Inspiratory Muscle Training for Breathless Patients With Chronic Obstructive Pulmonary Disease and Heart Failure

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Inspiratory Muscle Training for Dyspneic Patients With COPD-HF Overlap: a Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02579200
• Other study ID #: IMT COPD+HF
• Status: Recruiting
• Phase: Phase 4
• First received: March 10, 2015
• Last updated: October 14, 2016
• Start date: November 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: Queen's University
• Contact: J Alberto Neder, MD, PhD
• Phone: (+1) 613-549-6666
• Email: nederalb[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Heart Failure
• Heart Failure, Systolic
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven
Brazil	Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	Universidade Federal de São Paulo	Sao Paulo	SP

Sponsors (4)

Lead Sponsor	Collaborator
Queen's University	Federal University of Rio Grande do Sul, Federal University of São Paulo, Katholieke Universiteit Leuven

Countries where clinical trial is conducted

Belgium,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung hyperinflation	Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test	8 weeks	No
Other	Endothelial function as measured by non-invasive ultrasound images of the brachial artery.	Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery	8 weeks	No
Other	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	No
Primary	Dyspnea on daily life	Measured by the Baseline Dyspnea Index (BDI)	8 weeks	No
Secondary	Inspiratory muscle strength as measured by spirometry	Measured by Maximal Static Inspiratory Pressures (Pi,max)	8 weeks	No
Secondary	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)	8 weeks	No
Secondary	Dyspnea on exertion	Measured by Borg score during high intensity constant load cycling exercise test	8 weeks	No
Secondary	Time to exercise intolerance (Tlim)	Evaluated by high intensity constant load cycling exercise test	8 weeks	No