Pulmonary RehabilitationNCT05610358
Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease
A study testing smartphone application in people with Pulmonary Rehabilitation and Cardiac Rehabilitation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Rehabilitation, Cardiac Rehabilitation
- What is being tested?
- smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyspnea symptom >= mMRC 1 or NYHA II
- adults between 20 years and 80 or years
- Chronic respiratory disease
- 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
Show all 9Show fewer
- Chronic cardiovascular disease
- Reperfusion Therapy for angina pectoris or myocardial infarction
- Heart failure with reduced ejection fraction (LVEF < 50%)
Who cannot join
- history of acute exacerbation within 4 weeks
- unable to comply rehabilitation program
- not suitable for study on decision by duty physician
- no consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Sei Won Lee, MD PhD, 82-2-3010-3990, iseiwon@gmail.com
About this study
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.
- Conditions
- Pulmonary Rehabilitation, Cardiac Rehabilitation
- Being tested
- smartphone application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group will be provided the smartphone application and they will practice application based rehabilitation for 12 weeks. Receives: Device: smartphone application |
| Control | No intervention | Participants in the control group will not practice rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of maximal oxygen consumption (VO2max)
The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).
Measured: 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
Measured: 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).
Measured: 12 weeks
Secondary outcomes (12)
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
- shortness of breath when hurrying on the level or walking up a slight hill
- walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level
- stops for breath after walking ∼100 m or after few minutes on the level
- too breathless to leave the house, or breathless when dressing or undressing
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 weeks
change of hand grip strength
The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 weeks
change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)
This test measures total exercise duration.
Measured: 12 weeks
change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group)
This test measures metabolic equivalents (METs).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610358
- Sponsor's protocol ID
- 2022-1460
- Status last verified
- Jul 2023
- First submitted
- 3 Nov 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request.
Publications
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.
PubMed 41313804Chung 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.
PubMed 37730392
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05610358
- Acronym / sponsor ID
- 2022-1460
- Conditions
- Pulmonary Rehabilitation, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: smartphone applicationParticipants in the intervention group will be provided the smartphone application and they will practice application based rehabilitation for 12 weeks. |
| Control | No intervention | –Participants in the control group will not practice rehabilitation program. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- history of acute exacerbation within 4 weeks
- unable to comply rehabilitation program
- not suitable for study on decision by duty physician
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smartphone applicationIn this study, the investigators will provide smartphone application based 12-week pulmonary or cardiac rehabilitation program to patients with chronic respiratory or cardiovascular diseases. | Device | Intervention |
Primary outcome
change of maximal oxygen consumption (VO2max)
Time frame: 12 weeks
The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).
Change of Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) (Chronic respiratory disease group)
Time frame: 12 weeks
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
change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic cardiovascular disease group)
Time frame: 12 weeks
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 secondary outcomes
change of dyspnea symptom (Chronic respiratory disease group)
Time frame: 12 weeks
change of dyspnea symptom (Chronic cardiovascular disease group)
Time frame: 12 weeks
Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score
Time frame: 12 weeks
change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic respiratory disease group)
Time frame: 12 weeks
change of hand grip strength
Time frame: 12 weeks
change of limb muscle mass
Time frame: 12 weeks
change of forced expiratory volume in one second (FEV1) (Chronic respiratory disease group)
Time frame: 12 weeks
change of forced vital capacity (FVC) (Chronic respiratory disease group)
Time frame: 12 weeks
change of diffusing capacity of the lung for carbon monoxide (DLCO) (Chronic respiratory disease group)
Time frame: 12 weeks
Change of chest pain symptom (Chronic cardiovascular disease group)
Time frame: 12 weeks
change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)
Time frame: 12 weeks
change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Derived from this study: PubMed 41313804Chung 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.
- Derived from this study: PubMed 37730392Chung 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone application in people with Pulmonary Rehabilitation and Cardiac Rehabilitation, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sei Won Lee, MD PhD (82-2-3010-3990, iseiwon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of maximal oxygen consumption (VO2max) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610358, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.