Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia

March 25, 2026 updated by: yueh chu wu

Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia

This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Middle-aged and older adults with T2DM, particularly in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, negatively impacting quality of life. Effective interventions are urgently needed to slow disease progression. This randomized controlled trial will recruit 128 adults. Participants will be randomly assigned to either a control group or an intervention group. The intervention involves a multimodal exercise program and educational materials, while the control group receives standard health education. Assessments will be conducted at baseline, week 12, and week 24 to evaluate physical function, sarcopenia risk, metabolic control, and quality of life.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Taichung, Taiwan, Taiwan, 402306
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with both Type 2 Diabetes Mellitus (T2DM) and sarcopenia.
  • Maintained on a stable regimen of oral hypoglycemic agents.
  • Aged 45 years or older.
  • Capable of communicating effectively in Mandarin or Taiwanese.
  • Willing to provide informed consent or have it obtained from a legally authorized representative.

Exclusion Criteria:

  • • Limited limb or joint function that prevents exercise (e.g., recent fractures or dislocations).

    • Communication barriers or severe emotional/psychological issues (e.g., uncontrolled depression or severe mental illness).
    • Severe cognitive impairment (e.g., dementia).
    • End-stage renal disease (ESRD).
    • Major comorbidities or complications, including active diabetic foot ulcers, amputation, recent myocardial infarction, severe autonomic neuropathy, or a history of stroke within the last 3 years.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (Multimodal Exercise)
• Arm Description: Participants in this group will engage in a 12-week multimodal exercise program. The program includes supervised training sessions, home-based exercises, and digital support. They will also receive a "Diabetes and Muscle Health Handbook" to guide their training.
Behavioral: Multimodal Exercise Program
Participants will engage in a 12-week multimodal exercise program comprising supervised training sessions, home-based exercises, and digital support. To facilitate adherence and proper technique, participants will also receive a "Diabetes and Muscle Health Handbook" as a training guide.
Other Names:
  • Control Group
No Intervention: Control Group (Standard Care)
Participants in this group will serve as the control. They will receive a "Nutrition and Muscle Health Education Sheet" at the beginning of the study. They will not participate in the multimodal exercise program and will continue with their routine health management based on existing medical advice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal Muscle Mass Index (SMI)
Time Frame: Change from Baseline at Week 12 and Week 24
Determined by bioelectrical impedance analysis (BIA). Appendicular skeletal muscle mass (ASM, kg) is calculated as the sum of lean mass from both arms and legs. SMI is expressed as ASM divided by height squared (kg/m²). Low muscle mass is defined according to AWGS 2019 cut-off values (<7.0 kg/m² for men and <5.7 kg/m² for women).
Change from Baseline at Week 12 and Week 24
Physical Function (5TSTS)
Time Frame: Change from Baseline at Week 12 and Week 24
The Five-Times Sit-to-Stand Test (5TSTS) assesses lower limb muscle power. Participants are asked to stand up and sit down five times as quickly as possible with arms folded. The time to completion is recorded in seconds and analyzed as a continuous variable. According to the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, a completion time of ≥ 12 seconds is considered abnormal and indicates low physical performance.
Change from Baseline at Week 12 and Week 24
Handgrip Strength (HGS)
Time Frame: Change from Baseline at Week 12 and Week 24
Handgrip strength (HGS) is assessed using a digital dynamometer (e.g., Jamar or an equivalent device). During the assessment, participants stand with their testing arm fully extended. Two consecutive trials are performed for each hand, and the maximum grip strength value (in kilograms) is selected for data analysis. Based on the 2019 Asian Working Group for Sarcopenia (AWGS) consensus, low muscle strength is defined as < 28 kg for men and < 18 kg for women
Change from Baseline at Week 12 and Week 24
Sarcopenia Risk: Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF).
Time Frame: Change from Baseline at Week 12 and Week 24
Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF). The SARC-F assesses 5 items scored 0-10. A calf circumference ≤34 cm (men) or ≤33 cm (women) adds 10 points. Total SARC-CalF scores range from 0 to 20. Higher scores indicate a higher risk of sarcopenia (a worse outcome). A total SARC-CalF score ≥11 indicates a high risk.
Change from Baseline at Week 12 and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (SF-12)
Time Frame: Change from Baseline at Week 12 and Week 24
Assessed using the 12-Item Short Form Health Survey (SF-12). The survey covers eight domains summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better quality of life.
Change from Baseline at Week 12 and Week 24
Glycated Hemoglobin (HbA1c)
Time Frame: Change from Baseline at Week 12 and Week 24
Metabolic control is evaluated by HbA1c levels. Venous blood samples are collected after an overnight fast and analyzed using standardized high-performance liquid chromatography (HPLC). Values are reported as percentages. According to the American Diabetes Association (ADA) guidelines, the target HbA1c level for patients with type 2 diabetes mellitus (T2DM) is < 7.0%.
Change from Baseline at Week 12 and Week 24

Collaborators and Investigators

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

Sponsor

yueh chu wu

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 (Actual)

February 23, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSH-2026-A-036

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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