2024-519541-30-00招募中3 期
Can high-flow oxygen enhance oxygenation during exercise by optimizing the benefits of Pulmonary Rehabilitation in patients with Diffuse Interstitial Lung Disease (ILD) with oxygen desaturation during effort?
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- The primary endpoint will be the average SpO₂ achieved throughout the entire training period, comparing both groups.
研究概览
简要总结
To compare the level of oxygenation achieved during muscle training with conventional oxygen therapy systems (nasal cannula) and high-flow systems.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 30 years
- •Diagnosis of Interstitial Lung Disease (ILD) according to national and international guidelines
- •Signed informed consent form (Annex 1)
排除标准
- •Participation in a Respiratory Rehabilitation (RR) program (including training) in the last 6 months
- •Intolerance to the high-flow oxygen administration system; while no cases have been reported to date (Frat et al, New Engl J of Med 2015; 372: 2185-96; Stephan et al, JAMA 2015; 313: 2331-39)
- •Respiratory diseases other than ILD
- •Severe cardiac, neuromuscular, anemia, vascular diseases, or other serious comorbidities (primarily severe pulmonary hypertension per SEPAR Guidelines 2017)
- •Osteoarticular diseases that hinder exercise performance
- •Terminal illness (inability to perform exercises or treatment with opioids)
- •Life expectancy < 6 months
- •Cognitive disorders that prevent active participation
结局指标
主要结局
The primary endpoint will be the average SpO₂ achieved throughout the entire training period, comparing both groups.
The primary endpoint will be the average SpO₂ achieved throughout the entire training period, comparing both groups.
次要结局
- Dyspnea during daily life activities (mMRC scale, dyspnea domain of the CRQ)
- Dyspnea during exertion before and after the 6-minute walk test (6MWT) (Borg scale)
- Exercise capacity measured by the 6MWT without oxygen support
- Health-Related Quality of Life (HRQoL) assessed using the KBILD and SF36 questionnaires
- Full pulmonary function test (spirometry, lung volumes, diffusion, and blood gases)
- Adverse effects of the program
- Adverse events
- Program adherence
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
研究点 (5)
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