Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- ResMed
- 入组人数
- 108
- 试验地点
- 20
- 主要终点
- Physical Activity Level
研究概览
简要总结
To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen therapy. The study will also assess oxygen usage, quality of life, hospitalizations and death.
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
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
- •Patient is 40 years or older.
- •Patient has a documented diagnosis of COPD.
- •Patient qualifies for continuous (24/7) long-term oxygen therapy.
- •Patient is prescribed oxygen at ≤ 5 L/min.
- •Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.
- •Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.
- •Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization.
排除标准
- •Patient's condition is contraindicated for the use of a POC.
- •Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.
- •Patient is unable to complete the 6-minute walk test.
- •Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection, and/or acute bronchitis requiring antibiotics, or new/increased dose of systemic corticosteroids.
- •Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.
- •Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.
- •Patient has a life expectancy < 1 year.
- •Patient has non-COPD lung disease that may affect oxygenation or survival.
- •Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.
- •Patient is pregnant or planning to become pregnant.
- •Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.
- •Patient, in the opinion of the investigator, should be excluded from the study.
结局指标
主要结局
Physical Activity Level
时间窗: 12 weeks
Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.
次要结局
- St. George Respiratory Questionnaire (SGRQ)(12 weeks)
- Oxygen Usage(12 weeks)
- Hospital Anxiety and Depression Scale (HADS): Anxiety(12 weeks)