Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Physical Function (5TSTS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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.
研究组 & 干预措施
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.
干预措施: Multimodal Exercise Program (Behavioral)
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.
结局指标
主要结局
Physical Function (5TSTS)
时间窗: 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. Longer completion times indicate poorer physical performance
Handgrip Strength (HGS)
时间窗: Change from Baseline at Week 12 and Week 24
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).
Skeletal Muscle Mass Index (SMI)
时间窗: 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).
Sarcopenia Risk (SARC-CalF)
时间窗: Change from Baseline at Week 12 and Week 24
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.
次要结局
- Glycated Hemoglobin (HbA1c)(Change from Baseline at Week 12 and Week 24)
- Quality of Life (SF-12)(Change from Baseline at Week 12 and Week 24)
研究者
yueh chu wu
Diabetes Educator
Chung Shan Medical University