October 6, 2023
Keio University Hospital
Keio University School of Medicine
Grace Imaging Inc.
On October 3, 2023, a research group led by Dr. Yoshinori Katsumata, a senior lecturer at the Institute for Integrated Sports Medicine, and Dr. Shun Kohsaka, a senior lecturer at the Division of Cardiology, both of the Keio University School of Medicine, initiated an exploratory investigator-initiated clinical trial (a multicenter, exploratory, randomized controlled trial). The trial aims to evaluate the efficacy and safety of a physical training support and education program (SaMD) for heart failure patients who are unable to undergo outpatient cardiac rehabilitation (exercise therapy). This clinical trial will be conducted at Keio University Hospital with the support of its Clinical and Translational Research Center.
Heart failure is a condition in which the heart's function declines, making it unable to pump enough blood to the body. In addition to appropriate treatments such as medication, cardiac rehabilitation aimed at improving lifestyle habits like exercise and diet is considered crucial. However, outpatient exercise therapy as part of cardiac rehabilitation is provided to less than 10% of heart failure patients. Therefore, there is a need for a method, separate from the in-hospital exercise practices of regular clinical care, to evaluate and visualize patients' at-home exercise and provide effective exercise support to improve heart failure.
In response, this research group has developed an application to support the exercise of heart failure patients, called the "Exercise Support App." Patients wear a Fitbit smartwatch continuously, from which the "Exercise Support App" acquires exercise data such as step count and heart rate. Combined with information from weight and quality of life questionnaires, the application provides personalized exercise support to the user. The app is provided by Grace Imaging Inc., which is developing it in collaboration with the Keio University School of Medicine.
This clinical trial will accelerate the development of the "Exercise Support App" toward its approval as a medical device. Currently, more than 90% of heart failure patients do not receive appropriate exercise therapy covered by health insurance. By developing this new medical device, it is hoped that a society can be realized where such heart failure patients can lead more fulfilling lives.
This investigator-initiated clinical trial is being conducted as part of the research project "Research and Development of an Exercise Support Program for Cardiovascular Diseases" (Principal Investigator: Dr. Yoshinori Katsumata, Senior Lecturer, Institute for Integrated Sports Medicine, Keio University School of Medicine), under the Japan Agency for Medical Research and Development (AMED) Practical Research Project for Life-Style related Diseases including Cardiovascular Diseases and Diabetes Mellitus.
For the full press release, please see below.