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Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

24 de abril de 2017 actualizado por: Diogo Fanfa Bordin, University of Santa Cruz do Sul

Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program

Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline.

Hypothesis:

  1. The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR).
  2. TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
  3. Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program.
  4. There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
  5. TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP.
  6. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI.
  7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

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

    • Rio Grande do Sul
      • Santa Cruz do Sul, Rio Grande do Sul, Brasil
        • Universidade de Santa Cruz do Sul

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

40 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD

Exclusion Criteria:

  • Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.

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: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Experimental: Group TMI + Pulmonary Rehabilitation
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Experimental: Control Group
Inspiratory muscle training will be held three times a week for eight weeks
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Experimental: COPD group not rehabilitation
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Muscle electromyographic activity of the accessory Inspiration
Periodo de tiempo: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Inspiratory Muscle Training
Periodo de tiempo: Will be performed with frequency of three days non-consecutive week, for eight weeks
Will be performed with frequency of three days non-consecutive week, for eight weeks
Assessment of lung volumes
Periodo de tiempo: will be performed previously to the study and at the end, over eight weeks
will be performed previously to the study and at the end, over eight weeks
assessment of respiratory muscle strength
Periodo de tiempo: will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
breathing pattern assessment
Periodo de tiempo: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Dulciane N Paiva, Doctor, University of Santa Cruz do Sul
  • Investigador principal: Diogo F Bordin, Academic, University of Santa Cruz do Sul
  • Director de estudio: Dannuey M Cardoso, Master, University of Santa Cruz do Sul
  • Director de estudio: Andrea LG da Silva, Doctor, University of Santa Cruz do Sul

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 agosto de 2013

Finalización primaria (Actual)

1 de noviembre de 2014

Finalización del estudio (Actual)

1 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

3 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2013

Publicado por primera vez (Estimar)

18 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

24 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

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. .

Ensayos clínicos sobre Pulmonary Rehabilitation

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