Exercise Capacity and Daily Physical Activity in Obese Subjects With Treated Obstructive Sleep Apnea
2016年1月4日 更新者：Roger Goldstein、West Park Healthcare Centre
Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea, OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early death from heart problems. They are also associated with lower levels of physical activity. Exercise strategies for weight loss, increasing physical activity and improving fitness are needed for obesity. In Obese individuals with OSA
- The investigators will compare corridor walking tests compared to laboratory exercise tests. The null hypothesis is that the peak oxygen uptake achieved and the cardiopulmonary response during both the six-minute walk test and Incremental Shuttle Walk Test would not be different from that observed during an Incremental Treadmill Test.
- The investigators will investigate whether cycling or walking uses more calories for the same intensity. We hypothesise that cycling (weight supported) will be endured for long.
- The investigators will compare commonly used exercise tests with levels of daily physical activity.
The information from these three projects will help us set up the optimal exercise program for obese individuals.
研究概览
研究类型
观察性的
注册 (实际的)
16
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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Ontario
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Toronto、Ontario、加拿大、M6M 2J5
- West Park Healthcare Centre
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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
取样方法
概率样本
研究人群
Obstructive Sleep Apnea
描述
Inclusion Criteria:
- Obstructive Sleep Apnea
- Obesity BMI>30
- Controlled on Continuous Positive Airway Pressure for three months
Exclusion Criteria:
- cardiac co-morbidity e.g ischaemic heart disease, chronic heart failure, valvular heart disease
- pulmonary co-morbidity
- neurological condition limiting the ability to perform walking or cycling
- orthopaedic condition limiting the ability to perform walking or cycling
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
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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Peak oxygen uptake (Peak VO2) measured at the end of the Incremental Shuttle Walk Test (ISWT)
大体时间：All outcome measures will be performed within four weeks of each other
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Two Incremental Shuttle Walk tests will be performed within two hours on the same day with expired gas analysis measured by a portable gas analyser.
An ISWT is conducted over a 10m course and the speed is externally paced and increases each minute.
The participant is asked to continue until they are either too breathless or too tired to continue.
|
All outcome measures will be performed within four weeks of each other
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Six minute walk test (6MWT)
大体时间：Four weeks
|
The 6MWT will be performed over a 30 m level, straight course within an enclosed corridor.
The test protocol described by the American Thoracic Society will be modified to include standardized encouragement every 15 seconds to recommence walking if the participant chooses to rest during the test.
Participants will be familiarized with the test prior to participating in the study and, therefore, only one test will be performed.
|
Four weeks
|
|
Incremental Treadmill Test (ITM)
大体时间：Four weeks
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A maximal treadmill test will be performed once with expired gas analysis.
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Four weeks
|
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Incremental cycle test (ICE)
大体时间：Four weeks
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A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.
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Four weeks
|
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Endurance cycle ergometer
大体时间：Four weeks
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Two endurance cycle tests will performed at 60% and 80% of the maximal peak oxygen obtained on either the ICE or ITM
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Four weeks
|
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Endurance treadmill test
大体时间：Four weeks
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Constant speed endurance treadmill test will be performed at 60% and 80% of the peak oxygen uptake achieved on either the ITM or ICE to symptom limitation
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Four weeks
|
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Daily physical activity
大体时间：Four weeks
|
A sensewear armband will be worn for 7 days and only taken off for showering/bathing.
|
Four weeks
|
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：Roger S Goldstein, MBChB、West Park Healthcare Centre
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。
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
2010年11月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2013年7月15日
首先提交符合 QC 标准的
2013年8月23日
首次发布 (估计)
2013年8月29日
研究记录更新
最后更新发布 (估计)
2016年1月5日
上次提交的符合 QC 标准的更新
2016年1月4日
最后验证
2016年1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.