Rehabilitation of Chronic Diseases and Smart Health Management System Service
Primary Purpose
Pulmonary Rehabilitation, Cardiac Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
smartphone application
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- history of acute exacerbation within 4 weeks
- unable to comply rehabilitation program
- not suitable for study on decision by duty physician
- no consent
Sites / Locations
- Asan Medical Center, University of Ulsan College of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
smartphone application based 12-week pulmonary or cardiac rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
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.
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).
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).
Secondary Outcome Measures
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
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.
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).
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).
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
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.
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.
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.
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.
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.
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
change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
This test measures total exercise duration.
change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
This test measures metabolic equivalents (METs).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05383950
Brief Title
Rehabilitation of Chronic Diseases and Smart Health Management System Service
Official Title
Rehabilitation of Chronic Diseases and Smart Health Management System Service Provided by Hospital and Community Association
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Rehabilitation, Cardiac Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smartphone application based 12-week pulmonary or cardiac rehabilitation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
smartphone application
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)
Description
The distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time Frame
12 weeks
Title
change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)
Description
The maximum rate of oxygen consumption measured during incremental exercise test (cardiopulmonary exercise test).
Time Frame
12 weeks
Title
change of frailty index at 12 weeks (Chronic geriatric disease group)
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric disease group)
Description
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
Time Frame
12 weeks
Title
change from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric disease group)
Description
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.
Time Frame
12 weeks
Title
Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score at 12 weeks (all groups)
Description
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).
Time Frame
12 weeks
Title
change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score at 12 weeks (all groups)
Description
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).
Time Frame
12 weeks
Title
change of muscle strength at 12 weeks (all groups)
Description
The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg
Time Frame
12 weeks
Title
change of Short physical performance battery (SPPB) at 12 weeks (all groups)
Description
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.
Time Frame
12 weeks
Title
change of muscle mass at 12 weeks (all groups)
Description
The muscle mass is measured using the Bioelectrical Impedance Analysis. The cut off value for sarcopenia is < 7.26 kg/m^2.
Time Frame
12 weeks
Title
change of forced expiratory volume in one second (FEV1) at 12 weeks (Chronic respiratory disease group)
Description
The forced expiratory volume in one second (FEV1) is measured using spirometry. The value will be presented in % predicted value.
Time Frame
12 weeks
Title
change of forced vital capacity (FVC) at 12 weeks (Chronic respiratory disease group)
Description
The forced vital capacity (FVC) is measured using spirometry. The value will be presented in % predicted value.
Time Frame
12 weeks
Title
change of diffusing capacity of the lung for carbon monoxide (DLCO) at 12 weeks (Chronic respiratory disease group)
Description
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.
Time Frame
12 weeks
Title
Change of chest pain symptom at 12 weeks (Chronic cardiac disease group)
Description
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
Time Frame
12 weeks
Title
change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
Description
This test measures total exercise duration.
Time Frame
12 weeks
Title
change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
Description
This test measures metabolic equivalents (METs).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
history of acute exacerbation within 4 weeks
unable to comply rehabilitation program
not suitable for study on decision by duty physician
no consent
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
State/Province
Songpa
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sei Won Lee, MD PhD
Phone
+82-2-3010-3990
Email
iseiwon@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Rehabilitation of Chronic Diseases and Smart Health Management System Service
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