- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan - School of Nursing
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
People with COPD & recent exacerbation
The group consists of people with COPD who have had an exacerbation in the last year.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Physical activity during AECOPD
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sense of coherence
Tidsram: 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
Tidsram: 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
|
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Help seeking behavior
Tidsram: week 1 and week 15
|
Questionnaire assesses help seeking with respect to healthcare services.
|
week 1 and week 15
|
|
COPD Stigma Scale
Tidsram: week 1 and week 15
|
Questionnaire measures the stigma associated with having COPD.
|
week 1 and week 15
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Social Support for Exercise
Tidsram: week 1
|
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
|
week 1
|
|
COPD symptoms
Tidsram: week 1
|
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
|
week 1
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Janet L Larson, PhD, University of Michigan - School of Nursing
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HUM00062912
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