Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Tendency for ventricular arrhythmia
研究概览
简要总结
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.
详细描述
This study is a substudy of a planned study involving participants with an implantable cardioverter defibrillator (ICD), who will be randomly assigned to either take part in a exercise program for 12 weeks or serve as control and live as usual (Clinical Trials Unique Protocol ID: 2018/1592). In that study all participants will complete an exercise treadmill test to determine maximum oxygen uptake (VO2 peak).
In this study we wish to examine the acute effect of one single bout of high intensity exercise (i.e the VO2 peak test) on the tendency for ventricular arrhythmia. The study will evaluate changes in ICD-parameters and the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test.
The study will also examine if the acute effect after VO2 peak testing alters after completing 12 weeks of aerobic interval training or control respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation
- •ICD implanted at St Olavs hospital, Trondheim
- •In case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation.
排除标准
- •inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons
- •signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk
- •comorbidity where endurance training at more than moderate intensity is discouraged
- •severe cardiac valve disease
- •planned surgery within the next 3 months
- •inability to give informed consent
结局指标
主要结局
Tendency for ventricular arrhythmia
时间窗: 24 hours
Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring
次要结局
- Changes in acute effect of one single bout of high intensity exercise on tendency for ventricular arrhythmia after either 3 months of interval exercise or control(Baseline and after 12 weeks)
- Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)(24 hours)