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

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: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: Rehabilitation training

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 12 weeks after rehabilitation training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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.	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).	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.	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.	Time Frame: Baseline to 12 weeks after rehabilitation training

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sarcopenia; Muscle function; Muscle aging; Multimodal AI
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID 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