Pulmonary Rehabilitation Program in COPD Patient

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Tele-intervention

• Registration Number: NCT05906264
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-19
• Study Start: 2022-06-09
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Primary Completion: 2025-03-14
• Study Completion: 2025-03-14
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary rehabilitation, Intervention	Tele-intervention	Compared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of