Chronic Obstructive Pulmonary Disease Markers and Prognosis
2014年9月2日 更新者：Irma de Godoy、UPECLIN HC FM Botucatu Unesp
Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease
The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.
研究概览
地位
完全的
条件
详细说明
In a previous study, 133 COPD patients were followed-up during the period of one-year.
Analyses of the association between baseline characteristic and the occurence of disease exacerbation was performed.
In this study, the patients included in the previous research will be contacted and invited to participate in a complete evaluation after a three-year period.
The association of the changes in dyspnea perception, spirometry variables, body composition, quality of life and exercise tolerance measures with disease prognostic will be studied.
研究类型
观察性的
注册 (实际的)
133
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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SP
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Botucatu、SP、巴西、18618-000
- Botucatu School of Medicine
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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 95年 (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
非概率样本
研究人群
Pulmonary outpatient clinic
描述
Inclusion Criteria:
- COPD diagnosis according to the GOLD criteria
Exclusion Criteria:
- Asthma
- Inability to perform pulmonary function and exercise tolerance tests
- Recent myocardial infarction or unstable angina
- Congestive heart failure: class III/IV
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
队列和干预
团体/队列 |
|---|
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Study COPD population
Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease
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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 |
|---|---|---|
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Forced Expiratory Volume in the First Second (FEV1)
大体时间：Baseline and after three years
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FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.
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Baseline and after three years
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Exercise Tolerance
大体时间：Baseline and after three years
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Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min.
A research assistant timed the walk, and standardized verbal encouragement was given.
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Baseline and after three years
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Body Composition
大体时间：Baseline and after three years
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Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.
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Baseline and after three years
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Dyspnea
大体时间：Baseline and after three years
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Dyspnea was evaluated by Medical Research Council scale (MRC).
MRC scale consists of only five items and it is based on activities that cause dyspnea.
The patient reports the degree of dyspnea by choosing a value between 1 and 5.
A higher number indicates greater sensation of dyspnea.
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Baseline and after three years
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Health Status
大体时间：Baseline and after three years
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Saint George's Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status.
SGRQ includes three domains: symptoms, activities and impact of the disease.
Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8,
respectively).
A total score is also calculated based on the results of three domains, with a score maximum of 3989.4.
The total score is referred to as the percentage achieved by the patient related to this maximum score.
Minimum score means there is no impairment in the health status and high score means maximum dysfunction.
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Baseline and after three years
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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：Irma de Godoy, PhD, MD、Botucatu School of Medicine
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
- Ferrari R, Tanni SE, Caram LM, Correa C, Correa CR, Godoy I. Three-year follow-up of Interleukin 6 and C-reactive protein in chronic obstructive pulmonary disease. Respir Res. 2013 Feb 20;14(1):24. doi: 10.1186/1465-9921-14-24.
- Ferrari R, Tanni SE, Caram LM, Naves CR, Godoy I. Predictors of health status do not change over three-year periods and exacerbation makes difference in chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2011 Dec 9;9:112. doi: 10.1186/1477-7525-9-112.
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
2008年1月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2008年1月18日
首先提交符合 QC 标准的
2008年1月18日
首次发布 (估计)
2008年1月31日
研究记录更新
最后更新发布 (估计)
2014年9月3日
上次提交的符合 QC 标准的更新
2014年9月2日
最后验证
2014年5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
- upeclin/HC/FMB-Unesp-06
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