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临床试验/NCT03518177
NCT03518177已完成不适用

Comparison of the Effectiveness of Home and Supervised Pulmonary Rehabilitation in Candidate Patients With Bronchoscopic Lung Volume Reduction

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年5月15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
发起方
入组人数
66
试验地点
2
主要终点
Change from baseline distance covered in six-minute walk test at 8 weeks

研究概览

简要总结

The recent years, the use of bronchoscopic lung volume reduction in emphysema patients instead of surgical operations has become widespread. Before this procedure, the implementation of Pulmonary Rehabilitation became a necessity. The inadequacy of the number of Pulmonary Rehabilitation Centers in our country and in our city and the increasing number of mentioned operations have increased the need for different exercise program applications. Prior to valve and coil applications in our study, changes in clinical conditions of patients will be examined if Pulmonary Rehabilitation is performed at home or in a hospital.

详细描述

The records of emphysema patients referred to the Pulmonary Rehabilitation Unit for prophylactic pulmonary rehabilitation prior to bronchoscopic lung volume reduction will be recorded prospectively. Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation (Group 2). The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program and will be reevaluated after 8 weeks. The differences in the parameters of initial and rehabilitation end-tracing and the differences between the groups will be examined.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with emphysema and bronchoscopic lung volume reduction procedures decided by chest physician
  • Acceptance of participation in a 2-month Pulmonary Rehabilitation program.

排除标准

  • Possible orthopedic, cardiovascular or psychological disturbance that may prevent exercising.

研究组 & 干预措施

Hospital-based PR group

Experimental

The patient will receive an 8-week supervised Pulmonary Rehabilitation Exercise Program at hospital

干预措施: Hospital-based pulmonary rehabilitation (Other)

Home-based PR group

Experimental

The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program at home

干预措施: Home-based pulmonary rehabilitation (Other)

结局指标

主要结局

Change from baseline distance covered in six-minute walk test at 8 weeks

时间窗: 8 weeks

Change from baseline modified Medical Council Dyspnea score at 8 weeks

时间窗: 8 weeks

The scale will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.

Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

时间窗: 8 weeks

Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 8 weeks

时间窗: 8 weeks

The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

esra pehlivan

Principal Investigator

Istanbul Medipol University Hospital

研究点 (2)

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