FrailtyNCT07732530
Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults
A study testing Vivifrail Exercise Program and Acupoint Stimulation in people with Frailty and Sleep Quality, run by Tainan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frailty, Sleep Quality, Aging
- What is being tested?
- Vivifrail Exercise Program and Acupoint Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jun 2025to 31 Dec 2027
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are capable of undergoing frailty assessments.
- Individuals who possess effective communication skills.
- Aged 50 years or older.
- Willing to provide written informed consent, keep a 7-day sleep diary, and complete related questionnaires.
- Identified as pre-frail (frailty score of 1-2 points) according to the frailty phenotype criteria for the clinical trial phase.
Who cannot join
- 1. Individuals who are unwilling or unable to wear an actigraph (wrist monitor) or undergo physical measurements.
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
Tainan Hospital, Ministry of Health and Welfare
Tainan
Yu-Ching Hsu, MD, +886-6-2202121, tnhpcm2017@gmail.com
About this study
Official title: Exploring the Associations Among Frailty, Daily Physical Activity, Sleep, and Traditional Chinese Medicine Constitution in Taiwanese Older Adults, and Evaluating the Effects of Acupoint Stimulation Interventions
This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Participants will be randomly assigned to either the exercise training group (Vivifrail program) or the integrated group combining exercise with daytime and sleep-improving acupoint stimulation. The study evaluates the combined efficacy of these non-invasive interventions on reducing frailty severity, improving sleep, and enhancing daily physical functions.
- Conditions
- Frailty, Sleep Quality, Aging
- Being tested
- Vivifrail Exercise Program, Acupoint Stimulation
- Medical subject headings
- Frailty, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivifrail Exercise ProgramBehavioural
A 12-week home-based multimodal exercise program including daily walking, upper limb resistance training, balance exercises, and flexibility training, tailored to pre-frail older adults.
Acupoint StimulationOther
Daily home-based acupoint self-massage (2-3 times per day, 3-5 minutes per point) targeting specific meridians (including Spleen, Stomach, and Bladder meridians) to alleviate fatigue and promote sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Combined with Acupoint Stimulation | Experimental | Participants receive a 12-week multimodal intervention, including the Vivifrail exercise program (daily, 45-60 minutes) and personalized daytime and sleep acupoint stimulation (2-3 times daily). Receives: Behavioral: Vivifrail Exercise Program; Other: Acupoint Stimulation |
| Exercise Training Only | Active comparator | Participants receive the 12-week Vivifrail exercise program and sleep hygiene education, without any acupoint stimulation. Receives: Behavioral: Vivifrail Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frailty Score
Evaluated using the Fried frailty phenotype criteria, which includes five components: unintentional weight loss, weakness (grip strength), exhaustion, slowness (walking speed), and low physical activity. Each component is scored as 0 or 1, resulting in a total score ranging from 0 to 5. Higher scores indicate a worse outcome (higher severity of frailty).
Measured: Baseline, Week 4, and Week 12
Change in Sleep Quality
Measured via the Pittsburgh Sleep Quality Index (PSQI) questionnaire (global score ranges from 0 to 21, where higher scores indicate poorer sleep quality) and objective metrics from the 7-day wrist actigraphy (including total sleep time and sleep efficiency).
Measured: Baseline, Week 4, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start3 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tainan Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ching HSU, Tainan Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732530
- Sponsor's protocol ID
- A-ER-114-105
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 7 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Associations Among Frailty, Daily Physical Activity, Sleep, and Traditional Chinese Medicine Constitution in Taiwanese Older Adults, and Evaluating the Effects of Acupoint Stimulation Interventions
- ClinicalTrials.gov ID
- NCT07732530
- Acronym / sponsor ID
- A-ER-114-105
- Conditions
- Frailty, Sleep Quality, Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tainan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Participants will be randomly assigned to either the exercise training group (Vivifrail program) or the integrated group combining exercise with daytime and sleep-improving acupoint stimulation. The study evaluates the combined efficacy of these non-invasive interventions on reducing frailty severity, improving sleep, and enhancing daily physical functions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Combined with Acupoint Stimulation | Experimental | Behavioral: Vivifrail Exercise Program, Other: Acupoint StimulationParticipants receive a 12-week multimodal intervention, including the Vivifrail exercise program (daily, 45-60 minutes) and personalized daytime and sleep acupoint stimulation (2-3 times daily). |
| Exercise Training Only | Active comparator | Behavioral: Vivifrail Exercise ProgramParticipants receive the 12-week Vivifrail exercise program and sleep hygiene education, without any acupoint stimulation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who are capable of undergoing frailty assessments.
- Individuals who possess effective communication skills.
- Aged 50 years or older.
- Willing to provide written informed consent, keep a 7-day sleep diary, and complete related questionnaires.
- Identified as pre-frail (frailty score of 1-2 points) according to the frailty phenotype criteria for the clinical trial phase.
Key exclusion criteria (1 listed)
- 1. Individuals who are unwilling or unable to wear an actigraph (wrist monitor) or undergo physical measurements.
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 |
|---|---|---|
| Vivifrail Exercise ProgramA 12-week home-based multimodal exercise program including daily walking, upper limb resistance training, balance exercises, and flexibility training, tailored to pre-frail older adults. | Behavioural | Exercise Combined with Acupoint Stimulation, Exercise Training Only |
| Acupoint StimulationDaily home-based acupoint self-massage (2-3 times per day, 3-5 minutes per point) targeting specific meridians (including Spleen, Stomach, and Bladder meridians) to alleviate fatigue and promote sleep quality. | Other | Exercise Combined with Acupoint Stimulation |
Primary outcome
Change in Frailty Score
Time frame: Baseline, Week 4, and Week 12
Evaluated using the Fried frailty phenotype criteria, which includes five components: unintentional weight loss, weakness (grip strength), exhaustion, slowness (walking speed), and low physical activity. Each component is scored as 0 or 1, resulting in a total score ranging from 0 to 5. Higher scores indicate a worse outcome (higher severity of frailty).
Change in Sleep Quality
Time frame: Baseline, Week 4, and Week 12
Measured via the Pittsburgh Sleep Quality Index (PSQI) questionnaire (global score ranges from 0 to 21, where higher scores indicate poorer sleep quality) and objective metrics from the 7-day wrist actigraphy (including total sleep time and sleep efficiency).
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 7 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivifrail Exercise Program and Acupoint Stimulation in people with Frailty and Sleep Quality, run by Tainan Hospital, Ministry of Health and Welfare 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 5 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: looking for participants now, as of the sponsor's last update on 7 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?
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 Yu-Ching Hsu, MD (+886-6-2202121, tnhpcm2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frailty Score (time frame: Baseline, Week 4, and Week 12). The study lists 2 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 7 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.