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临床试验/NCT03940040
NCT03940040Unknown不适用

Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年5月28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
22
试验地点
1
主要终点
6-minute walk distance

研究概览

简要总结

To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

详细描述

This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

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
None

入排标准

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

入选标准

  • •Age 21 years and above
  • •Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7
  • •Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
  • •Fit to participate in exercise therapy as determined by both physician and physiotherapist
  • •Has the mental capacity to follow instructions
  • •Experience shortness of breath on exertion
  • •Have decreased ability to carry out activities due to shortness of breath
  • •Willing to participate in the exercise program

排除标准

  • •Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
  • •Pulmonary disorder other than COPD
  • •Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.

研究组 & 干预措施

Usual Care

Active Comparator

Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)

干预措施: Usual care (Other)

High flow nasal oxygen

Experimental

Patients will undergo pulmonary rehabilitation with high flow nasal oxygen

干预措施: High flow nasal oxygen (Other)

结局指标

主要结局

6-minute walk distance

时间窗: 6 weeks

It is the maximum distance walked in 6 minutes

次要结局

  • Hospital Anxiety Depression Scale(3 weeks, 6 weeks and 1 month after completion of program)
  • COPD Assessment Test score(3 weeks, 6 weeks and 1 month after completion of program)
  • Respiratory function test(3 weeks, 6 weeks and 1 month after completion of program)
  • 6-minute walk distance(3 weeks and 1 month after completion of program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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