Pulmonary Rehabilitation Program in COPD Patient

Samsung Medical Center

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Tele-intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05906264

SMC_COPD_Rehab

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Pulmonary rehabilitation, Control

No Intervention group

Description:

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

Pulmonary rehabilitation, Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Tele-intervention