Clinical trial NCT05906264: Pulmonary Rehabilitation Program in COPD Patient
Official title: Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary Rehabilitation
Tele-rehabilitation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Activity minutes in 1 month
timeFrame: 1 month after training
measure: Pulmonary function test
timeFrame: 1 month after training
measure: Dyspnea scale
timeFrame: 1 month after training
Secondary outcomes:
measure: Activity minutes in 3 months
timeFrame: 3 month after training
measure: Pulmonary function test
timeFrame: 3 month after training
measure: Dyspnea scale
timeFrame: 3 month after training
measure: Functional capacity
timeFrame: 3 month after training
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
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