- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07915310
Multimodal Assessment of Sarcopenia Using Shear Wave Elastography, Dual-Energy X-ray Absorptiometry, Bioelectrical Impedance Analysis, and Physical Performance Measures
The goal of this observational study is to learn whether shear wave elastography (SWE) parameters, combined with dual-energy X-ray absorptiometry (DXA), bioelectrical impedance analysis (BIA), and physical performance assessments, can help diagnose sarcopenia in older adults. The main questions it aims to answer are:
- Are SWE-derived muscle stiffness parameters associated with muscle mass, muscle strength, and physical performance?
- Can an integrated model including SWE parameters accurately identify sarcopenia compared with the DXA-based diagnosis?
Researchers will compare participants with sarcopenia to those without sarcopenia, to see if SWE parameters differ between groups and contribute to sarcopenia prediction.
Participants will:
- Undergo shear wave elastography of selected skeletal muscles
- Receive a DXA scan to measure appendicular skeletal muscle mass
- Receive a BIA measurement of body composition
- Complete muscle strength and physical performance assessments
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Ming Hsuan Huang, MD
- Telefonnummer: +886 073422121
- E-mail: min0711@vghks.gov.tw
Studiesteder
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-
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Kaohsiung City, Taiwan, 807
- Rekruttering
- Kaohsiung Veterans General Hospital
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Kontakt:
- Ming Hsuan Huang
- Telefonnummer: 886-0933603324
- E-mail: tatat6918@gmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Participants will be recruited from the outpatient clinics or inpatient ward of Kaohsiung Veterans General Hospita, Taiwan.
Beskrivelse
Inclusion Criteria:
- Adults aged 65 years and older
- Able to walk independently, with or without an assistive device
- Able to understand study procedures and provide written informed consent
- Able to perform related exam
Exclusion Criteria:
- Implanted electronic medical devices (e.g., cardiac pacemaker or defibrillator), which contraindicate BIA measurement
- Metal implants or prostheses in the regions measured by DXA or ultrasound
- History of fracture or surgery of the lower extremities within the past 6 months
- Neuromuscular disease affecting skeletal muscle (e.g., stroke with residual limb weakness, Parkinson's disease, myopathy, or amyotrophic lateral sclerosis)
- Skin lesions, wounds, or infection at the ultrasound measurement sites
- Acute illness or hospitalization within the past 4 weeks
- Cognitive impairment or psychiatric conditions that preclude completion of study assessments
- Inability to complete muscle strength or physical performance tests
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Sarcopenia
Participants diagnosed with sarcopenia according to the Asian Working Group for Sarcopenia (AWGS) 2025 consensus, defined as concurrent low muscle strength and low DXA-measured appendicular skeletal muscle mass. |
|
Non-sacropenia
Participants who do not meet the AWGS 2025 criteria for sarcopenia. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic accuracy of shear wave elastography parameters for sarcopenia
Tidsramme: Within 2 weeks of enrollment
|
Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of SWE parameters, alone and combined with BIA and physical performance measures, for identifying sarcopenia as defined by the AWGS 2025 consensus. |
Within 2 weeks of enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Appendicular skeletal muscle mass index measured by DXA
Tidsramme: Within 2 weeks of enrollment
|
Appendicular skeletal muscle mass divided by height squared (kg/m²), measured by dual-energy X-ray absorptiometry. |
Within 2 weeks of enrollment
|
|
Skeletal muscle mass index measured by BIA
Tidsramme: Within 2 weeks of enrollment
|
Appendicular skeletal muscle mass divided by height squared (kg/m²), measured by bioelectrical impedance analysis. |
Within 2 weeks of enrollment
|
|
Handgrip strength
Tidsramme: Within 2 weeks of enrollment
|
Maximum handgrip strength (kg) of the dominant hand measured with a handheld dynamometer. |
Within 2 weeks of enrollment
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 26-CT7-09(260617-1)
- KSVGH115-181 (Anden identifikator: KaohsiungVGH)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared publicly due to participant privacy and confidentiality requirements under Taiwan's Personal Data Protection Act and the conditions of institutional review board approval. De-identified data may be made available from the corresponding author upon reasonable request, subject to approval by the institutional review board.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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