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NCT Number: NCT07398495

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

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Atrophy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, Taiwan, 402306

Location status: Recruiting

Location contact

WU YUEH CHU

CONTACT

[email protected]

886-4-24739595 ext. 20340

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Exercise Program

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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.

Secondary outcomes

  1. 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%.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

yueh chu wu WU YUEH CHU

CONTACT

[email protected]

886-952680613

Sponsors and collaborators

Lead sponsor

yueh chu wu

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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