SarcopeniaNCT07715721
Exploration on the Relationship Between Distinct Sarcopenia, Traditional Chinese Medicine Body Constitution, and Circadian Rhythm Patterns of Older Adults and Impact of Acupoint-stimulated Interventions
A study testing Sleep Hygiene Education, Vivifrail Exercise Program and Comprehensive Geriatric and Traditional Chinese Medicine Assessment in people with Sarcopenia and Sleep Wake Disorders, run by Tainan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and impact of digital/remote courses combining traditional Chinese medicine (TCM) acupoint-stimulated interventions, health education, and exercise on sarcopenia and sleep disturbances across distinct age groups. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sarcopenia, Sleep Wake Disorders
- What is being tested?
- Sleep Hygiene Education, Vivifrail Exercise Program and Comprehensive Geriatric and Traditional Chinese Medicine Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 May 2023to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be able to understand and sign the informed consent form.
- For the geriatric cohorts: Individuals aged 65 and above.
- For the adult cohort: Individuals aged between 20 and 64.
- For the sleep disturbance cohorts: Presenting with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher.
- For the sarcopenia cohort: Evaluated and diagnosed with sarcopenia according to standard geriatric metrics.
Who cannot join
- Individuals with severe cognitive impairment, advanced dementia, or inability to communicate and follow instructions.
- Individuals with unstable medical conditions, acute cardiovascular events, or severe systemic diseases that preclude safe participation in exercise programs.
- Individuals with open wounds, active infections, or fractures at the targeted acupoint areas.
- Any other conditions that, in the judgment of the investigator, would jeopardize candidate safety or compliance.
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
Ministry of Health and Welfare Tainan Hospital
Tainan
Study Coordinator, +886-6-2200055, tnhpcm2017@gmail.com
About this study
The purpose of this study is to evaluate the clinical efficacy and impact of digital/remote courses combining traditional Chinese medicine (TCM) acupoint-stimulated interventions, health education, and exercise on sarcopenia and sleep disturbances across distinct age groups. By integrating multidisciplinary expertise encompassing TCM, geriatric medicine, geriatric health, community medicine, and epidemiology at Ministry of Health and Welfare Tainan Hospital, this project aims to explore the correlations among sarcopenia, sleep conditions, and TCM body constitution, while evaluating the feasibility of incorporating the simplified Body Constitution Questionnaire (BCQ) into anti-frailty screenings to establish an evidence-based, TCM-integrated intervention model. A total of at least 360 participants will be recruited at Ministry of Health and Welfare Tainan Hospital across two distinct operational phases. In the first phase, a comprehensive cross-sectional assessment will be conducted on 300 older adults aged 65 and above to establish a geriatric TCM body constitution database, utilizing 7-day actigraphy, scientific tongue and pulse diagnosis, the BCQ, and standard geriatric functional assessment scales (including SARC-F, Fried frailty index, ADL, IADL, WHOQOL-BREF, EQ-5D, mini nutritional assessment, ISI, PSQI, and ECOG score), with eligible and consenting participants referred for overnight polysomnography (PSG) based on physician assessment. In the second phase, longitudinal interventional trials will be executed with 180 participants divided into three specific cohorts. The sarcopenia cohort, comprising 60 older adults aged 65 and above, will undergo a 3-month intervention combining acupoint massage and the Vivifrail exercise program, with data evaluated at baseline, month 1, and month 3, followed by a final tracking period extending to month 4. The geriatric sleep disturbance cohort (60 older adults aged 65 and above) and the adult sleep disturbance cohort (60 younger adults aged 20-64), all presenting with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher, will participate in a 2-week curriculum consisting of sleep-related self-acupoint massage and sleep hygiene education, with clinical follow-ups scheduled at baseline, week 2, and week 6, a final tracking assessment at week 7, and intervention compliance monitoring conducted at week 3.
- Conditions
- Sarcopenia, Sleep Wake Disorders
- Being tested
- Sleep Hygiene Education, Vivifrail Exercise Program, Comprehensive Geriatric and Traditional Chinese Medicine Assessment
- Medical subject headings
- Sarcopenia, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.
Vivifrail Exercise ProgramOther
A 12-week customized multicomponent physical exercise program designed for frailty prevention and physical function enhancement.
