needs, such as:
- Common compulsory activities: physical fitness exercise, cognitive training, physical fitness combined with cognition, etc., and plan the dosage (intensity, each time and weekly frequency, etc.) according to the low, medium and high differences in physical fitness;
- Elective activity courses: Considering the elder attributes of each service location to plan "group common elective" and "individual elective" activities, such as: integrating favorite music elements and nostalgic elements of personal life experience into "daily life activities" The main activities (such as: planting/gardening, cooking, shopping or going out, etc. (B) Solicit and establish a connection and cooperation model between the community service organization and surrounding resources (such as clinics, foundations, volunteer groups, universities, etc.) Jointly participate in the care plan of this service agency.
The research team develops modular courses and establishes a professional teacher group for each module to provide teaching materials for service locations and personnel training.
(A) Continuing the results of the first-stage expert meeting, experts in various fields will be divided into groups to form an "activity curriculum planning group" (such as humanities and society, psychology, medical personnel, family members of dementia, etc.), and based on empirical research (type, Time, frequency, etc.) as a planning basis to develop care plans for different types of community dementia service locations and verify their effectiveness.
According to empirical research, such as for different types (dementia or mixed type) of strongholds or sunshine, plan compulsory (common activity) courses, and plan elective activity courses according to different attributes or needs, such as:
- Common compulsory activities: physical fitness exercise, cognitive training, physical fitness combined with cognition, etc., and plan the dosage (intensity, each time and weekly frequency, etc.) according to the low, medium and high differences in physical fitness;
- Elective activity courses: Considering the elder attributes of each service location to plan "group common elective" and "individual elective" activities, such as: integrating favorite music elements and nostalgic elements of personal life experience into "daily life activities" The main activities (such as: planting/gardening, cooking, shopping or going out, etc. (B) Solicit and establish a connection and cooperation model between the community service organization and surrounding resources (such as clinics, foundations, volunteer groups, universities, etc.) Jointly participate in the care plan of this service agency. (C) The research team develops modular courses and establishes a professional teacher group for each module to provide teaching materials for service sites and personnel empowerment training. (2) Data collection steps After the stronghold and Rizhao agreed to cooperate with the "Experts' Suggestion on Curriculum Adjustment", the first data collection was carried out, and then the new curriculum adjustment was carried out for three months, and then two data collections were carried out. The researchers conducted at least three to four times on these strongholds and Rizhao data collection (The first complete data collection is completed within one to two weeks before the formal adjustment of the course; the second time is collected within two weeks after the course is implemented for three months; the third time is 6 months after the start of implementation; the fourth time Collected 9-12 months after start of implementation. (3) Description of the data collection role of the researchers of this project: The objects of data collection are the elders, their families, and caregivers in the bases and Rizhao. The research team only makes suggestions on the courses in the institutions that are willing to participate, and makes suggestions on the implementation of course activities with the personnel who originally booked the courses. It is not the project that sends people to the base or directly leads the activities in Rizhao. The researchers of this project are Facilitator of course activities and data collector or evaluator of effectiveness items. (4) Objects and contents of data collection in strongholds and Rizhao Data collection content of the elders, their family members, and care workers in the base and Rizhao, except for the data collection content of the first stage In addition, in order to have a more comprehensive understanding of the changes in the performance of the elderly, the functions in the following table 2. will be collected again.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The objects of data collection are the elders, their families, and caregivers in the bases and Rizhao. The research team only makes suggestions on the courses in the institutions that are willing to participate, and makes suggestions on the implementation of course activities with the personnel who originally booked the courses. It is not the project that sends people to the base or directly leads the activities in Rizhao. The researchers of this project are Facilitator of course activities and data collector or evaluator of effectiveness items.
Key inclusion criteria (1 listed)
- Recruit the elders (and their family members) in community bases and Rizhao centers, caregivers of bases and Rizhao centers.
