Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Region Skane
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Maximal oxygen uptake (VO2peak)
研究概览
简要总结
The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.
详细描述
A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.
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
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs and symptoms of heart failure
- •Age ≥50 years
- •Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
- •Able to understand and follow exercise prescription
- •Currently physically inactive (less than 150 minutes/week moderate intensity exercise)
- •Exclusion criteria:
- •Currently or within the past 6 months been involved in cardiac rehab with exercise
- •Devices or implants not compatible with magnetic resonance imaging or exercise testing
- •Any orthopedic or medical condition affecting participation in testing and training
- •Signs of acute ischemia during baseline cardiopulmonary exercise testing
- •Participation in other clinical trials that may affect results
- •Moderate or severe valvular disease
- •Atrial fibrillation
- •Moderate or severe chronic obstructive pulmonary disease
- •NYHA class IV
排除标准
- 未提供
结局指标
主要结局
Maximal oxygen uptake (VO2peak)
时间窗: 12 weeks intervention
a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg
次要结局
- Health related quality of life(12 weeks intervention)
- Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)(12 weeks intervention)
- Mitochondrial function(12 weeks intervention)
- Cardiac volumes and function(12 weeks intervention)