Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change of maximal oxygen uptake during exercise, measured in ml/kg/min
研究概览
简要总结
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.
详细描述
Patients after surgical correction of tetralogy of Fallot (cTF) have impaired exercise tolerance as compared to healthy age-matched individuals. In this controlled trial, patients with cTF will be randomized to either interval training, continuous training, or usual care.
The aim of the study is to compare the effect of interval vs. continuous exercise training on:
i) exercise capacity ii) vascular function iii) arrhythmogenic potential iv) parameters of inflammation, hemostasis and heart failure severity v) health-related quality of life adults with cTF
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •congenital tetralogy of Fallot surgically corrected in childhood
排除标准
- •contraindications for exercise training,
- •uncontrolled dysrhythmias,
- •uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
- •unstable coronary or other arterial disease,
- •intellectual development disorder,
- •pregnancy.
研究组 & 干预措施
Interval training group
Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak heart rate) and low-intensity intervals (50-70% of peak heart rate).
干预措施: Exercise training (Other)
Continuous training group
Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 70-75% of peak heart rate.
干预措施: Exercise training (Other)
Usual care group
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.
结局指标
主要结局
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
时间窗: 3 months
次要结局
- Change of the value of blood fibrinogen, measured in g/l(3 months)
- Change of the ECG waves(3 months)
- Change in the result of the 6-minute walking test, measured in metres(3 months)
- Change of flow-mediated dilatation of the brachial artery, measured in %(3 months)
- Change of the value of blood N terminal-proBNP, measured in ng/l(3 months)
- Change of the value of blood D-dimer, measured in microg/l(3 months)
- Change of from-the-questionnaire-obtained quality of life, measured in points(3 months)
- Change of the heart rate variability(3 months)
- Change of the arterial stiffness coefficient(3 months)
研究者
Borut Jug
Assistant Professor
University Medical Centre Ljubljana