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.
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 58 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
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.
Chung Shan Medical University Hospital
Taichung, Taiwan, Taiwan
Physical Function (5TSTS)
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. Longer completion times indicate poorer physical performance
Time frame: Change from Baseline at Week 12 and Week 24
Handgrip Strength (HGS)
Measured using a digital dynamometer (e.g., Jamar or equivalent). Participants perform the test in a standing position with the arm fully extended. Two trials are performed for each hand, and the highest value (kg) is used for analysis. Low muscle strength is defined according to AWGS 2019 criteria (\<28 kg for men and \<18 kg for women).
Time frame: Change from Baseline at Week 12 and Week 24
Skeletal Muscle Mass Index (SMI)
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).
Time frame: Change from Baseline at Week 12 and Week 24
Sarcopenia Risk (SARC-CalF)
Assessed using the SARC-CalF questionnaire, combining the SARC-F (5 items: strength, walking, rising, climbing stairs, falls; scored 0-10) with calf circumference measurement. Calf circumference ≤34 cm (men) or ≤33 cm (women) adds 10 points to the score. A total SARC-CalF score ≥11 indicates a high risk of sarcopenia.
Time frame: Change from Baseline at Week 12 and Week 24
Glycated Hemoglobin (HbA1c)
Metabolic control 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.
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Time frame: Change from Baseline at Week 12 and Week 24
Quality of Life (SF-12)
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.
Time frame: Change from Baseline at Week 12 and Week 24