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临床试验/NCT04978831
NCT04978831已完成不适用

The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs, Fatigue and Pulmonary Function Parameters in Patients With COPD Who Followed Up by Wearable Technology

Inonu University1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
1
主要终点
Pulmonary Function Parameters

研究概览

简要总结

Purpose of the research; To determine the effects of wearable technology follow-up, breathing exercises with a breathing exercise device and reading aloud on vital signs, fatigue and respiratory function parameters in individuals with COPD. This research will be conducted using a randomized controlled trial model. "Personal Description Form", "COPD and Asthma Fatigue Scale", Visual Analog Scale and pulmonary function tests will be used in data collection.

研究设计

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

入排标准

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

入选标准

  • •Having been diagnosed with COPD for at least 6 months or before
  • •Not having a respiratory system defect caused by diseases other than COPD
  • •Not in the GOLD-4 COPD stage
  • •Being able to read and write Turkish
  • •Have no problems communicating or speaking
  • •Being able to use basic information technologies
  • •Using a smartphone
  • •Having an active internet connection

排除标准

  • •Having non-COPD pulmonary problems and diagnosed cardiovascular disease
  • •Not volunteering to participate in the study
  • •Having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process

研究组 & 干预措施

Control group

No Intervention

Respiratory exercise device group

Experimental

干预措施: PEP Device (Device)

Reading aloud group

Experimental

干预措施: Reading Aloud (Other)

结局指标

主要结局

Pulmonary Function Parameters

时间窗: 2 month

Change in FEV1/FVC ratio will be evaluated with pulmonary function test

Fatigue

时间窗: 2 month

The COPD and Asthma Fatigue Scale was developed by Revicki et al in 2010 to reveal the effect of COPD and Asthma on fatigue. The items of the questions in the scale, which consists of 12 questions in total, are graded with a 5-point Likert type as "never", "rarely", "sometimes", "often", "very often". A total of 12 to 60 points is obtained from the scale. A single score is obtained from the scale for the state of fatigue, and there is no evaluation of the sub-dimensions. An increase in this score indicates that the person's fatigue level is high.

次要结局

未报告次要终点

研究者

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

Gürkan ÖZDEN

Research Assistant

Inonu University

研究点 (1)

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