- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02579200
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
Study Overview
Status
Intervention / Treatment
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:
- Dyspnea on daily life
- Inspiratory muscle strength and endurance
- Dyspnea on exertion and time to exercise intolerance
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: J Alberto Neder, MD, PhD
- Phone Number: 3198 (+1) 613-549-6666
- Email: nederalb@gmail.com
Study Contact Backup
- Name: Daniel M Hirai, PT, PhD
- Phone Number: 3198 (+1) 613-549-6666
- Email: dmh4@queensu.ca
Study Locations
-
-
-
Leuven, Belgium
- Recruiting
- KU Leuven
-
Contact:
- Daniel Langer
- Email: Daniel.Langer@faber.kuleuven.be
-
-
-
-
RS
-
Porto Alegre, RS, Brazil
- Recruiting
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
-
Contact:
- Danilo C Berton
- Email: dcberton@gmail.com
-
-
SP
-
Sao Paulo, SP, Brazil
- Recruiting
- Universidade Federal de Sao Paulo
-
Contact:
- Luiz E Neri
- Email: lenery@pneumo.epm.br
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Inspiratory Muscle Training (IMT)
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea on daily life
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
Measured by Maximal Static Inspiratory Pressures (Pi,max)
|
8 weeks
|
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)
|
8 weeks
|
Dyspnea on exertion
Time Frame: 8 weeks
|
Measured by Borg score during high intensity constant load cycling exercise test
|
8 weeks
|
Time to exercise intolerance (Tlim)
Time Frame: 8 weeks
|
Evaluated by high intensity constant load cycling exercise test
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung hyperinflation
Time Frame: 8 weeks
|
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.
Time Frame: 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)
Time Frame: 8 weeks
|
Measured by heart rate variability explored in the frequency domain
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: J Alberto Neder, MD, PhD, Queen's University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMT COPD+HF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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