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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTainan Hospital, Ministry of Health and Welfare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleep Hygiene Education

    Behavioral

    A 2-week digital/remote curriculum focusing on sleep hygiene education and sleep-related self-care guidelines.

  • Vivifrail Exercise Program

    Other intervention

    A 12-week customized multicomponent physical exercise program designed for frailty prevention and physical function enhancement.

  • Comprehensive Geriatric and Traditional Chinese Medicine Assessment

    Other intervention

    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).

Treatment groups

360 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm A: Vivifrail + Acupoint MassageExperimental treatment 2 interventions
Group B: Arm B: Vivifrail OnlyActive comparator 2 interventions
Group C: Arm C: Geriatric Sleep Education + Acupoint MassageExperimental treatment 2 interventions
Group D: Arm D: Geriatric Sleep Education OnlyActive comparator 2 interventions
Group E: Arm E: Adult Sleep Education OnlyActive comparator 2 interventions
Group F: Arm F: Adult Sleep Education + Acupoint MassageExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Quality)

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.

Time frame
Baseline, Week 2, Week 3, Week 6, and Week 7

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.