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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| Federal University of São Paulo | OTHER |
| Federal University of Rio Grande do Sul | OTHER |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Active Comparator | POWERbreathe®KHA (IMT group) |
|
| Sham Training | Sham Comparator | POWERbreathe®KH2 (sham group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POWERbreathe®KHA (IMT group) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea on daily life | Measured by the Baseline Dyspnea Index (BDI) | 8 weeks |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Lung hyperinflation | Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test | 8 weeks |
| Endothelial function as measured by non-invasive ultrasound images of the brachial artery. |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J Alberto Neder, MD, PhD | Contact | (+1) 613-549-6666 | 3198 | nederalb@gmail.com |
| Daniel M Hirai, PT, PhD | Contact | (+1) 613-549-6666 | 3198 | dmh4@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| J Alberto Neder, MD, PhD | Queen's University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Recruiting | Leuven | Belgium |
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|
| POWERbreathe®KH2 (sham group) | Device | 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. |
|
| 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 |
Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery
| 8 weeks |
| Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement) | Measured by heart rate variability explored in the frequency domain | 8 weeks |
| Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
|
| Universidade Federal de São Paulo | Recruiting | São Paulo | São Paulo | Brazil |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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