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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Sei Won Lee, MD PhD contact

82-2-3010-3990

iseiwon@gmail.com

South Korea1 site, 1 recruiting
  • Asan Medical Center

    Seoul, 05505

    Sei Won Lee, MD PhD, 82-2-3010-3990, iseiwon@gmail.com

    Recruiting

Other trials in South Korea

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.

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 groups in NCT05610358
Study groupRoleWhat they receive
InterventionExperimentalParticipants in the intervention group will be provided the smartphone application and they will practice application based rehabilitation for 12 weeks.
Receives: Device: smartphone application
ControlNo interventionParticipants 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.

  1. change of maximal oxygen consumption (VO2max)

    The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).

    Measured: 12 weeks

  2. 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

  3. 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)
  1. 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

    1. shortness of breath when hurrying on the level or walking up a slight hill
    2. 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
    3. stops for breath after walking ∼100 m or after few minutes on the level
    4. too breathless to leave the house, or breathless when dressing or undressing

    Measured: 12 weeks

  2. 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

  3. 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

  4. 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

  5. change of hand grip strength

    The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg

    Measured: 12 weeks

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)

    This test measures total exercise duration.

    Measured: 12 weeks

  12. 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.

  1. First posted9 Nov 2022
  2. Study start1 Apr 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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 41313804
  • 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.

    PubMed 37730392

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.

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