Community CentersNCT06632899
Effects of "Comprehensive Health Promotion and Healthy Lifestyle Development" in Community-dwelling Elderly.
A study testing combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development in people with Community Centers, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The World Health Organization (WHO) defines "Active Aging" as continued engagement in social, economic, cultural, spiritual, and civic activities, emphasizing the importance of participation for older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Centers
- What is being tested?
- combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development
- 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
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memotial Hospital
Taoyuan, 龜山區, 333
Ching-Yi Wu, ScD, +886-3-2118800 Ext. 5761, cywu@mail.cgu.edu.tw
About this study
The World Health Organization (WHO) defines "Active Aging" as continued engagement in social, economic, cultural, spiritual, and civic activities, emphasizing the importance of participation for older adults. Personal health behaviors and habits influence both longevity and health status in later life, with healthy lifestyle development optimizing aging and enhancing well-being and quality of life.
WHO's Integrated Care for Older People (ICOPE) highlights six key indicators of physical and mental function-mobility, cognition, nutrition, vision, hearing, and depression-as critical to promoting active aging. These factors are also used to evaluate aging outcomes. Multidomain interventions are employed to address cognitive decline and dementia.
Read more
While research supports the benefits of multidomain interventions for cognitive improvement in older adults, consistent findings are lacking. Most interventions focus on exercise and cognitive training, with limited attention to other aging risk factors. Broader, more diverse interventions that actively involve older adults are needed to confirm the effects of these factors on cognitive function.
This study aims to evaluate the effects of multidomain interventions-covering exercise, cognitive training, nutrition, chronic disease management, vision and hearing care, fall prevention, psychosocial factors, and sleep-on mobility, cognition, daily functioning, and social participation in community-dwelling older adults
- Conditions
- Community Centers
- Being tested
- combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development
- Keywords
- Aged, community living elderly, active aging, multidomain interventions, health promotion, healthy lifestyle development.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle developmentBehavioural
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 (nutrition, chronic disease management, oral health, fall prevention and transportation safety, psychosocial factors and sleep) and healthy lifestyle development (Discussion and sharing on topics such as self-health management, goal setting, and the "health journal.")
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development |
| control group | No intervention | Not described |
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 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 Grip strength (GS)
Grip strength, a measure of body function, has been suggested as a biomarker of aging. The hand dynamometer is used to assess the upper limb strength of the participants. During the test, the participant's hand grips the handle with the second knuckle forming a right angle. The participant's elbow should be at a 90-degree angle, with their eyes looking straight ahead. The participant should squeeze the dynamometer tightly, ensuring it does not touch their body. GS assessment is a reliable and valid procedure among healthy participants as well as across various clinical populations.
Measured: baseline, after the intervention 12 weeks
Change scores of Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly
Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly covers five dimensions: cognition, muscle strength, functional ability, nutrition and oral health, and psychosocial aspects. Each dimension consists of four questions, totaling 20 questions. This evaluation is designed to assess multidomain intervention and is suitable for elderly individuals with varying levels of ability, including healthy, frail, those with mild cognitive impairment, or mild to moderate disability/dementia. After conversion, the total score of this scale ranges from 0 to 100. A higher post-test score compared to the pre-test score indicates greater effectiveness in implementing the health promotion program. The 20-item health-promotion program outcome measure is concise and has good reliability/ validity.
Measured: baseline, after the intervention 12 weeks
Change scores of the Acting Aging Scale
The Active Aging scale is administered through a questionnaire, utilizing a six-point Likert scale. The scale covers three dimensions: 1) "Health Promotion." 2) "Social Participation." 3) "Life Safety." Based on the participants' responses, six options ranging from "strongly disagree" to "strongly agree" are provided, with scores assigned from 1 to 6. A higher score indicates a higher level of active aging among the participants. the re-check validity of the measurement model was good, indicating that the scale could be applied to the senior population.
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 posted9 Oct 2024
- Study start6 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community CentersStudies of the same condition, open and under way.
