Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure. The ARISTOS-HF Trial: a Prospective Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- change in left ventricular dimension (mm) using resting 2-dimensional echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the Teichholz method
研究概览
简要总结
This study investigates the effects of aerobic, resistance, inspiratory training modalities outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming for the 'optimum' (greek, αριστος=aristos) training program for HF patients.
详细描述
Heart failure is a clinical syndrome characterized by symptoms of dyspnea, exercise intolerance and decreased quality of life. A weakness in both inspiratory and peripheral muscles is also reported. Aerobic training (AT) improves the functional status of HF patients (level of evidence IA). Additional benefits of inspiratory muscle training (IMT) and/or resistance training (RT) when combined with aerobic training (AT) in HF symptoms have also been found.
Four exercise groups will be studied in order to identify the optimum exercise program I. Aerobic-Resistance-Inspiratory training (ARIS) group II. Aerobic Training-Resistance Training (AT/RT) group III. Aerobic training-Inspiratory Muscle Training (AT/IMT) group IV. Aerobic Training (AT) group
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure (from New York Heart Association (NYHA) functional class II to NYHA III)
- •Left ventricular ejection fraction below or equal to 35%
排除标准
- •Uncontrolled arrhythmia
- •Pulmonary oedema or pulmonary congestion in the last 30 days
- •Cognitive, neurological or orthopaedic limitations
- •Respiratory infection during 30 days before the start of the study
- •Pulmonary limitations (e.g COPD)
结局指标
主要结局
change in left ventricular dimension (mm) using resting 2-dimensional echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the Teichholz method
时间窗: Before and after 12 weeks
evaluation of cardiac structure (LVEDD, LVESD in mm)
change in peak oxygen consumption (peakVO2, in ml/kg/min) using cardiopulmonary exercise testing (Medgraphics CPX/MAX, Medical Graphics Corp.,St. Paul, MN, USA, ZAN 600, ZAN Messgera¨te GmbH, Germany)
时间窗: Before and after 12 weeks
evaluation of maximal exercise capacity
次要结局
- Preference Program Survey(After 12 weeks)
- change in left ventricular ejection fraction, echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the biplane Simpson' s method(Before and after 12 weeks)
- change in walking distance using the 6-minute walking test (6MWT)(Before and after 12 weeks)
- change in quality of Life using the Minnesota Living with Heart Failure questionnaire(Before and after 12 weeks)
研究者
Laoutaris Ioannis
PhD FESC
Onassis Cardiac Surgery Centre