- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00870246
Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease (DMCOPD)
Influence of Diaphragmatic Mobility on the Exercise Capacity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Chronic Obstructive Pulmonary Disease (COPD) is characterized by progressive obstruction of the airways which is partially irreversible. COPD patients commonly present increased resistance to airflow, air trapping, and pulmonary hyperinflation that alters the chest wall placing the respiratory muscles in mechanical disadvantage, thereby increasing both respiratory drive and the sensation of dyspnoea. Furthermore, to prevent dyspnoea, COPD patients reduce their daily living activities leading to loss of physical condition, social isolation, depression and anxiety,whilst compromising their quality of life.
Forced expiratory volume in one second (FEV1) is the main parameter used to establish the severity of pulmonary impairment and disease progression.
Nevertheless, some studies have suggested that FEV1 does not adequately reflect the clinical manifestations of the disease and is only weakly associated with the severity of dyspnoea, health related quality of life (HRQOL) features, and the ability to perform activities of daily living.
Moreover, FEV1 appears not to be a predictor of mortality in COPD patients. Pulmonary hyperinflation has been related with adaptation in diaphragm muscle maintaining the muscle's capacity to generate power whilst reducing its displacement. The importance of the diaphragm in lung mechanics associated with hyperinflation has been the subject of frequent discussion owing to widespread use of lung volume reducing surgery which results in increased movement range of the diaphragm muscle. However, to date, the relationship between diaphragm mobility and functional capacity in COPD patients remains unknown.
The objective of the present study was to evaluate the influence of diaphragm mobility in the exercise capacity and dyspnoea of patients with COPD.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- patients with chronic obstructive pulmonary disease clinically stable (no respiratory crises or hospitalizations within the 30 days preceding the study outset)
- patients receiving optimized clinical medical treatment
Exclusion Criteria:
- patients suffering from other cardiorespiratory diseases
- patients with oxygen-dependent for any reason
- patients classified as obese or as underweight
- patients presenting other respiratory diseases or pleural scars on chest X-rays
Plan de estudios
¿Cómo está diseñado el estudio?
Cohortes e Intervenciones
Grupo / Cohorte |
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1
High mobility
|
2
Lower mobility
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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spirometer, capacity of exercise, dyspnea
Periodo de tiempo: 3 months
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
diaphragm mobility: the craniocaudal excursion of the intrahepatic branches of the portal vein with the B-mode ultrasound
Periodo de tiempo: 1 year
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1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Celso Carvalho, professor, Sao Paulo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 914/04
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