A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
研究概览
简要总结
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
详细描述
A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Since the patients will know if they have the Pursed Lipped Breathing Application and Spire tags, the outcome assessor will be blinded to which arm received the Application and tags.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, age ≥ 40 years old.
- •Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- •At least 10 pack years of smoking.
排除标准
- •Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
- •Unable to follow commands (cognitive impairment).
- •Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
- •Live in an area that does not have cellular service (Verizon).
研究组 & 干预措施
Home-base pulmonary rehabilitation with mindful breathing modu
Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet.
干预措施: Home-based pulmonary rehabilitation program (Behavioral)
Home-base pulmonary rehabilitation with mindful breathing modu
Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet.
干预措施: Mindful breathing module (Behavioral)
Home-base pulmonary rehabilitation with mindful breathing modu
Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet.
干预措施: Health coaching (Behavioral)
Home-base pulmonary rehabilitation
Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching
干预措施: Home-based pulmonary rehabilitation program (Behavioral)
Home-base pulmonary rehabilitation
Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching
干预措施: Health coaching (Behavioral)
结局指标
主要结局
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
时间窗: Baseline, 3 months, 6 months
The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score
时间窗: baseline, 3 months, 6 months
The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions.
次要结局
- Change in Daily Physical Activity(baseline, 3 months, 6 months)
研究者
Roberto P. Benzo
Principal Investigator
Mayo Clinic