Inspiratory Muscle Training for Breathless Patients With Chronic Obstructive Pulmonary Disease and Heart Failure
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|ClinicalTrials.gov Identifier: NCT02579200|
Recruitment Status : Unknown
Verified October 2016 by Dr. J. Alberto Neder, Queen's University.
Recruitment status was: Recruiting
First Posted : October 19, 2015
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive Heart Failure, Systolic||Device: POWERbreathe®KHA (IMT group) Device: POWERbreathe®KH2 (sham group)||Phase 4|
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.
To determine the effects of IMT on:
- Dyspnea on daily life
- Inspiratory muscle strength and endurance
- Dyspnea on exertion and time to exercise intolerance
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Inspiratory Muscle Training for Dyspneic Patients With COPD-HF Overlap: a Multicenter, Randomized Controlled Trial|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||July 2017|
Active Comparator: Inspiratory Muscle Training (IMT)
POWERbreathe®KHA (IMT group)
Device: POWERbreathe®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.
Sham Comparator: Sham Training
POWERbreathe®KH2 (sham group)
Device: POWERbreathe®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.
- Dyspnea on daily life [ Time Frame: 8 weeks ]Measured by the Baseline Dyspnea Index (BDI)
- Inspiratory muscle strength as measured by spirometry [ Time Frame: 8 weeks ]Measured by Maximal Static Inspiratory Pressures (Pi,max)
- Inspiratory muscle endurance as measured by a PowerBreathe device [ Time Frame: 8 weeks ]Assessed by Endurance Respiratory Muscle Protocol (Patients will breathe against 60% of Pi,max inspiratory load until task failure)
- Dyspnea on exertion [ Time Frame: 8 weeks ]Measured by Borg score during high intensity constant load cycling exercise test
- Time to exercise intolerance (Tlim) [ Time Frame: 8 weeks ]Evaluated by high intensity constant load cycling exercise test
- Lung hyperinflation [ Time Frame: 8 weeks ]Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test
- Endothelial function as measured by non-invasive ultrasound images of the brachial artery. [ Time Frame: 8 weeks ]Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery
- Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement) [ Time Frame: 8 weeks ]Measured by heart rate variability explored in the frequency domain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579200
|Contact: J Alberto Neder, MD, PhD||(+1) 613-549-6666 ext email@example.com|
|Contact: Daniel M Hirai, PT, PhD||(+1) 613-549-6666 ext firstname.lastname@example.org|
|Contact: Daniel Langer Daniel.Langer@faber.kuleuven.be|
|Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil|
|Contact: Danilo C Berton email@example.com|
|Universidade Federal de São Paulo||Recruiting|
|Sao Paulo, SP, Brazil|
|Contact: Luiz E Neri firstname.lastname@example.org|
|Study Chair:||J Alberto Neder, MD, PhD||Queen's University|