Remote Cardiac Rehabilitation by Tele-nursing with Wearable Medical Devices

JRCT ID: jRCTs032210535

Registered date:05/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cardiovascular diseases
• Date of first enrollment: 05/01/2022
• Target sample size: 600
• Study type: Interventional
• Intervention(s): Tele-nursing according to the obtained data of Apple Watch

Outcome(s)

• Primary Outcome: Total death, cardiovascular events
• Secondary Outcome: EF, e/e', BNP, CRP, PeakVO2, VE-VCO2 slop, muscle volume (Inbody), EQ5D (QOL score), ICER

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

Hospitalized cardiovascular patients who discharge on foot
1)Patients who gave written informed consent to participate in the study.
2)Men and women aged 20 years or older and younger than 90 years at the time of informed consent
3)Patients with a diagnosis of heart disease.
4)Patients who can attend outpatient cardiac rehabilitation after discharge

Exclude criteria

1)Acute myocardial infarction (within 2 days)
2)Before treatment of unstable angina pectoris
3)Pregnant or breastfeeding patients
4)Uncontrolled arrhythmias
5)Symptomatic severe aortic stenosis
6)Uncontrolled symptomatic heart failure
7)Acute pulmonary embolism or infarction
8)Acute myocarditis or pericarditis
9)Acute aortic dissection
10)Patients with difficulty walking
11)Mental illness that cannot communicate
12)After implantation of a pacemaker or implantable cardioverter defibrillator
13)Patients who are judged by the research director to be inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Nakayama Atsuko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Grants-in-Aid for Scientific Research,Grant by Sakakibara Heart Institute