None listed
Conditions
Interventions
Behavioral : Digital lung-conduction exercise (LCE) using digital devices (Digital LCE group) or LCE without digital devices (conventional LCE group), once daily, 5 days per week, for 8 weeks.
No inte
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged 19 years or older and under 80 years. 2. Breathlessness, Cough, and Sputum Scale (BCSS) score =3 points. 3. diagnosed with chronic obstructive pulmonary disease or in the high-risk group for COPD: aged 40 =years old with a smoking history of 10 =pack-years, or with a history of exposure to risk factors (fumes from cooking and heating fuel, or occupational dust, vapor, smoke, gas, other chemicals, or host factors (e.g., congenital factors, developmental abnormalities, low birth weight, prematurity, or childhood respiratory infections)). 4. those who agreed to participate in the clinical trial and signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1. those with forced expiratory volume in one second (FEV1) >30% of predicted value in pulmonary function test. 2. those unable to independently operate the digital lung-conduction exercise mobile application and electronic mask. 3. those with a history of concurrent medical conditions that could cause dyspnea other than respiratory diseases (e.g., congestive heart failure, hyperthyroidism, anemia, and panic disorder). 4. those with severe respiratory diseases, except for COPD risk factors (e.g., lung cancer, pneumonia, interstitial lung disease, active tuberculosis, pulmonary destruction due to tuberculosis, and history of pneumonectomy). 5. those with unstable cardiovascular disease (e.g., unstable angina, acute myocardial infarction, and severe aortic stenosis) or untreated severe pulmonary hypertension. 6. those with coexisting diseases that could interfere with treatment, safety assessment, or completion of this clinical trial, such as clinically significant impairment in oncological, neuropsychiatric, renal, hepatic, cardiovascular, respiratory, endocrine, or central nervous systems. 7. those with a history of acute exacerbation within the last 2 weeks. 8. those who show change in FEV1 or forced vital capacity (FVC) of =12% and =200mL before and after bronchodilator administration, or those who exhibit typical asthma symptoms (paroxysmal wheezing dyspnea). 9. those with other diseases that could lead to death or disability within a 1-year period (e.g., cancer, heart failure, coronary artery disease, cerebrovascular disease, renal failure, uncontrolled diabetes mellitus with severe complications, and uncontrolled hypertension). 10. those with conditions that make walking difficult or impede the improvement of walking ability (e.g., cerebrovascular disease, musculoskeletal diseases, and other severe nutritional deficiencies). 11. pregnant or lactating women. 12. those with a history of alcoholism or substance abuse. 13. current smokers (those who quit smoking within the last 1 year will be considered as current smokers). 14. those who the investigators determined were ineligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in chest expansion from baseline to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Breathlessness, Cough, and Sputum Scale (BCSS) scores from baseline to Week 8;Short-term effect in chest expansion at Visit 2;Change in pulmonary function test (forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC) from baseline to Week 8;Change in maximum inspiratory pressure and maximum expiratory pressure from baseline to Week 8;Change in 6-minute walk test from baseline to Week 8;Change in modified Medical Research Council dyspnea scale (mMRC) from baseline to Week 8;Change in COPD Assessment Test score from baseline to Week 8;Change in St. George’s Respiratory Questionnaire (SGRQ) score from baseline to Week 8 | — |
Countries
Korea, Republic of
Contacts
Public ContactYang Chun Park
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed