Can Nasal High-Flow Oxygen Therapy Improve Oxygenation During Exercise, Optimizing Benefits of Pulmonary Rehabilitation in Patients With Interstitial Lung Disease (ILD) With Exercise Desaturation?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
研究概览
简要总结
Objectives: 1.- To compare the level of oxygenation achieved during muscular training with conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To compare benefits achieved with both systems, in terms of: level of exercise during training; effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen therapy on the acute exercise in a subgroup of patients.
Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively. Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy in the acute exercise.
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
- None
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 30 years old
- •Diagnostic of ILD according to the national and international guidelines 23
- •Being clinically stable the previous 4 weeks
- •Acceptance to participate in the trial
排除标准
- •Have been enrolled in a PR program in the last previous 6 months
- •Respiratory Diseases other than ILD or severe comorbidities
- •Osteoarticular diseases which don't allow training
- •End-stage ILD, treatment with opiates or survival < 6 months
- •Cognitive alterations that preclude colaboration
研究组 & 干预措施
Conventional oxygen (EPIDOC)
Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.
干预措施: oxygen therapy (Drug)
Nasal High-Flow oxygen therapy (EPIDOAF)
Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.
干预措施: oxygen therapy (Drug)
结局指标
主要结局
Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
时间窗: 8 weeks
To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry.
次要结局
- Dyspnoea (benefits in borg scale) DURING effort.(8 weeks)
- Effort capacity (Benefits in terms of meters walked in the 6mwt).(8 weeks)
- Basal dyspnoea (mesured by mMRC scale).(8 weeks)
- Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).(8 weeks)
- Quality of life (SF36 questionnaire).(8 weeks)
- Quality of life (KBILD questionnaire).(8 weeks)