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

NCT02579200 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-10-18

No results posted yet for this study

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).

Conditions

  • Pulmonary Disease, Chronic Obstructive
  • Heart Failure, Systolic

Interventions

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.

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.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER
  • Federal University of São Paulo

    collaborator OTHER
  • Federal University of Rio Grande do Sul

    collaborator OTHER
  • Queen's University

    lead OTHER

Principal Investigators

  • J Alberto Neder, MD, PhD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • Belgium
  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579200 on ClinicalTrials.gov