Individualized respiratory exercise device originated in Türkiye: design, prototype, and first results

Background/aim: Respiratory muscle training (RMT) and breathing exercises are crucial components in cardiopulmonary rehabilitation. RMT includes inspiratory muscle training (IMT) and expiratory muscle training (EMT); however, existing RMT devices typically support only one of these. Incentive spirometers, which also provide visual feedback for breathing exercises, are frequently used. Achieving an RMT program requires multiple devices, which increases both the cost and complexity of the training regimen. This study aimed to design, calibrate, and test a novel individualized respiratory exercise device that integrates both IMT and EMT functions into a single unit, thereby offering a cost-effective, user-friendly alternative for comprehensive cardiopulmonary rehabilitation. Materials and methods: The design process involved a comparative analysis of existing RMT devices. A concept design was developed, followed by a three-dimensional-printed prototype. Calibration was performed using a pressure meter, with tests conducted on ten healthy volunteers across a range of inspiratory and expiratory pressures. Additionally, a pilot clinical study involving six healthy adults assessed the device's impact on maximum inspiratory and expiratory pressures (MIP, MEP) and functional exercise capacity during an eight-week RMT period. Results: The internal consistency of the lowest (0.919) and the highest (0.841) levels of inspiration pressure, and of the lowest (0.901) and the highest (0.856) levels of expiration pressure, were highly reliable. Each healthy participant who completed the eight-week RMT program showed increases in MIP, MEP, and six-minute walking distance. Conclusion: The novel respiratory exercise device successfully combines IMT and EMT functions with an incentive spirometer, enabling comprehensive respiratory exercises and RMT within a single unit. Its ease of use and adaptability make it a promising option for both clinical and home-based rehabilitation, potentially improving accessibility and adherence to cardiorespiratory rehabilitation protocols. Further clinical studies will investigate the effects of this novel device in cardiopulmonary rehabilitation.