Heart Failure, Systolic, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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
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: 1. Dyspnea on daily life 2. Inspiratory muscle strength and endurance 3. Dyspnea on exertion and time to exercise intolerance
Interventions
DEVICEPOWERbreathe®KHA (IMT group)
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.
DEVICEPOWERbreathe®KH2 (sham group)
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.
Sponsors
KU Leuven
Federal University of São Paulo
Federal University of Rio Grande do Sul
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea on daily life | 8 weeks | Measured by the Baseline Dyspnea Index (BDI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory muscle endurance as measured by a PowerBreathe device | 8 weeks | Assessed by Endurance Respiratory Muscle Protocol (Patients will breathe against 60% of Pi,max inspiratory load until task failure) |
| Inspiratory muscle strength as measured by spirometry | 8 weeks | Measured by Maximal Static Inspiratory Pressures (Pi,max) |
| Dyspnea on exertion | 8 weeks | Measured by Borg score during high intensity constant load cycling exercise test |
| Time to exercise intolerance (Tlim) | 8 weeks | Evaluated by high intensity constant load cycling exercise test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement) | 8 weeks | Measured by heart rate variability explored in the frequency domain |
| Endothelial function as measured by non-invasive ultrasound images of the brachial artery. | 8 weeks | Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery |
| Lung hyperinflation | 8 weeks | Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test |
Countries
Belgium, Brazil
Contacts
Primary ContactJ Alberto Neder, MD, PhD
Backup ContactDaniel M Hirai, PT, PhD
Outcome results
None listed