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临床试验/NCT03626519
NCT03626519已完成不适用

Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

Groupe Hospitalier du Havre6 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2019年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
6
主要终点
Change in Dyspnea after each tests

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dyspnoea is a common symptom among patients with Chronic Obstructive pulmonary Disease (COPD). Dyspnea is the primary symptom limiting exercise and daily activities in these patients. It has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. The aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with COPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • a diagnosis of COPD
  • Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
  • Clinically stable

排除标准

  • exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
  • exacerbation during the study
  • Inability to chew or patients with swallowing disorders

结局指标

主要结局

Change in Dyspnea after each tests

时间窗: The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

Change in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort

次要结局

  • Change in respiratory rate(Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.)
  • Change in tidal volume(The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.)
  • Change in inspiratory capacity(The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.)
  • Change in Oxygen Saturation(Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.)
  • Change in Cardiac Frequency(Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.)
  • Change in 6-min walk distance(The outcome will be measured at the end of each tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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