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In Republic of Korea, it is not easy to practice standard pulmonary rehabilitation (PR) or cardiac rehabilitation (CR). In this study, the investigators will provide newly developed smartphone application to patients with chronic respiratory or cardiovascular diseases. The investigators want to confirm whether participants, who perform smartphone application based 12-week PR or CR program, present improved exercise capacity, dyspnea symptom, muscle strength, or quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants in the intervention group will be provided the smartphone application and they will practice application based rehabilitation for 12 weeks. |
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| Control | No Intervention | Participants in the control group will not practice rehabilitation program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartphone application | Device | In this study, the investigators will provide smartphone application based 12-week pulmonary or cardiac rehabilitation program to patients with chronic respiratory or cardiovascular diseases. |
| Measure | Description | Time Frame |
|---|---|---|
| change of maximal oxygen consumption (VO2max) | The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test). | 12 weeks |
| Change of Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) (Chronic respiratory disease group) | Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40 | 12 weeks |
| change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic cardiovascular disease group) | A questionnaire assessing health related quality of life on 4 health dimensions (physical, mental, social, positive health dimension). Each item is scored 1-4, yielding a total between 8 and 40. The scores range from 8 (best performance) to 40 (worst performance). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change of dyspnea symptom (Chronic respiratory disease group) | Dyspnea symptom is measured according to the Modified Medical Research Council (mMRC) Dyspnea Scale. The mMRC scale is from 0 to 4: 0: no breathlessness except on strenuous exercise
|
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Inclusion Criteria:
Dyspnea symptom >= mMRC 1 or NYHA II
adults between 20 years and 80 or years
FEV1/FVC < 0.7 or FEV1< 0.8 of predicted value in pulmonary function test
bronchiectasis in more than one lobe on chest computed tomography
FVC or DLCO < 0.8 of predicted value in pulmonary function test
Reperfusion Therapy for angina pectoris or myocardial infarction
Heart failure with reduced ejection fraction (LVEF < 50%)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sei Won Lee, MD PhD | Contact | 82-2-3010-3990 | iseiwon@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41313804 | Derived | Chung C, Kim AR, Kang DY, Kim S, Oh J, Kim HJ, Park B, Lee SH, Kim D, Kwon H, Jo MW, Lee SW. Clinical Efficacy of Smartphone App-Based Pulmonary Rehabilitation in Chronic Respiratory Diseases: Randomized Controlled and Feasibility Trials. J Med Internet Res. 2025 Nov 28;27:e76801. doi: 10.2196/76801. | |
| 37730392 | Derived |
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The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request.
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| 12 weeks |
| change of dyspnea symptom (Chronic cardiovascular disease group) | Dyspnea symptom is measured according to the New York Heart Association Functional Classification (NYHA class). The NYHA class is from I to IV: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation (feeling heart beats), or dyspnea (shortness of breath). Class II(Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III(Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV(Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. | 12 weeks |
| Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score | A questionnaire assessing health related quality of life on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each item is scored 1-5, yielding a total between 5 and 25. The scores range from 5 (best performance) to 25 (worst performance). | 12 weeks |
| change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic respiratory disease group) | A questionnaire assessing health related quality of life on 4 health dimensions (physical, mental, social, positive health dimension). Each item is scored 1-4, yielding a total between 8 and 40. The scores range from 8 (best performance) to 40 (worst performance). | 12 weeks |
| change of hand grip strength | The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg | 12 weeks |
| change of limb muscle mass | The muscle mass is measured using the Bioelectrical Impedance Analysis. The cut off value for sarcopenia is < 7.26 kg/m^2. | 12 weeks |
| change of forced expiratory volume in one second (FEV1) (Chronic respiratory disease group) | The forced expiratory volume in one second (FEV1) is measured using spirometry. The value will be presented in % predicted value. | 12 weeks |
| change of forced vital capacity (FVC) (Chronic respiratory disease group) | The forced vital capacity (FVC) is measured using spirometry. The value will be presented in % predicted value. | 12 weeks |
| change of diffusing capacity of the lung for carbon monoxide (DLCO) (Chronic respiratory disease group) | The diffusing capacity of the lung for carbon monoxide (DLCO) is measured using single breath holding method. The value will be presented in % predicted value. | 12 weeks |
| Change of chest pain symptom (Chronic cardiovascular disease group) | Chest pain symptom is measured according to the Canadian Cardiovascular Society grading of angina pectoris (CCS angina grade). The CCS angina grade is from I to IV: Grade I: Angina with strenuous/rapid/prolonged exertion at work or recreation only; no angina with ordinary physical activity, e.g. walking, climbing stairs Grade II: Ordinary activity slightly limited: angina with walking/climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold/wind, under emotional stress, during few hours after awakening, walking >2 blocks on level ground, or climbing >1 flight of stairs at normal pace and normal conditions Grade III: Marked limitation of ordinary physical activity: angina with walking 1-2 blocks on level ground or climbing 1 flight of stairs at normal pace and normal conditions Grade IV: Inability to carry on any physical activity without discomfort; anginal syndrome may be present at rest | 12 weeks |
| change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group) | This test measures total exercise duration. | 12 weeks |
| change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group) | This test measures metabolic equivalents (METs). | 12 weeks |
| Chung C, Kim AR, Jang IY, Jo MW, Lee S, Kim D, Kwon H, Kang DY, Lee SW. Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases: a randomised controlled trial study protocol. BMJ Open. 2023 Sep 20;13(9):e072698. doi: 10.1136/bmjopen-2023-072698. |