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

14. oktober 2016 opdateret af: Dr. J. Alberto Neder, Queen's University

Inspiratory Muscle Training for Dyspneic Patients With COPD-HF Overlap: a Multicenter, Randomized Controlled Trial

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).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Inspiratory Muscle Training (IMT)
POWERbreathe®KHA (IMT group)
Enhed: 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.
Sham-komparator: Sham Training
POWERbreathe®KH2 (sham group)
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dyspnea on daily life
Tidsramme: 8 weeks
Measured by the Baseline Dyspnea Index (BDI)
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inspiratory muscle strength as measured by spirometry
Tidsramme: 8 weeks
Measured by Maximal Static Inspiratory Pressures (Pi,max)
8 weeks
Inspiratory muscle endurance as measured by a PowerBreathe device
Tidsramme: 8 weeks
Assessed by Endurance Respiratory Muscle Protocol (Patients will breathe against 60% of Pi,max inspiratory load until task failure)
8 weeks
Dyspnea on exertion
Tidsramme: 8 weeks
Measured by Borg score during high intensity constant load cycling exercise test
8 weeks
Time to exercise intolerance (Tlim)
Tidsramme: 8 weeks
Evaluated by high intensity constant load cycling exercise test
8 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lung hyperinflation
Tidsramme: 8 weeks
Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test
8 weeks
Endothelial function as measured by non-invasive ultrasound images of the brachial artery.
Tidsramme: 8 weeks
Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery
8 weeks
Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement)
Tidsramme: 8 weeks
Measured by heart rate variability explored in the frequency domain
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Queen's University

Samarbejdspartnere

KU Leuven
Federal University of Rio Grande do Sul
Federal University of São Paulo

Efterforskere

  • Studiestol: J Alberto Neder, MD, PhD, Queen's University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2015

Primær færdiggørelse (Forventet)

1. juni 2017

Studieafslutning (Forventet)

1. juli 2017

Datoer for studieregistrering

Først indsendt

10. marts 2015

Først indsendt, der opfyldte QC-kriterier

15. oktober 2015

Først opslået (Skøn)

19. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMT COPD+HF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med POWERbreathe®KHA (IMT group)

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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