Rehabilitation of Chronic Diseases and Smart Health Management System Service

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Rehabilitation; Cardiac Rehabilitation
• Intervention / Treatment: Device: smartphone application

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa
    • Seoul, Songpa, Korea, Republic of, 05505
      • Recruiting
      • Asan Medical Center, University of Ulsan College of Medicine
      • Contact: Sei Won Lee, MD PhD; Phone Number: +82-2-3010-3990; Email: iseiwon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smartphone application based 12-week pulmonary or cardiac rehabilitation	Device: smartphone application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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).	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).	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	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.	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.	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.	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.	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.	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	12 weeks
change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)	This test measures total exercise duration.	12 weeks
change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)	This test measures metabolic equivalents (METs).	12 weeks

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2022-0562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No