Effect of Exercise After Heart Transplantation (TEX)
2013年2月18日 更新者：Oslo University Hospital
Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
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.
研究概览
研究类型
介入性
注册 (实际的)
51
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Oslo、挪威、0027
- Department of Cardiology, Oslo University Hospital, Rikshospitalet
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Exercise
Interval-based aerobic exercise
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High intensity interval-based aerobic exercise training.
Duration: 1 year.
Three 8-weeks supervised periods of physical training 3 times per week.
Individual training 2 times per week between these periods.
其他名称：
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无干预：Control
No intervention other than regular follow up hospital visits
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Peak oxygen uptake (VO2peak)
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Isokinetic muscle strength of quadriceps and hamstrings
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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Quality of life measured by questionnaires
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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Myocardial function measured by echocardiography
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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Vascular tone and compliance measured by tonometry
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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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.
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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Analysis of isolated muscle cells from myocardial biopsy
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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Reinnervation as judged by autonomic nervous control (Heart Rate Variability)
大体时间：Before and after the intervention period of 1 year
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Before and after the intervention period of 1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Lars Gullestad, MD,PhD,Prof.、Oslo University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Nytroen K, Rolid K, Yardley M, Gullestad L. Effect of high-intensity interval training in young heart transplant recipients: results from two randomized controlled trials. BMC Sports Sci Med Rehabil. 2020 Jun 4;12:35. doi: 10.1186/s13102-020-00180-1. eCollection 2020.
- Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.
- Rustad LA, Nytroen K, Amundsen BH, Gullestad L, Aakhus S. One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Eur J Prev Cardiol. 2014 Feb;21(2):181-91. doi: 10.1177/2047487312469477. Epub 2012 Nov 26.
- Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年10月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2010年3月18日
首先提交符合 QC 标准的
2010年3月22日
首次发布 (估计)
2010年3月23日
研究记录更新
最后更新发布 (估计)
2013年2月20日
上次提交的符合 QC 标准的更新
2013年2月18日
最后验证
2013年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.