Kyrgyz Asthma Rehabilitation at High Altitude

Not Applicable

Completed

• Conditions: Effect of High Altitude
• Interventions: Other: altitude rehabilitation program; Other: rehabilitation program

• Registration Number: NCT02741583
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-18
• Study Start: 2016-05
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
altitude rehabilitation program	altitude rehabilitation program	3 weeks rehabilitation program at high altitude (3200m)
rehabilitation program	rehabilitation program	3 weeks rehabilitation program at low altitude (760m)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland