Inspiratory Muscle Training for Breathless Patients With Chronic Obstructive Pulmonary Disease and Heart Failure
Inspiratory Muscle Training for Dyspneic Patients With COPD-HF Overlap: a Multicenter, Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Chronic obstructive pulmonary disease (COPD) and heart failure with reduced left ventricular ejection fraction (HF) are leading causes of disability and death worldwide. Unfortunately, COPD and HF coexist in up to a third of elderly patients making the so-called COPD-HF overlap (CHO) a major challenge to Health Care Systems. In addition, population ageing anticipates that CHO prevalence will further increase in the next decades.
Intolerance to exertion due to disabling breathlessness is the hallmark of COPD and HF and these abnormalities are notoriously potentiated by diseases coexistence.
The inspiratory muscles are centrally related to the pathophysiology of exertional dyspnea in COPD and HF. In both populations a higher central motor command output is required to maintain adequate force generation in the face of weaker inspiratory muscles. This information is interpreted as "shortness of breath".
There is well established evidence gained from recent meta-analyses indicating that inspiratory muscle training (IMT), as a standalone therapy, significantly improves inspiratory muscle function (strength and endurance), dyspnea during daily activities, and functional exercise capacity in COPD and HF. Previous findings indicate that reduced pressure-generating capacity reflecting inspiratory muscle weakness is frequently observed in patients with COPD-HF and related to a clinically-relevant outcome: exertional dyspnea. These findings set the scene for a randomized controlled trial to investigate the potential role of IMT in dyspnea palliation in CHO patients.
Objectives
To determine the effects of IMT on:
- Dyspnea on daily life
- Inspiratory muscle strength and endurance
- Dyspnea on exertion and time to exercise intolerance
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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RS
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Porto Alegre, RS, Brasil
- Reclutamiento
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
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Contacto:
- Danilo C Berton
- Correo electrónico: dcberton@gmail.com
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SP
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Sao Paulo, SP, Brasil
- Reclutamiento
- Universidade Federal de Sao Paulo
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Contacto:
- Luiz E Neri
- Correo electrónico: lenery@pneumo.epm.br
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Leuven, Bélgica
- Reclutamiento
- KU Leuven
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Contacto:
- Daniel Langer
- Correo electrónico: Daniel.Langer@faber.kuleuven.be
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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:
- Previous diagnoses of COPD and HF under optimized clinical treatment as judged by the accompanying physician
- Reduced left ventricular ejection fraction (<50%)
- Non-reversible airway obstruction (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80 %)
- Respiratory muscle weakness (Pi,max < 70cmH2O)
- Persistent dyspnea on daily life (Baseline Dyspnea Index focal score <or= 8).
Exclusion Criteria:
- Inability to perform exercise tests
- Diagnosed psychiatric or cognitive disorders
- Progressive neurological or neuromuscular disorders having a major impact on exercise capacity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Inspiratory Muscle Training (IMT)
POWERbreathe®KHA (IMT group)
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2 training sessions/day consisting of 30 breaths (~50% maximal inspiratory pressure; Pi,max), 7 days/week (once/week supervised at research center), for 8 weeks using an electronic tapered flow resistive loading (TFRL) device (POWERbreathe®KH2, HaB International Ltd., Southam, UK).
Measurements of PImax will be performed every week and training loads will be increased continuously to maintain the actual ~50% Pimax values.
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Comparador falso: Sham Training
POWERbreathe®KH2 (sham group)
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2 training sessions/day of 30 breaths at an inspiratory load of no more than 10% of their initial Pi,max (POWERbreathe®KH2, HaB International Ltd., Southam, UK).
This training load will not be changed during the entire study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dyspnea on daily life
Periodo de tiempo: 8 weeks
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Measured by the Baseline Dyspnea Index (BDI)
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inspiratory muscle strength as measured by spirometry
Periodo de tiempo: 8 weeks
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Measured by Maximal Static Inspiratory Pressures (Pi,max)
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8 weeks
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Inspiratory muscle endurance as measured by a PowerBreathe device
Periodo de tiempo: 8 weeks
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Assessed by Endurance Respiratory Muscle Protocol (Patients will breathe against 60% of Pi,max inspiratory load until task failure)
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8 weeks
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Dyspnea on exertion
Periodo de tiempo: 8 weeks
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Measured by Borg score during high intensity constant load cycling exercise test
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8 weeks
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Time to exercise intolerance (Tlim)
Periodo de tiempo: 8 weeks
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Evaluated by high intensity constant load cycling exercise test
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8 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lung hyperinflation
Periodo de tiempo: 8 weeks
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Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test
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8 weeks
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Endothelial function as measured by non-invasive ultrasound images of the brachial artery.
Periodo de tiempo: 8 weeks
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Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery
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8 weeks
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Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement)
Periodo de tiempo: 8 weeks
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Measured by heart rate variability explored in the frequency domain
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: J Alberto Neder, MD, PhD, Queen's University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IMT COPD+HF
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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