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Pulmonary Rehabilitation Program in COPD Patient

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05906264
Enrollment
64
Registered
2023-06-15
Start date
2022-06-09
Completion date
2025-03-14
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Rehabilitation, Tele-rehabilitation

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.

Interventions

BEHAVIORALTele-intervention

Tele-intervention every week to check compliance and encourage the rehabilitation

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dyspnea scale1 month after trainingmMRC dyspnea scale (0-4)
Activity minutes in 1 month1 month after trainingmetabolic equivalents (METs)/day
Pulmonary function test1 month after trainingMaximum phonation time (seconds)

Secondary

MeasureTime frameDescription
Activity minutes in 3 months3 month after trainingmetabolic equivalents (METs)/day
Functional capacity3 month after training6 minute walk test (m/6min)
Pulmonary function test3 month after trainingPulmonary function test (FEV1/FVC)
Dyspnea scale3 month after trainingmMRC dyspnea scale (0-4)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026