- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
360
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
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Tainan, Taiwan
- Recrutamento
- Ministry of Health and Welfare Tainan Hospital
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Contato:
- Study Coordinator
- Número de telefone: +886-6-2200055
- E-mail: tnhpcm2017@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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).
|
|
Comparador Ativo: 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).
|
|
Experimental: 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).
|
|
Comparador Ativo: 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).
|
|
Comparador Ativo: 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).
|
|
Experimental: 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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de maio de 2023
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de julho de 2026
Primeira postagem (Real)
20 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- A-ER-111-447
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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