SarcopeniaSARC-AINCT07477574
Muscle-Specific Multimodal AI for Sarcopenia Diagnosis
A study testing Rehabilitation training in people with Sarcopenia, run by Seoul National University Bundang Hospital.
Trial summary
This study aims to develop a muscle-specific multimodal artificial intelligence (AI) model for the diagnosis of sarcopenia and to investigate the effects of rehabilitation training on muscle aging. Clinical, functional, and imaging data will be collected from participants with muscle function decline. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Rehabilitation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 65 years or older
- Individuals with reduced muscle function or at risk of sarcopenia
- Able to participate in rehabilitation training
- Able to understand the study procedures and provide written informed consent
Who cannot join
- Severe cardiovascular, neurological, or musculoskeletal conditions that limit participation in exercise
- Severe cognitive impairment
- Participation in other clinical trials that may influence study outcomes
- Any medical condition judged by the investigator to make participation unsafe
About this study
Official title: Development of Muscle-specific Multi-modal AI for Sarcopenia Diagnosis: Effects of Rehabilitation Training on Ant-muscle Aging
This study aims to develop a muscle-specific multimodal artificial intelligence (AI) model for the diagnosis of sarcopenia and to investigate the effects of rehabilitation training on muscle aging. Clinical, functional, and imaging data will be collected from participants with muscle function decline. Multimodal data, including muscle function measurements and clinical assessments, will be integrated to develop and validate an AI-based diagnostic model for sarcopenia. In addition, the effects of rehabilitation training on muscle function and muscle aging-related outcomes will be evaluated. The results of this study are expected to contribute to the development of digital biomarkers and precision rehabilitation strategies for sarcopenia.
- Conditions
- Sarcopenia
- Being tested
- Rehabilitation training
- Keywords
- Sarcopenia, Muscle aging, Multimodal AI, Muscle function
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation trainingBehavioural
Participants will perform a structured rehabilitation training program designed to improve muscle strength, physical performance, and muscle function. Clinical assessments and muscle function measurements will be collected before and after the rehabilitation program to evaluate the effects of training and to support the development of a muscle-specific multimodal AI model for sarcopenia diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Training | Experimental | Participants will undergo a structured rehabilitation training program aimed at improving muscle function and reducing muscle aging-related decline. Receives: Behavioral: Rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI model performance
The performance of the muscle-specific multimodal artificial intelligence (AI) model for detecting sarcopenia will be evaluated using the Area Under the Receiver Operating Characteristic Curve (AUC). The AUC evaluates the ability of the AI model to discriminate between participants with and without sarcopenia(e.g., handgrip strength, gait speed, and appendicular skeletal muscle mass). The AUC value ranges from 0.5 to 1.0, where higher values indicate better discrimination performance of the AI model.
Measured: Baseline to 12 weeks after rehabilitation training
Secondary outcomes (8)
Five-Times Chair Stand Test (5×STS)
Time required to complete the Five-Times Chair Stand Test, which assesses lower extremity muscle strength and functional performance. Participants will be instructed to stand up and sit down five times as quickly as possible with arms folded across the chest. The time required to complete the test will be recorded in seconds.
Measured: Baseline to 12 weeks after rehabilitation training
Gait Speed
Gait speed will be assessed using the 6-meter walk test. Participants will be instructed to walk at their usual pace over a 6-meter distance. Gait speed will be recorded in meters per second (m/s).
Measured: Baseline to 12 weeks after rehabilitation training
Appendicular Skeletal Muscle Mass (DEXA)
Appendicular skeletal muscle mass will be measured using Dual-energy X-ray Absorptiometry (DEXA). Muscle mass will be reported as appendicular lean mass (kg).
Measured: Baseline to 12 weeks after rehabilitation training
Appendicular Skeletal Muscle Mass (BIA)
Appendicular skeletal muscle mass will also be measured using Bioelectrical Impedance Analysis (BIA). Muscle mass will be reported as appendicular skeletal muscle mass (kg).
Measured: Baseline to 12 weeks after rehabilitation training
Sarcopenia Screening
Sarcopenia risk will be assessed using the Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls questionnaire (SARC-F).
Scores range from 0 to 10, with higher scores indicating greater risk of sarcopenia.
Measured: Baseline to 12 weeks after rehabilitation training
Handgrip Strength
Handgrip strength will be measured using a hand-held dynamometer. Maximum grip strength will be recorded in kilograms (kg).
