- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ming Hsuan Huang, MD
- Phone Number: +886 073422121
- Email: min0711@vghks.gov.tw
Study Locations
-
-
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Kaohsiung City, Taiwan, 807
- Recruiting
- Kaohsiung Veterans General Hospital
-
Contact:
- Ming Hsuan Huang
- Phone Number: 886-0933603324
- Email: tatat6918@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants will be recruited from the outpatient clinics or inpatient ward of Kaohsiung Veterans General Hospita, Taiwan.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of shear wave elastography parameters for sarcopenia
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appendicular skeletal muscle mass index measured by DXA
Time Frame: 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
Time Frame: 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
Time Frame: Within 2 weeks of enrollment
|
Maximum handgrip strength (kg) of the dominant hand measured with a handheld dynamometer. |
Within 2 weeks of enrollment
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 26-CT7-09(260617-1)
- KSVGH115-181 (Other Identifier: KaohsiungVGH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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