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

Recruiting now · Not applicable

Conditions studied: Sarcopenia, Sleep Wake Disorders

In brief

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.

Key facts

Study ID

NCT07715721

Run by

Tainan Hospital, Ministry of Health and Welfare

People needed

360

Starts

2023-05-19

Expected to finish

2027-12-31

Last updated by the study team

2026-07-27

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ministry of Health and Welfare Tainan Hospital — Tainan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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