Clinical trial NCT02741583: Kyrgyz Asthma Rehabilitation at High Altitude
Official title: Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2016-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: daily peak-flow variability
timeFrame: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements
measure: change in asthma control questionnaire score
timeFrame: baseline to week 3 and 15
Secondary outcomes:
measure: forced expiratory volume in 1 second (FEV1)
timeFrame: baseline to week 3 and 15
measure: average peak flow over 2 days
timeFrame: baseline to week 3 and 15
measure: spirometric values (Forced vital capacity (FVC), FEV1/FVC)
timeFrame: from baseline to week 3 and 15
measure: asthma-related quality of life (AQLQ)
timeFrame: from baseline to week 3 and 15
measure: generic quality of life (Short-Form 36(SF-36))
timeFrame: from baseline to week 3 and 15
measure: symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)
timeFrame: from baseline to week 3 and 15
measure: 6 minute walk distance
timeFrame: from baseline to week 3 and 15
measure: sit-to-stand test
timeFrame: from baseline to week 3 and 15
measure: arterial oxygen saturation by pulse oximetry
timeFrame: from baseline to week 3 and 15
measure: visual analog scale (VAS)
timeFrame: from baseline to week 3 and 15
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich Somaini, MD
role: STUDY_CHAIR
References:
citation: Saxer S, Schneider SR, Appenzeller P, Bader PR, Lichtblau M, Furian M, Sheraliev U, Estebesova B, Emilov B, Sooronbaev T, Bloch KE, Ulrich S. Asthma rehabilitation at high vs. low altitude: randomized parallel-group trial. BMC Pulm Med. 2019 Jul 24;19(1):134. doi: 10.1186/s12890-019-0890-y.