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临床试验/NCT03688334
NCT03688334已完成不适用

Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia

George Papanicolaou Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Exercise duration

研究概览

简要总结

Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.

Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month
  • IPF patients do not present with resting hypoxemia, but manifest exercise induced hypoxemia

排除标准

  • Major contraindications for CPET conduction
  • Not provision of informed consent -

研究组 & 干预措施

IPF patients (crossover)

Sham Comparator

Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing

干预措施: Medical air (sham O2) (Drug)

IPF patients

Active Comparator

Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing

干预措施: Oxygen 40 % (Drug)

结局指标

主要结局

Exercise duration

时间窗: through study completion, an average of a year

Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion

次要结局

  • Fatigue(through study completion, an average of a year)
  • Dyspnea(through study completion, an average of a year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Afroditi Boutou

Consultant in Respiratory Medicine

George Papanicolaou Hospital

研究点 (2)

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