- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07715721
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
23. července 2026 aktualizováno: Yu-Ching HSU, Tainan Hospital, Ministry of Health and Welfare
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.
Přehled studie
Postavení
Nábor
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
360
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Tainan, Tchaj-wan
- Nábor
- Ministry of Health and Welfare Tainan Hospital
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Kontakt:
- Study Coordinator
- Telefonní číslo: +886-6-2200055
- E-mail: tnhpcm2017@gmail.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Arm A: Vivifrail + Acupoint Massage
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.
|
A 12-week customized multicomponent physical exercise program designed for frailty prevention and physical function enhancement.
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).
|
|
Aktivní komparátor: Arm B: Vivifrail Only
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.
|
A 12-week customized multicomponent physical exercise program designed for frailty prevention and physical function enhancement.
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).
|
|
Experimentální: Arm C: Geriatric Sleep Education + Acupoint Massage
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.
|
A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.
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).
|
|
Aktivní komparátor: Arm D: Geriatric Sleep Education Only
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.
|
A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.
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).
|
|
Aktivní komparátor: Arm E: Adult Sleep Education Only
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.
|
A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.
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).
|
|
Experimentální: Arm F: Adult Sleep Education + Acupoint Massage
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.
|
A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.
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).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)
Časové okno: 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.
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Baseline, Week 2, Week 3, Week 6, and Week 7
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
19. května 2023
Primární dokončení (Odhadovaný)
31. prosince 2027
Dokončení studie (Odhadovaný)
31. prosince 2027
Termíny zápisu do studia
První předloženo
16. července 2026
První předloženo, které splnilo kritéria kontroly kvality
16. července 2026
První zveřejněno (Aktuální)
20. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
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