The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
2018年3月18日 更新者：Mehran Attari、University of Cincinnati
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
研究概览
详细说明
Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in class session and home practice) vs. no Yoga.
They will undergo holter monitoring, cardiac device interrogation, and I-123 mIBG imaging at the beginning and end of the study.
研究类型
介入性
阶段
- 不适用
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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Ohio
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Cincinnati、Ohio、美国、45219
- University of Cincinnati Medical Center
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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:
- Negative pregnancy test in females
- Ejection Fraction </= 40% assessed by echocardiogram within the last 12 months
- Stable dose of heart failure medications including afterload reducing medication such as ACE-I, ARB and hydralazine; beta blockers; digoxin and aldosterone antagonist for at least 4 months and no anticipated changes for 8 weeks. (i.e. no greater than a 50% dose change within the past month)
- Has an implantable pacemaker or ICD
- NYHA II-IV
Exclusion Criteria:
- pregnant or lactating female
- females without a pregnancy test
- co-administration of a positive inotrope (i.e. milrinone or dobutamine)
- history of significant medical non-compliance
- unwilling to adhere to the protocol
- Orthopedic limitation making yoga participation difficult
- Underlying cardiac rhythm other than sinus rhythm
- Recent history within 6 months prior to enrollment of unstable coronary artery disease (unstable angina, recent heart attack, recent revascularization, or decompensated heart failure)
- implantation of a cardiac resynchronization therapy device in the past 3 months.
- TIA, CVA, or major surgery in the past 3 months
- iodine or adreview (123-MIBG) allergy
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：No yoga training
This will be the control arm.
The patients in this arm will not receive any yoga training.
They will be continued on all their home, guideline-directed heart failure medications.
They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
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实验性的：Yoga training
The patients in this arm will receive yoga training.
This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total.
Patients will be asked to do home yoga practices at least twice a week and to document the date and time.
Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
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Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cardiac sympathetic activity following yoga training
大体时间：8 weeks
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A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
大体时间：8 weeks
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Association between heart to mediastinum ration and ventricular arrhythmia burden
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8 weeks
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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。
调查人员
- 首席研究员：Mehran Attari、University of Cincinnati
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。
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- Toise SC, Sears SF, Schoenfeld MH, Blitzer ML, Marieb MA, Drury JH, Slade MD, Donohue TJ. Psychosocial and cardiac outcomes of yoga for ICD patients: a randomized clinical control trial. Pacing Clin Electrophysiol. 2014 Jan;37(1):48-62. doi: 10.1111/pace.12252. Epub 2013 Aug 26.
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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 (实际的)
2017年9月30日
初级完成 (实际的)
2017年10月27日
研究完成 (实际的)
2017年10月27日
研究注册日期
首次提交
2017年7月20日
首先提交符合 QC 标准的
2017年7月20日
首次发布 (实际的)
2017年7月24日
研究记录更新
最后更新发布 (实际的)
2018年3月20日
上次提交的符合 QC 标准的更新
2018年3月18日
最后验证
2018年3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.
Yoga training的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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Southern Methodist UniversityKing's College London完全的
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Florida Atlantic UniversityNational Center for Complementary and Integrative Health (NCCIH)完全的
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Agri Ibrahim Cecen UniversityAgri Ibrahim Cecen University完全的
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Oslo University HospitalAkershus University Hospital, Lørenskog, Norway; Koc University Hospital, Istanbul, Turkey; Ataturk... 和其他合作者完全的
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Lancaster General HospitalMassachusetts General Hospital招聘中