Home Oxygen Therapy on the Physical Activity of Daily Living Utilizing the Cloud-Based Home Care System (HOTPAL-study)

未提供0 个研究点目标入组 30 人开始时间: 2024年2月21日最近更新: 2025年1月9日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 30
主要终点: Change in an equivalent of daily calorie consumption for a month before and 3 months after the initiation of home oxygen therapy (HOT)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 No limit（—）
性别: All

入选标准

•Patients with chronic respiratory failure meeting the criteria for home oxygen therapy or patients with chronic respiratory diseases who are considered to require home oxygen therapy by the attending phisician
•Patients over 20 years old
•Patients who have not been hospitalized for illnesses affecting their activities of daily living (ADL) within the last month

排除标准

•Patients with cancer (However, patients who have undergone curative treatment and are considered cured are eligible for inclusion)
•Patients with comorbidities including severe cardiac, psychiatric, and neuromuscular diseases
•Patients who spend almost the entire day in bed (Performance status is 3 or higher)
•Inappropriate for the enrolment by the judgement of the principal investigator or the subinvestigators

结局指标

主要结局

Change in an equivalent of daily calorie consumption for a month before and 3 months after the initiation of home oxygen therapy (HOT)

时间窗: a month before and 3 months after the initiation of home oxygen therapy (HOT)

*An equivalent of daily calorie consumption for a month = Sum of equivalent of daily calorie consumption divided by the number of physically active days

次要结局

Change in daily calorie consumption(Before initiation of HOT and after 1, 2, and 3 months of HOT)
Change in daily step counts and activity time(Before initiation of HOT and after 1, 2, and 3 months of HOT)
Change in activity time by intensity(Before initiation of HOT and after 1, 2, and 3 months of HOT)
Change in physical activity-related and depression-related indices(1 month before and 3 months after the initiation of HOT or at the time of discontinuation)
Change in oxygen saturation (SpO2) and pulse rate(Before initiation of HOT and after 1, 2, and 3 months of HOT)

研究者

发起方

未提供

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jRCT1030250124JCR Pharmaceuticals Co., Ltd.30