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临床试验/NCT00741832
NCT00741832Unknown不适用

The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2008年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
11
试验地点
1
主要终点
Inspiratory Capacity

研究概览

简要总结

From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that

  1. Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
  2. PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
  3. PEP breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate COPD patients.

详细描述

Expiratory airflow limitation is the pathophysiological hallmark of chronic obstructive pulmonary disease (COPD) that leads to air trapping and increases in dynamic hyperinflation (DH) and consequently causes dyspnea during exercise. Although pursed lips breathing is a simple technique that provides a positive back pressure may retard the airway collapsed, but previous studies showed an unsuccessful reduction of DH which might cause by insufficient back pressure. And thereby a conical positive expiratory pressure (C-PEP) has been developed in our laboratory to generate back pressure higher than pursed lips breathing. Moreover, an effect of PEP on DH has not carried out in patient with COPD. Therefore, the objective of the present study was to examine effects of a C-PEP on DH and respiratory response during exercise in patient with COPD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with stable mild-to-moderate COPD (Both stages: FEV1/FVC < 70%. Mild stage: FEV1 ≥ 80% predicted; Moderate stage: 50% ≤ FEV1 < 80% predicted according to Global Initiative Obstructive Lung Disease (GOLD) guideline).
  • •Free of exacerbations for more than 4 weeks (as defined by a change to pharmacological therapy, admission to hospital or ER or unscheduled clinic visit).
  • •Good communication

排除标准

  • •Older than 70 years old
  • •Musculoskeletal problems that limit mobility
  • •Cardiovascular disease
  • •Neurological or psychiatric illness
  • •Patient on long term oxygen or domiciliary noninvasive positive pressure ventilation
  • •Any other comorbidities which would affect ability to undertake exercise test

研究组 & 干预措施

C

Active Comparator

Patients (normal) breath during exercise

干预措施: Control breathing (Other)

I

Experimental

Patients breath while a conical positive expiratory pressure device during exercises

干预措施: Conical Positive Expiratory Pressure Device (C-PEP) (Device)

结局指标

主要结局

Inspiratory Capacity

时间窗: at 0th, 5th, ~20th minutes of exercises

Borg scale

时间窗: at 0th and 20th minutes of exercises

次要结局

  • Heart Rate(every minutes of exercise and recovery periods)
  • Exercise time(at the times when participants stop exercises)
  • Recovery time(the periods between end of symptomatic limited constance workload exercises to full recovery heart rate)
  • Respiratory rate(every minutes of exercise and recovery periods)
  • Inspiratory time(every minutes of exercise and recovery periods)
  • Expiratory time(every minutes of exercise and recovery periods)
  • Sp02(every minutes of exercise and recovery periods)
  • PetCO2(every minutes of exercise and recovery periods)
  • Mouth pressure(every minutes of exercise periods)
  • Flow rate(every minutes of exercise periods)

研究者

申办方类型
Other

研究点 (1)

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