Investigator-Initiated Trial of Cardiac Rehabilitation Medical Device Program

Single-Arm, Open-Label, Investigator-Initiated Clinical Trial to Evaluate the Feasibility and Utility of a Cardiac Rehabilitation Medical Device Program

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042230018

Enrollment

100

Registered

2023-05-01

Start date

2023-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases Cardiac diseases

Interventions

Late-stage convalescent cardiac rehabilitation and lifestyle guidance using the Cardiac Rehabilitation Medical Device Program

D000072038

Cardiac Rehabilitation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Contacts

Public ContactKazuhiro Terashima

Fujita Health University Hospital

kazuhiro.terashima@fujita-hu.ac.jp+81-562-93-2312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026