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
研究概览
详细说明
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
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：J Alberto Neder, MD, PhD
- 电话号码：3198 (+1) 613-549-6666
- 邮箱：nederalb@gmail.com
研究联系人备份
- 姓名：Daniel M Hirai, PT, PhD
- 电话号码：3198 (+1) 613-549-6666
- 邮箱：dmh4@queensu.ca
学习地点
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RS
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Porto Alegre、RS、巴西
- 招聘中
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
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接触：
- Danilo C Berton
- 邮箱：dcberton@gmail.com
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SP
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Sao Paulo、SP、巴西
- 招聘中
- Universidade Federal de Sao Paulo
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接触：
- Luiz E Neri
- 邮箱：lenery@pneumo.epm.br
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Leuven、比利时
- 招聘中
- KU Leuven
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接触：
- Daniel Langer
- 邮箱：Daniel.Langer@faber.kuleuven.be
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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假比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dyspnea on daily life
大体时间：8 weeks
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Measured by the Baseline Dyspnea Index (BDI)
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8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Inspiratory muscle strength as measured by spirometry
大体时间：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
大体时间：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
大体时间：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)
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lung hyperinflation
大体时间：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.
大体时间：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)
大体时间：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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合作者和调查者
调查人员
- 学习椅：J Alberto Neder, MD, PhD、Queen's University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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