2024/09/02
Keio University Hospital
Keio University School of Medicine
Grace Imaging Inc.
A joint research group from the Institute for Integrated Sports Medicine, Keio University School of Medicine (Senior Lecturer Yoshinori Katsumata and Professor Kazuki Sato), and Grace Imaging Inc. (CEO Daisuke Nakajima) conducted an investigator-initiated clinical trial (protocol number: LacS-001; jRCT2032220057) to verify whether the anaerobic threshold (AT)—a key indicator for exercise prescription in cardiac rehabilitation—could be estimated by continuously monitoring sweat lactate levels using a sweat lactate sensor during cardiopulmonary exercise testing in patients with heart disease, and has successfully met the primary endpoint for efficacy.
This clinical trial demonstrated that the AT can be estimated using the sweat lactate threshold (sLT) derived from sweat lactate measurements, thus meeting the primary endpoint and confirming the method's efficacy. In addition, no adverse events related to the application of the sweat lactate sensor occurred, confirming its safety. This method is simpler than conventional expired gas analysis and does not require expensive equipment. It is believed that utilizing such a system holds the potential for the proper implementation of rehabilitation for patients with heart disease and could lead to the wider adoption of exercise therapy among more patients. The joint research group will continue to advance the development of this device, aiming to obtain marketing approval as a medical device.
The results of this study were published in Scientific Reports on August 16, 2024 (JST).
Please see below for the full press release.