Effect of Tai Chi Versus Moderate-intensity Combined Exercise Training on Cardiovascular Health and Physical Functional Performance in Older Men and Women With T2DM
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- Cardiovascular Health Score
研究概览
简要总结
This randomized, single-blind, controlled clinical trial compares the effects of a 12-week Tai Chi program versus moderate-intensity combined exercise (MICE) training on cardiovascular health, glycemic control, and physical function in older adults with type 2 diabetes (T2DM). Sixty-six participants (33 men and 33 women) will be randomized 1:1:1 to Tai Chi (n = 22), MICE (n = 22), or a non-exercise control group (CON, n = 22).
The Tai Chi intervention involves three weekly Yang-style sessions, progressively increasing in duration and complexity while maintaining perceived exertion (PSE) below 12 (6-20 scale). The MICE program combines moderate-intensity walking (PSE 12-13) with six strengthening exercises (PSE 12-14), gradually increasing from 15 to 30 minutes/session and 1 to 3 sets over 12 weeks.
Primary outcomes include cardiovascular health (Life's Essential 8 index: diet, physical activity, nicotine exposure, sleep, BMI, lipids, blood glucose, and blood pressure) and glycemic control (fasting glucose, HbA1c). Secondary outcomes assess physiological mechanisms (heart rate variability, pulse wave velocity, flow-mediated dilation, carotid intima-media thickness), physical performance (6-minute walk test, grip strength, timed up-and-go), and quality of life (WHOQOL-BREF/OLD).
All evaluations will be conducted by blinded assessors under standardized conditions (21-24°C, morning fasting), except the 6MWT. Statistical analysis includes intention-to-treat repeated-measures ANOVA, ANCOVA for baseline adjustments, and per-protocol/adherence-adjusted analyses. Sample size (GPower) was calculated to detect a 0.8% HbA1c reduction with 90% power (30% attrition accounted for). An interim analysis at 50% completion will evaluate effect sizes/variability, with potential sample-size recalibration by an independent committee.
The study employs rigorous quality controls: standardized protocols, blinded assessments, and monitoring of confounders (medication changes, acute exercise effects). Ethical approval (CAAE: 88582225.1.0000.5398) ensures adherence to informed consent and privacy. By determining whether Tai Chi offers comparable or superior benefits to MICE for cardio metabolic health and functional capacity, this trial aims to inform evidence-based exercise prescriptions for older T2DM patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •only with type 2 diabetes
排除标准
- •if not able to perform physical exercise (Extreme neuropathy, wounds in the feet, and amputation risk.)
结局指标
主要结局
Cardiovascular Health Score
时间窗: At baseline (week 0) and after follow-up (week 12)
Life's Essential 8 Index (0-100 scale) Components: Health behaviors: Diet, physical activity, nicotine exposure, sleep quality Health factors: BMI, blood lipids, blood glucose, blood pressure
Fasting Plasma Glucose
时间窗: At baseline (week 0) and after follow-up (week 12)
Change in fasting plasma glucose (FPG) levels (measured in mg/dL).
Glycated Hemoglobin (HbA1c)
时间窗: baseline (Week 0) to follow-up (Week 12).
Change in glycated hemoglobin (HbA1c) levels (measured as % of total hemoglobin)
次要结局
- Carotid-femoral pulse wave velocity (PWVcf)(At baseline (week 0) and after follow-up (week 12))
- Brachial artery flow-mediated dilation (FMD)(At baseline (week 0) and after follow-up (week 12))
- Carotid Intima-Media Thickness(At baseline (week 0) and after follow-up (week 12))
- Central blood pressures(At baseline (week 0) and after follow-up (week 12))
- Brachial blood pressure (BP)(At baseline (week 0) and after follow-up (week 12))
- Heart rate variability (HRV) - frequency domain(At baseline (week 0) and after follow-up (week 12))
- Heart rate variability (HRV) - time domain(from baseline (Week 0) to follow-up (Week 12))
- Endurance performance(At baseline (week 0) and after follow-up (week 12))
- Handgrip Strength(At baseline (week 0) and after follow-up (week 12))
- Lower-limb muscle strength(At baseline (week 0) and after follow-up (week 12))
- Mobility(At baseline (week 0) and after follow-up (week 12))
- Ambulatory blood pressure monitoring (ABPM)(At baseline (week 0) and after follow-up (week 12))
- Ambulatory heart rate variability (HRV)(At baseline (week 0) and after follow-up (week 12))
研究者
Emmanuel Gomes Ciolac
Full Professor of Department of Physical Education
Universidade Estadual Paulista Júlio de Mesquita Filho