Wearable device-enhanced Interactive cardiac rehabilitation program Construction and implementation of "Remote Cardiac Rehabilitation with Fitbit Sense Project to Maximize Prevention of Recurrence of Cardiovascular Disease

UMIN ID: UMIN000047789

Registered date:18/05/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients who have undergone drug therapy, coronary stenting, or coronary artery bypass surgery for coronary artery disease
• Date of first enrollment: 2022/04/30
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Wearable device worn + online instruction for 3 months
Wearable device worn for 3 months

Outcome(s)

• Primary Outcome: Changes in aerobic capacity and exercise tolerance over 3 month
• Secondary Outcome: Cardiac rehabilitation rates, frequency and burden of digital device use, changes in coronary artery disease risk (blood pressure levels, lipid profile, diabetes biomarkers, smoking habits), and changes in patient attitudes

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Users of implantable medical devices such as cardiac pacemakers and defibrillators (2) Patients diagnosed with acute myocardial infarction, unstable angina pectoris not stabilized by medical treatment, uncontrolled arrhythmia causing subjective symptoms or hemodynamic abnormalities, uncontrolled heart failure, symptomatic severe aortic stenosis, or psychiatric disorder that prevents communication (3) Patients who are judged to be inappropriate for this study by the principal investigator and the research physician.

Related Information

• Primary Sponsor: Department of Cardiovascular Biology and Medicine, Juntendo University School of Medicine, Tokyo, Japan
• Source(s) of Monetary Support: M3, Inc.