Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
研究概览
简要总结
The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.
The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •aged ≥ 18 years
- •stable condition > 3 weeks (e.g. no exacerbations)
- •resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (6MWT)
- •informed consent as documented by signature.
排除标准
- •Severe daytime resting hypoxemia (SpO2 < 88%)
- •long-term oxygen therapy
- •unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease
- •inability to follow the procedures of the study, e.g. due to language problems psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle
- •women who are pregnant or breast feeding
- •enrolment in another clinical trial with active treatment.
研究组 & 干预措施
Normoxia
Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula.
干预措施: Standard ambiant air will be breathed during endurance training. (Other)
Hyperoxia
Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
干预措施: Oxygen (Other)
Hypoxia
This group will train at moderate altitude.
干预措施: Standard ambiant air will be breathed during endurance training. (Other)
结局指标
主要结局
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
时间窗: from baseline to 3 weeks
次要结局
- 6 minute walk test (6MWT)(3 weeks)
- mMRC score at normoxia vs hypoxia vs hyperoxia(3 weeks)
- Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia(3 weeks)
- Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia(3 months)
- Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia(3 weeks)
- CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia(3 weeks)
- 6 minute walk test (6MWT)(3 weeks)
- 6 minute walk test (6MWT)(3 weeks)
- Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia(3 weeks)
- mMRC score at normoxia vs hypoxia vs hyperoxia(3 weeks)
- CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia(3 weeks)
- Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia(3 weeks)
- Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia(3 months)