Kyrgyz Asthma Rehabilitation at High Altitude

Effect of High Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741583
• Other study ID #: Req-2016-00076
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: October 25, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Altitude Sickness
• Effect of High Altitude

Intervention

Other:
• altitude rehabilitation program
altitude exposure
• rehabilitation program
Rehabilitation at low altitude

Locations

Country	Name	City	State
Switzerland	Respiratory Clinic, University Hospital of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyzstan

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily peak-flow variability		assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements	Yes
Primary	change in asthma control questionnaire score		baseline to week 3 and 15	No
Secondary	forced expiratory volume in 1 second (FEV1)		baseline to week 3 and 15	No
Secondary	average peak flow over 2 days		baseline to week 3 and 15	No
Secondary	spirometric values (Forced vital capacity (FVC), FEV1/FVC)		from baseline to week 3 and 15	No
Secondary	asthma-related quality of life (AQLQ)		from baseline to week 3 and 15	No
Secondary	generic quality of life (Short-Form 36(SF-36))		from baseline to week 3 and 15	No
Secondary	symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)		from baseline to week 3 and 15	Yes
Secondary	6 minute walk distance		from baseline to week 3 and 15	No
Secondary	sit-to-stand test		from baseline to week 3 and 15	No
Secondary	arterial oxygen saturation by pulse oximetry		from baseline to week 3 and 15	No
Secondary	visual analog scale (VAS)		from baseline to week 3 and 15	No