- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan - School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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People with COPD & recent exacerbation
The group consists of people with COPD who have had an exacerbation in the last year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity during AECOPD
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sense of coherence
Time Frame: 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.
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week 1 and week 15
|
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Barriers efficacy scale
Time Frame: week 1 week 15
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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
|
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Help seeking behavior
Time Frame: week 1 and week 15
|
Questionnaire assesses help seeking with respect to healthcare services.
|
week 1 and week 15
|
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COPD Stigma Scale
Time Frame: week 1 and week 15
|
Questionnaire measures the stigma associated with having COPD.
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week 1 and week 15
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Support for Exercise
Time Frame: week 1
|
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
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week 1
|
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COPD symptoms
Time Frame: week 1
|
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
|
week 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janet L Larson, PhD, University of Michigan - School of Nursing
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00062912
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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