Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
2019年7月18日 更新者：Jeffrey W Christle、Technical University of Munich
A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting
Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease.
The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated.
The objective of this study is to translate regular exercise training into a community based setting.
A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training.
The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.
研究概览
详细说明
From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program.
Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training.
The last phase of 12 weeks, supervised training is only once/week.
Patients are asked to perform exercise training 3-5 times weekly.
At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn.
Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks.
Resistance training starts after 6 weeks and is performed within the supervised training.
All patients were offered an individual nutritional counseling.
研究类型
介入性
注册 (预期的)
500
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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Munich、德国、81675
- Klinikum rechts der Isar/ Technische Universitaet Muenchen
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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 至 85年 (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:
- Coronary artery disease and/or diabetes mellitus
- Heart failure
Exclusion Criteria:
- all conditions which are not compatible with exercise training:
- severe orthopedic disorders
- severe psychiatric disease
- severe valve insufficiency
- presence of myocardial ischemia (decision made by cardiologist)
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：预防
- 分配：不适用
- 介入模型：单组作业
- 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 training
All patients were included in the exercise training group
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Exercise intervention was divided into 3 phases: Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14). Nutritional counseling is offered up to 4 times in 6 months on an individual basis. |
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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Change in VO2peak in ml/kg/min
大体时间：6 months
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Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
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6 months
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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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Change in HbA1c for patients with diabetes
大体时间：6 months
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Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus
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6 months
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Change in hsCRP
大体时间：6 months
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high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
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6 months
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Change in E/e'
大体时间：6 months
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E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal
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6 months
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Change in quality of life measured by SF-36
大体时间：6 months
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The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
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6 months
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Change in insulin IU
大体时间：6 months
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Insulin dosage is measured in IE (international units)
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6 months
|
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Change in HDL- and LDL- cholesterol as well as triglycerides
大体时间：6 months
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all measured in mg/dl
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6 months
|
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Change in Adiponectin
大体时间：6 months
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Adiponectin is an adipokine which is released by fat tissue
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6 months
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Change in Watts at anaerobic threshold VAT
大体时间：6 months
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VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
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6 months
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Change in Watts at anaerobic threshold RCP
大体时间：6 months
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RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
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6 months
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Change in max. Watts
大体时间：6 months
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On bicycle ergometry, Watts are measured
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6 months
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Change in max. Watts/kg bodyweight
大体时间：6 months
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max.
Watts indexed b body weight
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6 months
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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
- 研究主任：Martin Halle, Prof.、Technical University Munic
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)
2011年4月1日
初级完成 (预期的)
2019年8月1日
研究完成 (预期的)
2020年1月1日
研究注册日期
首次提交
2017年5月26日
首先提交符合 QC 标准的
2017年7月2日
首次发布 (实际的)
2017年7月6日
研究记录更新
最后更新发布 (实际的)
2019年7月19日
上次提交的符合 QC 标准的更新
2019年7月18日
最后验证
2019年7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.
Exercise 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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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的