Tele-monitoring cardiac rehabilitation using remotely biological signal monitoring system for patients with cardiovascular disease -A pilot study focusing on safety of tele-monitoring cardiac rehabilitation-

JRCT ID: jRCTs032190217

Registered date:19/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cardiovascular disease
• Date of first enrollment: 19/02/2020
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Remotely monitoring cardiac rehabilitation

Outcome(s)

• Primary Outcome: Safety of tele-monitoring cardiac rehabilitation system
• Secondary Outcome: Peak oxygen intake; peak VO2, ,Body composition, frailty score, Short physical performance battery, Health related QOL score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Men and women over 20 years old
2. Patients who are 140-185cm tall
3. One who gained document consent by free will of the research subject after having sufficient explanation for participation in this research, with sufficient understanding.
4. Patients with cardiovascular disease (coronary artery disease, open heart surgery, chronic heart failure, aortic disease, peripheral artery disease) participating cardiac rehabilitation at Juntendo hospital
5. Patients who have been stably performing outpatient cardiac rehabilitation for 1 month

Exclude criteria

1. Patients who are weighing over 130kg
2. Patients with uncontrolled complications
3. Patients who meet the contraindications, discontinuation criteria for cardiac rehabilitation
4. Patients with unstable heart disease management
5. Patients who have cardiovascular events during the first month after outpatient cardiac rehabilitation
6. Patients who have difficulty in aerobic exercise with bicycle ergometer due to cerebral infarction or orthopedic diseases
7. Patients who are continuing treatment for malignant neoplas
8. Any other person who is deemed inappropriate by the Research Director
9. Pregnant or lactating woman
10. Men and women who have a pregnancy plan within 22 weeks

Related Information

• Primary Sponsor: Yokoyama Miho
• Source(s) of Monetary Support: Japan heart club research grant