- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan - School of Nursing
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physical activity during AECOPD
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sense of coherence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Social Support for Exercise
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Janet L Larson, PhD, University of Michigan - School of Nursing
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUM00062912
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