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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

2026년 7월 23일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (추정된)

360

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Tainan, 대만
        • 모병
        • Ministry of Health and Welfare Tainan Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
활성 비교기: 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).
실험적: 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).
활성 비교기: 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).
활성 비교기: 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).
실험적: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)
기간: 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.
Baseline, Week 2, Week 3, Week 6, and Week 7

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 5월 19일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 16일

QC 기준을 충족하는 최초 제출

2026년 7월 16일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 23일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다