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
연구 개요
상태
상세 설명
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
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Leuven, 벨기에
- 모병
- KU Leuven
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연락하다:
- Daniel Langer
- 이메일: Daniel.Langer@faber.kuleuven.be
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RS
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Porto Alegre, RS, 브라질
- 모병
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
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연락하다:
- Danilo C Berton
- 이메일: dcberton@gmail.com
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SP
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Sao Paulo, SP, 브라질
- 모병
- Universidade Federal de Sao Paulo
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연락하다:
- Luiz E Neri
- 이메일: lenery@pneumo.epm.br
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Inspiratory Muscle Training (IMT)
POWERbreathe®KHA (IMT group)
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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.
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가짜 비교기: Sham Training
POWERbreathe®KH2 (sham group)
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dyspnea on daily life
기간: 8 weeks
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Measured by the Baseline Dyspnea Index (BDI)
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8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Inspiratory muscle strength as measured by spirometry
기간: 8 weeks
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Measured by Maximal Static Inspiratory Pressures (Pi,max)
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8 weeks
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Inspiratory muscle endurance as measured by a PowerBreathe device
기간: 8 weeks
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Assessed by Endurance Respiratory Muscle Protocol (Patients will breathe against 60% of Pi,max inspiratory load until task failure)
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8 weeks
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Dyspnea on exertion
기간: 8 weeks
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Measured by Borg score during high intensity constant load cycling exercise test
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8 weeks
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Time to exercise intolerance (Tlim)
기간: 8 weeks
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Evaluated by high intensity constant load cycling exercise test
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8 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lung hyperinflation
기간: 8 weeks
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Evaluated by serial measurements of inspiratory capacity during high intensity constant load cycling exercise test
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8 weeks
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Endothelial function as measured by non-invasive ultrasound images of the brachial artery.
기간: 8 weeks
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Measured by ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery
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8 weeks
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Autonomic function as measured by a 10 lead ECG (MASON-LIKAR Lead electrode placement)
기간: 8 weeks
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Measured by heart rate variability explored in the frequency domain
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8 weeks
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공동 작업자 및 조사자
수사관
- 연구 의자: J Alberto Neder, MD, PhD, Queen's University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
POWERbreathe®KHA (IMT group)에 대한 임상 시험
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Federal University of Health Science of Porto Alegre완전한
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KU LeuvenQueen's University, Kingston, Ontario완전한
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Guangzhou Institute of Respiratory Disease완전한