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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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