Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Test Distance (6MWTD) (meters)
研究概览
简要总结
This is an interventional double-blind randomized controlled trial, to investigate the short and long-term effects of a supervised exercise training program in patients with IPF, depending on alternate patterns of oxygen supplementation during PR.
详细描述
The investigators hypothesize that PR service with supplemented oxygen supply regardless of hypoxemia may have significantly better short-term effects in patients with IPF. The study will take place in Corfu General Hospital, by the Departments of Pulmonary Medicine and Physiotherapy and Rehabilitation, respectively. Study participants will be divided in two equal arms 1:1 in a double-blind manner. One of the investigators blinded to their clinical data will assign each participant to PR service either i) with constant supplementary oxygen supply FiO2 50% regardless of saturation status Group A) or ii) without oxygen supply unless upon resting or exercise induced hypoxemia (saturation <88%) (Group B).
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 (Participant, Investigator)
盲法说明
participants are blindly randomized to receive oxygen or not during rehabilitation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of IPF based on current established criteria
- •no exacerbation previous 3 months
- •no participation in such program previous 3 months.
- •If on treatment with pirfenidone or nintedanib, this will be recorded and patient should be on treatment for at least 3-6 months to achieve stable state.
排除标准
- •concomitant diagnosis of congestive heart failure and lung cancer.
结局指标
主要结局
6 Minute Walk Test Distance (6MWTD) (meters)
时间窗: 2 months
Statistically significant short term effect on exercise capacity
Hospital Anxiety and Depression Scale (HADS) (units on scale)
时间窗: 2 months
Statistically significant short term effect on health related quality of life
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
时间窗: 2 months
Statistically significant short term effect on health related quality of life
次要结局
- 6 Minute Walk Test Distance (6MWTD) (meters)(12 months)
- Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)(12 months)
- Hospital Anxiety and Depression Scale (HADS) (units on scale)(12 months)
研究者
Ilias Papanikolaou
Consultant Pulmonary Physician
Corfu General Hospital