Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 7
- 主要终点
- peak VO2
研究概览
简要总结
Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.
详细描述
This is a randomized, prospective, multicenter, interventional study.
After study patients have given written consent they will be randomized either in the interventional group with a rehabilitation program or in the control group without rehabilitation program. Patients who are randomized in the control group are allowed to perform the rehabilitation program 12 months after randomisation. Patients in the interventional group will perform structured exercise training on 3 weekdays during a 12-weeks period. Training will be performed by ergometer and low-impact gymnastic and relaxation training.
All study participants have the following investigations at the beginning of the study and after 12 weeks:
- Cardiopulmonary exercise testing with spirometry
- 6-minute walk test
- Blood work: BNP, Creatinine, Sodium, Potassium, Urat, Cholesterol (HDL-L and LDL-L)
- Validated Heart failure questionnaires (SF-36 and Minnesota Living with heart failure questionnaire, German version for Basel, Zürich and Bern) All tests will be repeated as clinically indicated in a follow-up visit 12 months after baseline
Primary outcome is:
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
- •Patients with complex CHD including cyanotic heart disease, subaortic right ventricle physiology, single ventricle physiology, Ebstein anomaly with ≥ moderate tricuspid regurgitation and patients with Tetralogy of Fallot (including those with pulmonary atresia of Fallot type or double-outlet right ventricle of Fallot type) and either residual free pulmonary regurgitation or left- or right ventricular systolic dysfunction (demonstrated by echocardiography or cardiac MRI).
- •Peak VO2 < 85% of predicted (standardized for age, gender, weight and height) obtained by cardiopulmonary exercise testing
- •Sedentary lifestyle (< 30 minutes of regular exercise per week)
排除标准
- •Patients with dyspnea New York Heart Association (NYHA) class IV.
- •Severe left ventricular outflow tract obstruction.
- •Unstable angina or recent myocardial infarction (<12 months).
- •Uncontrolled ventricular arrhythmia.
- •Recent intervention (<12 months)
- •Life expectancy <12 months
- •No consent.
研究组 & 干预措施
Structured Exercise training
12 weeks ambulatory low level exercise training
干预措施: Structured exercise training (Behavioral)
Control group
No structured exercise training
结局指标
主要结局
peak VO2
时间窗: 12 weeks
Comparison between both groups
次要结局
- 6 minute walk test(12 months)
- VE/VCO2(12 months)
- QoL(12 months)
- BNP(12 months)
- peak VO2(12 months)
- heart rate response(12 weeks)
- Heart rate response(12 months)
- Adverse events(12 weeks)
- Cardiac adverse events(12 months)