Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA (OBESOMAC)
2018年1月22日 更新者：Centre Hospitalier Universitaire de Besancon
Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers.
Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.
研究概览
详细说明
Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.
Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.
It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.
To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.
研究类型
介入性
注册 (实际的)
32
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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Salins-les-Bains、法国、39110
- Centre de soins de suite et de réadaptation La Beline
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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
12年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Obese adolescents (BMI > 97th percentile),
- patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197),
- enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- without observed tonsils hypertrophy (Mallampati and Friedman scores),
- without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
- with physical activity certificate issued by a cardiologist
- covered by the national insurance scheme of his/her legal representative,
- having signed, as well as his(her) legal representative, the informed consent of participation.
Exclusion Criteria:
- Non obese adolescents (BMI < 97th percentile)
- patients aged under 12 or over 17 years old,
- not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- with observed tonsils hypertrophy (Mallampati and Friedman scores),
- with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
- without physical activity certificate issued by a cardiologist
- uncovered by the national insurance scheme of his/her legal representative,
- not having signed, as well as his(her) legal representative, the informed consent of participation.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Interventional group
Physical activity program coupled with compression socks wearing during 3 months.
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Venous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management. To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA. |
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有源比较器：control group
Physical activity program without compression socks during 3 months.
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Standard obesity care with physical activity program
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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 |
|---|---|---|
|
Change from Obstructive sleep apnea severity at 3 months.
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
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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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Upper airway resistances
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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upper airway resistance will be assessed by acoustic method
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Fluid shift
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
fluid shift will be assessed by bioimpedance analysis
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Calf and neck circumferences
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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Calf and neck circumferences will be assessed with nonelastic tape
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Calf and neck circumferences
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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Calf and neck circumferences will be assessed by plethysmography
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Anthropometric parameters
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Body composition
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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fat mass, fat free mass ( by bioimpedance analysis)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Pulmonary function during exercise
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Metabolic responses
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Hormonal responses
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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Inflammatory responses
大体时间：This study includes 2 assessments : baseline (T0) and 3 months (T3)
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C-reactive protein (ELISA and RIA technics)
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
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。
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
- Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
- Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.
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)
2015年8月27日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2015年7月22日
首先提交符合 QC 标准的
2015年10月26日
首次发布 (估计)
2015年10月27日
研究记录更新
最后更新发布 (实际的)
2018年1月24日
上次提交的符合 QC 标准的更新
2018年1月22日
最后验证
2018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.