A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST): A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptability (qualitative)
研究概览
简要总结
This is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (REST) to usual care for reducing stress in individuals with COPD.
详细描述
This is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (REST) to usual care for reducing stress in individuals with chronic obstructive pulmonary disease (COPD). The intervention is based on the breathing techniques of Pranayama. It was developed with patient and stakeholder input and is targeted for individuals with COPD who have moderate levels of stress and symptom burden. The intervention is a 15-minute breathing protocol which will be taught to participants and subsequently evaluated in a clinic setting with surveys, lung function, and cardiac assessments. This intervention will be pre-tested in 6 individuals, revised, and piloted in 30 individuals (15 in intervention group, 15 in control group). This study will answer the question of 1) whether a controlled breath protocol is feasible, acceptable, and safe for patients with COPD and 2) whether any modifications to the intervention are needed for a future multicenter trial to be proposed and conducted after the completion of the pilot trial. We will also 3) obtain sufficient estimates of variability in stress measures to inform statistical planning of a future trial.
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
- None
盲法说明
Only the statistician will be blinded to study group
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
- •Diagnosis of spirometry confirmed COPD (FEV1/FVC <0.70 + FEV1<80%)
- •Perceived Stress Scale > 13
- •Age >40 years old
- •Able to read, write, and speak in English
- •Able to attend 1 in person training session and 1 in person trial sessions
排除标准
- •Current regular practice of breathing exercises or pranayama
- •No access to internet or telephone
- •Recent hospitalization for COPD exacerbation or any reason in the past 30 days
- •Other primary lung disease (ILD, asthma, bronchiectasis) by self-report or chart review
- •Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids)
- •Severe cognitive impairment
研究组 & 干预措施
Behavioral Intervention (REST)
Participants randomized to this group will receive COPD education, research staff support, and the REST (controlled breath) intervention.
干预措施: REST (Behavioral)
Control
Participants randomized to this group will receive COPD education and research staff support.
干预措施: Education (Other)
结局指标
主要结局
Acceptability (qualitative)
时间窗: 6 months
Post-intervention semi-structured, in-depth interviews by telephone conducted by study coordinator to explore acceptability, barriers, facilitators, and survey burden
Acceptability (quantitative)
时间窗: 6 months
Post-intervention survey on intervention acceptability with Likert scale rated 1 to 10; 10 being most acceptable. Overall average score ≥8 of 10 defined as acceptable. Will assess patient reported enjoyment, difficulty, and adherence
Intervention Feasibility
时间窗: 6 months
IG: Completion of 2 in-person sessions (1 training, 1 trial) along with \>80% of daily individual practice of breathing protocol (15 minute twice daily)
Trial feasibility
时间窗: 6 months
Rates of screening, enrollment, retention, reasons for exclusion and refusals, and attrition. Attrition goal \<10% throughout study period.
次要结局
- Modified Medical Research Council dyspnea scale(Day 0, Day 8)
- Mindful Attention Awareness Scale(Day 0, Day 8)
- Perceived Stress Scale(Day 0, Day 8)
研究者
Trisha M. Parekh
Assistant Professor
University of Texas at Austin