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- Ensayo clínico NCT03511287
Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease (IMTinALD)
18 de abril de 2018 actualizado por: Veronica Franco Parreira, Federal University of Minas Gerais
Effects of Inspiratory Muscle Training in Inspiratory Muscle Function, Functional Capacity, Quality of Life, Lung Function, Breathing Pattern and Thoracoabdominal Motion in Patients With Advanced Lung Disease
The aim of this clinical trial is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease.
Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Inspiratory Muscle Training (IMT) should be considered an additional intervention in the pulmonary rehabilitation program for patients with advanced lung disease.
The aim of this study is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease.
It is a quasi-experimental study with longitudinal design.
Patients with advanced lung disease from the advanced lung disease and pre lung transplantation ambulatory performed home-based high intensity interval IMT for 8 weeks (two sessions per day, daily).
In each session patients executed two times 30 breaths with one-minute rest between them.
Resistance was set to the highest tolerable according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher.
An experienced physiotherapist was responsible for weekly adjustments on the resistance of training as well as new assessment of maximal inspiratory pressure.
Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention.
Patients were evaluated by the same experienced researcher in all three moments of the study.
Evaluations were performed in the Laboratory of research and evaluation of cardiorespiratory performance of Federal University of Minas Gerais.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 31270-901
- Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
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Belo Horizonte, Minas Gerais, Brasil, 30150-260
- Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- presence of inspiratory muscle weakness (Maximal Inspiratory Pressure - MIP ≤ 60 cmH2O or below the reference values proposed for the Brazilian population.
- completion of a 36 sessions of PR or nonattendance in any pulmonary rehabilitation by the time of inclusion and no perspective of initiating it in the next 8 weeks.
- absence of pre-existing neuromuscular, infectious, metabolic, psychiatric diseases or orthopedic problems that prevent from activities of daily living.
Exclusion Criteria:
- presented inspiratory muscle strength higher than 60 cmH2O or predicted value
- unable to follow commands related to the measurements or to the IMT
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: IMT group
Group intervention: home-based interval inspiratory muscle training:
|
Breathing through a device that offers resistance during inspiration.
In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Inspiratory muscle strength
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Maximal inspiratory pressure in cmH2O
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Change in Inspiratory Muscle Endurance
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Inspiratory endurance time in seconds
|
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Lung Function
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Spirometry
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Change in Breathing pattern
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation)
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Change in chest wall motion
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Optoelectronic plethysmography (lung volumes in liters)
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Change in Functional Capacity (direct measure)
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
|
Six minutes walking distance (meters)
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Change in Functional Capacity (inderect measure)
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
|
London chest activity of daily living scale (total score) - It evaluates the dyspnea in daily activities.
Consists in a 15 questions questionnaire with scores from 0-5 in each question.
Total score varies from 0 to 75, the higher the score the major the limitation on daily activities due to dyspnea.
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Quality of life
Periodo de tiempo: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Saint George Respiratory questionnaire (total score) It is a 50 questions questionnaire.
Total score can go from 0 to 100.
Higher scores indicate worse quality of life.
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Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Veronica Parreira, PhD, UFMG
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2015
Finalización primaria (Actual)
1 de diciembre de 2017
Finalización del estudio (Actual)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
11 de abril de 2018
Primero enviado que cumplió con los criterios de control de calidad
18 de abril de 2018
Publicado por primera vez (Actual)
27 de abril de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de abril de 2018
Última verificación
1 de abril de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CNPq 442973/2014-4
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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