- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
360
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Tainan, Taiwan
- Reclutamento
- Ministry of Health and Welfare Tainan Hospital
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Contatto:
- Study Coordinator
- Numero di telefono: +886-6-2200055
- Email: tnhpcm2017@gmail.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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).
|
|
Comparatore attivo: 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).
|
|
Sperimentale: 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).
|
|
Comparatore attivo: 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).
|
|
Comparatore attivo: 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).
|
|
Sperimentale: 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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 maggio 2023
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
16 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 luglio 2026
Primo Inserito (Effettivo)
20 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A-ER-111-447
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .