July 2, 2025
Keio University Hospital
Keio University School of Medicine
School of Medicine, University of Occupational and Environmental Health, Japan
Gifu University
Grace Imaging Inc.
A joint research group has conducted an exploratory, investigator-initiated clinical trial (a multicenter, randomized, controlled trial) of a futuristic exercise support and educational awareness program (SaMD) for outpatients with heart failure, and has confirmed its efficacy and safety. The group consists of Senior Assistant Professor Yoshinori Katsumata and Professor Kazuki Sato of the Institute for Integrated Sports Medicine, Keio University School of Medicine; Assistant Professor Hiroki Yamaoka, Associate Professor Shun Kohsaka, and Professor Masaki Ieda of the university's Division of Cardiology; Professor Masaharu Kataoka of the Second Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan; Clinical Lecturer Takayoshi Watanabe of the Department of Laboratory Medicine and Cardiology, Gifu University Hospital; and Grace Imaging Inc. (CEO: Daisuke Nakajima). This clinical trial was conducted at three institutions, including Keio University Hospital, with support from the Clinical and Translational Research Center at Keio University Hospital.
Heart failure is understood as a condition in which the heart's function declines, making it unable to pump enough blood to the body. The number of patients is increasing annually with the aging population (it is the leading cause of death from heart disease, with over 200,000 hospitalizations per year [2023 Vital Statistics of Japan]). In addition to appropriate drug therapy, cardiac rehabilitation aimed at improving lifestyle habits such as exercise and diet is considered crucial for managing heart failure. However, due to patient reluctance and clinical limitations, outpatient exercise therapy is currently provided to less than 10% of patients with heart failure.
Therefore, this research group has developed the "Exercise Support App," an application that supports exercise for patients with heart failure and provides education about the condition. Patients wear a Fitbit smartwatch at all times, from which the "Exercise Support App" continuously acquires information on their exercise status, such as step count and heart rate. Combined with data from body weight and quality of life questionnaires, the application helps manage the physical condition of individual patients by incorporating optimal exercise.
This clinical trial will accelerate the development of the "Exercise Support App" toward its approval as a medical device. By developing this new medical device, we aim to enable more patients with heart failure to engage in appropriate, evidence-based exercise therapy, thereby realizing a society where patients can lead fulfilling lives without disease progression or rehospitalization.
For the full press release, please see below.