Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Safety: Adverse Events
研究概览
简要总结
This project seeks to pilot-test the feasibility of using a melodica training program to teach pursed lip breathing for Veterans with chronic obstructive pulmonary disease (COPD) with moderate to severe dyspnea (shortness of breath). Dyspnea occurs commonly among COPD patients and can limit activities of daily living. Pursed lip breathing is a strategy that can improve dyspnea and exercise capacity among COPD patients. The melodica is a musical instrument that looks like a keyboard with a mouthpiece on the side. The melodica is played by exhaling through the mouthpiece while pressing the keys. The MELODY pilot project protocol has been grounded on concepts from occupational therapy; specifically, providing participants with a meaningful new activity that is enjoyable, that can be provided across a spectrum of skill levels, that can provide participants with a new sense of self, and that can improve health outcomes (i.e., dyspnea and exercise endurance).
详细描述
SPECIFIC AIMS:
Primary Aim 1: Evaluate the safety of a melodica training program to teach pursed lip breathing among Veterans with COPD with moderate to severe dyspnea. We hypothesize that a melodica training program can be safely implemented among COPD patients with severe dyspnea.
Primary Aim 2: Evaluate the feasibility of implementing a melodica training program to teach pursed lip breathing among Veterans with COPD with dyspnea. We hypothesize that it will be feasible to implement a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea; specifically that enrolled participants will attend >50% of sessions. We also hypothesize that transportation to the VA Medical Center to attend sessions will be identified as a significant barrier to participation.
Secondary Aim: Collect pilot-efficacy data of a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea. The objective is to understand whether melodica training improves dyspnea both in the short-term and in the longer-term over the course of the 8-week training program. We hypothesize that a melodica training program will reduce dyspnea by 30% in the short-term and 10% in the long-term. We also hypothesize that intervention participants will show gains in the secondary efficacy outcome measures of exercise endurance, pulmonary function, entering pulmonary rehabilitation, quality of life, patient global impression of change, and anxiety relative to controls.
RANDOMIZATION AND INTERVENTION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spirometry-confirmed COPD defined as a FEV1/FVC <0.7
- •moderate or severe dyspnea defined as a grade ≥3 on the ATS Dyspnea scale
排除标准
- •visual or hearing impairments
- •do not speak English
- •do not have an intact airway
- •have cognitive impairment
- •are unable to make a seal with their mouths
- •have a history of at least one hospital admission for congestive heart failure in the prior year
- •receiving Hospital-Based Home Care (HBHC) or Telehealth care for COPD management
结局指标
主要结局
Safety: Adverse Events
时间窗: Measured at baseline and before and after each of 16 program training sessions (8 week duration).
We will describe the frequency with which patients reported any adverse events they experienced as a consequence of participation in the program as well as specify the types of adverse events.
Safety: Dyspnea Visual Analog Line
时间窗: Baseline, before and after each training session (16 sessions over 8 weeks)
We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)
次要结局
- Feasibility: Program Participation(Measured at baseline)
- Feasibility: Attendance(Measured at every intervention session (total of 16 sessions over 8 weeks))
研究者
Dawn M. Bravata
Professor of Medicine & Adjunct Professor of Neurology
VA Quality Enhancement Research Intiative