2023-510440-20-00招募中4 期
Impact of oxygen therapy in exertion in physical activity of patients with fibrotic intertitial lung disease with exertional hypoxemia (AFOX study)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in the number of steps per day comparing the control group and the intervention group.
研究概览
简要总结
Feasibility study that evaluates the impact of oxygen therapy on exertion in physical activity measured by accelerometer (steps/day) in patients with fibrotic ILD with exertional hypoxemia (minimum SpO2 ≤ 88% in the 6MWT), at one month and after three months of follow-up.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged greater than or equal to 18 years.
- •Patients with a diagnosis of fibrotic ILD, defined by the presence of peripheral reticulation, traction bronchiectasis, volume loss and/or presence of “honeycombing” on high-resolution chest CT (HRCT).
- •Patients with minimum SpO2 ≤ 88% in the 6MWT performed in room air.
- •Stability of respiratory symptoms two weeks prior to inclusion.
排除标准
- •SpO2 ≤ 93% at rest
- •Coexistence of other respiratory diseases such as COPD or asthma
- •Moderate-severe pulmonary hypertension measured by transthoracic echocardiography
- •Cardiological, osteo-articular or cognitive comorbidities that prevent correct performance of the 6MWT or a correct measurement of daily physical activity
- •Diagnosis of neoplasia in active treatment
- •Hospital admission 2 months prior to inclusion in the study
- •Current smoker
- •Being in a current pulmonary rehabilitation program
结局指标
主要结局
Change in the number of steps per day comparing the control group and the intervention group.
Change in the number of steps per day comparing the control group and the intervention group.
次要结局
- Changes in dyspnea questionnaire (dyspnea-12), quality of life (K-BILD) and anxiety and depression (HADS) between control and intervention group
- Evaluate hours per day of oxygen therapy compliance
- Analytical changes in oxidative stress between contol and intervention group
研究者
Eva Balcells
Scientific
Consorci Mar Parc De Salut De Barcelona
研究点 (1)
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