Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Endurance time (in seconds) measured by endurance shuttle walk test
研究概览
简要总结
Although exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not been investigated yet. Given, that walking ability is the most important activity of daily life, the aim of our study is to investigate the effects of supplemental oxygen on endurance walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a double-blinded fashion and random order.
Since there are only limited pharmacological treatment options for IPF patients, this study may help to provide novel information about the short-term effects of supplemental oxygen. Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to facilitate patients´ participation in activities of daily life and not at least to improve patients´ quality of life.
详细描述
Rationale:
Exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis and predicts poorer outcomes. However, prospective studies with larger sample sizes and those investigating the effect of oxygen on endurance time, oxygen saturation and breathing frequency during walking are lacking. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of supplemental oxygen during walking in IPF patients.
The endurance shuttle walk test (ESWT) is a well validated test with high reliability and validity for measuring endurance walking capacity in patients with chronic obstructive pulmonary disease (COPD). The advantage of this test in contrast to the 6-minute walk test is that the ESWT is performed at 85% of the individual maximum that is close to the intensity of typical daily activities. Additionally, by using the ESWT it is possible to determine the maximum duration of exercise and to compare values at isotime (= time point when the shortest of the 3 ESWTs ends), whereas values at the end of different six-minute walk tests (6MWTs) are not comparable in case of different distances.
Aim:
To investigate the short-term effects of supplemental oxygen on endurance capacity during walking (ESWT) in patients with idiopathic pulmonary fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Endurance time (in seconds) measured by endurance shuttle walk test
时间窗: Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes
次要结局
- Change of breathing frequency during endurance shuttle walk test(change from baseline to the end of the ESWT, up to 20 minutes)
- Change of Oxygen saturation during endurance shuttle walk test(change from baseline to the end of the ESWT, up to 20 minutes)
- Change of heart rate during endurance shuttle walk test(change from baseline to the end of the ESWT, up to 20 minutes)
- Change of inspiratory capacity during endurance shuttle walk test(Change from baseline to the end of the ESWT, up to 20 minutes)
- Change of partial pressure of carbon dioxide during endurance shuttle walk test(Change from baseline to the end of the ESWT, up to 20 minutes)
研究者
Klaus Kenn
Prof. Dr.
Schön Klinik Berchtesgadener Land