Kyrgyz Asthma Rehabilitation at High Altitude

October 25, 2016 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Respiratory Clinic, University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
daily peak-flow variability
Time Frame: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements
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
baseline to week 3 and 15

Secondary Outcome Measures

Outcome Measure
Time Frame
forced expiratory volume in 1 second (FEV1)
Time Frame: baseline to week 3 and 15
baseline to week 3 and 15
average peak flow over 2 days
Time Frame: baseline to week 3 and 15
baseline to week 3 and 15
spirometric values (Forced vital capacity (FVC), FEV1/FVC)
Time Frame: from baseline to week 3 and 15
from baseline to week 3 and 15
asthma-related quality of life (AQLQ)
Time Frame: from baseline to week 3 and 15
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
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
from baseline to week 3 and 15
6 minute walk distance
Time Frame: from baseline to week 3 and 15
from baseline to week 3 and 15
sit-to-stand test
Time Frame: from baseline to week 3 and 15
from baseline to week 3 and 15
arterial oxygen saturation by pulse oximetry
Time Frame: from baseline to week 3 and 15
from baseline to week 3 and 15
visual analog scale (VAS)
Time Frame: from baseline to week 3 and 15
from baseline to week 3 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Req-2016-00076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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