Effects of a Multimodal Exercise Program on Physical Performance and Muscle Function in Middle-aged Patients With T2DM

Background Middle-aged adults with type 2 diabetes mellitus (T2DM), especially in Asian populations, are at increased risk of sarcopenia, reduced muscle function, and decline in physical performance. Effective and feasible exercise interventions are needed to support early prevention and healthy aging. Methods This is a multicenter randomized controlled trial. The study plans to recruit 66 adults aged 45 to 64 years with a confirmed diagnosis of T2DM. Participants will be randomly assigned to either a control group or an intervention group. The control group will receive a Nutrition and Muscle Health Education Sheet and continue routine health management. The intervention group will receive the same education sheet, a Diabetes and Muscle Health Handbook, and a 12-week multimodal exercise program. From Week 13 to Week 24, app-based maintenance reminders will be provided every two weeks. All participants will be assessed at baseline (Week 0), Week 6, Week 12, and Week 24. The Week 6 assessment is a mid-intervention assessment, the Week 12 assessment evaluates immediate post-intervention effects, and the Week 24 assessment evaluates sustained effects during the maintenance phase. Assessments include physical performance, muscle function, glycated hemoglobin (HbA1c), health-related quality of life, and the risk of sarcopenia. No additional invasive tests or additional research procedures will be introduced at Week 24. Outcome Measures The primary outcomes are physical performance and muscle function, including the Short Physical Performance Battery (SPPB), Five-Time Sit-to-Stand Test (5TSTS), handgrip strength, and Skeletal Muscle Index (SMI). Secondary outcomes include HbA1c, health-related quality of life measured by the SF-12, and sarcopenia risk assessed by SARC-CalF. Expected Outcomes This study aims to provide an evidence-based and feasible multimodal exercise prescription for middle-aged adults with T2DM and to support early intervention strategies for healthy aging.

NCT Number	NCT07255222
Lead Sponsor	Chung Shan Medical University
Conditions	Type 2 Diabetes Mellitus (T2DM)
Enrollment	66 participants
Start Date	2025-08-18
Primary Completion	2026-08-14 (estimated)
Study Completion	2026-12-14 (estimated)
Updated on ClinicalTrials.gov	2026-06-11