Kyrgyz Asthma Rehabilitation at High Altitude

• ClinicalTrials.gov Identifier: NCT02741583
• Recruitment Status: Completed
• First Posted: April 18, 2016
• Last Update Posted: October 26, 2016
• Sponsor: University of Zurich
• Collaborator: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
• Information provided by (Responsible Party): University of Zurich

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Effect of High Altitude	Other: altitude rehabilitation program; Other: rehabilitation program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
• Study Start Date: May 2016
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: altitude rehabilitation program; 3 weeks rehabilitation program at high altitude (3200m)	Other: altitude rehabilitation program; altitude exposure
Active Comparator: rehabilitation program; 3 weeks rehabilitation program at low altitude (760m)	Other: rehabilitation program; Rehabilitation at low altitude

Outcome Measures

Primary Outcome Measures :

1. daily peak-flow variability [ Time Frame: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements ]
2. change in asthma control questionnaire score [ Time Frame: baseline to week 3 and 15 ]

Secondary Outcome Measures :

1. forced expiratory volume in 1 second (FEV1) [ Time Frame: baseline to week 3 and 15 ]
2. average peak flow over 2 days [ Time Frame: baseline to week 3 and 15 ]
3. spirometric values (Forced vital capacity (FVC), FEV1/FVC) [ Time Frame: from baseline to week 3 and 15 ]
4. asthma-related quality of life (AQLQ) [ Time Frame: from baseline to week 3 and 15 ]
5. generic quality of life (Short-Form 36(SF-36)) [ Time Frame: from baseline to week 3 and 15 ]
6. symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c) [ Time Frame: from baseline to week 3 and 15 ]
7. 6 minute walk distance [ Time Frame: from baseline to week 3 and 15 ]
8. sit-to-stand test [ Time Frame: from baseline to week 3 and 15 ]
9. arterial oxygen saturation by pulse oximetry [ Time Frame: from baseline to week 3 and 15 ]
10. visual analog scale (VAS) [ Time Frame: from baseline to week 3 and 15 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Switzerland

Respiratory Clinic, University Hospital of Zurich

Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Investigators

• Study Chair: Silvia Ulrich Somaini, MD; University of Zurich

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02741583
• Other Study ID Numbers: Req-2016-00076
• First Posted: April 18, 2016
• Last Update Posted: October 26, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Altitude Sickness; Respiration Disorders; Respiratory Tract Diseases