The Effect of Aerobic Interval Training on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Early diastolic tissue velocity (e')
研究概览
简要总结
The aim of the study is to compare the effects of aerobic interval training and the IDF recommendations on physical activity on cardiac function and CV risk factors in patients with diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in patients with subclinical LV disease, improve both endothelial function and VO2max and thus reducing CV risk factors and CV disease. HbA1c will be more stable.
The aims of this study are to address the exercise prescription recommendations for patients with (T2DM) who have subclinical heart disease. The prescription recommendations will be assessed by randomising T2DM patients with subclinical heart disease to one of the following 2 groups for 3 months followed by a 9 month home-based program:
Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise recommendations of the International Diabetes Federation.
Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.
详细描述
The investigators primary hypotheses are that in patients with type 2 diabetes and subclinical heart disease:
Moderate Intensity Exercise will:
Not significantly improve myocardial function compared to controls,
Despite significant improvement (compared to controls) in:
Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 20-60 years with diagnose diabetes mellitus type 2 (without insulin) for less than 10 years and with diastolic dysfunction (E'<8), will be included.
排除标准
- •Overt CV disease
- •History of CAD
- •Moderate to severe valvular disease (AI MI 3-4, AS peak gradient > 15 mmHg=2m/s)
- •Atrial fibrillation or other severe arrhythmia
- •Congenital heart disease
- •Untreated hypertension >140/90
- •Retinopathy
- •Neuropathy
- •Micro or macroalbuminuria
- •EF < 40%
- •Ischemia at exercise echocardiography
- •Disease or disability making training difficult.
研究组 & 干预措施
. Moderate Intensity Exercise Group
Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.
干预措施: Exercise (Other)
Aerobic interval training
Exercise equivalent to the current guidelines achieved through high-intensity interval training.The exercise starts with warming-up for 10-min at 70% of HRmax before performing 4x4min intervals at 90-95% of HRmax, with 3-min active recovery at 70% of HRmax between each interval, and a 5-min cool-down period, giving a total of 40-min.
干预措施: Exercise (Other)
结局指标
主要结局
Early diastolic tissue velocity (e')
时间窗: 3 months
次要结局
- Early diastolic tissue velocity (e')(1 year)