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临床试验/NCT05906264
NCT05906264已完成不适用

Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年6月9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
64
试验地点
1
主要终点
Dyspnea scale

研究概览

简要总结

This study was designed in order to evaluate the compliance of a pulmonary rehabilitation program using a wearable device and the application effect of the program according to the characteristics of each patient, in COPD patients.

详细描述

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and airflow limitation. Symptoms of COPD often restricts exercise capacity and activities of daily life of patients. Accordingly, patients with symptomatic COPD have reduced health-related quality of life, which leads to substantial socioeconomic burden.

In order to overcome the limitation associated with COPD pharmacotherapy, the need for a combination of nonpharmacologic therapies, including pulmonary rehabilitation has been suggested constantly. Pulmonary rehabilitation is a method of relieving respiratory distress symptoms through exhalation and inspiratory training, improving exercise ability and contributes in improving lung function and overall quality of life.

Nevertheless, compliance of pulmonary rehabilitation in daily life is low in most COPD patients. Thus, we applied wearable device to detect and evaluate application, compliance and effectiveness pulmonary rehabilitation program in COPD patients, according to the patients' characteristics. Moreover, we sought to use the results of this study as a basic data to establish a strategy for a customized education program for each patient that can be applied to non-face-to-face digital therapeutics in the future.

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

入选标准

  • COPD patients 18 years of age or older
  • ECOG PS (Eastern Cooperative Oncology Group Performance Status) <2
  • Smart phone user
  • Those who understand the contents of the questionnaire and agree to the research

排除标准

  • Patients with history of lung cancer surgery
  • Patients with bronchiectasis, severe tuberculosis destroyed lung, active pulmonary tuberculosis, non-tuberculous mycobacterial lung disease (NTM), and idiopathic interstitial pneumonia

结局指标

主要结局

Dyspnea scale

时间窗: 1 month after training

mMRC dyspnea scale (0-4)

Pulmonary function test

时间窗: 1 month after training

Maximum phonation time (seconds)

Activity minutes in 1 month

时间窗: 1 month after training

metabolic equivalents (METs)/day

次要结局

  • Functional capacity(3 month after training)
  • Activity minutes in 3 months(3 month after training)
  • Pulmonary function test(3 month after training)
  • Dyspnea scale(3 month after training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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