Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- daily peak-flow variability
研究概览
简要总结
prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.
详细描述
Low altitude baseline measurements will be performed in Bishkek. Participants will then either be assigned to a rehabilitation program in Bishkek (760m) or in Tuja Ashu (3200m).
The rehabilitation programs in high or low altitude will be identically performed and will comprise
- asthma education and awareness
- instruction on inhaled therapies
- smoking cessation counseling
- respiratory and skeletal muscle training in groups
- guided walks / cycle ergometer training
- questionnaires on asthma control, quality of life
- spirometry and peak flow measurements
- echocardiography
Measurement on study subjects will be performed at baseline (Bishkek), during the rehabilitation program, after completion of the rehabilitation program and during a follow-up at week 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with atopic or non-atopic Asthma for at least 3 months
- •partly controlled on regular or on demand inhaled therapy according to guidelines.
- •asthma variability in peak expiratory flow > 10%/day and/or a reversible airflow obstruction in spirometry
- •History of asthma consisting of variable symptoms (cough, dyspnea, wheezing).
排除标准
- •Unstable and severely uncontrolled asthma needing systemic corticosteroids.
- •Need of continuous oral steroids for their asthma control
- •Heavy smokers (>20 cigarettes per day)
- •Severe concomitant diseases preventing patients to adhere to the protocol and/or altitude exposure (severe metabolic, kidney- or liver disease, heart failure (ejection fracture <50%).
- •Chronic lung diseases with a persistent FVC < 60% an/or arterial oxygen saturation <92%).
- •Severe mental- or musculoskeletal disorders
- •Pregnant or breast feeding women
- •Patient which are unable to comply with the study procedure.
结局指标
主要结局
daily peak-flow variability
时间窗: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements
change in asthma control questionnaire score
时间窗: baseline to week 3 and 15
次要结局
- forced expiratory volume in 1 second (FEV1)(baseline to week 3 and 15)
- average peak flow over 2 days(baseline to week 3 and 15)
- spirometric values (Forced vital capacity (FVC), FEV1/FVC)(from baseline to week 3 and 15)
- asthma-related quality of life (AQLQ)(from baseline to week 3 and 15)
- generic quality of life (Short-Form 36(SF-36))(from baseline to week 3 and 15)
- symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)(from baseline to week 3 and 15)
- 6 minute walk distance(from baseline to week 3 and 15)
- sit-to-stand test(from baseline to week 3 and 15)
- arterial oxygen saturation by pulse oximetry(from baseline to week 3 and 15)
- visual analog scale (VAS)(from baseline to week 3 and 15)