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

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

Last updated 2025-11-28

No results posted yet for this study

Summary

Background Middle-aged individuals with T2DM, especially in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, which negatively impacts their quality of life. Effective interventions are therefore urgently needed to slow the progression of the disease and mitigate these risks.

Methods

* Study Design: This is a multicenter randomized controlled trial.
* Participants: The study plans to recruit 66 adults, aged 45 to 64, with a confirmed diagnosis of T2DM.
* Group Assignment: Participants will be randomly assigned to either a control group or an intervention group.

* Control Group: Participants will receive only a "Nutrition and Muscle Health Education Sheet" and continue with their routine health management based on existing medical advice.
* Intervention Group: Participants will receive the same leaflet along with a "Diabetes and Muscle Health Handbook" and will take part in a 12-week multimodal exercise program.
* Assessments: All participants will be assessed at baseline, week 6, and week 12.

Outcome Measures

* Primary Outcomes:

o Physical Function: Short Physical Performance Battery (SPPB), Five-Times Sit-to-Stand Test (5TSTS), handgrip strength, and Skeletal Muscle Mass Index (SMI).
* Secondary Outcomes:

* Metabolic Control: Glycated hemoglobin (HbA1c).
* Quality of Life: SF-12 Quality of Life questionnaire.
* Sarcopenia Risk: Evaluated by the SARC-CalF questionnaire. Expected Outcomes This study aims to provide an evidence-based and feasible multimodal exercise prescription for middle-aged adults with T2DM. The findings are expected to support early intervention strategies for healthy aging and serve as a valuable reference for clinical practice and the development of public health policies.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

BEHAVIORAL

A Multimodal Exercise Intervention

Participants will receive the same leaflet along with a "Diabetes and Muscle Health Handbook" and will take part in a 12-week multimodal exercise program.

Sponsors & Collaborators

  • yueh chu wu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2025-12-31
Completion
2025-12-31

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