NCT01091194已完成2 期
Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Peak oxygen uptake (VO2peak)
研究概览
简要总结
This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Norwegian heart transplanted patients > 18 years of age
- •1-8 years after heart transplantation
- •Optimal medical treatment
- •Stable condition
- •Written informed consent
- •Must have access to a physical therapist or personal trainer in their hometown
- •Motivation for exercise
排除标准
- •Unstable condition
- •In need of revascularization or other invention
- •Infections, open wounds or skin diseases
- •Physical disabilities which prevent participation
- •Other diseases, illnesses or conditions which contradict exercise
研究组 & 干预措施
Exercise
Other
Interval-based aerobic exercise
干预措施: Interval-based aerobic exercise (Other)
Control
No Intervention
No intervention other than regular follow up hospital visits
结局指标
主要结局
Peak oxygen uptake (VO2peak)
时间窗: Before and after the intervention period of 1 year
次要结局
- Analysis of isolated muscle cells from myocardial biopsy(Before and after the intervention period of 1 year)
- Isokinetic muscle strength of quadriceps and hamstrings(Before and after the intervention period of 1 year)
- Quality of life measured by questionnaires(Before and after the intervention period of 1 year)
- Myocardial function measured by echocardiography(Before and after the intervention period of 1 year)
- Reinnervation as judged by autonomic nervous control (Heart Rate Variability)(Before and after the intervention period of 1 year)
- Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)(Before and after the intervention period of 1 year)
- Vascular tone and compliance measured by tonometry(Before and after the intervention period of 1 year)
- Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis.(Before and after the intervention period of 1 year)
研究者
研究点 (1)
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