Inspiratory Muscle Training for Breathless Patients With Chronic Obstructive Pulmonary Disease and Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether inspiratory muscle training is effective to improve breathless and exercise intolerance in symptomatic patients with chronic obstructive pulmonary disease (COPD) plus chronic heart failure (HF).

Detailed Description
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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

Official Title
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Inspiratory Muscle Training for Dyspneic Patients With COPD-HF Overlap: a Multicenter, Randomized Controlled Trial

Conditions
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Pulmonary Disease, Chronic Obstructive, Heart Failure, Systolic

Intervention / Treatment
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* Device: POWERbreathe®KHA (IMT group)
* Device: POWERbreathe®KH2 (sham group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inspiratory Muscle Training (IMT)<br>POWERbreathe®KHA (IMT group) | Device: POWERbreathe®KHA (IMT group)<br>* 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.<br>|
| Sham Comparator: Sham Training<br>POWERbreathe®KH2 (sham group) | Device: POWERbreathe®KH2 (sham group)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea on daily life | Measured by the Baseline Dyspnea Index (BDI) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory muscle strength as measured by spirometry | Measured by Maximal Static Inspiratory Pressures (Pi,max) | 8 weeks | 
| Inspiratory muscle endurance as measured by a PowerBreathe device | Assessed by Endurance Respiratory Muscle Protocol (Patients will breathe against 60% of Pi,max inspiratory load until task failure) | 8 weeks | 
| Dyspnea on exertion | Measured by Borg score during high intensity constant load cycling exercise test | 8 weeks | 
| Time to exercise intolerance (Tlim) | Evaluated by high intensity constant load cycling exercise test | 8 weeks |