NCT02579200

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

March 10, 2015

Last Update Submit

October 14, 2016

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

  • Dyspnea on daily life

    Measured by the Baseline Dyspnea Index (BDI)

    8 weeks

Secondary Outcomes (4)

  • Inspiratory muscle strength as measured by spirometry

    8 weeks

  • Inspiratory muscle endurance as measured by a PowerBreathe device

    8 weeks

  • Dyspnea on exertion

    8 weeks

  • Time to exercise intolerance (Tlim)

    8 weeks

Other Outcomes (3)

  • Lung hyperinflation

    8 weeks

  • Endothelial function as measured by non-invasive ultrasound images of the brachial artery.

    8 weeks

  • Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement)

    8 weeks

Study Arms (2)

Inspiratory Muscle Training (IMT)

ACTIVE COMPARATOR

POWERbreathe®KHA (IMT group)

Device: POWERbreathe®KHA (IMT group)

Sham Training

SHAM COMPARATOR

POWERbreathe®KH2 (sham group)

Device: POWERbreathe®KH2 (sham group)

Interventions

POWERbreathe®KHA (IMT group)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.

Inspiratory Muscle Training (IMT)
POWERbreathe®KH2 (sham group)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.

Sham Training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Inability to perform exercise tests
  • Diagnosed psychiatric or cognitive disorders
  • Progressive neurological or neuromuscular disorders having a major impact on exercise capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KU Leuven

Leuven, Belgium

RECRUITING

Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • J Alberto Neder, MD, PhD

    Queen's University

    STUDY CHAIR

Central Study Contacts

J Alberto Neder, MD, PhD

CONTACT

(+1) 613-549-6666nederalb@gmail.com

Daniel M Hirai, PT, PhD

CONTACT

(+1) 613-549-6666dmh4@queensu.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

March 10, 2015

First Posted

October 19, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)BE(1)