Kyrgyz Asthma Rehabilitation at High Altitude

University of Zurich (UZH)

Status: Completed

Conditions: Effect of High Altitude

Treatments: Other: altitude rehabilitation program; Other: rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT02741583

Req-2016-00076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

altitude rehabilitation program

Experimental group

Description:

3 weeks rehabilitation program at high altitude (3200m)

Treatment:

Other: altitude rehabilitation program

rehabilitation program

Active Comparator group

Description:

3 weeks rehabilitation program at low altitude (760m)

Treatment:

Other: rehabilitation program