Home oxygen therapy on the physical activity of daily living utilizing the cloud-based home care system (HOTPAL-study)

Background: Home oxygen therapy (HOT) is expected to enhance physical activity levels in patients with chronic respiratory failure by alleviating dyspnea. However, studies comparing physical activity levels before and after HOT initiation in the same patients are limited. The present study aims to objectively examine the effectiveness of HOT using a cloud-based home care system in patients with chronic respiratory failure. Methods: This prospective, multicenter, non-blinded, single-arm trial will enroll 30 patients with chronic respiratory failure scheduled to undergo HOT. Initiated on October 10, 2023, the study will conclude on September 30, 2025. Participants will receive oxygen concentrators equipped with usage-monitoring capabilities and dedicated pulse oximeters with an accelerometer function to measure oxygen saturation, pulse rate, and physical activity levels. Patients will be required to attach the pulse oximeter to their fingers at designated times to record pulse rates and percutaneous oxygen saturation values. Additionally, wearing the pulse oximeter around their necks will allow the accelerometer to measure physical activity levels. Beyond physical activity, factors such as dyspnea, quality of life, and depression will be evaluated before and after initiation of HOT. The primary outcome is the change in the monthly equivalent of daily calorie consumption before and 3 months after initiating HOT. Statistical analyses, including paired t tests, will be conducted to compare the mean and standard deviation of daily calorie consumption equivalence 1 month before and 3 months after HOT initiation. Discussion: The strength of the home oxygen therapy on the physical activity of daily living study will be its objective assessment of physical activity levels before and after initiating HOT. Additionally, we will evaluate the health-related quality of life.