- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan - School of Nursing
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Physical activity during AECOPD
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sense of coherence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Social Support for Exercise
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Janet L Larson, PhD, University of Michigan - School of Nursing
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUM00062912
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .