The Effect of a Short-Bout Combined Aerobic and Resistance Exercise Program on Physical Activity and Muscle Strength in Older Adults With Diabetes and Probable Sarcopenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 73
- 主要终点
- Change in Physical Activity Level
研究概览
简要总结
Older adults with diabetes are at high risk of developing sarcopenia. A preclinical stage, known as "probable sarcopenia" (defined by low muscle strength), represents a critical window for early intervention. Physical activity is an effective strategy, but many patients struggle to maintain regular exercise. This parallel-group randomized controlled trial aims to evaluate the effectiveness of a 12-week home-based, short-bout combined aerobic and resistance exercise program on physical activity level and muscle strength among older adults with diabetes and probable sarcopenia.
详细描述
The control group will receive usual community-based diabetes care. In addition to usual care, the intervention group will receive an individualized exercise program delivered in a short-bout, high-frequency format (resistance training: 3 days per week, three bouts per day at moderate intensity; aerobic training: 5 days per week, three bouts per day at moderate intensity). Primary outcomes are physical activity level and muscle strength. Assessments will be conducted at baseline, 12 weeks (post-intervention), and 24 weeks (follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years, diagnosed with type 2 diabetes mellitus (T2DM) for ≥1 year.
- •Meet the Asian Working Group for Sarcopenia (AWGS) 2025 criteria for probable sarcopenia.
- •Physical activity <150 minutes per week of moderate-intensity aerobic activity.
- •Conscious, able to communicate effectively in written or spoken language.
- •Able to use a smartphone independently (or with minimal assistance).
- •Voluntarily participate and provide written informed consent.
排除标准
- •Confirmed sarcopenia based on AWGS
- •History or current diagnosis of psychiatric disorders, or severe cognitive impairment.
- •Severe acute or chronic diabetic complications (e.g., diabetic ketoacidosis, proliferative diabetic retinopathy, stage IV-V diabetic nephropathy).
- •Severe congestive heart failure (NYHA class III-IV), or acute cardiac event, syncope, or loss of consciousness within the past year.
- •Severe pulmonary, hepatic, or renal insufficiency, or active malignancy.
- •Concurrent participation in another exercise intervention study.
- •Severe joint or muscle disease that strictly limits exercise (e.g., severe osteoarthritis, fracture, or other significant functional impairment), or other absolute contraindications to exercise.
- •Unintentional weight change >5% or major changes in medication regimen within the 3 months prior to enrollment.
- •Classified as poor health status (Group 3) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes in the Elderly (2024 Edition).
- •Implanted electronic medical device (e.g., cardiac pacemaker).
研究组 & 干预措施
Short-Bout Combined Aerobic and Resistance Exercise
Participants in the intervention arm will receive a 12-week home-based, short-bout combined aerobic and resistance exercise program in addition to usual community-based diabetes care. The program is designed according to the definition of short-bout accumulated exercise (SBAE), in which exercise is accumulated in multiple bouts of ≤10 minutes each, performed several times per day. Resistance training is performed 3 days per week with 3 bouts per day. Each bout consists of 2 exercises, with each exercise performed as 2 sets of 10 repetitions at moderate intensity. Aerobic training is performed 5 days per week with 3 bouts of 10 minutes each per day at moderate intensity.
干预措施: Short-Bout Combined Exercise Program (Behavioral)
Usual Community Diabetes Care
Participants receive usual diabetes care as provided in community settings, including routine medical follow-up, standard health education, and diabetes management support from community health centers. No structured exercise program or additional intervention is provided. After the trial, control participants are sent the same exercise program materials as the intervention group, and they can voluntarily choose to access and view them.
结局指标
主要结局
Change in Physical Activity Level
时间窗: Baseline, 12 weeks, and 24 weeks
Physical activity level measured using the Physical Activity Scale for the Elderly (PASE). The PASE score ranges from 0 to 400 or more, with higher scores indicating higher levels of physical activity.
Change in Muscle Strength
时间窗: Baseline, 12 weeks, and 24 weeks
Grip strength (kg) measured using a hand grip dynamometer. Higher values indicate greater muscle strength.
次要结局
- Change in Appendicular Skeletal Muscle Mass Index(Baseline, 12 weeks, and 24 weeks)
- Change in Skeletal Muscle Mass(Baseline, 12 weeks, and 24 weeks)
- Change in Physical Performance(Baseline, 12 weeks, and 24 weeks)
- Reversal rate of probable sarcopenia(Baseline, 12 weeks, and 24 weeks)
- Change in Glycated Hemoglobin(Baseline, 12 weeks, and 24 weeks)
- Change in Fasting Plasma Glucose(Baseline, 12 weeks, and 24 weeks)
- Change in Sarcopenia Awareness(Baseline, 12 weeks, and 24 weeks)
- Change in Sarcopenia risk(Baseline, 12 weeks, and 24 weeks)
- Change in Nutritional Status(Baseline, 12 weeks, and 24 weeks)
- Change in Frailty Level(Baseline, 12 weeks, and 24 weeks)
- Change in Fall risk(Baseline, at 12 weeks post-intervention, and at 24 weeks post-intervention)
- Change in Depressive Symptoms(Baseline, 12 weeks, and 24 weeks)
- Number of Adverse Events(Throughout the study (Baseline to 24 weeks))
- Cost-Utility Analysis Indicators(Baseline, 24 weeks)
- Process Evaluation Indicators(Throughout the study (Baseline to 24 weeks))
- Change in Total Body Water(Baseline, 12 weeks, and 24 weeks)
- Change in Inorganic Salt Mass(Baseline, 12 weeks, and 24 weeks)
- Change in Fat Mass(Baseline, 12 weeks, and 24 weeks)
- Yubi-wakka Test(Baseline, 12 weeks, and 24 weeks)
- Body Fat Percentage(Baseline, 12 weeks, and 24 weeks)
- Change in Protein Mass(Baseline, 12 weeks, and 24 weeks)
- Change in EuroQol-5D-5L Scores(Baseline, 12 weeks, and 24 weeks)
- Change in Affective Attitude toward Physical Activity(Baseline, 12 weeks, and 24 weeks)
- Change in Instrumental Attitude toward Physical Activity(Baseline, 12 weeks, and 24 weeks)
- Change in Perceived Capability for Physical Activity(Baseline, 12 weeks, and 24 weeks)
- Change in Perceived Opportunity for Physical Activity(Baseline, 12 weeks, and 24 weeks)
- Change in Intention to Engage in Physical Activity(Baseline, 12 weeks, and 24 weeks)
- Change in Physical Activity Regulation Behaviours(Baseline, 12 weeks, and 24 weeks)
- Change in Physical Activity Habit(Baseline, 12 weeks, and 24 weeks)
- Change in Physical Activity Identity(Baseline, 12 weeks, and 24 weeks)
研究者
Lu Han
PhD Candidate
Sun Yat-sen University