Pulmonary RehabilitationNCT05383950
Rehabilitation of Chronic Diseases and Smart Health Management System Service
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, cardiac, or geriatric 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
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2022to 31 Dec 2022
- 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 I
- adults between 20 years and 80 or years
- Chronic respiratory disease
- FEV1/FVC < 0.7 in pulmonary function test
- bronchiectasis in more than one lobe on chest computed tomography
- FVC of DLCO < 0.8 of predicted value in pulmonary function test
Show all 12Show fewer
- Chronic cardiac disease
- Reperfusion Therapy for angina pectoris or myocardial infarction
- Heart failure with reduced ejection fraction (LVEF < 50%)
- Chronic geriatric disease
- Ages between 60 and 80 years
- Clinical frailty scale between 1 and 4
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, University of Ulsan College of Medicine
Seoul, Songpa, 05505
Sei Won Lee, MD PhD, +82-2-3010-3990, iseiwon@gmail.com
About this study
Official title: Rehabilitation of Chronic Diseases and Smart Health Management System Service Provided by Hospital and Community Association
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, cardiac, or geriatric 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, cardiac, or geriatric diseases.
| Study group | Role | What they receive |
|---|---|---|
| smartphone application based 12-week pulmonary or cardiac rehabilitation | Experimental | Not described Receives: Device: smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)
The distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Measured: 12 weeks
change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)
The maximum rate of oxygen consumption measured during incremental exercise test (cardiopulmonary exercise test).
Measured: 12 weeks
change of frailty index at 12 weeks (Chronic geriatric disease group)
The frailty index is defined as the proportion of deficits present in an individual out of the total number of age-related health variables considered.
Frailty Index (FI) = (number of health deficits present) ÷ (number of health deficits measured)
For example, a person with 20 of 40 deficits collected has an FI score of 20/40 = 0.5
The frailty index ranges 0 (best performance) to 1 (worst performance).
Measured: 12 weeks
Secondary outcomes (13)
change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric 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 from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric 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 at 12 weeks (all groups)
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 at 12 weeks (all groups)
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 muscle strength at 12 weeks (all groups)
The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg
Measured: 12 weeks
change of Short physical performance battery (SPPB) at 12 weeks (all groups)
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.
The scores range from 0 (worst performance) to 12 (best performance). The cut off value for sarcopenia is ≤ 8.
Measured: 12 weeks
change of muscle mass at 12 weeks (all groups)
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) at 12 weeks (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) at 12 weeks (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) at 12 weeks (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 at 12 weeks (Chronic cardiac 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 at 12 weeks (Chronic cardiac disease group)
This test measures total exercise duration.
Measured: 12 weeks
change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac 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 posted20 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT05383950
- Sponsor's protocol ID
- 2022-0562
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chung C, Kim AR, Kim D, Kwon H, Lee SH, Jang IY, Jo MW, Kang DY, Lee SW. Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases. Sci Rep. 2024 Feb 6;14(1):3018. doi: 10.1038/s41598-024-53583-2.
PubMed 38321153
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Chronic Diseases and Smart Health Management System Service Provided by Hospital and Community Association
- ClinicalTrials.gov ID
- NCT05383950
- Acronym / sponsor ID
- 2022-0562
- Conditions
- Pulmonary Rehabilitation, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 May 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, cardiac, or geriatric 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smartphone application based 12-week pulmonary or cardiac rehabilitation | Experimental | Device: smartphone application |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Dyspnea symptom >= mMRC 1 or NYHA I
- adults between 20 years and 80 or years
- Chronic respiratory disease
- FEV1/FVC < 0.7 in pulmonary function test
- bronchiectasis in more than one lobe on chest computed tomography
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, cardiac, or geriatric diseases. | Device | smartphone application based 12-week pulmonary or cardiac rehabilitation |
Primary outcome
change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)
Time frame: 12 weeks
The distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)
Time frame: 12 weeks
The maximum rate of oxygen consumption measured during incremental exercise test (cardiopulmonary exercise test).
change of frailty index at 12 weeks (Chronic geriatric disease group)
Time frame: 12 weeks
The frailty index is defined as the proportion of deficits present in an individual out of the total number of age-related health variables considered. Frailty Index (FI) = (number of health deficits present) ÷ (number of health deficits measured) For example, a person with 20 of 40 deficits collected has an FI score of 20/40 = 0.5 The frailty index ranges 0 (best performance) to 1 (worst performance).
13 secondary outcomes
change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric disease group)
Time frame: 12 weeks
change from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric disease group)
Time frame: 12 weeks
Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score at 12 weeks (all groups)
Time frame: 12 weeks
change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score at 12 weeks (all groups)
Time frame: 12 weeks
change of muscle strength at 12 weeks (all groups)
Time frame: 12 weeks
change of Short physical performance battery (SPPB) at 12 weeks (all groups)
Time frame: 12 weeks
change of muscle mass at 12 weeks (all groups)
Time frame: 12 weeks
change of forced expiratory volume in one second (FEV1) at 12 weeks (Chronic respiratory disease group)
Time frame: 12 weeks
change of forced vital capacity (FVC) at 12 weeks (Chronic respiratory disease group)
Time frame: 12 weeks
change of diffusing capacity of the lung for carbon monoxide (DLCO) at 12 weeks (Chronic respiratory disease group)
Time frame: 12 weeks
Change of chest pain symptom at 12 weeks (Chronic cardiac disease group)
Time frame: 12 weeks
change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
Time frame: 12 weeks
change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac 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 26 May 2022.
- Derived from this study: PubMed 38321153Chung C, Kim AR, Kim D, Kwon H, Lee SH, Jang IY, Jo MW, Kang DY, Lee SW. Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases. Sci Rep. 2024 Feb 6;14(1):3018. doi: 10.1038/s41598-024-53583-2.
- Individual participant dataSharing planned: Undecided
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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.
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
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 12 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 26 May 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group) (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 NCT05383950, which also lists 1 linked publication.
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 26 May 2022.