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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
Sponsor:
Collaborators:
KU Leuven
Federal University of São Paulo
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Dr. J. Alberto Neder, Queen's University

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).

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Dyspnea on daily life [ Time Frame: 8 weeks ]
    Measured by the Baseline Dyspnea Index (BDI)


Secondary Outcome Measures :
  1. Inspiratory muscle strength as measured by spirometry [ Time Frame: 8 weeks ]
    Measured by Maximal Static Inspiratory Pressures (Pi,max)

  2. 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)

  3. Dyspnea on exertion [ Time Frame: 8 weeks ]
    Measured by Borg score during high intensity constant load cycling exercise test

  4. Time to exercise intolerance (Tlim) [ Time Frame: 8 weeks ]
    Evaluated by high intensity constant load cycling exercise test


Other Outcome Measures:
  1. Lung hyperinflation [ Time Frame: 8 weeks ]
    Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: J Alberto Neder, MD, PhD (+1) 613-549-6666 ext 3198 nederalb@gmail.com
Contact: Daniel M Hirai, PT, PhD (+1) 613-549-6666 ext 3198 dmh4@queensu.ca

Locations
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Belgium
KU Leuven Recruiting
Leuven, Belgium
Contact: Daniel Langer       Daniel.Langer@faber.kuleuven.be   
Brazil
Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil
Contact: Danilo C Berton       dcberton@gmail.com   
Universidade Federal de São Paulo Recruiting
Sao Paulo, SP, Brazil
Contact: Luiz E Neri       lenery@pneumo.epm.br   
Sponsors and Collaborators
Queen's University
KU Leuven
Federal University of São Paulo
Federal University of Rio Grande do Sul
Investigators
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Study Chair: J Alberto Neder, MD, PhD Queen's University

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Responsible Party: Dr. J. Alberto Neder, Study Chair, Queen's University
ClinicalTrials.gov Identifier: NCT02579200     History of Changes
Other Study ID Numbers: IMT COPD+HF
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive