First in Japan Clinical trial for an online cardiac rehabilitation system
Professor Yasushi Sakata (Cardiovascular Medicine) and colleagues have submitted notification to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) of their plan to conduct the first clinical trial on rehabilitation telemedicine in Japan. The trial, which has received from the Japan Agency for Medical Research and Development (AMED) Project for Medical Device Development1, will test the online cardiac rehabilitation2 device, RH-01.
Approximately 200,000 annual deaths in Japan are the result of heart disease (15.2% of total deaths and second greatest cause), with the most common of those being heart failure. Moreover, 1.2 million Japanese suffer from the disease, a number that is only expected to increase as the nation’s population ages. To improve the cardiovascular function, cardiac rehabilitation is available at outpatient clinics, but traveling to the clinic can be difficult for people who are infirmed and is why only approximately 10% of patients take part.
Therefore, Prof. Yasushi Sakata has led research on an online system that would allow patients to conduct the rehabilitation in their homes. This clinical study will evaluate the efficacy and safety of the rehabilitation from the home while the patient is under online observation. The system aims to be a model for using IoT technology in medicine and falls under the umbrella of the Society 5.03 plan.
Summary of the clinical trial
- Name: Multicenter, randomized trial to verify the efficacy and safety of RH-01 in heart disease patients who are candidates for cardiac rehabilitation.
- Objective: A 12-week, multicenter, randomized study to compare the efficacy and safety of RH-01 on patients with heart disease compared with patients who received cardiac rehabilitation at an outpatient clinic.
- Patients: Patients who generally qualify for cardiac rehabilitation such as patients who have had open heart surgery, heart failure and angina pectoris, macrovascular disease, or occlusive peripheral arterial disease
- Primary investigator: Yasushi Sakata (Osaka University Graduate School of Medicine)
- Number of participating centers: 8 across the country and 128 cases with the possibility of adding more.
Prof. Sakata has been collaborating with Dr. Tatsunori Taniguchi since 2015 through Program Innovators Development Program (MID)4 on a cardiac rehabilitation device for patients who for health reasons find it difficult to visit hospitals or clinics. In 2017, they launched a new university venture company, Remohab5, the maker of RH-01, which has continued this research as an industry-academic collaboration.
RH-01 allows medical personnel to supervise the cardiac rehabilitation of their patients online in real time. It includes an ergometer and electrocardiograph as part of its components. Prior to this clinical trial, a pilot study on a small number of heart patients was conducted in 2018.
The present clinical study will compare the in-home cardiac rehabilitation using RH-01 with cardiac rehabilitation done in an outpatient setting. Discussions with the Ministry for Health, Labour and Welfare have already begun about subsidies through Japan’s national health insurance.
This clinical trial is being supported by the Ministry for Health, Labour and Welfare and by Remohab (Tatsunori Taniguchi, CEO).
Significance to Societyt
Approval for RH-01 through this clinical trial will have a big effect on cardiac rehabilitation. Current guidelines recommend a patient receive cardiac rehabilitation three times a week in order to lower readmission rates. Because RH-01 will make it easier to receive cardiac rehabilitation, the patients’ quality of life should significantly improve, and the burden on caregivers including family members will be greatly reduced. So too will financial costs to the health system due to the reduced number of readmissions. Furthermore, in times like the current COVID-19 pandemic, avoiding trips to outpatient clinics will reduce the risk of infection.
1.Project for Medical Device Development
This project aims to nurture basic research made at academic institutions on medical devices and translate the results into industrial innovation.
Rehabilitation intended to return the patient back to normal living. The rehabilitation can include exercise and counseling.
A vision for Japan’s 5th iterative society. Following hunting (1.0), agriculture (2.0), industry (3.0), and information (4.0), Society 5.0 describes a future society based on big data that uses IoT to connect all people to all things, sharing information in new ways to conceive new ideas and values. Society 5.0 is envisioned to solve great challenges confronting Japan including an aging population and declining birthrate, rural depopulation, and income disparity.
A Stanford Biodesign Program Development Partner, Japan Biodesign aims to nurture talent who use design for medical innovation.
Located in Osaka, Japan, Remohab develops, manufactures, and sells/leases remote cardiac rehabilitation equipment. Tatsunori Taniguchi is its CEO.