Key exclusion criteria (1 listed)
- Because the plan hopes to conduct an extensive inventory/detection of the dementia and disability status of the elderly in the dementia stronghold and Rizhao Center, unless the subjects do not want to To join the research, there are no conditions for case scheduling in this plan
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 |
|---|---|---|
| (multiple training modalities, MTM)1. Invite experts to discuss the course content of each unit of MTM, and then invite teachers to take pictures , and combine them into one course for the benefit of the elderly in the institution. 2. Select 3 units to try out in the dementia base, and make corrections based on the feedback of the elders and the base staff. 3. Continue to complete other units based on the experience of the first 3 units. (2) In the Rizhao part, experts are mainly used to develop various course modules suitable for the elderly with dementia in Rizhao, and each module unit is tested on the elderly with dementia and then revised The planning task is mainly to establish a solution strategy. The method is to set up an "activity course module planning or design group" to develop various course modules suitable for Rizhao demented elders. | Behavioural | – |
Primary outcome
basic information
Time frame: Two weeks before intervention
Including gender, age, height, weight, marital status, education level, Gender: This pertains to the participant's biological gender and may be identified as either male or female. Age: Represents the participant's age, typically measured in years. Height: The participant's height, typically measured in centimeters or inches. Weight: The participant's weight, typically measured in kilograms or pounds. Marital Status: Describes the participant's current marital status, such as married, unmarried, divorced, etc. Educational Level: This indicates the participant's level of education, including degrees or other educational qualifications. Medical Conditions: Describes the participant's health condition, which may encompass past medical history, current illnesses, or chronic conditions.
cognitive function assessment
Time frame: Two weeks before intervention
(SPMSQ - Short Portable Mental Status Questionnaire): Description: SPMSQ, a concise cognitive screening tool, assesses memory and cognitive function via questions on orientation, memory, and mathematical abilities. (Mini-Mental State Examination; MMSE): Description: MMSE, widely used for cognitive function assessment, covers domains like orientation, registration, attention, calculation, recall, language, and visuospatial skills. (Cognitive Abilities Screening Instrument; CASI): Description: CASI, a comprehensive tool, assesses attention, concentration, orientation, short-term memory, language, and visual construction. Scoring: Scores can range from 0 to 100, with higher scores indicating better cognitive function. Specific cutoff scores may be used to identify different levels of cognitive impairment.
Psychiatric and behavioral symptoms
Time frame: Two weeks before intervention
Use NPI or other mental behavioral scales that are more suitable for Rizhao elders NPI (Neuropsychiatric Inventory): Description: The NPI is a tool designed to assess neuropsychiatric behaviors, particularly in the elderly. It covers various domains such as hallucinations, anxiety, depression, insomnia, etc., providing insights into the assessed individual's behavioral symptoms. Scoring: Each domain has corresponding scores, and a total score helps assess the severity of neuropsychiatric symptoms.
daily life functions
Time frame: Two weeks before intervention
Measured by Pap scale and IADL. Barthel Index: Description: The Barthel Index assesses an individual's activities of daily living and self-care abilities, especially in rehabilitation and residential care settings. It includes basic activities like eating, bathing, dressing, toileting, etc. Scoring: Each activity is assigned specific scores, and the total score is used to evaluate the overall self-care abilities of the individual. Higher scores indicate better daily living skills. IADL (Instrumental Activities of Daily Living): Description: IADL is used to assess more complex daily living skills, such as shopping, cooking, using the phone, handling finances, etc. These skills reflect an individual's level of independence in social and home settings. Scoring: IADL scores are used to evaluate the individual's capabilities in these more complex activities. Higher scores indicate stronger independent abilities.
body movement function
Time frame: Two weeks before intervention
Hand Grip Strength: Description: Hand grip strength is a test to assess an individual's hand muscle strength, usually measured using a hand dynamometer. Single Leg Stand: Description: Single leg stand is a test to assess balance and stability, typically requiring the individual to stand on one leg for a certain duration to test their control of the center of gravity. Five Times Sit-to-Stand: Description: This test assesses lower limb strength and the ability to stand up, requiring the individual to stand up and sit down five times to test muscle strength and coordination. Timed Up and Go: Description: Timed Up and Go is a test assessing dynamic balance and walking ability. It requires the individual to stand up from a chair, walk a distance, and then return to sit down. Walking Speed: Description: Walking speed tests assess the individual's speed during walking, serving as an important indicator of daily activity ability and quality of life.
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 11 Aug 2026.
- 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.
Li-Jiun Liaw study director
Kaohsiung Medical University Department of Physical Therapy Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise, run by Kaohsiung Medical University Chung-Ho 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 1 inclusion and 1 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 11 Aug 2026. 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?
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?
basic information (time frame: Two weeks before intervention). The study lists 5 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 11 Aug 2026.