Inspiratory Muscle Training for Breathless Patients With Chronic Obstructive Pulmonary Disease and Heart Failure
Inspiratory Muscle Training for Dyspneic Patients With COPD-HF Overlap: a Multicenter, Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- Dyspnea on daily life
- Inspiratory muscle strength and endurance
- Dyspnea on exertion and time to exercise intolerance
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
-
Leuven, Belgien
- Rekrytering
- KU Leuven
-
Kontakt:
- Daniel Langer
- E-post: Daniel.Langer@faber.kuleuven.be
-
-
-
-
RS
-
Porto Alegre, RS, Brasilien
- Rekrytering
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
-
Kontakt:
- Danilo C Berton
- E-post: dcberton@gmail.com
-
-
SP
-
Sao Paulo, SP, Brasilien
- Rekrytering
- Universidade Federal de Sao Paulo
-
Kontakt:
- Luiz E Neri
- E-post: lenery@pneumo.epm.br
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Inspiratory Muscle Training (IMT)
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 Comparator: Sham Training
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dyspnea on daily life
Tidsram: 8 weeks
|
Measured by the Baseline Dyspnea Index (BDI)
|
8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Inspiratory muscle strength as measured by spirometry
Tidsram: 8 weeks
|
Measured by Maximal Static Inspiratory Pressures (Pi,max)
|
8 weeks
|
|
Inspiratory muscle endurance as measured by a PowerBreathe device
Tidsram: 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
Tidsram: 8 weeks
|
Measured by Borg score during high intensity constant load cycling exercise test
|
8 weeks
|
|
Time to exercise intolerance (Tlim)
Tidsram: 8 weeks
|
Evaluated by high intensity constant load cycling exercise test
|
8 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lung hyperinflation
Tidsram: 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.
Tidsram: 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)
Tidsram: 8 weeks
|
Measured by heart rate variability explored in the frequency domain
|
8 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: J Alberto Neder, MD, PhD, Queen's University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IMT COPD+HF
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .