A Clinical Study to Evaluate the Efficacy and Safety of Pulmonary Rehabilitation Software EB-S100 in Patients with Chronic Obstructive Pulmonary Disease

A Multicenter, Prospective, Comparative, Randomized Clinical Trial to Compare and Evaluate the Efficacy and Safety of the Pulmonary Rehabilitation Software 'EB-S100' in Patients with Chronic obstructive pulmonary Disease, Against a Standard Treatment Control Group.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012275

Enrollment

Registered

2026-07-14

Start date

2025-11-07

Completion date

Unknown

Last updated

2026-07-20

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

Conditions

None listed

Interventions

Medical Device : Participants in the intervention group will undergo an 8-week home-based pulmonary rehabilitation program using the digital therapeutic device EB-S100. EB-S100 is a mobile application

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All of the following inclusion criteria must be met to participate in this clinical study. 1. Adults aged 19 years or older 2. Patients diagnosed with chronic obstructive pulmonary disease (COPD) according to the Korean clinical practice guidelines for COPD 1) FEV1/FVC ratio < 0.7 on pulmonary function testing 2) Patients diagnosed with COPD who require pulmonary rehabilitation exercise therapy 3. Able to read and write Korean without difficulty 4. Able to use mobile applications on general-purpose devices such as smartphones or tablet PCs without difficulty 5. Subjects who voluntarily agree to participate in this clinical study

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following exclusion criteria will not be eligible to participate in this clinical study. 1. Respiratory muscle dysfunction 2. Psychiatric disorders that prevent communication or compliance with instructions 3. Diseases or conditions that impair walking or make improvement in walking ability difficult, including cerebrovascular diseases, musculoskeletal disorders, or other severe malnutrition 4. Other diseases that may result in death or disability within one year, including severe cancer, coronary artery disease, heart failure, or diabetes mellitus with severe complications 5. Pregnant women 6. Subjects deemed unsuitable for study participation at the investigator’s discretion

Design outcomes

Primary

Measure	Time frame
Change in six-minute walk distance (6MWD)	—

Secondary

Measure	Time frame
Change in dyspnea severity assessed by the modified Medical Research Council (mMRC) scale;Change in COPD Assessment Test (CAT) score;Change in quality of life assessed by the EuroQol 5-Dimension (EQ-5D);Incidence, frequency, and severity of adverse events during the study period	—

Countries

Korea, Republic of

Contacts

Public ContactDEOG KYEOM KIM

Seoul Metropolitan Government Seoul National University Boramae Medical Center

kimdkmd@gmail.com+82-2-870-2228

Outcome results