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

Phase 3

• Conditions: Cardiovascular disease

• Registration Number: JPRN-jRCTs032190217
• Lead Sponsor: Yokoyama Miho

Brief Summary

Convalescent cardiac rehabilitation using remote biological signal monitoring via the Internet was found to be feasible, with no monitoring problems and improved exercise tolerance. However, it was also shown that IT literacy on the subject side may be important for the realization of implementation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-19
• Study Completion: 2021-07-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of tele-monitoring cardiac rehabilitation system

Secondary Outcome Measures

Name	Time	Method
Peak oxygen intake; peak VO2, ,Body composition, frailty score, Short physical performance battery, Health related QOL score