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临床试验/NCT01852006
NCT01852006已完成不适用

Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?

McGill University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise

研究概览

简要总结

Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia) and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches yield meaningful symptom improvements there remains many COPD patients incapacitated by dyspnea. Accumulating evidence suggests that abdominal binding (AB) is a potentially novel method of improving respiratory muscle function and, by extension, dyspnea and exercise tolerance in COPD. Thus, the purpose of this randomized, cross-over study is to test the hypothesis that AB improves exertional dyspnea and exercise tolerance in symptomatic patients with COPD by improving dynamic respiratory muscle function. To this end, the investigators will examine the effects of AB on detailed assessments of baseline pulmonary function (spirometry, plethysmography), dyspnea (sensory intensity & affective responses), neural respiratory drive (diaphragm EMG), contractile respiratory muscle function (esophageal, gastric & transdiaphragmatic pressures), ventilation, breathing pattern and cardiometabolic function during symptom-limited constant load cycle exercise (75% Wmax) in 20 patients with GOLD stage II/III COPD.

研究设计

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

入排标准

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

入选标准

  • Male or Female
  • Aged ≥40 years
  • Ambulatory
  • Cigarette smoking history ≥15 pack years
  • No change in medication dosage or frequency of administration, with no exacerbations or hospitalization in the preceding 6 weeks.
  • Post-bronchodilator Forced Expiratory Volume in 1 second between 30-80% predicted
  • Post-bronchodilator Forced Expiratory Volume in 1 second/forced vital capacity ratio of <70%

排除标准

  • Presence of active cardiopulmonary disease other than COPD
  • Use of domiciliary oxygen
  • Exercise-induced arterial blood oxyhemoglobin desaturation to <80% on room air.
  • Body Mass Index <18.5 or ≥35 kg/m
  • Allergy to latex
  • Allergy to lidocaine or its "caine" derivates.

结局指标

主要结局

Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise

时间窗: Patients will be followed until all study visits are complete, an expected average of 2 weeks

次要结局

  • Exercise Endurance Time (EET)(Patients will be followed until all study visits are complete, an expected average of 2 weeks)

研究者

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

Dennis Jensen, Ph.D.

Assistant Professor

McGill University

研究点 (2)

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