Evaluation of the Effects of the Oxygen Supplementation During 6-minute Walking Test in Patients With Chronic Respiratory Failure or Exertional Hypoxiemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Change in 6-Minute Walk Distance With Supplemental Oxygen
研究概览
简要总结
The aim of this multicenter crossover trial is to describe the effect of adding a therapeutic dose of exertional oxygen therapy, in terms of exercise performance, gas exchange, heart rate, symptoms perception and subjective easiness of performance, in a cohort of subjects hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and/or exertional hypoxemia due to chronic obstructive pulmonary disease or interstitial lung disease.
Researchers will compare the walking performance during 6-minute walk test performed with the liters of oxygen administered as prescribed at rest (for patients with chronic respiratory failure) or in room air (for patients with exertional hypoxemia only), to the performance during a 6-minute walk test performed with the double the flow rate prescribed at rest, or with 2 L/min for patients with exertional hypoxemia only. The two tests will be performed in random order, at least 3 hours apart and no later than 24 hours apart from each other.
The main outcome will be the difference between the distance walked in the two 6-minute walk test in the two conditions. Furthermore, will be also collected and compared: the oxygen saturation and heart rate every minute, the initial and final dyspnea and fatigue, as assessed by Borg scale, and the easiness of performance through a dedicated questionnaire. The estimated sample size will be 114 patients.
This study will provide some basis for a more accurate prescription of exercise-related oxygen therapy, offering insights into the phenotype of patients who may derive the greatest benefit from this intervention. It will also stimulate discussion regarding the optimal timing and dosing of oxygen administration during exertion in patients with respiratory failure.
详细描述
Although supplemental oxygen enhances acute exercise performance in COPD, its long-term impact on quality of life and mortality remains unproven. Current guidelines suggest treating exertional desaturation (SpO2<90%), but the lack of standardized titration protocols, particularly using the 6MWT, limits clinical consistency. While many patients with chronic respiratory failure (CRF) receive dual-level oxygen prescriptions (rest vs. exercise), it is unclear if this approach yields significant functional gains. Therefore, In light of these considerations, the present multicenter crossover study aims to describe the effect of adding a therapeutic dose of exertional oxygen therapy in terms of:
- exercise performance
- gas exchange
- heart rate
- symptom perception
- subjective easiness of performance in a cohort of patients hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and/or exertional hypoxia due to a chronic respiratory disease at the time of discharge from an inpatient rehabilitation attempt.
As secondary aim, the study will also evaluate any difference in the response among different diseases.
This study will be conducted on subjects with chronic respiratory diseases admitted to the Pulmonary Units of the ICS Maugeri , for rehabilitation will be evaluated for inclusion in the protocol. After approval of the project by the Ethical Committee, those who meet the following criteria at the time of discharge will be enrolled in the study.
We will enroll 3 different groups of patients:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation
- •One of the following conditions at discharge:
- •Chronic obstructive pulmonary disease with exertional hypoxemia
- •Chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy
- •Interstitial lung disease with chronic respiratory failure requiring long-term oxygen therapy
- •Clinically stable condition for at least one month
- •Optimized medical therapy during hospitalization
- •Ability to perform the 6-minute walk test
- •Signed informed consent
排除标准
- •Lung diseases other than chronic obstructive pulmonary disease or interstitial lung disease
- •Resting oxygen flow requirement greater than 4 liters per minute
- •Orthopedic, neurological, or cognitive conditions that may limit walking performance
- •Recent cardiovascular or cerebrovascular events within the previous 3 months
研究组 & 干预措施
6-Minute Walk Test With Usual Oxygen or Room Air (O2REST)
All participants perform the 6-minute walk test with standard oxygen flow (or room air for participants with exertional hypoxemia only). This arm represents the standard condition for comparison.
The test may be administered as first or second test, in a random order, according to the crossover design.
干预措施: Usual Oxygen During 6-Minute Walk Test (Other)
6-Minute Walk Test With Supplemental Oxygen (O2PLUS)
All participants perform the 6-minute walk test using a higher oxygen flow during exercise to evaluate the effects of supplemental oxygen on walking performance and symptoms.
The test may be administered as first or second test, in a random order, according to the crossover design.
干预措施: Supplemental Oxygen During 6-Minute Walk Test (Other)
结局指标
主要结局
Change in 6-Minute Walk Distance With Supplemental Oxygen
时间窗: Within 24 hours (during two 6-minute walk tests performed on the same day)
This outcome measures the difference in walking distance during the 6-minute walk test when participants use supplemental oxygen (O2PLUS) compared to their usual oxygen setting or room air (O2REST). The change is calculated as the distance walked with supplemental oxygen minus the distance walked with usual oxygen or room air. This outcome reflects the short-term effect of supplemental oxygen on exercise performance.
次要结局
- Oxygen Saturation During the 6-Minute Walk Test(During each 6-minute walk test)
- Heart Rate During the 6-Minute Walk Test(During each 6-minute walk test)
- Dyspnea Before and After the 6-Minute Walk Test(Before the test, immediately after the test, and 3 minutes after recovery)
- Muscles Fatigue Before and After the 6-Minute Walk Test(Before the test, immediately after the test, and 3 minutes after recovery)
- Blood Pressure Before and After the 6-Minute Walk Test(Before and immediately after each 6-minute walk test)