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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Inspiratory Muscle Training on Dyspnea Perception During Exercise in Patients With COPD

NCT01900873

COPD Severe Systemic Illness-induced Respiratory Muscle Wasting

COMPLETED NA

Effects of Inspiratory Muscle Training on Shortness of Breath (Dyspnea) and Postural Control in Patients With COPD

NCT03240640

Copd Inspiratory Muscle Weakness

COMPLETED NA

The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome

NCT02794935

Chronic Heart Failure

UNKNOWN NA

Inspiratory Muscle Training in HFpEF

NCT06510231

Heart Failure

RECRUITING NA

Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

NCT02917824

Asthma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive Heart Failure, Systolic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inspiratory Muscle Training (IMT)

POWERbreathe®KHA (IMT group)

Group Type ACTIVE_COMPARATOR

POWERbreathe®KHA (IMT group)

Intervention Type DEVICE

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 Training

POWERbreathe®KH2 (sham group)

Group Type SHAM_COMPARATOR

POWERbreathe®KH2 (sham group)

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No