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

Phase 4

• Conditions: Pulmonary Disease, Chronic Obstructive; Heart Failure, Systolic
• Interventions: Device: POWERbreathe®KHA (IMT group); Device: POWERbreathe®KH2 (sham group)

• Registration Number: NCT02579200
• Lead Sponsor: 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).

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

Study Timeline

• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2015-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory Muscle Training (IMT)	POWERbreathe®KHA (IMT group)	POWERbreathe®KHA (IMT group)
Sham Training	POWERbreathe®KH2 (sham group)	POWERbreathe®KH2 (sham group)

Primary Outcome Measures

Name	Time	Method
Dyspnea on daily life	8 weeks	Measured by the Baseline Dyspnea Index (BDI)

Secondary Outcome Measures

Name	Time	Method
Inspiratory muscle strength as measured by spirometry	8 weeks	Measured by Maximal Static Inspiratory Pressures (Pi,max)
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)
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

Trial Locations

Locations (3)

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, Brazil

KU Leuven; 🇧🇪 Leuven, Belgium