Muscle-Specific Multimodal AI for Sarcopenia Diagnosis (SARC-AI)

March 12, 2026 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rehabilitation Training
Participants will undergo a structured rehabilitation training program aimed at improving muscle function and reducing muscle aging-related decline.
Behavioral: Rehabilitation training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks after rehabilitation training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Five-Times Chair Stand Test (5×STS)
Time Frame: Baseline to 12 weeks after rehabilitation training
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.
Baseline to 12 weeks after rehabilitation training
Gait Speed
Time Frame: Baseline to 12 weeks after rehabilitation training
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).
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 will be measured using Dual-energy X-ray Absorptiometry (DEXA). Muscle mass will be reported as appendicular lean mass (kg).
Baseline to 12 weeks after rehabilitation training
Appendicular Skeletal Muscle Mass (BIA)
Time Frame: Baseline to 12 weeks after rehabilitation training
Appendicular skeletal muscle mass will also be measured using Bioelectrical Impedance Analysis (BIA). Muscle mass will be reported as appendicular skeletal muscle mass (kg).
Baseline to 12 weeks after rehabilitation training
Sarcopenia Screening
Time Frame: Baseline to 12 weeks after rehabilitation training

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.
Baseline to 12 weeks after rehabilitation training
Handgrip Strength
Time Frame: Baseline to 12 weeks after rehabilitation training
Handgrip strength will be measured using a hand-held dynamometer. Maximum grip strength will be recorded in kilograms (kg).
Baseline to 12 weeks after rehabilitation training
Single Muscle Fiber Contractile Properties
Time Frame: Baseline to 12 weeks after rehabilitation training

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.
Baseline to 12 weeks after rehabilitation training
Short Physical Performance Battery (SPPB)
Time Frame: Time Frame: Baseline to 12 weeks after rehabilitation training
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.
Time Frame: Baseline to 12 weeks after rehabilitation training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-2505-970-002
  • RS-2025-00560295 (Other Grant/Funding Number: the National Research Foundation of Korea(NRF) grant funded by the Korea government(MSIT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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