High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Effect of exercise on peak oxygen uptake
研究概览
简要总结
Compared to end-stage heart failure, a patient's situation is usually greatly improved after a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term, ranging from 50 to 70% in most studies. While effective rehabilitation, including regular exercise, is considered an effective tool of improving health related quality of life (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of different rehabilitation programs among HTx recipients is limited. Exercise training is considered one of the most central parts in rehabilitation, but the mode of exercise used in different studies varies considerably. It is documented that high intensity interval training (HIT) has superior effects compared to training with moderate intensity in cardiac and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered unphysiological. However, the investigators have recently demonstrated highly beneficial effects on exercise capacity, muscle strength, body composition, reduced progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study the investigators want to test the hypothesis that systematic aerobic exercise with high intensity improve exercise capacity also in newly transplanted recipients, and secondarily that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Clinically stable HTx recipients approximately 8-12 weeks after HTx.
- •Age > 18 years, both sexes
- •Received immunosuppressive therapy as per local protocol.
- •Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 9- 12 months.
排除标准
- •Unstable condition or postoperative complications
- •Recent severe rejection episodes
- •Physical disabilities which prevent participation
- •Other diseases or disabilities that contradict/refrain from exercise.
结局指标
主要结局
Effect of exercise on peak oxygen uptake
时间窗: Baseline to one year
Change in ml/kg/min
次要结局
- Effect of exercise on health related quality of life(Baseline to one year)
- Effect of exercise on chronotropic responses(Baseline to one year)
- Effect of exercise on muscle strength(Baseline to one year)
- Effect of exercise on endothelial function(Baseline to one year)
- Effect of exercise on biomarkers(Baseline to one year)
- Effect of exercise on safety and tolerability(Baseline to 3 years follow-up)
- Effect of exercise on myocardial function(Baseline to one year)
- Long-term effects of exercise(Baseline to 3 years follow-up)
- Effect of exercise on progression of coronary artery vasculopathy (CAV)(Baseline to one year)
研究者
Kari Nytrøen
Post doc
Oslo University Hospital
