Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease

Cardiac Rehabilitation Clinical Trial

Official title:

Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610358
• Other study ID #: 2022-1460
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Asan Medical Center
• Contact: Sei Won Lee, MD PhD
• Phone: 82-2-3010-3990
• Email: iseiwon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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
• Chronic cardiovascular disease
• Reperfusion Therapy for angina pectoris or myocardial infarction
• Heart failure with reduced ejection fraction (LVEF < 50%)

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases
• Pulmonary Rehabilitation

Intervention

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 or cardiovascular diseases.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of maximal oxygen consumption (VO2max)	The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).	12 weeks
Primary	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	12 weeks
Primary	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).	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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).	12 weeks
Secondary	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).	12 weeks
Secondary	change of hand grip strength	The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)	This test measures total exercise duration.	12 weeks
Secondary	change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group)	This test measures metabolic equivalents (METs).	12 weeks