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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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RS
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Porto Alegre, RS, Brasil
- Recrutamento
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
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Contato:
- Danilo C Berton
- E-mail: dcberton@gmail.com
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SP
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Sao Paulo, SP, Brasil
- Recrutamento
- Universidade Federal de Sao Paulo
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Contato:
- Luiz E Neri
- E-mail: lenery@pneumo.epm.br
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Leuven, Bélgica
- Recrutamento
- KU Leuven
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Contato:
- Daniel Langer
- E-mail: Daniel.Langer@faber.kuleuven.be
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dyspnea on daily life
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Inspiratory muscle strength as measured by spirometry
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Lung hyperinflation
Prazo: 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.
Prazo: 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)
Prazo: 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
- Cadeira de estudo: J Alberto Neder, MD, PhD, Queen's University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IMT COPD+HF
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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