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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sei Won Lee, MD PhD; Phone Number: 82-2-3010-3990; Email: iseiwon@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
    • 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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in the intervention group will be provided the smartphone application and they will practice application based rehabilitation for 12 weeks.	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.
No Intervention: Control; Participants in the control group will not practice rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of maximal oxygen consumption (VO2max)	The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).	12 weeks
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
change of hand grip strength	The muscle strength measures hand grip strength. The cut-off value for sarcopenia is < 30 kg	12 weeks
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
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
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
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
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
change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)	This test measures total exercise duration.	12 weeks
change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group)	This test measures metabolic equivalents (METs).	12 weeks
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

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2022-1460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request.

Drug and device information, study documents

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