BETA: Beneficial Effects of Exercise Training in Patients With Implantable Cardioverter-Defibrillators
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of arrhythmia burden, heart rate trend, increase in patients activity.
研究概览
简要总结
Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Therefore the investigators assumed that the population of patients with implantable cardioverter-defibrillators (ICD) with impaired left ventricular function may also benefit from a cardiovascular training in terms of improved quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and therapeutic effects of exercise training are very limited or not available.
This prospective randomized study examines the feasibility and benefits of exercise therapy in patients with ICD and congestive heart failure.
详细描述
Detailed anamnesis and a clinical examination will be performed in order to determine the patient's eligibility for the study. The randomisation either to the exercise- or to the control-arm will be performed at baseline. Follow-up visits are planned after four weeks and after three months same for both arms. The close-up visit is planned after 6 months.
The exercise-arm starts off with an introduction into physical training at the Department of Sports Medicine at the University in Tübingen. Ergospirometry and 6-min walk test will be performed to determine the patients' performance. Then the patients will be encouraged to exercise at home. The scales and intensities of physical training will vary interpersonally depending on patients individual performance. Pedometers and the ICD-integrated "Cardiac Compass" function will be used to verify work load, intensity and duration of the physical strain. The patients will be consulted by telephone regularly to affirm the study compliance. The physical activity in the control-arm will be monitored using the ICD-integrated "Cardiac Compass" function.
ICD-programming
- VT/SVT discrimination "on",
- "Cardiac Compass" feature "on"
- VT/VF detection and pacing-programming remain adjusted to clinical situation of the patient
Baseline- and follow-up visits
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both gender at a minimum age of 18 years
- •ICD-systems with "Cardiac-Compass" (Medtronic)-diagnostic feature
- •ICD system implanted for at least three months
- •congestive heart failure, NYHA II and III
- •LVEF ≤ 40 %
- •compensated state, optimized and stable pharmacological therapy at least for the last three months
- •load capacity of at least 50 watt at baseline.
排除标准
- •unable or unwilling to give informed consent
- •acute coronary syndrome during the past thirty days
- •hemodynamically relevant valvular defect
- •instable arterial hypertension
- •severe COPD
- •reduced work load capacity caused by instable angina pectoris, peripheral vascular, neurological or orthopaedic concomitant disease
- •hypertrophic obstructive cardiomyopathy (HOCM)
- •pulmonary-arterial hypertension (PAP systolic ≥ 60 mmHg).
结局指标
主要结局
Reduction of arrhythmia burden, heart rate trend, increase in patients activity.
时间窗: 6 months
次要结局
- Ineffective ICD-interventions, injury risk due to syncope, hospitalization, death. LVEF (echocardiography), VO2max, anaerobic threshold (AT), respiratory compensation point (RCP) and equivalents for O2 and CO2 (ergospirometry) BNP plasma level(6 months)