Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Exercise tolerance
研究概览
简要总结
The investigators plan to conduct a study to find out if giving portable oxygen therapy (during physical activity) to patients with interstitial lung disease will improve quality of life, exercise tolerance, shortness of breath, and blood vessel function. Oxygen will be provided for a period of 8 weeks. Additionally, the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy, through check-in phone calls with a respiratory therapist and by providing additional educational material.
详细描述
Brief Summary:
The investigators plan to conduct a study to find out if giving portable oxygen therapy (during physical activity) to patients with interstitial lung disease will improve quality of life, exercise tolerance, shortness of breath, and blood vessel function. Oxygen will be provided for a period of 8 weeks. Additionally, the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy, through check-in phone calls with a respiratory therapist and by providing additional educational material.
Detailed Description:
BACKGROUND
Interstitial lung disease (ILD) is comprised of a group of pulmonary diseases that are characterized by inflammation and/or lung parenchymal fibrosis. Individuals with ILD may be normoxic at rest; however, underlying impairments in gas exchange can contribute to a reduction in oxygen saturation (SpO2) during exertion. Hypoxemia can cause inflammation and cardiovascular dysfunction, which could lead to cardiac events. A recent study found that 78% of ILD patients had cardiovascular comorbidity, which was predictive of death within this ILD cohort.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Single-blind investigation, investigator and assessors will be blinded to the condition/treatment arm
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with fibrotic ILD (all sub-groups of ILD) who have normal oxygen saturation at rest (SpO2 > 90%) but develop exertional hypoxemia as demonstrated by a SpO2 = 80-89% with activity (measured during 6MWT).
排除标准
- •Use of home oxygen therapy within the previous year for the management of ILD, co-morbid conditions that may require oxygen therapy (such as COPD, cardiovascular disease, or other illnesses), or individuals that require the use of non-invasive ventilation. Additionally, individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded. Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials and ambulation will also be excluded. Individuals with peripheral vascular disease will be excluded from measurement of vascular function (flow mediated dilation).
研究组 & 干预措施
Arm 3 - Exertional Oxygen + Support
8 weeks of portable oxygen use (from a concentrator) during exertion, plus additional phone calls with a respiratory educator and educational material
干预措施: Education and Support (Behavioral)
Arm 2 - Exertional Oxygen
8 weeks of portable oxygen use (from a concentrator) during exertion
干预措施: Exertional Oxygen (Drug)
Arm 3 - Exertional Oxygen + Support
8 weeks of portable oxygen use (from a concentrator) during exertion, plus additional phone calls with a respiratory educator and educational material
干预措施: Exertional Oxygen (Drug)
Arm 1 - Usual Care
8 weeks of usual care with no supplemental oxygen provided
结局指标
主要结局
Exercise tolerance
时间窗: Before and immediately after the intervention
6 minute walk distance
Health Related Quality of Life, (EuroQol-5 Dimension-5 Level; EQ-5D-5L)
时间窗: Before and immediately after the intervention
Questionnaire for Health-Related Quality of Life. Possible Range = 5-25; 5 = 11111 (no problems on any dimension); 25 = 55555 (extreme problems on all dimensions)
Feasibility of investigation
时间窗: 2 years
Number of patients recruited and completing the protocol in each arm
Health Related Quality of Life, (King's Brief Interstitial Lung Disease Questionnaire; KBILD)
时间窗: Before and immediately after the intervention
Health status questionnaire. Domain and total score ranges are 0-100; 100 represents best health status
次要结局
- Pulmonary Artery Pressure(Before and immediately after the intervention)
- Dyspnea (Dyspnea-12 Questionnaire)(Before and immediately after the intervention)
- Vascular function(Before and immediately after the intervention)
- Cough (Leicester cough questionnaire; LCQ)(Before and immediately after the intervention)
- Cardiac Output(Before and immediately after the intervention)
- Systemic Inflammation(Before and immediately after the intervention)