- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan - School of Nursing
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical activity during AECOPD
Délai: 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.
|
week 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sense of coherence
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Social Support for Exercise
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Janet L Larson, PhD, University of Michigan - School of Nursing
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM00062912
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