A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- San Diego Shortness of breath Questionnaire
研究概览
简要总结
In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.
详细描述
In this randomized, double-blinded, sham-controlled clinical trial, the investigators will test the effectiveness of the use of a positive expiratory device (PEP Buddy) vs. sham in participants with COPD in Pulmonary Rehabilitation and after discharge from Pulmonary Rehabilitation for up to one year. The investigators will compare changes in quality of life metrics and measurements of functional capacity between the intervention and sham groups over the course of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both participants and research team will be blinded. Participants will be provided with a device in an opaque box, both PEP Buddy and sham packaging will be the same. The dives themselves will look similar and the difference between PEP Buddy and sham will not be able to be determined by the naked eye.
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral to Pulmonary Rehabilitation for COPD
- •FEV1 <80% predicted
- •Participants must be able to exercise on 4L/m nasal cannula O2
排除标准
- •Those deemed by the study personnel to have a lung disease other than COPD impacting their daily dyspnea
- •Those that are unable to perform study procedures or are unwilling or unable to use PEP Buddy
- •Those that have a component of lung disease driven by aspiration or neurological conditions affecting the face or oropharynx
- •Those with a life expectancy of <1 year
- •Those with a known surgical intervention that will require a prolonged recovery in the year after enrollment
- •Those with a malignancy beyond Stage I or non-melanoma skin cancer
- •Those shown shown to have memory loss of MOCA testing
研究组 & 干预措施
PEP Buddy
This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless
干预措施: PEP Buddy (Device)
Sham
This arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless
干预措施: PEP Buddy Sham (Device)
结局指标
主要结局
San Diego Shortness of breath Questionnaire
时间窗: 12 Months
This is a standardized survey used to quantify the impact of daily respiratory symptoms on quality of life. This will be collected on enrollment and the investigators will compare the change between groups at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment.
Daily steps measured by wrist-wron accelerometer
时间窗: 12 Months
Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.
次要结局
- One-Minute Sit to Stand test(12 Months)
- Six Minute Walk Test(12 months)
- St. George Respiratory Questionaire(12 Months)