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Acute Exacerbation of COPD and Physical Activity - Preliminary Study

2021年8月2日 更新者:Janet L. Larson、University of Michigan
People with chronic obstructive pulmonary disease (COPD) are very sedentary and efforts to establish an active lifestyle are challenging because of periodic acute exacerbations of COPD that interrupt physical activity patterns and contribute to further decline in physical activity. The purpose of this preliminary research is to learn more about the experience of acute exacerbations of COPD (AECOPD) from the perspective of the patient and his/her family and to learn how AECOPDs affect physical activity.

研究概览

地位

终止

详细说明

Individuals with chronic obstructive pulmonary disease (COPD) are very sedentary and their physical activity is often interrupted by acute exacerbations of COPD (AECOPD). Little is known about the expectations had by individuals with COPD and the effects of these expectations on their physical activity. To increase the understanding of these expectations in people with COPD, a study is proposed to explore their experience of daily fluctuations in symptoms and AECOPDs, focusing on how these experiences influence health promoting behaviors, especially physical activity (PA).

This study will involve an enrollment visit during which consent will be obtained, survey data will be administered (that they may take home), spirometry testing will be conducted, and a physical activity monitor (ActivPAL device) will be applied to be worn one week to allow us to understand their usual PA. A clinical ethnographic interview will then be conducted one week following enrollment, at which point the questionnaires and ActivPAL device will be collected. A second clinical ethnographic interview will be conducted one week following the first. Survey data will again collected at week 15 by mail.

研究类型

观察性的

注册 (实际的)

23

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

    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan - School of Nursing

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

55年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

People with COPD, who have had an exaccerbation in the last year who live in the greater Ann Arbor area and their family members.

描述

Inclusion Criteria:

  • People who have emphysema or chronic bronchitis as their primary health problem
  • People who have had a respiratory infection or an exacerbation of their COPD within the last year.
  • People who are 55 years or older
  • Family member of someone who meets the above criteria.

Exclusion Criteria:

  • Other lung diseases as their primary pulmonary problem.
  • Mobility problems that limit physical activity

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
People with COPD & recent exacerbation
The group consists of people with COPD who have had an exacerbation in the last year.

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
Physical activity during AECOPD
大体时间:week 1
Subjects will be asked to report how they managed their physical activity during the last AECOPD. Current physical activity will be measured with accelerometry and by the CHAMPS questionnaire.
week 1

次要结果测量

结果测量
措施说明
大体时间
Sense of coherence
大体时间:week 1 and week 15
Questionnaire that measures one's global orientation to life and the extent to which one sees life as comprehensible, manageable and meaningful.
week 1 and week 15
Barriers efficacy scale
大体时间:week 1 week 15
Questionnaire that measures barriers to exercise and physical activity. The subjects reports the level of confidence they have that they can overcome each barrier.
week 1 week 15
Help seeking behavior
大体时间:week 1 and week 15
Questionnaire assesses help seeking with respect to healthcare services.
week 1 and week 15
COPD Stigma Scale
大体时间:week 1 and week 15
Questionnaire measures the stigma associated with having COPD.
week 1 and week 15

其他结果措施

结果测量
措施说明
大体时间
Social Support for Exercise
大体时间:week 1
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
week 1
COPD symptoms
大体时间:week 1
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
week 1

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:Janet L Larson, PhD、University of Michigan - School of Nursing

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

2013年2月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2021年7月1日

研究注册日期

首次提交

2013年6月3日

首先提交符合 QC 标准的

2013年6月3日

首次发布 (估计)

2013年6月6日

研究记录更新

最后更新发布 (实际的)

2021年8月10日

上次提交的符合 QC 标准的更新

2021年8月2日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • HUM00062912

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.

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