- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan - School of Nursing
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Physical activity during AECOPD
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sense of coherence
Prazo: 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.
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week 1 and week 15
|
|
Barriers efficacy scale
Prazo: 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
Prazo: 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
Prazo: week 1 and week 15
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Questionnaire measures the stigma associated with having COPD.
|
week 1 and week 15
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Social Support for Exercise
Prazo: week 1
|
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
|
week 1
|
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COPD symptoms
Prazo: week 1
|
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
|
week 1
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Janet L Larson, PhD, University of Michigan - School of Nursing
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HUM00062912
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