Comprehensive Geriatric and Traditional Chinese Medicine AssessmentOther
A comprehensive cross-sectional assessment for 300 older adults, including 7-day actigraphy, scientific tongue and pulse diagnosis, the simplified Body Constitution Questionnaire (BCQ), and standard geriatric functional assessment scales. Eligible and consenting participants are referred for overnight polysomnography (PSG).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Vivifrail + Acupoint Massage | Experimental | Older adults aged 65 and above with sarcopenia who receive the 12-week Vivifrail exercise program (45-60 minutes per session, daily) combined with traditional Chinese medicine acupoint massage. Longitudinal data tracking is conducted at baseline, month 1, month 3, and month 4. Receives: Other: Vivifrail Exercise Program; Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment |
| Arm B: Vivifrail Only | Active comparator | Older adults aged 65 and above with sarcopenia who receive the 12-week Vivifrail exercise program alone (45-60 minutes per session, daily) without the acupoint massage component. Longitudinal data tracking is conducted at baseline, month 1, month 3, and month 4. Receives: Other: Vivifrail Exercise Program; Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment |
| Arm C: Geriatric Sleep Education + Acupoint Massage | Experimental | Older adults aged 65 and above with sleep disturbances (PSQI >= 5) who receive a 2-week digital course on sleep hygiene education combined with sleep-related self-acupoint massage (20-30 minutes per week). Data are evaluated at baseline, week 2, week 3, week 6, and week 7. Receives: Behavioral: Sleep Hygiene Education; Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment |
| Arm D: Geriatric Sleep Education Only | Active comparator | Older adults aged 65 and above with sleep disturbances (PSQI >= 5) who receive the 2-week digital course on sleep hygiene education alone (20-30 minutes per week) without self-acupoint massage. Data are evaluated at baseline, week 2, week 3, week 6, and week 7. Receives: Behavioral: Sleep Hygiene Education; Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment |
| Arm E: Adult Sleep Education Only | Active comparator | Younger adults aged 20-64 with sleep disturbances (PSQI >= 5) who receive the 2-week digital course on sleep hygiene education alone (20-30 minutes per week) without self-acupoint massage. Data are evaluated at baseline, week 2, week 3, week 6, and week 7. Receives: Behavioral: Sleep Hygiene Education; Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment |
| Arm F: Adult Sleep Education + Acupoint Massage | Experimental | Younger adults aged 20-64 with sleep disturbances (PSQI >= 5) who receive the 2-week digital course on sleep hygiene education combined with sleep-related self-acupoint massage (20-30 minutes per week). Data are evaluated at baseline, week 2, week 3, week 6, and week 7. Receives: Behavioral: Sleep Hygiene Education; Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire used to evaluate sleep quality. It consists of 19 individual items, generating 7 component scores that each range from 0 to 3. The total global score ranges from 0 to 21, where the minimum score is 0 and the maximum score is 21. Higher total global scores indicate poorer sleep quality.
Measured: Baseline, Week 2, Week 3, Week 6, and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start19 May 2023
- 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 SarcopeniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 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
- NCT07715721
- Sponsor's protocol ID
- A-ER-111-447
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration on the Relationship Between Distinct Sarcopenia, Traditional Chinese Medicine Body Constitution, and Circadian Rhythm Patterns of Older Adults and Impact of Acupoint-stimulated Interventions
- ClinicalTrials.gov ID
- NCT07715721
- Acronym / sponsor ID
- A-ER-111-447
- Conditions
- Sarcopenia, Sleep Wake Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tainan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 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.
The purpose of this study is to evaluate the clinical efficacy and impact of digital/remote courses combining traditional Chinese medicine (TCM) acupoint-stimulated interventions, health education, and exercise on sarcopenia and sleep disturbances across distinct age groups. By integrating multidisciplinary expertise encompassing TCM, geriatric medicine, geriatric health, community medicine, and epidemiology at Ministry of Health and Welfare Tainan Hospital, this project aims to explore the correlations among sarcopenia, sleep conditions, and TCM body constitution, while evaluating the feasibility of incorporating the simplified Body Constitution Questionnaire (BCQ) into anti-frailty screenings to establish an evidence-based, TCM-integrated intervention model. A total of at least 360 participants will be recruited at Ministry of Health and Welfare Tainan Hospital across two distinct operational phases. In the first phase, a comprehensive cross-sectional assessment will be conducted on 300 older adults aged 65 and above to establish a geriatric TCM body constitution database, utilizing 7-day actigraphy, scientific tongue and pulse diagnosis, the BCQ, and standard geriatric functional assessment scales (including SARC-F, Fried frailty index, ADL, IADL, WHOQOL-BREF, EQ-5D, mini nutritional assessment, ISI, PSQI, and ECOG score), with eligible and consenting participants referred for overnight polysomnography (PSG) based on physician assessment. In the second phase, longitudinal interventional trials will be executed with 180 participants divided into three specific cohorts. The sarcopenia cohort, comprising 60 older adults aged 65 and above, will undergo a 3-month intervention combining acupoint massage and the Vivifrail exercise program, with data evaluated at baseline, month 1, and month 3, followed by a final tracking period extending to month 4. The geriatric sleep disturbance cohort (60 older adults aged 65 and above) and the adult sleep disturbance cohort (60 younger adults aged 20-64), all presenting with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher, will participate in a 2-week curriculum consisting of sleep-related self-acupoint massage and sleep hygiene education, with clinical follow-ups scheduled at baseline, week 2, and week 6, a final tracking assessment at week 7, and intervention compliance monitoring conducted at week 3.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A: Vivifrail + Acupoint Massage | Experimental | Other: Vivifrail Exercise Program, Other: Comprehensive Geriatric and Traditional Chinese Medicine AssessmentOlder adults aged 65 and above with sarcopenia who receive the 12-week Vivifrail exercise program (45-60 minutes per session, daily) combined with traditional Chinese medicine acupoint massage. Longitudinal data tracking is conducted at baseline, month 1, month 3, and month 4. |
