Overview

This trial has been completed.

Condition effect of high altitude
Treatments altitude rehabilitation program, rehabilitation program
Sponsor University of Zurich
Collaborator National Center of Cardiology and Internal Medicine, Kyrgyzstan
Start date May 2016
End date October 2016
Trial size 50 participants
Trial identifier NCT02741583, Req-2016-00076

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
3 weeks rehabilitation program at high altitude (3200m)
altitude rehabilitation program
altitude exposure
(Active Comparator)
3 weeks rehabilitation program at low altitude (760m)
rehabilitation program
Rehabilitation at low altitude

Primary Outcomes

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

Secondary Outcomes

Measure
forced expiratory volume in 1 second (FEV1)
time frame: baseline to week 3 and 15
average peak flow over 2 days
time frame: baseline to week 3 and 15
spirometric values (Forced vital capacity (FVC), FEV1/FVC)
time frame: from baseline to week 3 and 15
asthma-related quality of life (AQLQ)
time frame: from baseline to week 3 and 15
generic quality of life (Short-Form 36(SF-36))
time frame: from baseline to week 3 and 15
symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)
time frame: from baseline to week 3 and 15
6 minute walk distance
time frame: from baseline to week 3 and 15
sit-to-stand test
time frame: from baseline to week 3 and 15
arterial oxygen saturation by pulse oximetry
time frame: from baseline to week 3 and 15
visual analog scale (VAS)
time frame: from baseline to week 3 and 15

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Zurich.