Frail Elderly SyndromeTHISCENCT03056768
Taiwan Health Promotion Intervention Study for Elders
A study testing Multidomain intervention in people with Frail Elderly Syndrome and Cognitive Impairment, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people. Design: Methods: Randomized controlled trial Setting: Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Cognitive Impairment, Cognitive Decline
- What is being tested?
- Multidomain intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2014to 24 Jul 2016
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Prefrail or frail community-dwelling people
Who cannot join
- Institutionalized or ADL dependent
- Diagnosed dementia
- Limited life expectancy
About this study
Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.
Design:
Read more
Methods: Randomized controlled trial
Setting:
Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)
Measurements:
Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.
Read the detailed description
Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.
Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.
- Being tested
- Multidomain intervention, Active control
- 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
1-year multidomain health promotion (physical, cognitive, nutritional intervention)
Active controlBehavioural
Health promotion activities provided by local health bureau.
| Study group | Role | What they receive |
|---|---|---|
| active control | Active comparator | Health promotion provided by local health bureau. Receives: Behavioral: Active control |
| multidomain intervention | Experimental | 1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions) Receives: Behavioral: Multidomain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline frailty score at 12 months
Measured by Cardiovascular Health Study(CHS) definition
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start30 Aug 2014
- Primary completion5 Oct 2015
- Study completion24 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Outcomes assessor
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Liang-Kung Chen, MD, PhD, Principal investigator, Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056768
- Sponsor's protocol ID
- 14001A
- Acronym
- THISCE
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho MY, Lee WJ, Yen KH, Liang CK, Peng LN, Lin MH, Loh CH, Hsiao FY, Chen LK. Tailoring multidomain intervention programs to reduce cognitive and physical decline in older adults: Examining rural-urban differences in a nationwide cluster-randomized controlled trial. J Prev Alzheimers Dis. 2025 Sep;12(8):100231. doi: 10.1016/j.tjpad.2025.100231. Epub 2025 Jun 12.
PubMed 40514302Liang CK, Lee WJ, Chou MY, Hwang AC, Lin CS, Peng LN, Hsiao FY, Loh CH, Chen LK. Roles of Baseline Intrinsic Capacity and its Subdomains on the Overall Efficacy of Multidomain Intervention in Promoting Healthy Aging among Community-Dwelling Older Adults: Analysis from a Nationwide Cluster-Randomized Controlled Trial. J Prev Alzheimers Dis. 2024;11(2):356-365. doi: 10.14283/jpad.2024.20.
PubMed 38374742
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Health Promotion Intervention Study for Elders
- ClinicalTrials.gov ID
- NCT03056768
- Acronym / sponsor ID
- THISCE / 14001A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 30 Aug 2014 (actual)
- Primary completion
- 5 Oct 2015 (actual)
- Study completion
- 24 Jul 2016 (actual)
- First posted
- 17 Feb 2017 (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.
Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.
Design:
Methods: Randomized controlled trial
Setting:
Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)
Measurements:
Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.
Detailed description
Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.
Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active control | Active comparator | Behavioral: Active controlHealth promotion provided by local health bureau. |
| multidomain intervention | Experimental | Behavioral: Multidomain intervention1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Prefrail or frail community-dwelling people
Key exclusion criteria (3 listed)
- Institutionalized or ADL dependent
- Diagnosed dementia
- Limited life expectancy
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 intervention1-year multidomain health promotion (physical, cognitive, nutritional intervention) | Behavioural | multidomain intervention |
| Active controlHealth promotion activities provided by local health bureau. | Behavioural | active control |
Primary outcome
Change from baseline frailty score at 12 months
Time frame: 12 months
Measured by Cardiovascular Health Study(CHS) definition
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 17 Feb 2017.
- Derived from this study: PubMed 40514302Ho MY, Lee WJ, Yen KH, Liang CK, Peng LN, Lin MH, Loh CH, Hsiao FY, Chen LK. Tailoring multidomain intervention programs to reduce cognitive and physical decline in older adults: Examining rural-urban differences in a nationwide cluster-randomized controlled trial. J Prev Alzheimers Dis. 2025 Sep;12(8):100231. doi: 10.1016/j.tjpad.2025.100231. Epub 2025 Jun 12.
- Derived from this study: PubMed 38374742Liang CK, Lee WJ, Chou MY, Hwang AC, Lin CS, Peng LN, Hsiao FY, Loh CH, Chen LK. Roles of Baseline Intrinsic Capacity and its Subdomains on the Overall Efficacy of Multidomain Intervention in Promoting Healthy Aging among Community-Dwelling Older Adults: Analysis from a Nationwide Cluster-Randomized Controlled Trial. J Prev Alzheimers Dis. 2024;11(2):356-365. doi: 10.14283/jpad.2024.20.
- Individual participant dataSharing planned: No
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Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
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Type2diabetes, Frail Elderly Syndrome
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.
Liang-Kung Chen, MD, PhD principal investigator
Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain intervention in people with Frail Elderly Syndrome and Cognitive Impairment, run by Taipei Veterans General Hospital, 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 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: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline frailty score at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056768, which also lists 2 linked publications.
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 17 Feb 2017.