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
調査の概要
状態
詳細な説明
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
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
RS
-
Porto Alegre、RS、ブラジル
- 募集
- Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
-
コンタクト：
- Danilo C Berton
- メール：dcberton@gmail.com
-
-
SP
-
Sao Paulo、SP、ブラジル
- 募集
- Universidade Federal de Sao Paulo
-
コンタクト：
- Luiz E Neri
- メール：lenery@pneumo.epm.br
-
-
-
-
-
Leuven、ベルギー
- 募集
- KU Leuven
-
コンタクト：
- Daniel Langer
- メール：Daniel.Langer@faber.kuleuven.be
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
偽コンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dyspnea on daily life
時間枠：8 weeks
|
Measured by the Baseline Dyspnea Index (BDI)
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inspiratory muscle strength as measured by spirometry
時間枠：8 weeks
|
Measured by Maximal Static Inspiratory Pressures (Pi,max)
|
8 weeks
|
|
Inspiratory muscle endurance as measured by a PowerBreathe device
時間枠：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
時間枠：8 weeks
|
Measured by Borg score during high intensity constant load cycling exercise test
|
8 weeks
|
|
Time to exercise intolerance (Tlim)
時間枠：8 weeks
|
Evaluated by high intensity constant load cycling exercise test
|
8 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lung hyperinflation
時間枠：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.
時間枠：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)
時間枠：8 weeks
|
Measured by heart rate variability explored in the frequency domain
|
8 weeks
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：J Alberto Neder, MD, PhD、Queen's University
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。