EFFORT Asthma: Effects of Diet and Exercise in Asthma (EFFORT)
2016年7月27日 更新者：Louise Lindhardt Toennesen、University of Copenhagen
EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.
This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise.
The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.
研究概览
详细说明
After screening and enrollment, a total of 200 Danish sedentary, non-obese asthma patients will be randomized to one of four groups: 1) control group (no intervention), 2) physical exercise intervention, 3) diet intervention (a diet with an overall high content of protein and a low glycemic index) or 4) exercise plus diet intervention.
Asthma is defined as respiratory symptoms and at least one positive asthma test. Patients will continue their regular doses of anti-asthma treatment unchanged throughout the study period. Type of anti-inflammatory medicine will be recorded and the adherence to the therapy will be assessed before the intervention period and at follow-up using questionnaires
研究类型
介入性
注册 (实际的)
149
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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Copenhagen NV、丹麦、2400
- Respiratory Research Unit, Birpebjerg Hospital
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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 65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:
- >18 years old
- Uncontrolled or partly uncontrolled asthma
- Capable of exercising on bike
- Sedentary (currently do less than 60 min of structured/planned physical activity per week)
Exclusion Criteria:
BMI ≥ 30.0 or <20.5
- Chronic obstructive pulmonary disease (COPD), pregnancy, other inflammatory or metabolic diseases
- The use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：exercise
exercise (Aerobe training) 3 times per week
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Aerobe exercise 3 times a week in 8 weeks
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实验性的：Diet
A diet with an overall high protein content and a low glycemic index
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Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
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实验性的：Diet+Exercise
A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week.
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Aerobe exercise 3 times a week in 8 weeks
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
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无干预：control
Regular lifestyle (no intervention)
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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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Asthma Control Questionnaire (Juniper) (ACQ).
大体时间：Within 10 days (+/- 1 day) of completing the intervention
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Within 10 days (+/- 1 day) of completing the intervention
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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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Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.
大体时间：Within 10 days (+/- 1 day) of completing the intervention
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The response-dose-ratio (RDR) will be calculated as the percentage fall in forced expiratory volume in 1 second (FEV1) after the last dose of inhaled dried mannitol powder delivered, divided by the cumulative dose of inhaled mannitol.
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Within 10 days (+/- 1 day) of completing the intervention
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Systemic low-grade inflammation, as measured by serum-levels (in microgram/ml) of high sensitivity C-reactive protein, interleukin 6 (IL-6), IL-8, tumor necrosis factor alpha (TNF-alpha) and leptin.
大体时间：Within 10 days (+/- 1 day) of completing the intervention
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Within 10 days (+/- 1 day) of completing the intervention
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Fractional exhaled nitric oxide (FeNO)
大体时间：Within 10 days (+/- 1 day) of completing the intervention
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FeNO (a marker of eosinophilic inflammation)
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Within 10 days (+/- 1 day) of completing the intervention
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Sputum inflammatory cell count
大体时间：Within 10 days (+/- 1 day) of completing the intervention
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Number and type of inflammatory cells in induced sputum
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Within 10 days (+/- 1 day) of completing the intervention
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Adipose tissue inflammatory properties as measured by levels of messenger ribonucleic acid (mRNA) of IL-6, IL-8, leptin and TNF-alpha in abdominal fat biopsies.
大体时间：Within 10 days (+/- 1 day) of completing the intervention
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Within 10 days (+/- 1 day) of completing the intervention
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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
- 学习椅：Vibeke Backer, Professor、Respiratory Research Unit, Bispebjerg Hospital
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
2015年1月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2016年7月1日
研究注册日期
首次提交
2015年1月16日
首先提交符合 QC 标准的
2015年1月30日
首次发布 (估计)
2015年2月4日
研究记录更新
最后更新发布 (估计)
2016年7月28日
上次提交的符合 QC 标准的更新
2016年7月27日
最后验证
2016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的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的