Investigator-Initiated Trial of Cardiac Rehabilitation Medical Device Program

JRCT ID: jRCTs042230018

Registered date:01/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cardiovascular Diseases
• Date of first enrollment: 01/05/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Late-stage convalescent cardiac rehabilitation and lifestyle guidance using the Cardiac Rehabilitation Medical Device Program

Outcome(s)

• Primary Outcome: Percentage change in walking distance in the 6-minute walk test at 5 months after the start of late recovery cardiac rehabilitation using the cardiac rehabilitation medical device program compared to before the start of rehabilitation.

Secondary Outcome

- Adverse events that occurred during late recovery cardiac rehabilitation using the Cardiac Rehabilitation App that resulted in discontinuation of rehabilitation, and the percentage of adverse events
- Number and incidence of cardiovascular events defined as follows
- Acute myocardial infarction, angina pectoris
- Unstable angina pectoris
- Major vascular disease (aortic dissection)
- Cerebral hemorrhage
- Cerebral infarction
- Rehabilitation continuation rate at 3 and 5 months
- Assessment of QOL and depression using QOL and depression questionnaires (Hospital anxiety and depression scale (HADS) Japanese version (30, 31), Japanese version BDI-II : Beck Depression Questionnaire (32), EQ-5D-5L (33))
- CPX readings (Peak VO2, AT, VE-VCO2 slope)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Age 18 years or above
(2) Provision of written informed consent
(3) Diagnosed with the following cardiovascular diseases and considered to be eligible for cardiac rehabilitation by the principal/sub-investigator
- Acute myocardial infarction, angina pectoris
- Chronic heart failure
- Post cardiac surgery (coronary artery bypass surgery, TAVI (transcatheter aortic valve implantation), post valvular disease surgery)
- Arrhythmia, post device implantation
- After implantable VAD (ventricular assist device)
- After heart transplantation
- Pulmonary hypertension
- Major vascular disease (aortic dissection, after major vascular surgery, after stent graft insertion)
-Peripheral arterial disease (intermittent claudication)
(4) Unable or unwilling to undergo standard outpatient cardiac rehabilitation
(5) Able to carry and use a smart phone

Exclude criteria

(1) Patients with untreated unstable angina pectoris
(2) Pregnant or lactating women
(3) Patients with uncontrolled arrhythmia
(4) Patients with symptomatic severe aortic stenosis
(5) Patients with uncontrolled symptomatic heart failure
(6) Patients with acute pulmonary embolism or infarction
(7) Patients with acute myocarditis or pericarditis
(8) Patients with acute aortic dissection
(9) Living alone
(10) Patients who have difficulty performing cardiac rehabilitation due to difficulty walking or communicating
(11) Patients with a pacemaker or implantable cardioverter-defibrillator after implantation

Related Information

• Primary Sponsor: Izawa Hideo
• Source(s) of Monetary Support: CaTe Inc.