Clinical Need: As the US population ages, managing pathologies that largely affect older adults, including sarcopenia (e.g., loss of muscle mass and strength), represents a significant and growing clinical challenge. In addition to increased rates of sarcopenia with age, it is well-accepted that its incidence and impact increases after acute illness, placing persons at additional risk for functional decline, institutionalization, or death. Resistance-based exercises promote muscle regeneration and strength, and are an advised therapy for such patients. Yet, exercises are normally conducted either under direct clinical oversight, or unsupervised by patients at home, where compliance rates are low. Limitations: Current regimens rely on self-report diaries or verbal reports that may be inaccurate and subject to recall bias. Remote monitoring systems that measure, track, analyze, and provide patient-oriented feedback may overcome these limitations and enhance exercise regimen engagement. An at-home device that monitors and transmits exercise data to the user and clinician represents a potential solution to this clinical challenge. Our Product ? BandPass is a remote-sensing, bluetooth-enabled resistance exercise band that will accurately gauge force through a potentiometric sensor rigidly fixed to elastic-tubing purposely designed for resistance training. The device is similar to currently available exercise bands familiar to clinicians and patients, with the significant novel addition of integrated force monitoring and internet-connectivity. A mobile app and cloud-based platform will provide computational resources for data visualization, storage and analysis, which will enable direct patient feedback, clinical monitoring of patient compliance and progress, and serve as a platform for more advanced operations such as automatic exercise-type classification to ease user burden (e.g., minimizing required interactions between the user and mobile device). We hypothesize that BandPass will provide clinically relevant data on compliance and use of exercise training with feedback that will be personalized. Specific Objectives: We specifically propose to design custom electronics and housing for BandPass and to perform in-lab validation studies of device accuracy, precision, and long-term stability. BandPass will be interfaced to a mobile app and cloud-based platform we will implement for data transmission, storage, and analysis. Finally, we will deploy BandPass in a human subjects pilot study to demonstrate usability and system stability in an at-home setting. Future Directions: SynchroHealth is a small company developing an mHealth platform that uses internet-connected devices to help improve quality of life in older adults. This device will complement our existing efforts. By the end of this Phase 1 effort, we will have demonstrated that BandPass is functional in a human population and we will have provided evidence that this approach can be deployed effectively in an at-home setting. This will position us for Phase 2 funding focused on optimizing our device for manufacturing, developing and optimizing a full suite of cloud-based analysis tools and mobile applications, conducting clinical trials aimed at demonstrating efficacy, and preparing to register this as a 510(k)-exempt device for marketing purposes and establishing Current Good Manufacturing Practices (CGMP).
Clinical care for older adults that suffer from sarcopenia (e.g. loss of muscle mass and strength) typically involves the use of physical therapy regimens that rely on patients performing a series of at-home resistance-based exercises in order to retain or build muscle strength and prevent further atrophy. Resistance exercises using elastic bands has been a primary tool for clinicians, however remotely monitoring a patient?s compliance, confirming the quality of exercises performed, and tracking performance has been a significant challenge, with no tools currently available to provide this level of insight. Here, we propose to develop BandPass, an internet-enable resistance exercise band instrumented to automatically sense forces generated during exercise which will enable remote monitoring, compliance checking, and exercise classification and help to overcome the current shortcomings in clinical management of these patients.
