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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00611182
Dyspnea in Patients With Pulmonary Fibrosis
This study has two aims:
- To determine the relationship of shortness of breath (dyspnea) to other conditions present in patients with pulmonary fibrosis.
- To define the relationship between shortness of breath and rate of functional decline in patients with pulmonary fibrosis.
Visão geral do estudo
Status
Condições
Descrição detalhada
Idiopathic Pulmonary Fibrosis is the most common form of chronic fibrosing lung disease seen by pulmonologists, with an estimated 128,000 cases in the United States alone. It is almost surely a disorder related to aging, with a median age at the time of diagnosis of approximately 65 years; IPF is almost unheard of under the age of 50. Dyspnea is common in patients with IPF, and is often the primary symptom of the disease. It is tightly linked to quality of life in IPF, suggesting that the experience of dyspnea has wide-ranging and clinically-significant consequences. Despite its importance, surprisingly little is known about the etiology or functional impact of dyspnea in this disease.
This research proposal focuses on defining the relationship of dyspnea to comorbidity and the rate of functional decline in patients with IPF
Aim 1: To determine the relationship of dyspnea to other conditions present in patients with IPF.
Dyspnea is a complex symptom, related to both mechanical and cognitive factors. The mechanisms of dyspnea in IPF remain unknown, but there are several likely contributors that are both IPF and non-IPF related. Although IPF is a chronic disease of the elderly, no one has investigated the relationship between common geriatric conditions and dyspnea. It is well established that the perception of dyspnea depends equally on factors that influence the intensity of the experience of breathlessness (such as thoracic restriction and weakness) and the distress which that intensity produces. Gender, ethnicity, anxiety, pain, and depression all may contribute to the distress caused by dyspnea (and therefore its intensity) in IPF.
Aim 2: To define the relationship between dyspnea and rate of functional decline in IPF.
Numerous studies have looked at predictors of survival in patients with IPF, and both baseline and change in dyspnea over time have been shown to be significantly associated. The prediction of future morbidity, however, is largely unstudied. Established markers of functional decline in geriatric patients include weight loss, decline in walking speed over 4 meters, and the onset of disability as defined by the ability to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). Dyspnea likely impacts patients' activity levels and/or motivation to stay active, and may contribute to worsening functional decline.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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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:
- 18 years of age and older with pulmonary fibrosis, and able to travel to University of California San Francisco for study visits
Exclusion Criteria:
- None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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1
Patients with Pulmonary Fibrosis
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Dyspnea
Prazo: 6 months
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6 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Functional status
Prazo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Harold R. Collard, MD, University of California, San Francisco
Publicações e links úteis
Links úteis
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H5476-31357-01
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