Measured: Baseline to 12 weeks after rehabilitation training
Single Muscle Fiber Contractile Properties
Contractile properties of permeabilized single muscle fibers will be assessed using a single muscle fiber mechanics system (Aurora Scientific, Canada). Measurements will include maximum isometric force (Po, mN), specific force (kN/m²), and rate of force redevelopment (ktr, s-¹) obtained from isolated muscle fibers.
Higher values of maximum isometric force and specific force indicate greater muscle fiber contractile capacity.
Measured: Baseline to 12 weeks after rehabilitation training
Short Physical Performance Battery (SPPB)
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes balance tests, gait speed, and the chair stand test. Total score ranges from 0 to 12, with higher scores indicating better physical performance.
Measured: Time Frame: Baseline to 12 weeks after rehabilitation training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Young Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477574
- Sponsor's protocol ID
- B-2505-970-002
- Other IDs
- RS-2025-00560295
- Acronym
- SARC-AI
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Muscle-specific Multi-modal AI for Sarcopenia Diagnosis: Effects of Rehabilitation Training on Ant-muscle Aging
- ClinicalTrials.gov ID
- NCT07477574
- Acronym / sponsor ID
- SARC-AI / B-2505-970-002
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Muscle aging, Multimodal AI, Muscle function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a muscle-specific multimodal artificial intelligence (AI) model for the diagnosis of sarcopenia and to investigate the effects of rehabilitation training on muscle aging. Clinical, functional, and imaging data will be collected from participants with muscle function decline. Multimodal data, including muscle function measurements and clinical assessments, will be integrated to develop and validate an AI-based diagnostic model for sarcopenia. In addition, the effects of rehabilitation training on muscle function and muscle aging-related outcomes will be evaluated. The results of this study are expected to contribute to the development of digital biomarkers and precision rehabilitation strategies for sarcopenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Training | Experimental | Behavioral: Rehabilitation trainingParticipants will undergo a structured rehabilitation training program aimed at improving muscle function and reducing muscle aging-related decline. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Adults aged 65 years or older
- Individuals with reduced muscle function or at risk of sarcopenia
- Able to participate in rehabilitation training
- Able to understand the study procedures and provide written informed consent
Key exclusion criteria (4 listed)
- Severe cardiovascular, neurological, or musculoskeletal conditions that limit participation in exercise
- Severe cognitive impairment
- Participation in other clinical trials that may influence study outcomes
- Any medical condition judged by the investigator to make participation unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation trainingParticipants will perform a structured rehabilitation training program designed to improve muscle strength, physical performance, and muscle function. Clinical assessments and muscle function measurements will be collected before and after the rehabilitation program to evaluate the effects of training and to support the development of a muscle-specific multimodal AI model for sarcopenia diagnosis. | Behavioural | Rehabilitation Training |
Primary outcome
AI model performance
Time frame: Baseline to 12 weeks after rehabilitation training
The performance of the muscle-specific multimodal artificial intelligence (AI) model for detecting sarcopenia will be evaluated using the Area Under the Receiver Operating Characteristic Curve (AUC). The AUC evaluates the ability of the AI model to discriminate between participants with and without sarcopenia(e.g., handgrip strength, gait speed, and appendicular skeletal muscle mass). The AUC value ranges from 0.5 to 1.0, where higher values indicate better discrimination performance of the AI model.
8 secondary outcomes
Five-Times Chair Stand Test (5×STS)
Time frame: Baseline to 12 weeks after rehabilitation training
Gait Speed
Time frame: Baseline to 12 weeks after rehabilitation training
Appendicular Skeletal Muscle Mass (DEXA)
Time frame: Baseline to 12 weeks after rehabilitation training
Appendicular Skeletal Muscle Mass (BIA)
Time frame: Baseline to 12 weeks after rehabilitation training
Sarcopenia Screening
Time frame: Baseline to 12 weeks after rehabilitation training
Handgrip Strength
Time frame: Baseline to 12 weeks after rehabilitation training
Single Muscle Fiber Contractile Properties
Time frame: Baseline to 12 weeks after rehabilitation training
Short Physical Performance Battery (SPPB)
Time frame: Time Frame: Baseline to 12 weeks after rehabilitation training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation training in people with Sarcopenia, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AI model performance (time frame: Baseline to 12 weeks after rehabilitation training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.