High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in aerobic capacity measured as oxygen consumption
研究概览
简要总结
The purpose of this study is to determine whether endurance exercise of either high or moderate intensity can reverse structural and functional changes of the heart in patients with diastolic heart failure, and to investigate which type of exercise is best in terms of aerobe capacity and quality of life.
The investigators expect that high intensity endurance exercise is superior to moderate intensity endurance exercise.
详细描述
This study is a prospective randomized controlled intervention study comparing two active arms. Eligible patients are being sampled consecutively by cardiologists, and randomized to either high or moderate intensity endurance exercise. Endpoints are measured at baseline, 4 weeks and 7 months. The intervention is considered safe, and the study has been approved by the Regional Ethics Committee (REK-midt).
This project has been financially supported by the Norwegian ExtraFoundation for Health and Rehabilitation through EXTRA funds.
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
- Single (Outcomes Assessor)
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
- •Sedentary lifestyle
- •Normal systolic function left ventricular ejection fraction (LVEF) < 50%
- •New York Heart Association (NYHA) class II or III
- •Diastolic dysfunction (E/é < 15 or E/é 8-15 and N-terminal proBNP > 220pg/ml)
- •Medically stable the last 4 weeks
- •Written informed consent
排除标准
- •Other causes of dyspnea than diastolic heart failure
- •Personal preferences or characteristics prohibiting the person from attending inpatient cardiac rehabilitation
- •Not able to perform physical exercise
结局指标
主要结局
Change in aerobic capacity measured as oxygen consumption
时间窗: Baseline and 7 months
Cardiopulmonary exercise test
次要结局
- Changes in everyday activity level(Baseline to 7 months)
- Change in diastolic filling pressure measured as E/é(Baseline to 7 months)
- Arterial function measured as blood-vessel elasticity(Baseline to 7 months)
- Cardiac function measured as volume, size, efficacy(Baseline to 7 months)
- Quality of life(Baseline to 7 months)
- Feasibility, measured as attrition rate and compliance with exercise(Baseline to 7 months)
- Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP(Baseline to 7 months)