| Arm B: Vivifrail Only | Active comparator | Other: Vivifrail Exercise Program, Other: Comprehensive Geriatric and Traditional Chinese Medicine AssessmentOlder adults aged 65 and above with sarcopenia who receive the 12-week Vivifrail exercise program alone (45-60 minutes per session, daily) without the acupoint massage component. Longitudinal data tracking is conducted at baseline, month 1, month 3, and month 4. |
| Arm C: Geriatric Sleep Education + Acupoint Massage | Experimental | Behavioral: Sleep Hygiene Education, Other: Comprehensive Geriatric and Traditional Chinese Medicine AssessmentOlder adults aged 65 and above with sleep disturbances (PSQI >= 5) who receive a 2-week digital course on sleep hygiene education combined with sleep-related self-acupoint massage (20-30 minutes per week). Data are evaluated at baseline, week 2, week 3, week 6, and week 7. |
| Arm D: Geriatric Sleep Education Only | Active comparator | Behavioral: Sleep Hygiene Education, Other: Comprehensive Geriatric and Traditional Chinese Medicine AssessmentOlder adults aged 65 and above with sleep disturbances (PSQI >= 5) who receive the 2-week digital course on sleep hygiene education alone (20-30 minutes per week) without self-acupoint massage. Data are evaluated at baseline, week 2, week 3, week 6, and week 7. |
| Arm E: Adult Sleep Education Only | Active comparator | Behavioral: Sleep Hygiene Education, Other: Comprehensive Geriatric and Traditional Chinese Medicine AssessmentYounger adults aged 20-64 with sleep disturbances (PSQI >= 5) who receive the 2-week digital course on sleep hygiene education alone (20-30 minutes per week) without self-acupoint massage. Data are evaluated at baseline, week 2, week 3, week 6, and week 7. |
| Arm F: Adult Sleep Education + Acupoint Massage | Experimental | Behavioral: Sleep Hygiene Education, Other: Comprehensive Geriatric and Traditional Chinese Medicine AssessmentYounger adults aged 20-64 with sleep disturbances (PSQI >= 5) who receive the 2-week digital course on sleep hygiene education combined with sleep-related self-acupoint massage (20-30 minutes per week). Data are evaluated at baseline, week 2, week 3, week 6, and week 7. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be able to understand and sign the informed consent form.
- For the geriatric cohorts: Individuals aged 65 and above.
- For the adult cohort: Individuals aged between 20 and 64.
- For the sleep disturbance cohorts: Presenting with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher.
- For the sarcopenia cohort: Evaluated and diagnosed with sarcopenia according to standard geriatric metrics.
Key exclusion criteria (4 listed)
- Individuals with severe cognitive impairment, advanced dementia, or inability to communicate and follow instructions.
- Individuals with unstable medical conditions, acute cardiovascular events, or severe systemic diseases that preclude safe participation in exercise programs.
- Individuals with open wounds, active infections, or fractures at the targeted acupoint areas.
- Any other conditions that, in the judgment of the investigator, would jeopardize candidate safety or compliance.
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 |
|---|---|---|
| Sleep Hygiene EducationA 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines. | Behavioural | Arm C: Geriatric Sleep Education + Acupoint Massage, Arm D: Geriatric Sleep Education Only, Arm E: Adult Sleep Education Only, Arm F: Adult Sleep Education + Acupoint Massage |
| Vivifrail Exercise ProgramA 12-week customized multicomponent physical exercise program designed for frailty prevention and physical function enhancement. | Other | Arm A: Vivifrail + Acupoint Massage, Arm B: Vivifrail Only |
| Comprehensive Geriatric and Traditional Chinese Medicine AssessmentA comprehensive cross-sectional assessment for 300 older adults, including 7-day actigraphy, scientific tongue and pulse diagnosis, the simplified Body Constitution Questionnaire (BCQ), and standard geriatric functional assessment scales. Eligible and consenting participants are referred for overnight polysomnography (PSG). | Other | Arm A: Vivifrail + Acupoint Massage, Arm B: Vivifrail Only, Arm C: Geriatric Sleep Education + Acupoint Massage, Arm D: Geriatric Sleep Education Only, Arm E: Adult Sleep Education Only, Arm F: Adult Sleep Education + Acupoint Massage |
Primary outcome
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)
Time frame: Baseline, Week 2, Week 3, Week 6, and Week 7
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire used to evaluate sleep quality. It consists of 19 individual items, generating 7 component scores that each range from 0 to 3. The total global score ranges from 0 to 21, where the minimum score is 0 and the maximum score is 21. Higher total global scores indicate poorer sleep quality.
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 27 Jul 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 Sleep Hygiene Education, Vivifrail Exercise Program and Comprehensive Geriatric and Traditional Chinese Medicine Assessment in people with Sarcopenia and Sleep Wake Disorders, 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 4 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 27 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality) (time frame: Baseline, Week 2, Week 3, Week 6, and Week 7). 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 27 Jul 2026.