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

Обзор

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.

Вмешательства

• Поведенческое Sleep Hygiene Education
  A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.
• Другое Vivifrail Exercise Program
  A 12-week customized multicomponent physical exercise program designed for frailty prevention and physical function enhancement.
• Другое Comprehensive Geriatric and Traditional Chinese Medicine Assessment
  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).

Первичные конечные точки

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality) [Срок оценки: Baseline, Week 2, Week 3, Week 6, and Week 7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Ministry of Health and Welfare Tainan Hospital — Tainan

Идентификаторы

NCT: NCT07715721 · A-ER-111-447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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