Pulmonary Rehabilitation Program in COPD Patient

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Tele-intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pulmonary rehabilitation, Control<br>for COPD patients, who have been trained with the pulmonary rehabilitation program Compliance will be checked by monitoring wearable device at one month Pulmonary function and symptom improvement effect will be checked at 3 months | |
| Active Comparator: Pulmonary rehabilitation, Intervention<br>Compared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation | Behavioral: Tele-intervention<br>* Tele-intervention every week to check compliance and encourage the rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity minutes in 1 month | metabolic equivalents (METs)/day | 1 month after training | 
| Pulmonary function test | Maximum phonation time (seconds) | 1 month after training | 
| Dyspnea scale | mMRC dyspnea scale (0-4) | 1 month after training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity minutes in 3 months | metabolic equivalents (METs)/day | 3 month after training | 
| Pulmonary function test | Pulmonary function test (FEV1/FVC) | 3 month after training | 
| Dyspnea scale | mMRC dyspnea scale (0-4) | 3 month after training | 
| Functional capacity | 6 minute walk test (m/6min) | 3 month after training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation, Tele-rehabilitation