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临床试验/NCT01796379
NCT01796379已完成不适用

High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Oslo University Hospital4 个研究点 分布在 3 个国家目标入组 80 人开始时间: 2013年2月1日最近更新:
适应症

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

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

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kari Nytrøen

Post doc

Oslo University Hospital

研究点 (4)

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