Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal Exercise Program.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Sarcopenia. Basic parameters: 45 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Physical Function (5TSTS) [Time frame: Change from Baseline at Week 12 and Week 24]
- Handgrip Strength (HGS) [Time frame: Change from Baseline at Week 12 and Week 24]
- Skeletal Muscle Mass Index (SMI) [Time frame: 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]
Secondary outcome measures (2)
- Glycated Hemoglobin (HbA1c) [Time frame: Change from Baseline at Week 12 and Week 24]
- Quality of Life (SF-12) [Time frame: Change from Baseline at Week 12 and Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chung Shan Medical University Hospital — Taichung
Publications
- Wu YC, Liao LN, Lai YF, Huang HE, Liao WC, Huang CN. Sustained and attenuated effects of transitioning from supervised to self-managed resistance training in older adults with type 2 diabetes and sarcopenia: a randomized controlled trial. Acta Diabetol. 2026 Jul 13. doi: 10.1007/s00592-026-02736-y. Online ahead of print. PMID 42440096
Identifiers
NCT: NCT07398495 · CSH-2026-A-036