Kyrgyz Asthma Rehabilitation at High Altitude

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial

Conditions
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Effect of High Altitude

Intervention / Treatment
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* Other: altitude rehabilitation program
* Other: rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: altitude rehabilitation program<br>3 weeks rehabilitation program at high altitude (3200m) | Other: altitude rehabilitation program<br>* altitude exposure<br>|
| Active Comparator: rehabilitation program<br>3 weeks rehabilitation program at low altitude (760m) | Other: rehabilitation program<br>* Rehabilitation at low altitude<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily peak-flow variability |  | assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements | 
| change in asthma control questionnaire score |  | baseline to week 3 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |