- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04117399
Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients
Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients (COPD)
Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals. Risk of falls is multi-factorial and impaired balance has been shown to contribute.
The investigators aimed to demonstrate that, IMT performed during a PRP may improve Postural control in COPD patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic obstructive pulmonary disease COPD is a preventable and treatable disease. According to the WHO, COPD would be the third leading cause of death by 2030. This disease is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases. However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall.
Individuals with COPD, especially those with inspiratory muscle weakness, increased their reliance on ankle muscle proprioceptive signals and decreased their reliance on back muscle proprioceptive signals during balance control, resulting in a decreased postural stability compared to healthy controls. These proprioceptive changes may be due to an impaired postural contribution of the inspiratory muscles to trunk stability.
Inspiratory muscle training (IMT) has been shown to be an effective modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea and health-related quality of life. However, the effect of inspiratory muscle training on postural control is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on posture in COPD patients.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sousse, Túnez, 4002
- Bilel TOUNSI
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Were COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consert
Exclusion Criteria:
- Were previous pneumonectomy or lobectomy in the past 6 months
- Spontaneous risk of pneumothorax or rib fracture
- Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
- Lower limb injury
- Neurological injury or disease
- The absence of written informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Grupo IMT
Entrenamiento de los músculos inspiratorios + ejercicio aeróbico
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The experimental group receives inspiratory muscle training and aerobic exercise.
The Active Comparator group received only aerobic exercise group received only aerobic exercise.
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Comparador activo: Grupo de control
ejercicio aeróbico
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The experimental group receives inspiratory muscle training and aerobic exercise.
The Active Comparator group received only aerobic exercise group received only aerobic exercise.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Balance outcomes
Periodo de tiempo: Basline, After 2 months
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Balance were measured by stabilometry to evaluate postural control in COPD patients.
Two principals variabels were evaluated: the center of pressure in the mediolateral direction (CoP ML) ; the center of presure in anteroposterior direction (CoP AP).
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Basline, After 2 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Smith MD, Chang AT, Seale HE, Walsh JR, Hodges PW. Balance is impaired in people with chronic obstructive pulmonary disease. Gait Posture. 2010 Apr;31(4):456-60. doi: 10.1016/j.gaitpost.2010.01.022. Epub 2010 Mar 4.
- Janssens L, Brumagne S, McConnell AK, Claeys K, Pijnenburg M, Burtin C, Janssens W, Decramer M, Troosters T. Proprioceptive changes impair balance control in individuals with chronic obstructive pulmonary disease. PLoS One. 2013;8(3):e57949. doi: 10.1371/journal.pone.0057949. Epub 2013 Mar 1.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- COPD-POSTURE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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