Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
关键词
抽象
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).
日期
| 最后验证: | 01/31/2019 |
| 首次提交: | 10/16/2017 |
| 提交的预估入学人数: | 10/24/2017 |
| 首次发布: | 10/29/2017 |
| 上次提交的更新: | 02/02/2019 |
| 最近更新发布: | 02/04/2019 |
| 实际学习开始日期: | 05/31/2017 |
| 预计主要完成日期: | 05/31/2020 |
| 预计完成日期: | 05/31/2020 |
状况或疾病
干预/治疗
Procedure: Pulmonary rehabilitation
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: High flow oxygen supplementation Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A). | |
| Placebo Comparator: Oxygen supplementation upon hypoxemia Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B). |
资格标准
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - concomitant diagnosis of congestive heart failure and lung cancer. |
结果
主要结果指标
1. 6 Minute Walk Test Distance (6MWTD) (meters) [2 months]
2. Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) [2 months]
3. Hospital Anxiety and Depression Scale (HADS) (units on scale) [2 months]
次要成果指标
1. 6 Minute Walk Test Distance (6MWTD) (meters) [12 months]
2. Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) [12 months]
3. Hospital Anxiety and Depression Scale (HADS) (units on scale) [12 months]
