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
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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