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

NCT07255222 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

BEHAVIORAL

A Multimodal Exercise Intervention

Participants will receive educational materials and participate in a 12-week multimodal exercise program, followed by app-supported maintenance reminders every two weeks through Week 24.

Sponsors & Collaborators

  • Chung Shan Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-08-14
Completion
2026-12-14

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255222 on ClinicalTrials.gov