- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01034098
Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Obesity-related changes in lung volumes have shown to affect breathing mechanisms. During exercise, altered breathing mechanisms increase potential for expiratory flow limitation and compromise exercise capacity. Estrogen and progesterone are potent respiratory stimulants, and their effects in the physiologic regulation of breathing are down-regulated after menopause. Therefore, we theorized that the combined obesity and reduced sex hormone levels after menopause work as a double jeopardy to cause mechanical ventilatory constraint which aggravates dyspnea sensation during exercise, and thus a reduction in exercise capacity. The purpose of this study was to exam the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.
From doctoral referral and advertisement, 24 obese (BMI ≧ 27 kg/m2) and 26 lean post-menopausal women were recruited for the study. Pulmonary function and body composition were measured at rest. A maximal flow volume loop (MFVL) was obtained at baseline. All subjects then performed an incremental exercise test on a cycle ergometer with workload increasing 25 watts every 3 min. During exercise, at each workload, the tidal exercise FV loops were obtained and an inspiratory capacity (IC) maneuver was conducted to assess changes in end-expiratory lung volume (EELV) and end inspiratory lung volume (EILV). Dyspnea and leg fatigue were assessed using the Borg scale. Analysis of variance with repeated measurements was used to test the significance of the mean differences between the two groups during exercise. Linear regression analysis was used to determine whether changes in dynamic lung volumes during exercise were related to changes in Borg scores. Statistical significance was established at p<0.05.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei, Taiwán
- School and Graduate Institute of Physical Therapy, National Taiwan University
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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:
- Postmenopausal women (for at least 1 year)
- Age below 69 y/o
- Not receiving hormone replacement therapy
Exclusion Criteria:
- Cardiopulmonary disease
- Musculoskeletal disease affecting results of maximal exercise test
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Post-menopausal women
Post-menopausal women (without hormone replacement therapy)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Dynamic lung volume: end-expiratory lung volume (EELV), end-inspiratory lung volume (EILV)
Periodo de tiempo: At least 1 year post-menopause
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At least 1 year post-menopause
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Pulmonary function
Periodo de tiempo: At least 1 year post-menopause
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At least 1 year post-menopause
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Breathing pattern
Periodo de tiempo: At least 1 year post-menopause
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At least 1 year post-menopause
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Ventilatory response
Periodo de tiempo: At least 1 year post-menopause
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At least 1 year post-menopause
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Visual analog scale (VAS) for dyspnea and leg fatigue
Periodo de tiempo: At least 1 year post-menopause
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At least 1 year post-menopause
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Li-Ying Wang, Ph.D., School and Graduate Institute of Physical Therapy, National Taiwan 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
- 9461701144
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