- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan - School of Nursing
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Physical activity during AECOPD
Tijdsspanne: week 1
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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.
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week 1
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Sense of coherence
Tijdsspanne: week 1 and week 15
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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
Tijdsspanne: 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.
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week 1 week 15
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Help seeking behavior
Tijdsspanne: week 1 and week 15
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Questionnaire assesses help seeking with respect to healthcare services.
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week 1 and week 15
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COPD Stigma Scale
Tijdsspanne: week 1 and week 15
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Questionnaire measures the stigma associated with having COPD.
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week 1 and week 15
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Social Support for Exercise
Tijdsspanne: week 1
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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
Tijdsspanne: week 1
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Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
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week 1
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Janet L Larson, PhD, University of Michigan - School of Nursing
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00062912
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