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临床试验/NCT05687396
NCT05687396招募中不适用

Virtual Reality in Chronic Obstructive Pulmonary Disease: Randomized Contolled Trial

Pamukkale University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
1 minute sit and stand test

研究概览

简要总结

In addition to conventional pulmonary rehabilitation, virtual reality will be applied during the hospitalization period of individuals hospitalized for COPD exacerbation. It is aimed to get more efficiency from the interventions in this short time.

详细描述

Subjects with COPD exacerbation will be divided two groups. Group-1 will exercise with a bicycle ergometer until fatigue in addition to pulmonary rehabilitation. Group-2 will do the same exercises. Subjects in Group-2 will use virtual reality simulation, which is designed as cycling in the forest while cycling. Treatment will continue until discharge. CAT score, mMRC dyspnea score, hospital anxiety and depression score and London chest daily living activity score will be examined before and after treatment.

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
Double (Care Provider, Investigator)

入排标准

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

入选标准

  • Individuals who are in COPD exacerbation period, FEV1 <70%, GOLD 2-3 spirometric stage, Hodkinson mental test score > 6 and who want to participate in the study voluntarily will be included in the study.

排除标准

  • If there is respiratory disease considered more significant than COPD (bronchiectasis, lung cancer requiring active therapy, or asthma), Heart failure New York Heart Association (NYHA) stage 3-4, Significant hemoptysis, surgical or non-surgical lung volume in the past 6 months Individuals with reduction procedures, Lung transplantation or pneumonectomy surgery in the last 6 months, pulmonary embolism or pulmonary edema, acute myocardial infarction, acute heart failure, vertigo, epilepsy and visual impairment will be excluded from the study.

结局指标

主要结局

1 minute sit and stand test

时间窗: 5 minutes

performance

Chronic Obstructive Pulmonary Disease Assessment Test

时间窗: 3-7 days

The test assessts COPD symptoms, higher scores mean bad stiation

Modified Medical Research Council

时间窗: 3-7 days

The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea.

London chest activity of daily living

时间窗: 3-7 days

The test assessts dyspnea that occurs during daily living activities. The total score can range from 0 to 75 points, with higher values translating to greater limitation in activities of daily living.

Hospital anxiety and depression scale

时间窗: 3-7 days

The test has 2 subparameter as anxiety and depression. Each question in the test contains 4 options expressing frequency on a scale 0 to 3. Higher scores mean bad stiation for each parameter.

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

Erhan KIZMAZ

Principal Investigator

Pamukkale University

研究点 (2)

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