Exploration on the Relationship Between Distinct Sarcopenia, Traditional Chinese Medicine Body Constitution, and Circadian Rhythm Patterns of... | NCT07715721

NCT07715721

Overview

NCT ID: NCT07715721
Lead Sponsor: Tainan Hospital, Ministry of Health and WelfareOTHER
Official Title: 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
Brief Summary: 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: May 19, 2023Actual
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 360Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Ministry of Health and Welfare Tainan Hospital

Similar Studies

Participant Group/Arms

Arm A: Vivifrail + Acupoint MassageExperimental

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.

Other: Vivifrail Exercise Program

Other: Comprehensive Geriatric and Traditional Chinese Medicine Assessment

Arm B: Vivifrail OnlyActive Comparator

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.

Other: Vivifrail Exercise Program

Arm C: Geriatric Sleep Education + Acupoint MassageExperimental

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.

Behavioral: Sleep Hygiene Education

Arm D: Geriatric Sleep Education OnlyActive Comparator

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.

Behavioral: Sleep Hygiene Education

Arm E: Adult Sleep Education OnlyActive Comparator

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.

Behavioral: Sleep Hygiene Education

Arm F: Adult Sleep Education + Acupoint MassageExperimental

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.

Behavioral: Sleep Hygiene Education