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临床试验/NCT03198780
NCT03198780
已完成
不适用

A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Minnesota HealthSolutions1 个研究点 分布在 1 个国家目标入组 10 人2018年10月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Obstructive Pulmonary Disease
发起方
Minnesota HealthSolutions
入组人数
10
试验地点
1
主要终点
Participant assessment of device feasibility
状态
已完成
最后更新
6年前

概览

简要总结

To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.

详细描述

For this pilot study patients who meet the conventional criteria for pulmonary rehabilitation at their clinical appointments will be recruited and scheduled to return for the study. After completing the informed consent, patients will be taught how to don and doff the pulse oximeter, the source of the heart rate and oxygen signals. Patients will participate in a demonstration on how to perform the intervention. Recruitment will continue until five patients have completed the pilot in a clinic setting. If necessary, the prototype will be modified and testing resumed. Once the prototype system has met the criteria for success in the clinic, five of patients will be asked to use the prototype at the clinic and to take it home for a week and perform the intervention at least five times.

注册库
clinicaltrials.gov
开始日期
2018年10月1日
结束日期
2019年7月31日
最后更新
6年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Minnesota HealthSolutions
责任方
Sponsor

入排标准

入选标准

  • Patients must be ≥40 years old
  • have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing
  • have clinically significant breathlessness (breathless when walking on the level or walking a mild hill)
  • be a current or previous smoker with at least 10 pack-years of cigarette smoking
  • be hospitalized for an exacerbation of COPD.

排除标准

  • Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  • Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

结局指标

主要结局

Participant assessment of device feasibility

时间窗: up to 1 week

Participants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention

次要结局

  • Device Use Assessed by Pulse Oximetry Data(up to 1 week)

研究点 (1)

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