Effect of High-Intensity Interval Exercise Training Compared With Moderate-intensity Continuous Training on Endothelial Function and Cardiorespiratory Fitness of Type 1 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Endothelial Dependent Mediated Vascular Dilation
研究概览
简要总结
To study the effect of 8 week high-intensity interval training (HIIT) compared with moderate intensity (MCT) interval training and sedentary patients(CON) with type 1 diabetes. Adult T1DM patients without known complications are randomised in blocks into these 3 groups according to their baseline flow mediated dilation (FMD). After 8 week exercise training, the main outcome, FMD, is re-evaluated. Additional variables such as VO2 peak for cardiovascular fitness, oxidative stress and endothelial independent vasodilation to study vascular rigidity are also evaluated.
详细描述
In a randomized controlled open trial, 36 adult type 1 diabetes mellitus (T1DM) patients without known complications were randomized into 3 groups: HIIT n=12; MCT n=12 and a sedentary control group (CON) n=12. Total sample size was calculated to a power of 80% alha 0.05 and a difference in mean FMD of 2%. Before randomisation, flow mediated dilation (FMD) and maximal exercise capacity (VO2 peak)is determined. Block Randomisation based on FMD rank values are done to equalize baseline FMD. Exercise sessions are performed in cycle ergometers during 40 minutes, 3 times a week, along 8 weeks. HIIT protocol, intensity vary from 50 to 85% of the maximum heart rate (HRmax), while in MCT, HR remained stable at 50% HRmax. Endothelial function was measured by flow mediated dilation (FMD) for endothelium-dependent vasodilation (EDVD) and smooth-muscle function was measured by nitroglycerine mediated dilation (endothelium independent vascular dilation) - (EIVD). Peak oxygen consumption (VO2peak) and oxidative stress markers were determined before and after the training period. ED was defined as an increase of less than 8% in vascular diameter after cuff release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically inactive or not involved in exercise training programs in the previous 6 months
- •Interested in starting an exercise training program.
排除标准
- •Pregnancy
- •Co-morbidities not related to diabetes
- •Drugs other than insulin
- •Loss of renal function (serum creatinine above 1.5 mg/dl),
- •Moderate to severe retinopathy or blindness,
- •Suspected or confirmed coronary artery disease,
- •Severe peripheral neuropathy
- •Foot ulcers or history of previous foot ulcer
- •Suspected or confirmed clinical autonomic neuropathy.
研究组 & 干预措施
High Intensity Interval Training
High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks
干预措施: High Intensity Interval Training (Behavioral)
Moderate Continuous Exercise Training
Moderate Continuous Interval Training
干预措施: Moderate Continuous Exercise Training (Behavioral)
Non-exercise
Sedentary Type 1 Diabetes Controls.
干预措施: Non-exercise (Other)
结局指标
主要结局
Endothelial Dependent Mediated Vascular Dilation
时间窗: 8 weeks
Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm
次要结局
- Endothelial independent vascular dilation(8 weeks)
- Peak oxygen consumption(8 weeks)