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临床试验/NCT02579200
NCT02579200Unknown4 期

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

Queen's University3 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
4 期
入组人数
50
试验地点
3
主要终点
Dyspnea on daily life

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

结局指标

主要结局

Dyspnea on daily life

时间窗: 8 weeks

Measured by the Baseline Dyspnea Index (BDI)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. J. Alberto Neder

Study Chair

Queen's University

研究点 (3)

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