The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease (BPCeaux)
2015年3月24日 更新者：Centre Hospitalier Universitaire de Nīmes
The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment).
An exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy.
Exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.
研究概览
研究类型
介入性
注册 (实际的)
39
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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-
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Aix les Bains、法国、73100
- Private practice: Karim Berkani
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Amélie les Bains Palalda、法国、66110
- Private practice: Jean Hérété
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Briey、法国、54150
- Private practice: Pierre Ethève
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Ceret、法国、66400
- Private practice: Marc Bellier
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Perpignan、法国、66000
- Private practice: Pierre Olivier
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Saint Amand les Eaux、法国、59230
- Private practice: Muriel Nouvelle
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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
40年 至 80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:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient must have chronic obstructive pulmonary disease
- Obstructive ventilation problem: Tiffeneau index (expiratory volume in one second / slow vital capacity) < 70%
- Expiratory volume in one second < 80% of the theoretical value
- Reversibility < 12% after inhalation of bronchodilators
- Smokers or ex smokers
- Available for study monitoring
- Has access to diagnostic, medical and therapeutic care according to the best, current criteria (see the recommendations of the French Language Pseumologist Society)
Exclusion Criteria:
- The patient is participating in another study
- The patient has participated in another study in the past 12 months
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is in military service (unavailable for monitoring)
- Patient is on parole or otherwise has their liberty restricted by administrative or judiciary decision
- The patient is pregnant, or does not have contraception
- The patient is breastfeeding
- Patient has neoplastic disease
- Patient has asthma
- Patient has another, evolving pulmonary disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
- Patient has a clinical history indicating asthma or another respiratory disease (in particular bronchiectasis, pneumoconiosis and other occupational diseases, history of pulmonary neoplasia, HIV, immunosuppressive therapy including corticosteroids in the long term
- Patient has respiratory insufficiency
- Hypereosinophilic patient (the number of polynuclear eosinophils is > 0.5 giga/l; confirmed on 2 hemograms)
- Recent psychiatric trouble (less than 1 year)
- Takes illegal drugs
- Patient does not have pneumological care according to the standards set by the French Language Pneumologist Society
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Standard
The patients randomized into this arm of the study will not have spa therapy.
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实验性的：Spa Therapy
The patients randomized into this arm of the study will have 3 weeks of spa therapy
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3 weeks of spa therapy
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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 |
|---|---|---|
|
Number of exacerbations
大体时间：12 months after the beginning of treatment
|
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI).
An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum.
Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing.
A TI = systemic corticoids and/or antibiotics.
An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
|
12 months after the beginning of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in the BODE score
大体时间：3 weeks
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3 weeks
|
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change in SF36 questionnaire scores
大体时间：3 weeks
|
the SF36 quality of life questionnaire
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3 weeks
|
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Cost (€)
大体时间：3 weeks
|
Costs are evaluated from the point of view of payers associated with the pathology.
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3 weeks
|
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C reactive protein (mg/l)
大体时间：3 weeks
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blood work
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3 weeks
|
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Eosiniphil count (thou/ml)
大体时间：3 weeks
|
blood work
|
3 weeks
|
|
Number of exacerbations
大体时间：3 weeks
|
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI).
An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum.
Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing.
A TI = systemic corticoids and/or antibiotics.
An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
|
3 weeks
|
|
change in the BODE score
大体时间：3 months
|
3 months
|
|
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change in the BODE score
大体时间：6 months
|
6 months
|
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change in the BODE score
大体时间：9 months
|
9 months
|
|
|
change in the BODE score
大体时间：12 months
|
12 months
|
|
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change in SF36 questionnaire scores
大体时间：3 months
|
the SF36 quality of life questionnaire
|
3 months
|
|
change in SF36 questionnaire scores
大体时间：6 months
|
the SF36 quality of life questionnaire
|
6 months
|
|
change in SF36 questionnaire scores
大体时间：9 months
|
the SF36 quality of life questionnaire
|
9 months
|
|
change in SF36 questionnaire scores
大体时间：12 months
|
the SF36 quality of life questionnaire
|
12 months
|
|
Cost (€)
大体时间：3 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
3 months
|
|
Cost (€)
大体时间：6 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
6 months
|
|
Cost (€)
大体时间：9 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
9 months
|
|
Cost (€)
大体时间：12 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
12 months
|
|
Number of exacerbations
大体时间：3 months
|
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI).
An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum.
Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing.
A TI = systemic corticoids and/or antibiotics.
An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
|
3 months
|
|
Number of exacerbations
大体时间：6 months
|
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI).
An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum.
Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing.
A TI = systemic corticoids and/or antibiotics.
An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
|
6 months
|
|
Number of exacerbations
大体时间：9 months
|
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI).
An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum.
Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing.
A TI = systemic corticoids and/or antibiotics.
An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
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9 months
|
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：Nicolas Molinari, PhD、Centre Hospitalier Universitaire De Nimes
- 首席研究员：Jean Victor Hérété, MD、Amélie les Bains
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
2011年5月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2011年2月15日
首先提交符合 QC 标准的
2011年2月15日
首次发布 (估计)
2011年2月16日
研究记录更新
最后更新发布 (估计)
2015年3月25日
上次提交的符合 QC 标准的更新
2015年3月24日
最后验证
2015年3月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- LOCAL/2010/NM-02
- 2010-A00693-36 (其他标识符：RCB number)
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.
Spa therapy的临床试验
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Association Francaise pour la Recherche ThermaleUniversity Hospital, Grenoble; Floralis撤销
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的