{"type":"trials","record":{"id":28576,"source_id":"clinicaltrials-gov","external_id":"NCT07715721","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.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Tainan Hospital, Ministry of Health and Welfare","enrollment":360,"countries":["Taiwan"],"start_date":"2023-05-19","completion_date":"2027-12-31","last_update_date":"2026-07-27","source_url":"https://clinicaltrials.gov/study/NCT07715721","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:15.763923+00:00","last_seen_at":"2026-09-25T06:25:39.067+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"20 Years","comparator":"Arm B: Vivifrail Only; Arm D: Geriatric Sleep Education Only; Arm E: Adult Sleep Education Only","organization":"Tainan Hospital, Ministry of Health and Welfare","interventions":["Sleep Hygiene Education","Vivifrail Exercise Program","Comprehensive Geriatric and Traditional Chinese Medicine Assessment"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Q…"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","source_has_results":false},"controlled_terms":["Sarcopenia","Sleep Wake Disorders","Sleep Hygiene Education","Vivifrail Exercise Program","Comprehensive Geriatric and Traditional Chinese Medicine Assessment"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:25:42.287439+00:00","duplicate_cluster_key":"id:nct07715721","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-05-19 to 2027-12-31","comparator":"Arm B: Vivifrail Only; Arm D: Geriatric Sleep Education Only; Arm E: Adult Sleep Education Only","confidence":"structured-source","population":"ALL · 20 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:39.079Z","intervention":["Sleep Hygiene Education","Vivifrail Exercise Program","Comprehensive Geriatric and Traditional Chinese Medicine Assessment"],"participants":360,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (Range: 0-21, Higher Scores Indicate Poorer Sleep Q…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"circadian-rhythms","is_published":true,"match_reasons":["Title contains controlled term: circadian rhythm.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Circadian rhythms","slug":"circadian-rhythms"}},{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sarcopenia","slug":"sarcopenia"}},{"topic_slug":"sleep","is_published":true,"match_reasons":["Title contains controlled term: circadian.","Abstract contains controlled term: sleep.","Source terminology contains: sleep.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sleep","slug":"sleep"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/28576","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}