- More trials run by Chang Gung 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
- NCT06632899
- Sponsor's protocol ID
- 202400825B0
- Status last verified
- May 2024
- First submitted
- 8 Oct 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of "Comprehensive Health Promotion and Healthy Lifestyle Development" in Community-dwelling Elderly.
- ClinicalTrials.gov ID
- NCT06632899
- Acronym / sponsor ID
- 202400825B0
- Conditions
- Community Centers
- Keywords
- Aged, community living elderly, active aging, multidomain interventions, health promotion, healthy lifestyle development.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Oct 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 World Health Organization (WHO) defines "Active Aging" as continued engagement in social, economic, cultural, spiritual, and civic activities, emphasizing the importance of participation for older adults. Personal health behaviors and habits influence both longevity and health status in later life, with healthy lifestyle development optimizing aging and enhancing well-being and quality of life.
WHO's Integrated Care for Older People (ICOPE) highlights six key indicators of physical and mental function-mobility, cognition, nutrition, vision, hearing, and depression-as critical to promoting active aging. These factors are also used to evaluate aging outcomes. Multidomain interventions are employed to address cognitive decline and dementia.
While research supports the benefits of multidomain interventions for cognitive improvement in older adults, consistent findings are lacking. Most interventions focus on exercise and cognitive training, with limited attention to other aging risk factors. Broader, more diverse interventions that actively involve older adults are needed to confirm the effects of these factors on cognitive function.
This study aims to evaluate the effects of multidomain interventions-covering exercise, cognitive training, nutrition, chronic disease management, vision and hearing care, fall prevention, psychosocial factors, and sleep-on mobility, cognition, daily functioning, and social participation 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 group | Experimental | Behavioral: combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development |
| control group | No intervention | – |
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 |
|---|---|---|
| combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle developmentDosage: 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 (nutrition, chronic disease management, oral health, fall prevention and transportation safety, psychosocial factors and sleep) and healthy lifestyle development (Discussion and sharing on topics such as self-health management, goal setting, and the "health journal.") | Behavioural | intervention group |
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 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 Grip strength (GS)
Time frame: baseline, after the intervention 12 weeks
Grip strength, a measure of body function, has been suggested as a biomarker of aging. The hand dynamometer is used to assess the upper limb strength of the participants. During the test, the participant's hand grips the handle with the second knuckle forming a right angle. The participant's elbow should be at a 90-degree angle, with their eyes looking straight ahead. The participant should squeeze the dynamometer tightly, ensuring it does not touch their body. GS assessment is a reliable and valid procedure among healthy participants as well as across various clinical populations.
Change scores of Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly
Time frame: baseline, after the intervention 12 weeks
Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly covers five dimensions: cognition, muscle strength, functional ability, nutrition and oral health, and psychosocial aspects. Each dimension consists of four questions, totaling 20 questions. This evaluation is designed to assess multidomain intervention and is suitable for elderly individuals with varying levels of ability, including healthy, frail, those with mild cognitive impairment, or mild to moderate disability/dementia. After conversion, the total score of this scale ranges from 0 to 100. A higher post-test score compared to the pre-test score indicates greater effectiveness in implementing the health promotion program. The 20-item health-promotion program outcome measure is concise and has good reliability/ validity.
Change scores of the Acting Aging Scale
Time frame: baseline, after the intervention 12 weeks
The Active Aging scale is administered through a questionnaire, utilizing a six-point Likert scale. The scale covers three dimensions: 1) "Health Promotion." 2) "Social Participation." 3) "Life Safety." Based on the participants' responses, six options ranging from "strongly disagree" to "strongly agree" are provided, with scores assigned from 1 to 6. A higher score indicates a higher level of active aging among the participants. the re-check validity of the measurement model was good, indicating that the scale could be applied to the senior population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development in people with Community Centers, 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-yi Wu, ScD (#886-3-2118800, 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 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 9 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.